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IMMUNOTHERAPY
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EXPRESSION Co-Founder and Director, Bicycle Attendees
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Therapeutics 22 Conference Speakers
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ENGINEERING Engineering
STREAM Display of Antibodies Engineering Antibodies
Bispecific Antibodies

ONCOLOGY Antibodies for Advancing Bispecific Antibodies Antibody-Drug Conjugates II:
STREAM Cancer Therapy to the Clinic for Oncology Advancing Toward the Clinic

IMMUNOTHERAPY Preventing Toxicity Adoptive Agonist
STREAM in Immunotherapy T-Cell Therapy Immunotherapy Targets

EXPRESSION Optimizing Protein Expression
Difficult to Express Proteins
STREAM Protein Expression System Engineering

ANALYTICAL Characterization Biophysical Analysis of Protein Aggregation
STREAM of Biotherapeutics Biotherapeutics and Stability

IMMUNOGENICITY & Immunogenicity: Regulatory Strategies for Immunogenicity Optimizing Bioassays for
BIOASSAY STREAM and Clinical Relevance Assay Assessment Biologics

BIOCONJUGATES Antibody-Drug Conjugates I: Antibody-Drug Conjugates II:
Fusion Protein Therapeutics
STREAM New Targets, Payloads and Alternative Formats Advancing Toward the Clinic

THERAPEUTICS Drug Discovery for Biologics and Vaccines Agonist Immunotherapy
STREAM Autoimmunity and Inflammation for Infectious Disease Targets

SPONSOR & EXHIBITOR INFO Dinner Dinner
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Regulatory Requirements Across Introduction to Structure-Based
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Bicycles and Bicycle Drug Conjugates: Next Young Scientist Keynote: Programming Proteins by
CONFERENCE-AT-A-GLANCE Generation Therapeutics Deep Sequencing and Design

SPONSORS Sir Gregory Winter, Ph.D., Tim Whitehead, Ph.D.,
FRS, Master, Trinity College and Co-Founder and Assistant Professor, Chemical Engineering and Materials
SHORT COURSES Director, Bicycle Therapeutics Science, Michigan State University
Bicycles® are a novel therapeutic class of constrained bicyclic peptides Next-generation sequencing has presented protein scientists with the
TRAINING SEMINARS that combine antibody-like affinity and selectivity with small molecule-like ability to observe entire populations of molecules before, during, and after
tissue penetration, tunable exposure and chemical synthesis. They have a high-throughput screen or selection for function. My group leverages this
potential in many indications, including oncology, where Bicycles’ unique unprecedented wealth of sequence-function information to design and
ENGINEERING properties have been used to develop Bicycle Drug Conjugates™ (BDCs); engineer protein affinity, specificity, and function and to infer structural
STREAM a novel toxin delivery platform which greatly improves toxin loading into complexes of proteins. My talk will present an overview of the above and detail
tumour tissues. This presentation will describe both the Bicycle® and BDC methodological improvements that enable the engineering work.
ONCOLOGY platforms.
STREAM About
About Tim Whitehead is an Assistant Professor at Michigan State University in the
IMMUNOTHERAPY Sir Gregory Winter is the Master of Trinity College Cambridge and was Departments of Chemical Engineering and Materials Science, Biomedical
until recently a member of the Medical Research Council Laboratory of Engineering, and Biosystems Engineering. He has won an NSF CAREER award,
STREAM
Molecular Biology (LMB) in Cambridge, U.K., and has served as both Deputy holds 6 patents (5 licensed), and has published over 30 research articles in
and Acting Director. He was one of the early pioneers of the science of journals like Science, Nature Biotechnology, and Nature Methods.
EXPRESSION protein engineering, focusing first on enzymes (with Alan Fersht) and
STREAM then antibodies. In particular he invented techniques to humanise rodent The PEGS Young Scientist Keynote
antibodies for use as therapeutics, in the course of which he helped to The PEGS Boston Young Scientist Keynote recognizes a rising star in the
ANALYTICAL develop alemtuzumab/Campath-1H. Later, he developed methods to field of protein science who has completed a postdoc in the last five years.
STREAM make fully human antibodies against human self-antigens using antibody Nominations of candidates for this role were solicited from leading industry
libraries. His inventions are used in most of the antibody products on the and academic research labs in the fall of 2016, and the final selection was
market, including the humanised antibodies alemtuzumab/Campath-1H, made on the basis of input provided by a 14-person group of scientific
IMMUNOGENICITY & trastuzumab/Herceptin, bevacizumab/Avastin, palivizumab/Synagis and advisors.
BIOASSAY STREAM the first human antibody (adalimumab/Humira) to be approved by the U.S. CHI’s Young Scientist Keynotes join the company’s Student Fellowships and
Food and Drug Administration. Featured Poster Presentations as ways of supporting the increased visibility
BIOCONJUGATES of those new to our field. Please visit the PEGS website following the 2017
STREAM meeting for details on how you can nominate a candidate for the 2018
Sir Gregory has also acted as an entrepreneur to translate his scientific
inventions to medicines. He was a founder of Cambridge Antibody meeting.
THERAPEUTICS Technology (1989) and Domantis (2000) and Bicycle Therapeutics
STREAM (2009); these companies pioneered the use of antibody libraries to make
fully human antibody therapeutics including adalimumab/Humira and
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Ph.1:00 PM AFTERNOON 2:00 ... Ph.S. M. Principal Scientist. Director. Merck Research ONCOLOGY Pharmaceuticals Labs STREAM Enrique Escandon Ph. Biologics Discovery- STREAM Antibodies Part I: Focus on Early Discovery DMPK.D. Ph. Senior Principal Scientist.. Ph.D. Biologics Discovery. Gadi Bornstein. Pfizer. Senior Manager. Ph. Kurella.D. Strohl.C. Bioagilytix Enrique Escandon Ph. Senior Principal Scientist.D. Ph. Mohammad Tabrizi.. Associate Director..D. Just Biotherapeutics THERAPEUTICS STREAM SC5: Introduction to Design of Experiments Perceval Sondag. Klakamp. Merck Research Laboratories ENGINEERING SC2: Translational Considerations for Development of Monoclonal Vaishnavi Ganti..S. M... Novartis TRAINING SEMINARS Seema Kumar. DMPK and Disposition.D.D..D. REGISTRATION INFORMATION Register Online! PEGSummit.D. Molecular Engineering Unit. Merck Research Laboratories Bioptix IMMUNOTHERAPY Vaishnavi Ganti. Ph... STREAM Bioptix Corp.D.. Associate Attending and Deputy Chief. Adusumilli. Molecular Engineering Unit. Senior Statistician. Biotherapeutics and New Modalities BIOASSAY STREAM Assistant Professor.. BIOCONJUGATES SC4: The Multi-Attribute Method (MAM) for Improving Product and SC11: Adoptive Therapy with CAR T Cells STREAM Process Development Prasad S. Director Biologics Discovery. Pfizer.A. Ph.. Vice President of Chemistry and Biochemistry. Merck Research Laboratories Gadi Bornstein. Inc. Arlenda SPONSOR & EXHIBITOR INFO SC6: In silico Protein Docking Vinodh B. Ph. Business Development Manager... Director Biologics Discovery. Senior Manager. Senior Scientist. Global Correlative Science Leader. Ph. Memorial Sloan Kettering Cancer Center Richard Rogers. Novartis Veronica Juan..D. Ph. LLC SC3: Genomics in the Service of Cancer Immunotherapy SC10: Bioanalysis of Biomarkers: ADCs. Director.com | 5 .. Mohammad Tabrizi.. Inc.D. Kurella. F.. Children’s Hospital Boston and Harvard Medical School Darshana Jani.. Thoracic Surgery. Senior Research Scientist. Ph. Merck Research SC9: Target Selection for Biologics ANALYTICAL Laboratories STREAM William R. Ph.com *Separate Registration Required A Division of Cambridge Innovation Institute PEGSummit.. EMD Serono Pharmaceuticals Corinna Krinos Fiorotti. President. Intrexon Scott L. Associate Principal Scientist. Scientist 4. Ph. Merck Research STREAM DMPK.D. SC7: Translational Considerations for Development of Monoclonal SHORT COURSES Multi-Domain Biotherapeutics and New Modalities Antibodies Part II: Focus on Nonclinical Development to the Clinic Darshana Jani.D. M. Merck Research Labs SC8: In silico Immunogenicity Predictions – A Hands-On Workshop EXPRESSION Vinodh B. BiStro Biotech Consulting.D. Ph.D. Multi-domain IMMUNOGENICITY & Zoltan Szallasi. Informatics Program. Non-Clinical Statistics.. Principal Scientist. Senior Scientist.D.D. Pediatrics. Scott L.. REGISTER BY DECEMBER 23 & SHORT COURSES* SAVE UP TO $550 COVER SUNDAY. Global Correlative Science Leader. APRIL 30 CONFERENCE-AT-A-GLANCE MORNING 10:00 AM . M. Ph. Protein Sciences.D. DMPK and Disposition. Ph. Merck Research Laboratories Laboratories Veronica Juan. Protein Sciences.D. Vice President of Chemistry and Biochemistry.D. Associate Principal Scientist. HOTEL & TRAVEL Intexon Corp. Klakamp..5:00 PM SPONSORS SC1: Preclinical and Clinical Immunogenicity Bioanalysis: ADCs.S.D. Ph.

D.com | 6 .D. Genentech. MAY 4 CONFERENCE-AT-A-GLANCE DINNER 6:00 . Medicine/ Richard Altman. Chiou.D. Senior Manager. M. University of Kentucky Markey Cancer Center EXPRESSION Weijing Sun. GI Cancers Section of STREAM SC17: Transient Protein Production in Mammalian Cells Hematology-Oncology. Internal Medicine. Stat4ward LLC Isabel Figueroa..D. University of Pittsburgh School of Medicine Henry C. Pharmaceutics and Pharmaceutical SC13: Phenotypic Screening Applications and Technologies Chemistry.. Hospira. Ph.. M. CSO. PTPK. Ph.8:30 PM DINNER 5:45 . Co-Director. US Serono Pharmacopeia Bonnie Rup. Independent Consultant IMMUNOTHERAPY SC18: Clinical Prospects of Cancer Immunotherapy STREAM Gaurav Goel.. Ph. Principal Science & Standards Liaison. Associate Director.8:15 PM SPONSORS SC12: Study Design and Statistical Data Analysis of Flow Cytometry SC15: Critical Considerations for the Design and Development of SHORT COURSES Assays Antibody-Drug Conjugates Shuguang Huang. Director Science & Standards. Professor. Assistant Professor. MA. EMD Steven L.. Division of Medical Oncology. Assistant Professor. Amgen Hematology-Oncology.D.D.. Global Biologics. Ph. Protein Technologies. Director. R&D.D. a National Laboratory for Cancer Research. Ph. Risk Biologics Assessment and Regulatory Requirements Maura C. Walfish. MS.. Medicine. US ONCOLOGY Jim McNally. FACP. DINNER 6:00 . Frederick Liming Shi. REGISTER BY DECEMBER 23 & SHORT COURSES* SAVE UP TO $550 COVER TUESDAY. Inc.Quantitative Pharmacology & Drug Disposition.D. Inc. Protein Expression Laboratory. Scientist. TRAINING SEMINARS Shawn Owen. Senior Group Leader. Director. and Adjunct Professor. GI Cancer Center of Excellence. Pfizer Company IMMUNOGENICITY & BIOASSAY STREAM *Separate Registration Required BIOCONJUGATES STREAM MEDIA PARTNERS THERAPEUTICS STREAM Sponsoring Society Lead Sponsoring Publications SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Web Partners Sponsoring Publications Register Online! PEGSummit. MAY 2 THURSDAY.D.D. MedImmune ENGINEERING SC16: New USP Initiatives for Characterization and Release of STREAM SC14: Overcoming the Challenges of Immunogenicity Assays. MS.com INTERNATIONAL FierceBiotech THE BIOTECH INDUSTRY’S DAILY MONITOR A Division of Cambridge Innovation Institute PEGSummit.. University of Utah Steven Rust. Cell Biology. Ph... Ph. Kibbey.. Global Pharmacopeia STREAM Early Development . Bioassay Development. Ph.D. Life Science Solutions. Associate Director and Immunogenicity Expert. Ph. Scientist. ANALYTICAL Thermo Fisher Scientific STREAM SC19: Strategic Bioassay Design and Analysis Dominic Esposito. Ph.9:00 PM Medicine.. Leidos Biomedical Research.D.

and perform antibody NGS studies. 8:30am-5:45pm Day 2: May 4.. 2017 TS4: REGULATORY REQUIREMENTS ACROSS THE PRODUCT COVER Day 1: May 1. we will explore therapeutic approaches that harness our structure-based drug design and development. Postdoctoral Fellow.com | 7 . EXPRESSION include predictive models and how to report immunogenicity incidents both STREAM Instructor: internally and externally. which have applications immunogenicity during preclinical.5:20pm Day 2: May 5. guiding experimental design. 8:30am-12:30pm Day 1: May 1. academic scientists and and Controls (CMC) section of regulatory filings. Other topics molecular barcoding and error correction. 8:30am-12:30pm DEVELOPMENT LIFECYCLE | May 3-4.D. 1:40pm. with a focus on phase SHORT COURSES career protein scientists wanting a detailed update on the current state of the appropriate requirements. From vaccines presentations. 8:30am -5:30pm Day 2: May 2. engineered. and because Seminars are conducted differently than conference programming. This two-day training quantitative approach to measuring the diversity and distribution of antibody seminar provides a practical. 8:30am-12:30pm Next-generation sequencing (NGS) of antibody repertoires provides a ONCOLOGY All protein drugs generate an immunogenic response. Harvard Medical School National Research Council Canada HOTEL & TRAVEL Matthew Woodruff.D. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar. Senior Vice President and European Chief Scientific STREAM Officer. National Research Council Canada REGISTRATION INFORMATION Register Online! Each CHI Training Seminar offers 1. Ph. Ph. Ph. we ask that attendees commit to attending the entire program.May 2.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. BioAgilytix TS6: INTRODUCTION TO STRUCTURE-BASED DRUG DESIGN AND DEVELOPMENT | May 4-5. Emory University Traian Sulea. and the protein engineers wanting an introduction into how structure can aid in STREAM immunology behind them. Human Health Therapeutics. We go over the practical details The seminar begins by detailing the science behind immunogenicity. Sai Reddy. Instructors: Instructors: SPONSOR & EXHIBITOR INFO Kevin Bonham.D. 8:30am-12:30pm CONFERENCE-AT-A-GLANCE comprehensive tutorial in the concepts. and what to do if you observe analyze. academic scientists and career THERAPEUTICS by exploring specific examples of current and future therapeutics... Curriculum Fellow. as to not disturb the hands-on style instruction being offered to the other participants. Bramhill Biological Consulting. 8:30am-12:30pm seminar offers an introduction to the concepts. Ph. and NOT engaging in track hopping. This Training Seminar will help researchers learn how to design. Biologics Consulting Group David Bramhill. strategies and tools of protein The successful development of a pharmaceutical product requires not only engineering – and explains the role of this discipline in the progression of good science. Microbiology and Immunobiology Christopher Corbeil.. predict and prevent. Senior Research Officer. and lunch will be provided to all registered attendees on the full day of the class. A Division of Cambridge Innovation Institute PEGSummit. Though CHI encourages track hopping between conference programs. Senior Consultant. strategies and tools of In this course. comprehensive overview of immunogenicity. 8:30am-3:40pm BIOASSAY STREAM 2017 CHI’s Introduction to Structure-Based Drug Design and Development training Day 1: May 3. Founder. In the interest of maintaining the highest quality learning environment for Training Seminar attendees. Instructor: ETH Zurich ANALYTICAL Arno Kromminga. how to assess. 2017 AND ENGINEERING | May 3-4.. but also compliance with FDA regulatory expectations. The class is directed at scientists course will include a comprehensive review of the Chemistry. 2017 STREAM Day 1: May 3. clinical and post-market development. 2017 IMMUNOGENICITY & TS3: IMMUNOLOGY FOR DRUG DISCOVERY SCIENTISTS | May 3-4. followed by assay and bioanalytical processing and analysis. Assistant Professor. Cambridge Healthtech REGISTER BY DECEMBER 23 & SAVE UP TO $550 TS1: INTRODUCTION TO PROTEIN ENGINEERING| May 1-2. Day 1: May 4. 8:30am-5:45pm Day 2: May 4.D. This seminar will consist of BIOCONJUGATES knowledge of the immune system to treat human disease. Human Health Therapeutics. we will of some of the common computational tools used in the field. Biosystems Science and Engineering. Manufacturing new to the industry or working in support roles. data STREAM the latest international Guidances. Research Officer. but after these have been distributed no additional books will be available. Department. the causes.D. breakout problem solving sessions and live demonstrations STREAM to cancer (not to mention cancer vaccines!) and diabetes to IBD. Ph. PEGSummit.D. The class is explore how the immune system can be shaped. Instructor: TRAINING SEMINARS Instructor: Christina Vessely. Ph... 8:30am -5:30pm Day 2: May 2.com Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. and harnessed directed at scientists new to the industry. PhD. Ph. LLC TS5: NEXT-GENERATION SEQUENCING FOR ANTIBODY DISCOVERY ENGINEERING TS2: INTRODUCTION TO IMMUNOGENICITY May 1 . IMMUNOTHERAPY in antibody discovery and engineering. of antibody NGS including library construction and quality control.D. 8:30am-5:45pm Day 2: May 4. STREAM libraries. and advanced methods for improving accuracy by assessment strategies for traditional and emerging biologics.. field. This SPONSORS biotherapeutic research and development. as applicable. 2017 CHI’s Introduction to Protein Engineering training seminar offers a Day 1: May 3. we ask that Training Seminars not be disturbed once they have begun. Training Seminars will include morning and afternoon refreshment breaks.

and throughout their social media TRAINING SEMINARS networks. 2017 if they • Students not accepted for the 2017 Student Fellowship.com | 8 . biotech. 2017. Applications are due by February 3. IMMUNOGENICITY & REASONS YOU SHOULD PRESENT YOUR RESEARCH BIOASSAY STREAM POSTER AT THIS CONFERENCE: • Your poster will be seen by • Receive $50 off your BIOCONJUGATES our international delegation. conference onsite at their college. A poster title and abstract • All accepted 2017 Student Fellows will be asked to help promote the are due at the time of the application. SHORT COURSES • Fellows are required to present a scientific poster. IMMUNOTHERAPY STREAM EXPRESSION STREAM PRESENT A POSTER ANALYTICAL Cambridge Healthtech Institute encourages attendees to gain STREAM further exposure by presenting their work in the poster sessions. Present your poster at PEGS and REGISTRATION INFORMATION be automatically entered to win. Fellows will receive a poster COVER presentation slot and a savings of over $900 on their registration fee.D. and will not be required to present a poster STREAM • Accepted 2017 Student Fellows will receive a discounted conference rate of • ADDED BONUS! Poster competition features cash prizes.com guide for details. A Division of Cambridge Innovation Institute PEGSummit. Excludes Short Courses. $295*. your abstract must be submitted. Good luck! To secure a poster board and inclusion in the conference materials. can register at a ENGINEERING were accepted for the 2017 Student Fellowship discounted rate $595*. which must be paid in full by March 10. technology Register Online! advances and implications of the work presented. registration STREAM representing leaders from • Your poster abstract will be top pharmaceutical. 2017. CONFERENCE-AT-A-GLANCE STUDENT FELLOWSHIP DETAILS: SPONSORS • Interested students must complete the below application for the 2017 • This fellowship is limited to 20 students and is for the Premium Conference Student Fellowship Package. published in our conference academic and government materials THERAPEUTICS institutions STREAM • Automatically entered into poster competition SPONSOR & EXHIBITOR INFO POSTER COMPETITION! Two poster awards will be given at the conference for a cash prize HOTEL & TRAVEL for best poster. • All applications will be reviewed by the scientific review committee and the accepted students will be notified no later than February 17. See program PEGSummit. clarity of concepts presented. 2017. candidates are encouraged to apply for the PEGS conference Student Fellowship. REGISTER BY DECEMBER 23 & STUDENT FELLOWSHIP SAVE UP TO $550 Present Your Poster to 2. 2017. Winners will be chosen by delegate voting onsite using the program guide app.200+ Protein Engineering Researchers Full time graduate students and Ph. audience engagement. Credit card information (Open to all poster presenters) ONCOLOGY is requested at the time of the application and will be charged upon STREAM application approval. One winner from each poster session will be chosen based on visual appearance of poster. approved and your registration paid in full by March 17. May 1-5.

REGISTER BY DECEMBER 23 & SAVE UP TO $550 ENGINEERING STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Display of Antibodies SHORT COURSES TRAINING SEMINARS Engineering Antibodies ENGINEERING STREAM Engineering Bispecific Antibodies ONCOLOGY STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.com | 9 .com A Division of Cambridge Innovation Institute PEGSummit.

Norviel Associate Professor. Pfizer Laubach Career Development Assistant THERAPEUTICS Professor. University of California.. The phage-antibodies are used to target and bind specific analytes protein-protein interactions in cancer cells and induce cell death. we show REGISTRATION INFORMATION while the phage genome is genetically modified to generate amplified signals in targeted delivery of a RAS/RAP specific protease to pancreatic cells. Chemistry.. please see page 5-6 for course details. Ph. we have created various biomimetic supramolecular nanostructures. STREAM 11:20 Precision Delivery of Proteins into the Cytosol of Cells Bradley L.. Massachusetts Institute of Technology STREAM 9:10 Protein Engineering of Phage-Antibody Complexes for Biomarker Detection There are a number of methods to deliver bioactive peptides and proteins into mammalian cells for biotechnological purposes. Once cells from outside of cells is highly desired for diverse purposes. named cytotransmab. Chemistry. Most approaches do not allow Jennifer Cha. real time with specific primers. Ajou University conformational entropy and large hetero-oligomeric complexes can enable The ability of an IgG-format antibody to reach the cytosol of target mammalian IMMUNOGENICITY & subnanometer resolution in single particle cryo-electron microscopy. Professor. Director. I will show how resulting materials can be STREAM utilized as functional nanomaterials for biomedical and biosensor applications.D. Pentelute. Irvine STREAM K. Craik.. J. SC3: Genomics in the Service of Cancer Immunotherapy Faculty Scientist. Ph. Professor. BIOCONJUGATES and validation as bona fide therapeutic targets. Using the self-assembly TRAINING SEMINARS MONDAY. Pioneer STREAM Fabs that recognize 3D protein conformations against proteins with high Research Center for iMab. and its will be presented where Fabs are accelerating both structural and functional application for directly targeting disease-associated cytosolic proteins after studies of dynamic and complex protein targets to accelerate their understanding systematic administration. Biological Systems and Engineering. REGISTER BY 19th Annual | May 1-2. Molecular Science and Technology. A single-step process produces long-range-ordered films showing multiple levels of hierarchical organization. Professor.D.com A Division of Cambridge Innovation Institute PEGSummit. Applied Chemistry and Biological Engineering.. 10:45 Chairperson’s Remarks IMMUNOTHERAPY University of California. Examples will introduce the cytosol-penetrating antibody. Professor. Ph. From Library to Structure and Back: Mapping Receptor 10:10 Coffee Break ONCOLOGY Ligand Interaction by Phage Display STREAM 8:30 Chairperson’s Remarks Cytoplasmic Delivery Gregory A. Register Online! PEGSummit.D. Ph. Weiss.D. Massachusetts Institute of Technology EXPRESSION 8:40 KEYNOTE PRESENTATION: Targeting Dynamic Protein Targets for 10:50 Cytosol-Penetrating IgG Antibody and Its Application for Directly STREAM Structural and Functional Insight Targeting Disease-Associated Cytosolic Proteins Charles S. Ph. We show the delivered cargo can disrupt antibodies. Dane Wittrup. Pharmaceutical Chemistry. Lawrence Berkeley National SPONSORS Laboratory SC9: Target Selection for Biologics I will demonstrate a facile biomimetic process to create functional nanomaterials SHORT COURSES *Separate registration required. Chemical Engineering & Bioengineering.com | 10 .. Berkeley. In this talk.D. Graduate ANALYTICAL California. Ph. San Francisco School. Through ENGINEERING 7:00 am Registration and Morning Coffee the directed evolution of the phages.R. University of Yong-Sung Kim. Here. Further. Mares Professor. MAY 1 processes. we present a macromolecular delivery platform based This talk will highlight our recent efforts at using protein engineering to build on an engineered bacterial transport machine that allows for facile delivery of HOTEL & TRAVEL covalent crosslinks between bacteriophage and the Fc portion of monoclonal bioactive variants to the cytosol of cells. these Fabs can probe dynamic complex assembly in cells. 2017 DECEMBER 23 & SAVE UP TO $550 Display of Antibodies Generating New Medicines COVER Recommended Short Courses* 9:40 Bio-Inspired Phage Material Assembly and Applications CONFERENCE-AT-A-GLANCE Seung-Wuk Lee. I BIOASSAY STREAM engineered. Molecular Biology & Biochemistry. The resulting materials show distinctive optical and photonic properties. University of Colorado. Boulder and intrabodies. utilizing M13 phage.D.. Professor. Ph.D. Chemical & Biological SPONSOR & EXHIBITOR INFO for routine precision delivery of chemical entities such as mirror image peptides Engineering. Bioengineering.

Senior Vice President. The presentation will describe the use of V(D)J 8:25 Chairperson’s Remarks recombination mediated de novo antibody sequence diversification. such as GPCRs and ion channels. enabling rapid selection of high quality IMMUNOGENICITY & antibodies. AbCheck routinely applies Phage or Yeast Display under various Sequencing and Design conditions. We will show an example. Innovative Targeting Solutions THERAPEUTICS Cell-based biosensors are extremely sensitive and can be used to detect a diverse Emerging Applications and Platforms for Novel Screening STREAM range of biological targets. AbCheck will present new technological developments Tim Whitehead.D. Bioengineering and SPONSOR & EXHIBITOR INFO display and antigen dependent signaling based biosensors to generate a powerful Chemical Engineering. Antibody based cell HOTEL & TRAVEL biosensor libraries will provide unparalleled access to traditionally challenging 8:30 Genetically-Encoded Libraries of Chemically-Modified Peptides multi-pass membrane targets. My talk will present an overview of the above and detail ANALYTICAL We have developed an antibody discovery platform that enables efficient methodological improvements that enable the engineering work. STREAM expression of a library of antibodies in IgG format on the surface of both a 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing mammalian virus and the cell surface.com 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing peptide scaffolds with variable.D. where Bicycles’ unique properties Vera Molkenthin. Chemistry. rabbits into selected human frameworks containing specifically diversified CDR1 ONCOLOGY and CDR2 regions. Ph. Bicycle Therapeutics SHORT COURSES improve the cellular uptake and pharmacokinetic profiles of bioactive cyclotides. Hitachi America Associate Professor. Bicycles® are a novel therapeutic class of constrained bicyclic peptides that combine antibody-like affinity and selectivity with small molecule-like tissue 12:20 pm Further Advancements for Human Antibody Sponsored By penetration.o.. tunable exposure and chemical synthesis. Biosensor Display. They are often limited to handling of structures made of 20 natural amino acids. engineer protein affinity. University of Southern California 4:00 Chairperson’s Remarks The cyclotide scaffold has a tremendous potential for the development of CONFERENCE-AT-A-GLANCE therapeutic leads based on their extraordinary stability and potential for grafting 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation and molecular evolution applications. complexes of proteins. Ph.. genetically-encoded “unnatural” modifications. Ph. We have also modified this technology to enable the direct 6:55 End of Day BIOASSAY STREAM incorporation of multipass membrane proteins into the viral membrane. a novel toxin ENGINEERING AbCheck has developed Mass Humanization to generate humanized libraries. Ph. Ph. where a large Therapeutics SPONSORS cyclotide-based genetically encoded library was used to screen for low nanomolar Sir Gregory Winter.D. in their native Ratmir Derda. Ph. Chief Scientist. Smith. delivery platform which greatly improves toxin loading into tumour tissues. Pharmacology and Pharmaceutical COVER Sciences. Science. For selecting high affinity binders from the resulting. Master. Camarero. mammalian Jennifer Cochran. These libraries allow attacking unsolved problems in molecular recognition and discovery of ligands for “undruggable targets” such as carbohydrate binding proteins. MAY 2 BIOCONJUGATES Sponsored By 1:20 Luncheon Presentation II: The Use of Biosensor Display STREAM Libraries in Antibody Discovery 8:00 am Registration and Morning Coffee Paul Kang. Stanford University new antibody discovery platform. AbCheck s.D. Antigen expressing virus can be readily purified and used for antibody selection. and function and to infer structural Vaccinex. This STREAM This approach utilizes batch cloning of CDR3 immune repertoires from immunized presentation will describe both the Bicycle® and BDC platforms. Ph. They have potential TRAINING SEMINARS Discovery in many indications. Inc. specificity... including oncology. have been used to develop Bicycle Drug Conjugates™ (BDCs).D.D.D. School of Pharmacy. REGISTER BY Display of Antibodies DECEMBER 23 & 11:50 Rapid Screening of Cyclotide-Based Libraries against SAVE UP TO $550 Intracellular Protein-Protein Interactions PLENARY KEYNOTE SESSION Julio A.. We use GE-libraries of peptides as a starting Register Online! 2:20 Problem-Solving Breakout Discussions material for multi-step organic synthesis to produce GE-molecules that combine PEGSummit. FRS. In this talk.. highly 4:55 Young Scientist Keynote: Programming Proteins by Deep STREAM diverse library. CSO. A Division of Cambridge Innovation Institute PEGSummit.. We will also present different strategies to Director. Trinity College and Co-Founder and inhibitors of the Hdm2-HdmX complex. Chemical Engineering and Materials regarding its human antibody discovery and optimization platform. University of Alberta environments.r. Assistant Professor. My group leverages this EXPRESSION Complex Membrane Antigens unprecedented wealth of sequence-function information to design and STREAM Ernest S. REGISTRATION INFORMATION Genetically-encoded (GE) libraries of polypeptides are one of the major sources 1:50 Session Break of discovery of biological drugs. during. Michigan State University IMMUNOTHERAPY Next-generation sequencing has presented protein scientists with the STREAM 12:50 Luncheon Presentation I: Antibody Library Display on Sponsored By ability to observe entire populations of molecules before. and after a Mammalian Virus: Application to both Soluble and a high-throughput screen or selection for function. Associate Professor.com | 11 . TUESDAY. Assistant Professor. Research & Chief Scientific Officer. Discovery Research.

we are able recapitulate native antibodies. binding.. ONCOLOGY specificity has led them to become the largest and fastest growing class of STREAM therapeutic proteins. Ph. remains obscure. Clearly identifying the epitope at which they bind their 11:55 Antibody Discovery Using Natural and Nature-Emulating Diversity cognate antigen provides insight into their mechanism of action and helps Libraries IMMUNOTHERAPY differentiate antibodies that bind the same antigen. that is based on our clustering of CDR structures (doi:10. Director. Anesthesia.. Ph. Ph. vaccine and therapeutic development. Program in SHORT COURSES molecular mechanisms through which antibodies bias cytokine function and built Developmental Therapeutics. Biosciences. Naïve human antibody CDR sequences were collated and used to design EXPRESSION non-redundant synthetic CDRs matching the naturally occurring diversities. Santa Barbara REGISTRATION INFORMATION The functional composition of antibody repertoires. a marked hierarchy between libraries. Postdoctoral Fellow.D. In benchmarking.D. Research Scientist. Van Blarcom. but merely counting the number of different clones does not fully characterize a library’s selective NGS with Display: Phage. implemented TRAINING SEMINARS in Rosetta. Ph. and displayed to construct phage Ab library. Garcia Lab. Bradbury. CNRS-ESPCI 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing BIOCONJUGATES STREAM Efficient selection requires sufficiently diverse libraries.D... Ph.. Yeast and Bacterial potential.. They follow simple 2:00 Chairperson’s Remarks STREAM statistical laws. IMMUNOGENICITY & MedImmune Ltd 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or BIOASSAY STREAM Enjoy Lunch on your Own 10:50 Hierarchy and Extremes in Selections from Antibody Libraries Clément Nizak.10.com binding specificities present within antibody repertoires in health and disease.. Such phage Epitope Mapping Strategies Ab library was used to isolate high quality renewable antibodies (rAbs).D. The convergence of display library technologies. President & CSO. REGISTER BY Display of Antibodies DECEMBER 23 & SAVE UP TO $550 9:00 Reprogramming Immunity with Engineered Interleukin-2 Engineering Novel Functionalities into Variable Regions Antibodies Jamie Spangler.2010. Pfizer Inc. R&D. University of STREAM precisely and efficiently map the epitopes of a panel of antibodies in parallel over California. 10:00 Coffee Break in the Exhibit Hall with Poster Viewing These synthetic non-redundant CDRs were inserted into the well expressing STREAM V-gene frameworks. A Division of Cambridge Innovation Institute PEGSummit. Bio. The ability of antibodies to bind an antigen with a high degree of affinity and binding affinity 2-50 fold. We elucidated the Roland L. We describe a method to Eunice Zhou. R&D. David Lowe.. This digital serology approach provides a new tool to support diagnostics. Professor. We provide a quantitative approach to MedImmune Ltd SPONSOR & EXHIBITOR INFO measure the selective potential of a library..com | 12 .D. but its concurrent promotion of both immune effector cells and regulatory T cells has limited its efficacy as an immunotherapeutic.D. 2:05 Mapping the Targets of Antibody Repertoires for Diagnostic and Therapeutic Development HOTEL & TRAVEL Patrick S. which can be interpreted with extreme value theory. Laboratory of Biochemistry. Stanford University School of Medicine Andrew M. Ph. Molecular & Cellular 11:20 Chairperson’s Remarks COVER Physiology and Structural Biology. Adjunct Professor. Director. Ph. as defined by the collection of unique antigen-epitope binding specificities. San Francisco the course of several weeks.D.D. Associate Research Fellow. Antibody Discovery and Protein Engineering.D. which ANALYTICAL are essential reagents for determining how proteins function under normal and STREAM 10:45 Chairperson’s Remarks pathophysiological conditions. and show David Lowe.030). Serimmune Inc. Associate Adjunct Professor.. Fox Chase Cancer Center on our insights to engineer promising cytokine-targeted antibody therapeutics. M. with Increased Affinity presenting an exciting opportunity for targeted therapy. Ph. Staff Scientist. Certain anti- 11:25 Computational Design and Experimental Validation of Antibodies SPONSORS IL-2 antibodies selectively direct cytokine activity toward particular cell subsets. Los Alamos National Interleukin-2 (IL-2) is a multi-functional cytokine that regulates immune Laboratory CONFERENCE-AT-A-GLANCE homeostasis. We analyzed phage display selection outcome by high-throughput THERAPEUTICS sequencing to quantitatively characterize selective potentials. We have STREAM designed new CDRs for two antibodies and were able to increase the experimental Therapeutics Division.1016/j. robust NGS technology. Institute for Cancer Research. 9:30 Synthetic Human Antibody Fragment Libraries for CAR T Cell jmb. Jr. and computational advances Register Online! has provided an opportunity to characterize the diversity of antigen epitope PEGSummit. Ph. Dunbrack. Daugherty. University of California.. We have developed an antibody design computational protocol.. Antibody Discovery and Protein Engineering. Rinat Laboratories. The program replaces CDRs with loops of different lengths and ENGINEERING Therapy conformations and performs sequence design on the inserted CDR to improve Thomas J.D.

Royal Institute of Technology Screening of Full-Length IgG Libraries There is a need for precise classification of responsive patients for their safe Roger R. NBE-Therapeutics AG CONFERENCE-AT-A-GLANCE and cost-effective treatment. 5:30 Registration for Dinner Short Courses
 STREAM 3:20 Sponsored Presentation (Opportunity Available) Recommended Dinner Short Course* ONCOLOGY 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing STREAM SC13: Phenotypic Screening Applications and Technologies 4:25 Next-Generation Sequencing of mRNA Display Selections *Separate registration required. Assistant Professor. some which were present as germlines of non-responding patients.. TRAINING SEMINARS 3:05 High-Throughput Screening for Antibody Sponsored By Discovery Using Mirrorball 5:25 End of Display of Antibodies ENGINEERING Christyne Kane. Personal secreted expression. functional screening can be seamlessly integrated into the SHORT COURSES medicine and antibody engineering using gram-positive display will be covered. ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.. Bristol-Myers IMMUNOTHERAPY Squibb STREAM Applications of NGS with mRNA display selection will be discussed. antibody discovery workflow. Martin Wright.com A Division of Cambridge Innovation Institute PEGSummit. on the surface of B lymphocytes. Beerli. Ph. Inc. This will include methods to recover low-abundance sequences from a diverse EXPRESSION population and additional methods for rapid optimization of antibodies and other STREAM polypeptides.D. Senior Scientist. please see page 5-6 for course details. Associate Director. REGISTER BY Display of Antibodies DECEMBER 23 & SAVE UP TO $550 2:35 Bacterial Surface Display for Antibody Engineering and New Platform Development of Phage Display of Antibodies Stratification of Patients Johan Rockberg. Selection Technologies. CSO.D. We use bacterial display for structural epitope Transpo-mAb is a novel and highly efficient non-viral antibody discovery and mapping of the approved drug eculizumab to C5 identifying six residues essential engineering platform. Ph.D. 4:55 Transpo-mAb: Transposon-Mediated B Cell Display and Functional COVER KTH . will be presented. Several examples. Proteomics and Nanobiotechnology.com | 13 . Ph. Due to a built-in switch between surface and Instead we show potential of another drug (OmCI) for these groups.. including the direct identification of mAbs suitable as backbones of antibody drug conjugates..D. allowing for the efficient display of full-length antibodies SPONSORS for binding. AbbVie Bioresearch Center. Ph.

Head. Boston Children’s We have developed droplet-based microfluidic platforms for the discovery of STREAM Hospital. Ph. Ph. Program in therapeutic antibodies.D.. Professor of Genetics. Ph. Ph. TNFα. Research. Boston Children’s Hospital primary. New antibody derived from different donors. Risk A dual variable domain immunoglobulin. and crystallography to characterize in detail the humoral THERAPEUTICS High Resolution Imaging and Structural Biology immune response to the staphylococcal protein IsdB. Assistant Professor.D.D.. of Biological Sciences. Flow cytometry is A Division of Cambridge Innovation Institute PEGSummit.D. epitope mapping. Antibody and Assay Development..com discovery. European Molecular Biology Optimizing Antibody Affinities Laboratory (EMBL) EXPRESSION Frederick Alt.com | 14 . York University HOTEL & TRAVEL Creating molecular recognition interfaces that discriminate subtle chemical 11:55 Antibody Specificity Profiling by Combining NGS with a Plug-and- differences remains a major challenge in protein engineering. Following immunization. Engineering and Targeting of the Next Generation of Antibody Therapeutics COVER Recommended Short Courses* 9:40 Electron Microscopy Structures of Dual Variable Domain CONFERENCE-AT-A-GLANCE Immunoglobulin (DVD-Ig1) and its Complex with Target Antigen SC13: Phenotypic Screening Applications and Technologies Paul Matsudaira. the binding is primarily driven by the germline-encoded CDR-H2. The technology allows the direct screening of >1 million Cellular and Molecular Medicine. Rinat-Pfizer STREAM We employed single-B cell cloning. Interestingly. Professor. Harvard Medical School. we use NGS to identify candidate antigen specific clones from immunized repertoires. (e. please see page 5-6 for course details. Langone Medical Center. Biosystems Science and Engineering. forms 1:2 and 2:2 complexes SHORT COURSES Assessment and Meeting Regulatory Requirements with its antigen. Biologics Design. Crystal Zurich structures and mechanistic studies revealed a surprising mechanism underlying In this presentation. arguably the smallest difference in antigens. variant such as HIV. BIOASSAY STREAM We validated this system by substantially improving the antigen binding affinity of 11:25 Germline-Encoded Neutralization of a Staphylococcus Aureus an existing therapeutic antibody. STREAM 7:30 am Registration and Morning Coffee 10:10 Coffee Break in the Exhibit Hall with Poster Viewing 8:30 Chairperson’s Remarks ONCOLOGY STREAM Robin Barbour. Virulence Factor by the Human Antibody Repertoire BIOCONJUGATES Andy Yeung. Director. We have generated (Dis)play Hybridoma Platform REGISTRATION INFORMATION synthetic antibodies against histone tails that cleanly discriminate the difference Sai Reddy. flexibility with different angles between the Fab arms and dynamics by the two TRAINING SEMINARS Fab’s outer domains: without TNFα (DVD-Ig1 alone) and with TNFα (DVD-Ig1/TNFα WEDNESDAY. non-immortalized plasma cells (optionally from humans) in a single ANALYTICAL We will describe our new approach to utilize natural primary and secondary experiment and also facilitates assays for the effect of antibodies on target cells STREAM mechanisms of antibody optimization in vivo to improve therapeutic antibodies. National University SPONSORS of Singapore SC14: Overcoming the Challenges of Immunogenicity Assays. ETH of a single methyl group. In a complementary approach we use the technology to We use genetically modified ES cells to rapidly generate chimeric mice that derive vaccine candidates starting with neutralizing antibodies against pathogens extensively diversify a given therapeutic antibody. Ph.D. Specifically. REGISTER BY 18th Annual | May 3-4. PEGSummit. MAY 3 complexes). IMMUNOGENICITY & therapeutic antibodies with superior properties to the prototype can be selected.. Ph. In addition. the structures of these molecules and complexes were ENGINEERING studied using single particle cryoEM and preliminary findings will be discussed. phage display. modulating GPCRs). Prothena Deep Sequencing and B-Cell Screening Biosciences 10:55 Droplet Microfluidics in High-Throughput Antibody Discovery and IMMUNOTHERAPY Vaccine Development STREAM 8:40 KEYNOTE PRESENTATION: New High-Throughput Model for Christoph Merten.. with a binding mechanism nearly identical for each SPONSOR & EXHIBITOR INFO Shohei Koide. Charles A. high-throughput sequencing. 2017 DECEMBER 23 & SAVE UP TO $550 Engineering Antibodies New Science and Technologies for the Selection.D. Our negative stain TEM studies show that DVD-Ig1 displays *Separate registration required. Janeway Professor of Pediatrics. which has led to the design of new antibody formats with a novel mammalian hybridoma display platform for antibody screening and suitable for achieving exceptional specificity. we then integrate these antibody clonal libraries into our hybridoma platform using CRISPR-Cas9 genome editing. Associate Research Fellow.g.. Group Leader Microfluidics. DVD-Ig1. We show that in all donors a STREAM 9:10 Novel Mechanism of Antigen Recognition by Extremely Specific heavily biased use of two immunoglobulin heavy chain germlines generated ultra- Synthetic Antibodies high affinity neutralizing antibodies. I will show how we are combining this NGS-based analysis Register Online! their exquisite specificity. Dept. Professor.

Through innovative use of mutant forms of IL-33 and appropriate design of screening campaigns. Biologics. a highly potent inhibitor 12:25 pm CHO Cell Line Engineering for Enhanced Sponsored By of IL-33 was identified.. Inc. This occurs rapidly.D. Scientific Services Manager. critically analyze their accuracy. University of Texas Health Science Center at Houston 8:35 Modeling and Docking Antibody Structures with Rosetta STREAM Jeliazko Jeliazkov. Professor and Robert A. Director. and STREAM Sequences of the variable domain exons are human while all genetic machinery epitope mapping is demonstrated. Head. This REGISTRATION INFORMATION directions in cancer immunotherapy. and charged patches on the surface of the protein structure. a testament to how understanding of target structure and COVER Productivity and Stability biology is key to the identification of potential therapeutic drug candidates. Furthermore. Molecular Biophysics. posing a challenge in identifying A Division of Cambridge Innovation Institute PEGSummit. resulting in large conformational changes. Scientist. The platform is seen as best-in-class by multiple Big Pharma and other licensees subsequent to extensive validation and benchmarking.D. Welch Distinguished University Chair in Chemistry. in binding. Our recent studies have University SPONSOR & EXHIBITOR INFO demonstrated a potential new mechanism of cancer suppression of immunity Structures of antibodies in complex with their antigens can give insight into by impairment of antibody effector function mediated by proteolytic enzymes in therapeutic mechanisms and suggest improved antibody designs. CSO. antibodies that inhibit the action of IL-33. elevated gene Combining Immune Functionality with Synthetic SPONSORS transcription. Register Online! Elizabeth England. Their application to reducing aggregation.. Therapeutic Strategy GlaxoSmithKline THERAPEUTICS Zhiqiang An. Computational Modeling for Antibody Engineering MedImmune BIOCONJUGATES 8:30 Chairperson’s Remarks STREAM 2:15 Counteracting Tumor Evasion of Antibody Immunity by a Novel Ruud de Wildt. Ph. are of mouse origin. Isogenica Limited SHORT COURSES extensive transcriptomic and FISH-RNA/DNA data we have generated for our CHO-K1 cell line (CHO-M). Pierre-Alain Girod. We have HOTEL & TRAVEL the tumor microenvironment. kappa and lambda repertoire in a single organism. Biopharm. 4:45 Problem-Solving Breakout Discussions EXPRESSION 5:45 Networking Reception in the Exhibit Hall with Poster Viewing 1:25 Luncheon Presentation II (Sponsorship Opportunity Available) or STREAM Enjoy Lunch on Your Own 7:00 End of Day ANALYTICAL 1:55 Session Break STREAM THURSDAY. Johns Hopkins Immune suppression is recognized as a hallmark of cancer and this notion is largely based on studies on cellular immunity.. and demonstrate applications to large-scale repertoire analysis as well as Celiac disease and 2:45 Discovering Antibodies to a Moving Target pulmonary hypertension. Ph. Chief Business Officer. Scientist. Chemical 12:55 Luncheon Presentation I: The Trianni Mouse: Sponsored By Computing Group ENGINEERING Best-In-Class Technology for Human Antibody Discovery We describe a computational method for identifying and measuring hydrophobic STREAM David Meininger. optimized secretion and metabolic machinery to handle the Diversity increased protein loads along with cellular phenotypic stability. MAY 4 Mechanisms of Action 8:00 am Morning Coffee IMMUNOGENICITY & 2:10 Chairperson’s Remarks BIOASSAY STREAM Elizabeth England. high quality production cell lines secreting optimal levels of recombinant 3:15 llamdA™ Next Generation VHH Library: CONFERENCE-AT-A-GLANCE protein require stable integration of the recombinant DNA. Using the Guy Hermans. Research Assistant. Autoimmune/All Epitope and STREAM a “true” Bispecific. PEGSummit. REGISTER BY Engineering Antibodies DECEMBER 23 & SAVE UP TO $550 then used to screen and isolate antigen-specific antibodies. we are exploring strategies to restore developed computational methods (1) to create atomically accurate models of the lost functions to the damaged antibodies. Ph. Antibody Selections.com | 15 .com MedImmune MedImmune has shown that IL-33 forms disulphide bonds. improving solubility. Antibody Discovery and Protein Engineering. Selexis Sponsored By Stable. talk will present the methods. Antibody Discovery and Protein Engineering. which represent potentially new antibodies from their sequences and (2) to dock those models to antigens. 4:00 Refreshment Break in the Exhibit Hall with Poster Viewing IMMUNOTHERAPY Additional strains in development include Plasma Ig. we will describe how we are significantly boosting 3:30 Improving Developability with Protein Surface Sponsored By TRAINING SEMINARS production capabilities and cell line stability of our CHO-M cell line. Charge and Hydrophobic Patch Analysis Nels Thorsteinson.D. Trianni. An analysis of protein The Trianni Mouse is the only human transgenic antibody discovery platform complexes in the PDB suggests that hydrophobic patches play an important role ONCOLOGY offering a complete heavy. CSO.

Scientist. University of Washington Alzheimer’s Disease and Other Tauopathies Rosetta computational design can create proteins that target neutralizing epitopes Gai Ayalon. Using Raising antibodies to complex cellular targets such as ion channels. These computationally designed binders represent a new class of effector function could be advantageous. we describe both how these calculations coupled receptors (GPCRs) and other multi-spanning membrane targets is STREAM can be utilized for workflowed triage among multiple candidates.com A Division of Cambridge Innovation Institute PEGSummit. This talk will describe the strategies implemented by GSK to identified liabilities such as aggregation propensity while maintaining affinity and successfully identify high potency neutralizing antibodies for such targets. but in a smaller molecule that is both more manufacturable and pre-clinical models in vivo and in cell based experiments. and Sponsored By potentially for antibodies against other neurodegeneration targets as well.. Head. Neuroscience. REGISTER BY Engineering Antibodies DECEMBER 23 & SAVE UP TO $550 9:05 Computational Design of de novo Anti-Influenza Minibinder Antibodies for Emerging Targets Proteins Aaron Chevalier. We propose that effector function status SHORT COURSES protein therapeutics for infectious diseases. effector function is not SPONSORS stable. We discovered that in antibodies. STREAM 10:05 Coffee Break in the Exhibit Hall with Poster Viewing 12:05 pm Targeting Islet Amyloid Polypeptide (IAPP) as an EXPRESSION Immunotherapy for Type 2 Diabetes STREAM Robin Barbour. Prothena Biosciences ANALYTICAL Islet Amyloid Polypeptide (IAPP) is a 37 amino acid aggregation prone peptide STREAM that is co-secreted with insulin. BIOCONJUGATES STREAM 12:35 End of Engineering Antibodies THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.com | 16 .D. Antibody and Assay Development. and the toxicity of IAPP aggregates are believed to contribute to the pathophysiology of type 2 diabetes. stability. CSO. STREAM Computational tools that can be used in the optimization process for putative GlaxoSmithKline antibody drug candidates have greatly improved in the past several years. Ph. and that attenuation of viral infectivity. Virvio. Senior Principal Scientist. is an important consideration when designing therapeutic tau antibodies. These designed proteins bind like broadly neutralizing Tau is a prime therapeutic target for Alzheimer’s disease. which presents type 2 diabetes-relevant BIOASSAY STREAM phenotypes such as pancreatic IAPP deposition and loss of insulin-secreting beta- cells. Schrödinger Ruud de Wildt. Head. Research. Antibody Selections. and showed that anti-IAPP immunotherapy slowed the disease progression in this model. Institute of 11:05 Optimizing Antibodies for Targeting the Tau Protein for COVER Protein Design. 9:35 Computational Approaches in Antibody Design: TRAINING SEMINARS Identifying and Reducing Liabilities Early in the 11:35 Progress and Challenges with the Isolation and Optimization of Discovery Process Antibodies against Multi-Spanning Transmembrane Targets ENGINEERING David Pearlman. G-protein ONCOLOGY the BioLuminate software platform. Director. We used a transgenic IMMUNOGENICITY & rat model that expresses human IAPP. Ph...D.. Translational Investigator. Ph. Biopharm.D. using IMMUNOTHERAPY the ADIMABTM yeast-based platform and in vivo immunization approaches. In animal models they inhibit the function of hemagglutinin and prevent required for targeting tau efficaciously with tau antibodies. and how tools typically very challenging due to their complex nature and limited antigen such as FEP can be used to suggest sequence engineering that can ameliorate availability. Inc. Genentech CONFERENCE-AT-A-GLANCE on Influenza hemagglutinin.

Head. purification. Head. a fully human CD20xCD3 bispecific antibody. as highly 1:40 Chairperson’s Remarks engineered molecules they pose new design.and multi-specifics. and testing of large panels of these candidate therapeutic molecules. PEGSummit. expression.. Cheung. Bispecific (or multi-specific) antibody (BsAb) Annelise Vuidepot. A Division of Cambridge Innovation Institute PEGSummit.. Ph. Pediatric Oncology. Enid A. Haupt Chair. REGISTER BY 8th Annual | May 4-5. Pieris Cancer immunotherapy has emerged as key modality to achieve long term Pharmaceuticals GmbH REGISTRATION INFORMATION response in cancer therapy. Characterization of the in vitro and in vivo properties of this bispecific will be discussed. TCRs. PRS-343 dose-dependently leads to strong tumor growth inhibition introduced to enhance their activity. IMMUNOTHERAPY Christian Klein. alternative scaffolds.D.D.com accompanied by high tumor infiltration with human lymphocytes (hCD45+). Head of Science. Ph. Target selection and affinity engineering of TCRs are critical steps in the development of potent ImmTAC molecules through a robust THERAPEUTICS process involving in-depth molecular and cellular analyses.D. We demonstrate the platform’s EXPRESSION 1:50 KEYNOTE PRESENTATION: Engineering Bispecific Antibodies for high-throughput capability when handling novel molecule-specific designs and its STREAM built-in tools for developability and manufacturability assessments. as well as the need for associated peptide) and an anti-CD3 scFv domain (recruiting and activating T tumor HLA and costimulatory molecules. The positive functional data of PRS-343 and an excellent developability profile support investigation of its anti-cancer activity in clinical trials. CARs can provide significant advantages over traditional mAb molecules. Immunocore BIOASSAY STREAM constructs can drive polyclonal T cells into solid tumors to enhance the anti. cloning. Oncology Programs. Roche Glycart AG companies enables the automation. bsAb can also be cells).. ENGINEERING Bispecific Antibodies for Cancer Immunotherapy 3:20 Design and Evaluation of Next-Generation Biologics for Cancer STREAM 12:00 pm Registration Immunotherarpy Maria Wendt. Bispecifics. For payload delivery.D. Biologics. Department Head. Ph.D. However.D.. poor cell trafficking. Ph.. Regeneron Pharmaceuticals SPONSORS This presentation will describe Regeneron’s bispecific antibody platform as well SC11: Adoptive Therapy with CAR T Cells as the development of REGN1979.D. 1BB/GPC3) HOTEL & TRAVEL Roche Glycart AG Christine Rothe. Discovery Oncology oDTA. Cancer Immunotherapy Nai-Kong V. are bispecific reagents comprising a monoclonal TCR (binding a unique tumour- BIOCONJUGATES These antibodies bypass the need for prior immunization. A number of antibody-based cancer immunotherapies We used the Anticalin® platform to generate the 4-1BB-based bispecifics PRS- has been approved recently and/or is currently being investigated in clinical trials. 343 (4-1BB/HER2) and PRS-342 (4-1BB/GPC3).com | 17 .. engineering. SHORT COURSES *Separate registration required. Ph. Vice President. Protein Science. Discovery & Alliance Management.. ImmTAC molecules are extremely efficient and specific in recognising and STREAM exploited in multistep targeting to vastly improve the therapeutic ratio. Our workflow platform employed by top biopharma STREAM Development (pRED). Ph. Pharma Research and Early and analytics challenges. development of new T cell redirecting bispecifics for solid tumor indications will be discussed. ADCs. Development of Novel Targets IMMUNOGENICITY & and the absence of memory. STREAM 2:20 Novel Approaches in the Use of Bispecific Antibodies for Cancer Immunotherapy 4:50 Tumor-Localized Costimulatory T-Cell Engagement by the 4-1BB SPONSOR & EXHIBITOR INFO Christian Klein. please see page 5-6 for course details. along with findings from preclinical and phase 1 clinical studies. In a humanized mouse Register Online! pharmacological properties of T cell bispecific antibodies and novel strategies model.D. production. Both bispecifics lead to efficient This presentation will give an overview over the design and the in vitro and in vivo tumor target-dependent T-cell activation in ex vivo assays. Ph. Memorial 3:50 Refreshment Break ANALYTICAL Sloan Kettering Cancer Center STREAM Conventional IgG monoclonal antibodies (mAbs) utilize Fc-dependent 4:20 Enhanced Affinity TCR-Based Cancer Immunotherapy: mechanisms which are constrained by low killing potency. Associate Director.. 2017 DECEMBER 23 & SAVE UP TO $550 Engineering Bispecific Antibodies The Future of Immunotherapy Development COVER Recommended Short Courses* 2:50 Development of T Cell Redirecting Fully Human Bispecific CONFERENCE-AT-A-GLANCE Antibodies SC3: Genomics in the Service of Cancer Immunotherapy Eric Smith. Genedata ONCOLOGY 12:35 Luncheon in the Exhibit Hall with Poster Viewing STREAM Bi. Immune Mobilising Monoclonal TCRs against Cancer (ImmTACTM) molecules tumor response despite the immunosuppressive tumor microenvironment. MAY 4 In addition. M. enabling target cell killing. Pharma Research and Early Development (pRED). TRAINING SEMINARS THURSDAY. Cancer (CD137) Bispecific Agonists PRS-343 (4-1BB/HER2) & PRS-342 (4- Immunotherapy Discovery.

In this presentation we will ENGINEERING describe novel approaches we have developed to identify target combinations STREAM 8:30 Chairperson’s Remarks and novel bi-/multi-specific formats to reveal novel biology and/or address key Eric Smith. more precisely “cryptic” viral epitopes that are unmasked in endosomes during cellular invasion. ONCOLOGY 8:35 The “Evil Hitch-Hiker” Effect: Bispecific Antibodies to Target 11:05 Tuning Bispecific Antibodies for Efficacy and Safety STREAM Viruses in Endosomes Stephen J. Protein and Antibody Kartik Chandran. These approaches may increase the specificity of STREAM DART® molecules towards clinical applications. describe the design REGISTRATION INFORMATION and engineering the molecules and present in vitro and in vivo proof-of-concept studies. Ph. This approach should be widely applicable to the development of STREAM antiviral immunotherapeutics.D. M. Senior Research Advisor. ADPE. 9:35 Sponsored Presentation (Opportunity Available) 12:05 pm Engineering Anti-PDL1 Antibody Based Bifunctional Fusion SPONSOR & EXHIBITOR INFO Protein and Bispecific Antibody for Enhanced Antitumor Activity 10:05 Coffee Break Zhenping Zhu.. Jonah Rainey. LLC This talk will cover the rationale for dual target engagement.D. we developed bispecific antibodies unattainable with antibody combinations.D. the CAR for tumor relative to normal tissue. Professor.. but if a second protein is present it would be inhibited. Biologics. Regeneron Pharmaceuticals biological questions. Associate Director. Inc. Executive Vice President. MAY 5 Center. Register Online! 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or PEGSummit. Scientist II. Antibody Engineering. Ph. Ph. Lilly Biotechnology Center IMMUNOTHERAPY Muriel Block Faculty Scholar in Virology. and provide novel receptor/cellular engagements EXPRESSION To target these epitopes in Ebola virus. MedImmune. This presentation will focus on new STREAM that coopt virus particles themselves for endosomal delivery. The key challenge now is identify the right target combinations and designing the right bi-/multi- Applications Outside Oncology specific molecule(s) to achieve the desired outcomes. we generated and tested several HIVenv a CAR T cell can be engineered such that it would be triggered in the presence STREAM x CD3 bispecific DART® molecules capable of redirecting T cells against latently. it could also be engineered such that two target proteins would be THERAPEUTICS design and present data that support further development of HIVenv x CD3 required for maximal activation. In this talk. Biologics. Ph. Inc. Kadmon HOTEL & TRAVEL Corporation. which includes a second binding domain on the BIOASSAY STREAM CAR T cell that can lead to either an inhibitory or amplifying signal. REGISTER BY Engineering Bispecific Antibodies DECEMBER 23 & SAVE UP TO $550 5:20 End of Day Developing Assays for Selecting Target Combinations 5:20 Registration for Dinner Short Courses 10:30 Chairperson’s Remarks COVER G. Staff Scientist. can increase Annie Lam.. AbbVie Bioresearch SHORT COURSES FRIDAY. Ph. we will discuss considerations that guide our molecular Alternatively.D... To eliminate this reservoir. Distinguished Research Fellow. MacroGenics. Blockade of the advances in bispecific technology and novel therapeutic modalities realized endosomal virus-receptor interaction by these antibodies afforded broad antiviral through fine-tuning of bispecific antibody binding to cell surface receptors..D. The principal barrier to HIV cure is a remarkably stable reservoir of latently specificity of our CAR T cells for cancer cells versus normal cells. Ph.. Ph. The technological challenges of making bi-/multi-specific biologics are mostly TRAINING SEMINARS 8:00 am Morning Coffee solved and several formats are now in clinical development. target specific cell types. 11:35 Overcoming Obstacles to CAR T Cell Therapy in Solid Tumors Sujith K.D.. Joseph. please see page 5-6 for course details.D. Demarest. Microbiology and Immunology.. Department of Pediatrics Center for Cell 9:05 Preclinical Development of HIVenv x CD3 Bispecific DART® and Gene Therapy Baylor College of Medicine IMMUNOGENICITY & Molecules for Elimination of Latent HIV Reservoirs Our bispecific CAR technology. LLC Recommended Dinner Short Course* 10:35 Bi-and Multi-Specific Biologics for Cancer Immunotherapy: CONFERENCE-AT-A-GLANCE SC18 Clinical Prospects for Cancer Immunotherapy Selecting Target Combinations and Designing Biologics to Modulate *Separate registration required. Senior Scientist. BIOCONJUGATES infected cells. ANALYTICAL efficacy in vivo.D. of one target protein. Anti-Tumor T Cell Functions SPONSORS Tariq Ghayur.D. Bispecifics. Albert Einstein College of Medicine Bispecific antibodies provide more than the ability to deliver two drugs in one STREAM Conventional antiviral immunotherapies cannot access the exquisitely sensitive molecular package. For example. They can be used to fine tune receptor binding. Ph.com Enjoy Lunch on Your Own 1:05 Refreshment Break A Division of Cambridge Innovation Institute PEGSummit. infected cells. Harold and Engineering.com | 18 .

Rogers Professorship in efficacy because of c-MET mediated resistance mechanisms. Scientist. COVER Mahiuddin Ahmed. Pediatrics. Mary Nell and Ralph B.and CD63-specific ADCs. Memorial Sloan Kettering Cancer Center Therapeutic antibodies have shown tremendous success in the treatment of CONFERENCE-AT-A-GLANCE human disease. Furthermore. Hence. targeting non-T cell- EXPRESSION inflamed tumor tissues by antibody-guided LIGHT creates a T cell-inflamed 3:40 End of Conference STREAM microenvironment and overcomes tumor resistance to checkpoint blockade. Ernst. IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. Global Head ADCs and Targeted NBE STREAM tumors. However several physiological compartments. The resulting bsHER2xCD63his-ADC 3:10 Balancing Selectivity and Efficacy of Bispecific EGFR x c-MET demonstrated strong binding. Southwestern Medical Center construct bispecific EGFR x c-MET antibodies employing affinity-optimized binding IMMUNOTHERAPY moieties to balance selectivity and anti-tumor efficacy and to evaluate their Targeting tumors with tumor necrosis factor superfamily member LIGHT activates STREAM potential for an innovative antibody-drug conjugate approach. REGISTER BY Engineering Bispecific Antibodies DECEMBER 23 & SAVE UP TO $550 Compartmental Targeting and Payload Delivery Strategies 2:40 Beyond TfR: Identification of Novel Targets to Facilitate Uptake of Therapeutic Antibodies into the Brain 1:35 Chairperson’s Remarks James A. leading to the production of chemokines that recruit massive numbers of T cells. Protein Chemistry and Neuroscience. we aim to Immunology.. internalization and lysosomal accumulation in Antibodies and Antibody-Drug Conjugates ENGINEERING HER2-positive tumor cells as well as potent cytotoxicity against HER2-positive Björn Hock.com | 19 . Our data indicates that targeting LIGHT might be a potent strategy to increase the ANALYTICAL responses to checkpoint blockades and other immunotherapies in non-T cell- STREAM inflamed tumors. Ph.. Merck KGaA (Darmstadt. Ph.com A Division of Cambridge Innovation Institute PEGSummit.D.. lymphotoxin beta receptor signaling. Furthermore. whereas the other binding domain would facilitate targeting to the lysosomal compartment (anti-CD63). Antibody Science. Research and Early Development. Genentech. therapeutic antibodies in neuro-degeneration. SPONSORS Targeting HER2 and CD63 Improved transport into these compartments could extend the opportunities for Bart De Goeij. Ph.. which was not observed with monovalent HER2.D. SHORT COURSES To improve efficacy of antibody-drug conjugates (ADCs). Inc.D. Senior Scientist. Immunotherapies. M. Senior Director. University of Texas. Ph.V. including the 1:40 Efficient Payload Delivery by a Bispecific Antibody-Drug Conjugate central nervous system (CNS).D. EGFR-directed inhibitors might struggle with limited Yang-Xin Fu. in which one binding domain would provide tumor specificity facilitate receptor-mediated transcytosis into the brain. we have designed a This presentation will focus on the selection of novel targets in the vasculature to bispecific ADC. TRAINING SEMINARS (anti-HER2). GenMab A. Germany) Therapies targeting the tumor-associated antigen epidermal growth factor 2:10 Increased T Cell Infiltration into Tumor Microenvironment to receptor (EGFR) often suffer from toxicities due to basal EGFR expression in ONCOLOGY STREAM Overcome Checkpoint Blockade Resistance normal tissue. gRED.D.. Therapeutics. allow for limited penetration of large molecules. Assistant Attending. improving both safety and efficacy.

REGISTER BY DECEMBER 23 & SAVE UP TO $550 ONCOLOGY STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Antibodies for Cancer Therapy Advancing Bispecific Antibodies and Combination SHORT COURSES TRAINING SEMINARS Therapy to the Clinic ENGINEERING STREAM ONCOLOGY Antibody-Drug Conjugates II: Advancing Toward the Clinic STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.com | 20 .com A Division of Cambridge Innovation Institute PEGSummit.

Professor.. 2017 DECEMBER 23 & SAVE UP TO $550 Antibodies for Cancer Therapy Creating the Next Generation of Winning Strategies COVER Recommended Short Courses* 9:40 Concerted Antibody Drug and Target Discovery by Phage Display CONFERENCE-AT-A-GLANCE Christoph Rader.. Antibodies Part II: Focus on Nonclinical Development to the Clinic To complement bottom-up target discovery strategies based on genomics and TRAINING SEMINARS *Separate registration required. M. Ph. including antibody-drug conjugates. Antibody Therapy Section. San Francisco One of the most challenging tasks in antibody therapy development is target Register Online! selection.D. Jr. proteomics. bispecific antibodies. The Immuno- Biology. BIOASSAY STREAM clinical trials difficult to interpret. and chimeric SHORT COURSES SC7: Translational Considerations for Development of Monoclonal antigen receptor T cells.. we are beginning to identify patterns that will inform future generations of the optimal design of CAR‐T cell immunotherapy BIOCONJUGATES trials. University of Washington cancers. M. we developed novel top-down.D. Germany) EXPRESSION STREAM David G.. Professor. Chief. While precision medicine and combination treatments may offer ANALYTICAL potential to further increase ORRs from checkpoint inhibitors to 40–50%.com | 21 . Duke University Medical Center STREAM Terry J. University of California. James and Alice Chen Professor. Fry. This presentation will overview different approaches and where the of preclinical and clinical studies. please see page 5-6 for course details.D.D. National Cancer Institute antigen. currently limits their broader utility for cancer therapy. sorted B CD19 antigen loss may occur in approximately one third of patients achieving cells obtained from patients with autoantibodies against the relevant target. Darmstadt.. Oncology. Fred Hutchinson Cancer oncology agents. other factors need to be considered to PEGSummit. Hematologic Malignancies Section. IMMUNOGENICITY & manufacturing strategies. Associate Professor. and shown to cell (CAR-T) therapy. In an effort to develop novel therapeutic antibodies against a tumor specific Pediatric Oncology Branch..D. Medicine. THERAPEUTICS Targeting Strategies to Overcome Leukemic Resistance to CAR Therapy Pharmacology and Cancer Biology.. REGISTER BY 7th Annual | May 1-2.com maximize the therapeutic window. MAY 1 STREAM 10:10 Coffee Break 7:00 am Registration and Morning Coffee ONCOLOGY STREAM Emerging Targets 10:50 KEYNOTE PRESENTATION: Immunotherapy – The Need for Novel 8:30 Chairperson’s Remarks IMMUNOTHERAPY Targets? Mitchell Ho. Immunology.D. Radiology. novel STREAM The recent successes of CD19‐specific chimeric antigen receptor (CAR)‐modified immunotherapy approaches may further unlock new mechanisms that attack T cell immunotherapy are built on a foundation provided by previous generations cancer cells.. Patz. NIH Oncology Translational Innovation Platform at EMD Serono (a business of Merck 8:40 CAR‐T Strategies Targeting Hematologic and Solid Malignancies KGaA. we isolated and expressed DNA sequences from single.D. there are huge unmet needs in a number of difficult-to-treat Research Center. He will then discuss the preclinical development of REGISTRATION INFORMATION multispecific immunotherapeutic targeting approaches to prevent leukemic 11:50 Target Selection in Antibody Therapy Development resistance due to antigen-loss. Radiology. In addition to tumor specificity. Despite the many differences in CAR design. and clinical delivery that make comparisons between next significant advances may come from. This strategy represents an alternative HOTEL & TRAVEL trial demonstrating successful remission induction in patients relapsing after paradigm in antibody drug discovery. target agnostic approaches that are based on whole-cell selections of antibody libraries from immune and naïve antibody repertoires by phage display. Ph. M. National Cancer Institute. ENGINEERING MONDAY.D. 11:20 Development on Novel Therapeutic Antibodies for Cancer Derived STREAM from Single Human B Cells 9:10 Beyond CD19: Alternative and Multispecific Immunotherapeutic Edward F. Senior Vice President and Global Head. Fry will discuss results from a CD22-targeted CAR-T cause tumor growth inhibition in vivo. Dr. A Division of Cambridge Innovation Institute PEGSummit. Leonard Despite the impact on overall response rates (ORRs) made by the new immuno- and Norma Klorfine Endowed Chair for Clinical Research. CD19 CAR-T cell therapy. Professor. Cellular Immunotherapy. Investigator and Head. Ph. Ph. Anesthesia. Maloney. Ph. We will describe some of our approaches for cell surface target discovery and our experience in translational development of human antibodies binding to selected targets. The Scripps Research SC2: Translational Considerations for Development of Monoclonal Institute SPONSORS Antibodies Part I: Focus on Early Discovery The paucity of suitable targets for monoclonal antibodies and their derived entities. A SPONSOR & EXHIBITOR INFO remission following CD19-targeted chimeric antigen receptor expressing T recombinant antibody was then produced in mammalian cells. Laboratory of Molecular STREAM Laszlo Radvanyi. Medical Director.. Bin Liu.

. CSO. Blood and Marrow Transplantation. Therapeutics. Bicycle Therapeutics focused on inhibition of mechanisms that suppress anti-tumoral immunity. A retrospective. tunable exposure and chemical synthesis. PD-L1. we have identified competitive binders to a ranage of targets... unprecedented wealth of sequence-function information to design and HOTEL & TRAVEL 10:00 Coffee Break in the Exhibit Hall with Poster Viewing engineer protein affinity. which STREAM 2:20 Problem-Solving Breakout Discussions is a single chain variable fragment (scFv) fused to the signal domains of a T cell 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing receptor (TCR). SHORT COURSES Massachusetts General Hospital 12:50 Luncheon Presentation (Sponsorship Opportunity Available) or TRAINING SEMINARS Enjoy Lunch on your Own 8:30 CD19-Targeted CAR T Cell Therapies in the Lab and in the Clinic Marco Davila.D. My talk will present an overview of the above and detail REGISTRATION INFORMATION methodological improvements that enable the engineering work. My group leverages this systemic therapy with available imaging. Chapman. ANALYTICAL Bicycles® are a novel therapeutic class of constrained bicyclic peptides that Indoleamine-2.. We have shown that the scaffold is 8:25 Chairperson’s Remarks amenable to being engineered with a range of half-life extension technologies. Soldano Ferrone. Ph. This 9:30 Clinical Features and Response to Systemic Therapy in a Historical presentation will describe both the Bicycle® and BDC platforms.. Avacta Life Sciences 8:00 am Registration and Morning Coffee COVER Affimers® are a new protein scaffold with great potential for the generation of biotherapeutics.D. specificity. MAY 2 SAVE UP TO $550 Scaffold for Biotherapeutics Sponsored By Amrik Basran. Associate Member. FRS. Ph. Chemical Engineering and Materials There is little data available regarding the pattern of first metastases in resected STREAM Science. BIOASSAY STREAM have been used to develop Bicycle Drug Conjugates™ (BDCs). Department of STREAM 4:55 Young Scientist Keynote: Programming Proteins by Deep Medicine. Professor of Medicine.D. large diverse libraries Anti-PD1 Therapy and Resistance Mechanisms in the CONFERENCE-AT-A-GLANCE have been created by engineering in peptide loops into the scaffold backbone. Memorial Sloan Kettering Cancer Center. Lee Moffitt Cancer Center and Research Institute ENGINEERING A major advance for T cell therapy is the chimeric antigen receptor (CAR). IMMUNOTHERAPY 9:00 Combined Inhibition of IDO1 and PD-1 as an Effective Therapeutic STREAM 4:00 Chairperson’s Remarks Strategy in Cancer 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation Peggy Scherle. Ph. M. where Bicycles’ unique properties antibodies to checkpoint receptors.D. including oncology. 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing Register Online! 6:55 End of Day PEGSummit.com A Division of Cambridge Innovation Institute PEGSummit.D. Master.. Vice President.. SPONSORS including the immune check point. We review the clinical experience with CD19-targeted CAR T cells ONCOLOGY in patients with B cell malignancies and recent pre-clinical studies that suggest STREAM new directions in CAR design that can enhance function CAR T cell function in PLENARY KEYNOTE SESSION patients. and function and to infer structural complexes of proteins.. Incyte Corporation EXPRESSION Antibodies to checkpoint receptors have demonstrated unprecedented efficacy in Therapeutics STREAM Sir Gregory Winter.Affimers: A Novel TUESDAY. Ph. single-institution cohort was assembled of all patients ability to observe entire populations of molecules before.D. Based on the protease inhibitor Stefin A. Preclinical Pharmacology. Cohort of Advanced or Unresectable Mucosal Melanoma BIOCONJUGATES Paul B.3-dioxygenase-1 (IDO1) has also emerged as an immunotherapy STREAM combine antibody-like affinity and selectivity with small molecule-like tissue target due to its role in regulating T-cell responses. Treatment of Malignant Diseases Using phage display. M. Attending Physician and Section Head. They have potential data will be described that support the combination of IDO1 inhibition with IMMUNOGENICITY & in many indications.D. and after with advanced/unresectable MM between 1995 and 2012 who had received SPONSOR & EXHIBITOR INFO a high-throughput screen or selection for function. REGISTER BY Antibodies for Cancer Therapy DECEMBER 23 & 12:20 pm Cancer Biotherapeutics . M. Trinity College and Co-Founder and a broad range of tumors types and represent a new paradigm in cancer treatment Director.D. during.com | 22 . Preclinical and early clinical penetration. Surgery. Weill Sequencing and Design Cornell Medical College THERAPEUTICS Tim Whitehead. Ph. Michigan State University mucosal melanomas (MMs) as well as the response of advanced MM to cytotoxic Next-generation sequencing has presented protein scientists with the therapy. 1:50 Session Break H. Division of Surgical Oncology. Assistant Professor. a novel toxin delivery platform which greatly improves toxin loading into tumour tissues.

Xencor. Stanford University EXPRESSION Cells in the Tumor Microenvironment We have adapted an engineered integrin-binding peptide-Fc fusion to recruit STREAM Yan Qu. exert powerful cytotoxicity against Register Online! tumor cells in vitro and in vivo. Engineering. Hitachi America Associate Professor. in-depth understanding of PDL1’s is further enhanced by checkpoint blockade inhibitors. Proteins Jennifer Cochran.D. Pfizer immune cell effector functions to tumors. creating a universal T-cell product. Bioengineering and 11:50 Novel Insights on the Effect on Anti-PDL1 on the NK and Myeloid Chemical Engineering. Jonathan H.. combined to create extremely potent therapeutics. Antibody Biotherapeutics. Bristol-Myers Squibb TRAINING SEMINARS positive T cells to promote stronger T cell activation.. Unum Therapeutics HOTEL & TRAVEL Immunotherapy is a promising option for cancer treatment.. Ph. Novel Scaffolds and Antibody Immunotherapy Fragments COVER 10:50 Bispecific Antibodies for T Cell Recruitment and Dual Checkpoint 2:00 Chairperson’s Remarks Blockade Horacio G. two different synergistic mechanisms enhance STREAM Antibodies the potency by up to 100-fold or more.. including melanoma and colon carcinoma. and discuss ONCOLOGY For many applications. Inc. Associate Professor. Each of the individual components has an EC50 in the low nM range. REGISTER BY Antibodies for Cancer Therapy DECEMBER 23 & SAVE UP TO $550 New Generation of Targeting Approaches for Single Domain Antibodies. Ph. Ph. A Division of Cambridge Innovation Institute PEGSummit.D. Ph. Recent results of clinical trials specifically manipulating a patient’s own T-cell response provide REGISTRATION INFORMATION compelling evidence and clinical benefit. Senior Director. domains (two Adnectins and a helical peptide) that have separate inhibitory actions. Desjarlais. Ph. mAbs 4:25 Antibody Coupled T Cell Receptor (ACTR): A New Modality for SPONSOR & EXHIBITOR INFO Naked Antibodies Seth Ettenberg. Nastri. Executive Director. Incyte CONFERENCE-AT-A-GLANCE John R. Our recent preclinical data suggest that the effects of PD-L1 3:05 Sponsored Presentation (Opportunity Available) BIOASSAY STREAM blockade on NK and myeloid suppressor cells in the tumor microenvironment are 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing antibody isotype dependent. expression pattern within the tumor microenvironment is required for optimal IMMUNOGENICITY & isotype selection. Because growth in several tumor models.D. Protein Design. We will discuss application of the platform to create of a Barrier in Combinectin: A Novel Trispecific HIV-1 Entry Inhibitor with SHORT COURSES pipeline of T cell-redirecting CD3 bispecifics that have compelling in vivo activity. CSO. promote enhanced T cell activation in vitro and in vivo.D.com | 23 . with a concomitant boost in the resistance Luis Alvarez-Vallina.D.. Ph. Aarhus University barrier. we have developed a technology platform that allows the rapid and efficient engineering of mono and multispecific tandem trimerbodies with defined 2:35 Integrin-Targeted Combination Immunotherapy Using Fusion IMMUNOTHERAPY STREAM stoichiometry and controlled orientation of the antigen binding domains. Ph.. Senior Principal Scientist. The Antibody Society and Editor-in- STREAM Chief. Recently. which STREAM PD-L1 can be expressed on activated T cells. Ph. Davis. This approach allows for the production of a single PEGSummit. Several checkpoint pairs. The co-administration of peptide-Fc Antibodies blocking PD-1/PD-L1 axis have been designed as either hIgG4 or as fusion and an immune stimulating cytokine results in significant control of tumor ANALYTICAL an engineered hIgG1 isotypes which has low or no binding to the FcγR. We have designed a biological HIV-1 entry inhibitor with three linked active including PD1 x CTLA4. but ENGINEERING 11:20 Breaking Symmetry: Towards a New Generation of Bispecific when fused into a single molecule. Principal Scientist. We describe the design and optimization of the Combinectin.D.. T-cells engineered to express an Antibody Coupled T-cell Receptor (ACTR).. asymmetric configurations where one antigen is bound the general principal of how symmetric and asymmetric synergy can be used and STREAM multivalently and another is bound monovalently may be advantageous.com cellular product to be combined with many different tumor-targeting antibodies.D. Corporation Xencor’s bispecific antibody platform utilizes a strongly hetero-dimerizing Fc SPONSORS 2:05 Synergy Generates Picomolar Potency and a High Resistance domain and a scFv-Fab-Fc format to create high-yield and highly developable bispecific antibodies. Clinical Promise and a series of bispecific antibodies that selectively target double-checkpoint. BIOCONJUGATES Emerging Companies and Novel Approaches STREAM 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own 4:20 Chairperson’s Remarks THERAPEUTICS 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing Janice M. CSO. Reichert.D. the ectodomain of CD16 fused to costimulatory and CD3z signaling domains.

D. CureMeta LLC COVER Almost all solid tumor patient deaths are due to metastatic cancer. REGISTER BY Antibodies for Cancer Therapy DECEMBER 23 & 4:40 Bstrongximab. Integration ONCOLOGY of an albumin binding domain extends the half-life of CPABs. We will describe our strategy of analyzing these diverse yet hugely ANALYTICAL potential targets encompassing various cancers.. CureMeta is a biotech company developing novel antibody-based therapeutics to treat and cure CONFERENCE-AT-A-GLANCE patients with metastatic cancers. apoptotic cell death and tumor growth retardation in vivo. SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. SHORT COURSES 4:55 Engineering Alphabodies to Generate Potent Inhibitors of TRAINING SEMINARS Intracellular Protein-Protein Interactions Yvonne McGrath. Bstrongximab is the lead drug in CureMeta’s pipeline. IMMUNOGENICITY & BIOASSAY STREAM 5:25 End of Antibodies for Cancer Therapy 5:30 Registration for Dinner Short Courses BIOCONJUGATES STREAM Recommended Dinner Short Course* THERAPEUTICS SC12: Study Design and Statistical Data Analysis of Flow Cytometry STREAM Assays *Separate registration required. Ph.com A Division of Cambridge Innovation Institute PEGSummit. The scenario gets more complicated with recent STREAM strategies of combination therapy with almost all monoclonal antibody therapies available. please see page 5-6 for course details. thereby allowing for STREAM efficient tumor uptake.com | 24 . We are generating novel antibodies and potent ADCs specific to embryonic targets which are not expressed in normal healthy SPONSORS tissues but are re-expressed in aggressive and metastatic cancer. We have developed unique STREAM non-immune and synthetic antibody libraries and used them in antibody display technologies to develop monoclonal antibody products against multiple targets. Ph.. 5:10 Immuno-Oncology Target Selection and Monoclonal Antibody IMMUNOTHERAPY Development Process STREAM Maloy Ghosh. CSO. disrupt the Mcl-1:BAK complex thereby activating BAK and apoptotic cell death. CSO.D.. Complix NV The Cell Penetrating Alphabody (CPAB) is a unique protein scaffold designed ENGINEERING to target therapeutically important intracellular PPI. CEO. Mike Schopperle.D. Zumutor Biologics Rapid scientific understanding of Immuno-oncology led to an explosion of EXPRESSION information on drug targets. We will show that CPABs STREAM targeting the anti-apoptotic protein Mcl-1 enter cancer cells in vitro. a Novel Antibody-Drug-Conjugate Targeting SAVE UP TO $550 Metastatic and Aggressive Cancers W. Ph.

a myeloid-specific immune checkpoint. beyond checkpoint Rakesh Dixit. Vice President and Head. With the advent of T cell–redirecting antibody (TRAB) may be a solution to recent problems facing SPONSOR & EXHIBITOR INFO bi-specific antibodies. and many other diseases. Oncology Research. 2017 REGISTER BY DECEMBER 23 & Advancing Bispecific Antibodies and SAVE UP TO $550 Combination Therapy to the Clinic Creating the Killer Combo COVER CONFERENCE-AT-A-GLANCE Recommended Short Courses* of the cellular distribution of all the constructs suggested that the major clearance mechanism was linked to binding/association with liver sinusoidal endothelial SPONSORS cells. Chugai Pharmaceutical Co.D. Global Head. Research Advisor and Group Leader.. First-in-Class T Cell–Redirecting Bispecific Antibody THERAPEUTICS There have been significant advances in tumor directed immunotherapy. Ph. non-clinical safety. a significant subset of patients still fails to benefit from 8:30 Chairperson’s Remarks current immune therapies.D. MAY 3 10:55 KEYNOTE PRESENTATION: Immunotherapy for Cancer: The Need ENGINEERING for More Effective Combination Therapies STREAM 7:30 am Registration and Morning Coffee Ronald Herbst. Overall. Ph. an understanding of hematopoiesis (VEGF). This drug candidate BIOASSAY STREAM hematopoietic cell transplantation.D. as well as chimeric antigen receptors. Evaluation A Division of Cambridge Innovation Institute PEGSummit. Chugai’s ART-Ig technology enables HOTEL & TRAVEL effects of cellular therapy. Company Register Online! The present work evaluated factors in vivo that result in the aberrant peripheral 12:25 pm Sponsored Presentation (Opportunity Available) PEGSummit.com clearance of several bispecific antibody (BsAb) constructs. 5th Annual | May 3-4.D. also combines well with anti-programmed death receptor-1 (anti-PD1) therapy in preclinical models. Institute for Stem Cell Biology and 11:25 OMP-305B83: A Novel. Clinical Fellow in Medicine. MedImmune STREAM patients to immunotherapy. large scale production of this asymmetric and bispecific antibody. Eli Lilly and presented. Frigault. Translational Sciences. Vice President. of minimally passaged patients-derived tumor xenografts.D. more effective combinations. However. Therapeutics targeting CD47 represent a (DLL4) ligand in the Notch pathway as well vascular endothelial growth factor new strategy for treating cancer. Oncomed Pharmaceutical ANALYTICAL programmed cell removal. we are now able to cancer immunotherapy. Antibody optimization. OMP-305B83 is in clinical development in Oncology both as a BIOCONJUGATES 9:10 Bi-Specific T Cell Engagers and Chimeric Antigen Receptors: T single agent and in combination with several standards of care. Enjoy Lunch on Your Own reduced FcRn interactions or poor molecular/biochemical properties. Ph. M. The CD47/SIRPα axis.com | 25 . Despite their success they’re unable to engage one of the most powerful subsets of the host immune response – T cells. please see page 5-6 for course details. are needed to further broaden and deepen the response of cancer IMMUNOTHERAPY Assessment. Ph. Senior Vice President. malignancy. New. TRAINING SEMINARS WEDNESDAY.. Results showed rapid 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or clearance of all the BsAbs in vivo that was not attributable to target binding.. beyond checkpoint STREAM monotherapies. Ph. Dana-Farber Cancer Institute 11:55 ERY974. Biologics Discovery Dept. R&D. Weiskopf.. 8:40 Personalized Antibody-Mediated Immunotherapy Approaches EXPRESSION Kipp A. Updated data will STREAM Cells Strike Back be presented... pharmacology (including combination study with REGISTRATION INFORMATION 9:40 Aberrant Bispecific Antibody Clearance other immunotherapies or chemotherapies) and design of the Phase I study will be Amita Datta-Mannan.. Ltd. Stanford University School of Medicine Antibody for the Treatment of Solid Tumors Insights into myeloid development have informed us of mechanisms of Jakob Dupont. ERY974 is a fully IgG-type TRAB that targets glypican-3 combine the targeting specificity of monoclonal antibodies with the cytotoxic and exhibits highly potent anti-tumor efficacy. therapeutics. Ph. For the Targeting Glypican-3: A Highly Tumor-Selective Antigen STREAM last two decades..D. MedImmune Combination therapies with anti-PD1/PD-L1 and anti-CTLA4 have already ONCOLOGY Advances in Bispecific Biologics and CAR T Cell Therapies increased response rates in certain cancer indications. Matthew J. This drug candidate has broad. monoclonal antibodies have been on the forefront of cancer Mika Sakurai. Potent DLL4 & VEGF Targeting Bispecific STREAM Regenerative Medicine.D. DABT. Research Scientist. Biologics Safety blockade. potent anti-tumor activity in a wide variety IMMUNOGENICITY & and myeloid cell development has implications for regenerative medicine.. limits macrophage removal of HSCs but can be exploited by OMP-305B83 is a novel bispecific antibody that targets both Delta-like Ligand 4 STREAM hematologic and solid malignancies. SC3: Genomics in the Service of Cancer Immunotherapy SHORT COURSES 10:10 Coffee Break in the Exhibit Hall with Poster Viewing SC11: Adoptive Therapy with CAR T Cells *Separate registration required.

University of Minnesota Innovative Engineering Approaches to Improve Drug We have performed clinical trials using NK cell infusions. MAY 4 termed as immune-related adverse events (IRAEs). Ph. targeting both solid and hematologic malignancies. THERAPEUTICS STREAM 8:30 Chairperson’s Remarks 12:05 pm Engineering Manufacturable IgG-like Bispecifics for Steven Coats. As these projects mature. Ph. with Bispecifics: From Bench to Bedside exceptional characteristics. and fragment MedImmune now has multiple bispecific molecules that have progressed to clinical development. Director. Blankenship. Miller. immunotherapies also generate dysimmune toxicities collectively THURSDAY.. This talk will review projects. Roche Pharmaceutical A pipeline of ADAPTIR therapeutics is currently under development from early IMMUNOTHERAPY Research and Early Development. Director Antibody Engineering & CMC... STREAM Updates will be provided on advanced ADAPTIR therapeutics.D. by unbalancing the BIOASSAY STREAM immune system.D. Vrije Universiteit Brussel (VUB) A Division of Cambridge Innovation Institute PEGSummit. However. Ph. Protein Engineering. Bispecific antibodies can specifically activate T-cells and induce IMMUNOGENICITY & tumor cell killing in an MHC-independent manner. and demonstrate co-inhibition of two different targets leads to synergistic bone Register Online! 9:05 Nanobodies (Entering) in Clinical Phase: Update on their formation in rodents and non-human primates. such as the IgG-single chain Fv. Medicine. However. IL-15 is a cytokine critical for NK cell development 11:05 From the Bench to the Clinic: Developing Next-Generation ENGINEERING and homeostasis. there have been valuable lessons formats. Bioengineering Sciences. Scheer.. ADPE.com | 26 . which Efficacy limits their clinical efficacy. The major limitation TRAINING SEMINARS is their lack of specificity and their inability to proliferate when targeted. Molecular Biology & Protein Engineering.D. Ph. LLC Significant progress has been made in the design and development of HOTEL & TRAVEL recombinant bispecific IgG-fusions. we’ve taken 8:00 am Morning Coffee parallel engineering approaches to modulate binding affinity to T-cells. Vice President. Aptevo Therapeutics ONCOLOGY 2:45 The Two Faces of Interleukin-2: Engineering towards Induction of The ADAPTIRTM (modular protein technology) platform of bispecific protein STREAM Immune Tolerance or towards Immune Activation therapeutics has unique properties compared to other bispecific antibody formats. MedImmune data are presented here. Masonic Cancer Center. Head. R&D. IgG-like bispecific formats. Ekkehard Moessner. Roche Innovation Center Zurich discovery to clinical stage. R&D.com Immunogenicity 12:35 End of Advancing Bispecific Antibodies and Combination Therapy Chloé Ackaert.D. Senior Scientist. Vice President. These STREAM approaches are yielding variants with a broad range of binding affinities and are Bispecifics: From Bench to Bedside (Cont. Deputy Director. Division of Hematology. Ph. Ph. Cellular and Molecular Immunology. REGISTER BY Advancing Bispecific Antibodies and Combination Therapy to the Clinic DECEMBER 23 & 1:55 Session Break Nanobodies. Boehringer Ingelheim ANALYTICAL Pharmaceuticals. MedImmune.D. describe a manufacturable IgG-like bispecific design. some of which are discussed in this talk. PEGSummit. Jonah Rainey. Inc.D. In an attempt to minimize BIOCONJUGATES IRAEs and to raise the threshold for MTD (maximum tolerated dose). Lead Scientist.D.. CONFERENCE-AT-A-GLANCE 2:15 Generation of BiKEs and TriKEs to Improve NK Cell-Mediated 9:35 Sponsored Presentation (Opportunity Available) SPONSORS Targeting of Tumor Cells 10:05 Coffee Break in the Exhibit Hall with Poster Viewing Jeffrey S. Camel to the Clinic Antibodies Lab. including MOR209/ 3:15 Sponsored Presentation (Opportunity Available) ES414 and ES425. Ph. Professor. with clinical data demonstrating translatability to humans. EXPRESSION 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing 11:35 Modulating Target Binding Affinity to Minimize Immune-Related STREAM Adverse Events 4:45 Problem-Solving Breakout Discussions Justin M.. Oncology and SHORT COURSES Transplantation. Antibody Engineering.. STREAM 5:45 Networking Reception in the Exhibit Hall with Poster Viewing Unprecedented durable clinical response for tumor targeting can be achieved by 7:00 End of Day immunotherapy. the variable domain of heavy-chain only antibodies naturally SAVE UP TO $550 occurring in camelids.. success of full length IgG-like bispecific engineering and REGISTRATION INFORMATION learned and perspectives gained. are the smallest antigen-binding antibody fragments.) being profiled to understand how they maintain the balance of efficacy and safety. The latest Steven Coats. MedImmune Promoting Bone Mass Accrual and Fracture Repair SPONSOR & EXHIBITOR INFO 8:35 Bispecific Antibody Efficacy and Safety: From Research to Clinic Guna Kannan. Affinita Biotech G. Due to their sequences foreign to human. We have recently developed a class of molecules that combine ADAPTIRTM Molecules STREAM antigen specificity and IL-15’s proliferative activity together into a novel class of multifunction molecules we call trispecific killer engagers (TriKEs). Post-Doctoral Researcher.. Several Nanobodies are (entering) in clinical phase. M.D. Preclinical data will be presented for multiple production without additional process manipulation is limited. COVER 2:10 Chairperson’s Remarks their immunogenicity is of special concern and analyzed in more detail. John W. Ph.D.

and 3) relationship between mediators. This information SC9: Target Selection for Biologics *Separate registration required. HOTEL & TRAVEL murine tumor models to profile ADC activity in immune-competent settings and characterized pharmacodynamic changes in the tumor microenvironment to 5:20 End of Day REGISTRATION INFORMATION inform rational combination approaches. Ph. 2) MPS variability across patient populations.. Additionally. Associate Research Fellow. we are building a as LBAs and LC-MS/MS methods for the bioanalysis of ADCs using Kadcyla® rich dataset for biomarker analysis. we are employing fully syngeneic (ado-trastuzumab emtansine) as a case study. characteristics and function of the MPS affect the PK and PD of ADCs. LLC their recognition and interaction with the mononuclear phagocyte system (MPS) • Tumor-initiating cells (TICs) remain controversial and will remain so until where the conjugated drug is cleared via interactions with the MPS. Biomedicine Design. Director. Carl Uli Bialucha.. Clinical efficacious dose Antibody-Drug Conjugates *Separate registration required. A Division of Cambridge Innovation Institute PEGSummit. Inc.D.com | 27 .. Associate Professor. Research & Development. Pfizer Quantitative modeling and simulation was used to analyze data on 10 ADCs SC15: Critical Considerations for the Design and Development of in patient trials or approved for oncology indications. to Eradicate Tumor-Initiating Cells University of North Carolina at Chapel Hill EXPRESSION Scott J. Ph.. Inc. CSO. we have begun to generate population-based assays (LBA) and LC–MS-based platforms are needed to overcome challenges in vivo activity datasets on several emerging ADC programs. to optimize clinical trial design and determine SHORT COURSES likelihood of success versus clinical standard of care.D.D. 7th Annual | May 4-5.com Alison Betts. It is important ANALYTICAL findings in the lab translate into drugs providing clear clinical benefit to patients to evaluate how mediators. Monte Carlo clinical trial SPONSORS simulations were performed to predict objective response rate. BIOASSAY STREAM Modeling and Simulation Approaches 4:50 Challenges and Solutions Associated with Bioanalysis of Antibody BIOCONJUGATES Drug Conjugates in Support of Clinical Studies STREAM 2:20 Novel Approaches for Modeling Pre-Clinical Activity of ADCs and Rafiq Islam. TRAINING SEMINARS THURSDAY. This presentation will examine the different methodologies such SPONSOR & EXHIBITOR INFO response data with molecular features across these models. Novel THERAPEUTICS Biomedical Research. MAY 4 3:20 Sponsored Presentation (Opportunity Available) 12:00 pm Registration 3:50 Refreshment Break ENGINEERING STREAM 12:35 Luncheon in the Exhibit Hall with Poster Viewing PKPD and Bioanalytics of ADCs in Support of Clinical 1:40 Chairperson’s Remarks Development ONCOLOGY John Lambert.D. characteristics and function of the MPS and the IMMUNOGENICITY & PK and PD of ADCs in patients. Senior Director. Oncology Biotherapeutics. bioanalytical approaches and strategies including a combination of ligand-binding STREAM Using PTX mouse clinical trials. Ph. Novartis Institutes for these novel therapeutic products present unique bioanalytical challenges. Celerion. Executive Vice President and Distinguished Research Fellow..D. Vice President. Informing Biomarker Strategy Since ADCs are generally complex heterogeneous mixtures of multiple species. please see page 5-6 for course details. recommended Phase II and clinically approved doses. 5:20 Registration for Dinner Short Courses 2:50 Predicting Clinical Success of ADCs using a Mechanistic Modeling Register Online! & Simulation Approach Recommended Dinner Short Course* PEGSummit.D. Bioanalytical Services. AbbVie The PKPD of carrier-mediated agents (CMA) and ADC agents are dependent on STREAM Stemcentrx. Ph.D. Pharm. please see page 5-6 for course details.. Zamboni. can be used to select the best ADC.. By integrating unique to ADCs. TOND2I Lab. Ph. 2017 REGISTER BY DECEMBER 23 & Antibody-Drug Conjugates II: SAVE UP TO $550 Advancing Toward the Clinic Lessons Learned from Preclinical and Early Trials to Drive Clinical Success COVER CONFERENCE-AT-A-GLANCE Recommended Short Course* was predicted from preclinical PK/PD studies and compared with clinical MTD. We will discuss: 1) pharmacologic methods to characterize STREAM • Antibody-drug conjugates are a promising class of drugs able to target and specifically reduce the frequency of TICs ADCs ex vivo and in vivo. Director. STREAM ImmunoGen 4:20 Relationship between the Mononuclear Phagocyte System and the Pharmacokinetics and Pharmacodynamics of Antibody Drug Conjugates IMMUNOTHERAPY in Patients STREAM 1:50 KEYNOTE PRESENTATION: Leveraging Antibody-Drug Conjugates William C. Ph. Dylla.

Lessons learned from different antigens. II clinical development for the treatment of Non-Hodgkin lymphoma. Senior Vice President. XMT-1536 will enter clinical development in late 2017. Several of these ADCs have advanced to conditions. Halozyme is a Dolaflexin ADC targeting NaPi2b that is highly active in models of NSCLC SPONSORS Therapeutics adenocarcinoma and epithelial ovarian cancer. Executive Vice President and Distinguished Research Fellow. and highly expressed on most B-cell malignancies. RNA and gene amplification detection methods.D. Thanos....D... Philogen Ed Reilly. Seattle Genetics Anti-CD37 Antibody Radionuclide Conjugate Betalutin® ENGINEERING Antibody-drug conjugates are emerging as an important therapeutic option for Jostein Dahle. CSO.D. Again TRAINING SEMINARS Jonathan Drachman. Ph. Betalutin is currently in Phase I/ ONCOLOGY early trial design will be discussed. Ph. Ph. Oncology Discovery. Appropriate patient selection biomarker strategies have been STREAM in patients with cancer or with chronic inflammatory conditions.com A Division of Cambridge Innovation Institute PEGSummit.. IMMUNOGENICITY & BIOASSAY STREAM 10:05 Coffee Break 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or 10:35 ImmunoGen’s ADC Platform Technologies: Current Progress and Enjoy Lunch on Your Own BIOCONJUGATES STREAM Future Prospects 1:05 Refreshment Break John Lambert.D. CTO. Bergstrom.D. Senior Research Fellow..D. Oncology Discovery. This presentation will focus on the development of a tumor-target specific ADC from 9:35 Sponsored Presentation (Opportunity Available) discovery to clinical trials. Ph. AbbVie EXPRESSION Antibodies represent ideal vehicles for the delivery of cytokines to the site of Abbvie has multiple antibody drug conjugate (ADC) programs encompassing STREAM disease and for the selective modulation of the immune system in pathological various linker payload combinations. REGISTER BY Antibody-Drug Conjugates II: Advancing Toward the Clinic DECEMBER 23 & SAVE UP TO $550 FRIDAY. Ph. 9:05 Antibody-Cytokine Fusion Proteins for the Therapy of Cancer and IMMUNOTHERAPY of Chronic Inflammation 12:05 pm Development of a Tumor-Specific ADC: From Discovery to STREAM Dario Neri.D. Research and 11:35 Treatment of Non-Hodgkin Lymphoma with the Beta-Emitting Development. In this lecture.D. As more clinical trials are 177Lu-satetraxetan-lilotomab (Betalutin®) is a novel CD37-binding antibody completed. CMO.com | 28 . M. AbbVie
 SPONSOR & EXHIBITOR INFO 1:40 Synergistic Potential of Combining Antibody-Drug Conjugate and HOTEL & TRAVEL Immunotherapy for Cancer Treatment Herren Wu. XMT-1536 has significantly SHORT COURSES improved efficacy and tolerability compared to a monomethyl auristatin E ADC 8:35 Clinical Development of ADCs: From Bench to Clinic and Back against the same target. MAY 5 11:05 Update on Mersana’s Antibody-Drug Conjugates: Progress into the Clinic 8:00 am Morning Coffee Donald A. XMT-1536 Christopher D. Chemistry and Applied Biosciences.. Swiss Federal Clinical Trials Institute of Technology (ETH Zurich). XMT-1522 entered clinical development in October 2016. Ph. Senior Director. CD37 is an internalizing transmembrane antigen technological advances. Ph. ImmunoGen Novel ADC Concepts with Promising Preclinical Results THERAPEUTICS STREAM 1:35 Chairperson’s Remarks Ed Reilly. Nordic Nanovector ASAc STREAM both hematologic malignancies and solid tumors. Mersana Therapeutics COVER XMT-1522 is a HER2-targeting ADC that induces complete regressions in models Preclinical and Clinical Updates of heavily-pretreated HER2-positive breast tumors. M. Updated STREAM clinical and pre-clinical data will be presented. MedImmune. developed including protein. clinical trials where objective responses in patients with different solid tumors ANALYTICAL cytokine fusion proteins that we have moved to advanced controlled clinical trials have been observed. I will present preclinical and clinical data on antibody. LLC. payloads.D. Senior Research Fellow. Professor.D. as well as breast and non- CONFERENCE-AT-A-GLANCE small cell lung cancer (NSCLC) without HER2 gene amplification and lower HER2 8:30 Chairperson’s Remarks expression. and Co-Founder. Ph.. CMO and Executive Vice President.. REGISTRATION INFORMATION • Race to develop combinatory cancer therapy of ADC and IO • Promising preclinical results • Opportunities and challenges Register Online! PEGSummit. Biotherapeutics Discovery. it may be possible to identify patterns that will help guide future radionuclide conjugate (ARC).

STREAM 3:10 Probody Drug Conjugates for the Treatment of Cancer EXPRESSION Jason Sagert.D. Here we screened a panel of over 70 tumor cell lines derived from SPONSORS various solid tumor malignancies. Oncology.. 2:40 Novel Medicines that Exploit Extracellular Protein-Protein ENGINEERING Interactions STREAM James R.or BRAF-Mutated Tumors of Various Types In Preclinical Studies COVER Christopher D. These results support further development of HTI-1511 as a possible treatment for EGFR overexpressing tumors. Ph. Halozyme Therapeutics CONFERENCE-AT-A-GLANCE We have previously described HTI-1511. Preclinical data supporting the IMMUNOGENICITY & development of PDCs will be presented.com | 29 . This platform allows the targeting of antigens that STREAM are highly expressed on tumor cells with high prevalence across multiple types of cancer regardless of normal tissue expression.. This talk will therefore describe a new level of therapeutic precision that depends on protein-protein proximity and not simply expression. Biotherapeutics Discovery. Thanos. REGISTER BY Antibody-Drug Conjugates II: Advancing Toward the Clinic DECEMBER 23 & 2:10 HTI-1511. Senior Director. Centrose The talk will review the development of EDCs to multiple cancer-related targets ONCOLOGY and describe their extracellular mechanism which resembles necrosis. CytomX Therapeutics STREAM Probody™ Drug Conjugates (PDCs) are a class of antibody-based therapeutics that remain in a substantially inert. masked form until activated proteolytically in ANALYTICAL the tumor microenvironment.D. Senior Scientist II. A Novel Anti-EGFR-ADC.. Prudent. BIOASSAY STREAM 3:40 End of Conference BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.D. STREAM data using cynomolgus monkey models will be discussed. including those with downstream TRAINING SEMINARS activating mutations in the KRAS/BRAF pathway. Ph. Demonstrates Significant SAVE UP TO $550 Activity against KRAS. Evaluations in several human xenograft tumor models and patient derived tumor models in mice demonstrated potent tumor SHORT COURSES regression. President & CEO. In addition. where a CD20-specific EDC was able to eliminate all CD20+ B-cells while having no effect on other cells IMMUNOTHERAPY or tissues. Ph. an ADC in pre-clinical development that targets EGFR.com A Division of Cambridge Innovation Institute PEGSummit.

REGISTER BY DECEMBER 23 & SAVE UP TO $550 IMMUNOTHERAPY STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Preventing Toxicity in Immunotherapy SHORT COURSES TRAINING SEMINARS Adoptive T Cell Therapy ENGINEERING STREAM Agonist Immunotherapy Targets ONCOLOGY STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.com A Division of Cambridge Innovation Institute PEGSummit.com | 30 .

Ph.D. Medical Oncologist.D. Dartmouth College Potential off-target toxicity is also identified through molecular analyses and The mechanisms involved in the efficacy of CAR T cells can be investigated using further explored through pre-clinical testing. We will then discuss toxicity issues arising when CTLA-4 PEGSummit. MHC complexes. M. Professor. their low persistence after infusion and their functional impairment in the immunosuppressive microenvironment. CAR receptors designed to ANALYTICAL target murine tumor ligands can be used to understand the key mechanisms of STREAM action against tumors and the nature of toxicity observed in immune intact and 11:20 Preventing Self-Reactivity of Engineered TCRs deficient mice.D. inefficient homing of CART cells to tumor locations.D.D..D. Director. CSO. Monitoring and Preventing Cross Reactivity TRAINING SEMINARS 10:45 Chairperson’s Remarks MONDAY. By incorporating an affinity-enhancing A Division of Cambridge Innovation Institute PEGSummit.com | 31 . Essential to the development STREAM Toxicity of CAR T Cells of ImmTAC molecules is a robust pre-clinical testing package. of which cross- reactivity is central. M. REGISTER BY 2nd Annual | May 1-2.D.. Institute Immune Mobilising Monoclonal TCRs Against Cancer (ImmTAC) molecules are IMMUNOTHERAPY 8:40 Immune Intact Preclinical Models to Understand Efficacy and highly efficient and specific at targeting tumor cells.. we have developed a model for studying on- CONFERENCE-AT-A-GLANCE target/off-tumor toxicity. Natural central tolerance STREAM Farber Cancer Institute culls T-cells that have a high affinity for self peptide-MHC.. Cancer Immunology and Virology. We will present our latest in vitro and in SPONSOR & EXHIBITOR INFO vivo CART cell data on new technology to overcome these barriers. Memorial Sloan Kettering Cancer Center Sarah Richman. MAY 1 Michael Postow. Dana. Toxicity in Combination Studies 9:40 A Higher-Affinity Variant of a GD2-Specific CAR That Significantly 11:50 A Different Way of Thinking about Toxicities of Combination HOTEL & TRAVEL Enhances Potency in vivo and Allows for a Novel Model of On-Target Immune Checkpoint Blockade REGISTRATION INFORMATION Off-Tumor Toxicity Michael Postow. The Geisel School includes not only normal cell screens but also specialised cell type cultures. particularly for solid tumors. Dana-Farber Cancer Bent Jakobsen. Instructor. Ph. Memorial Sloan Kettering Cancer Center ENGINEERING 7:00 am Registration and Morning Coffee STREAM Building Preclinical Models 10:50 KEYNOTE PRESENTATION: Ensuring Safety of ImmTACTM ONCOLOGY 8:30 Chairperson’s Remarks STREAM Therapy: Development of a Preclinical Package Wayne Marasco. please see page 5-6 for course details. IMMUNOGENICITY & Andrew Sewell.. Professor. Department of Medicine. Ph. M.. Ph. SC3: Genomics in the Service of Cancer Immunotherapy SPONSORS 10:10 Coffee Break SC11: Adoptive Therapy with CAR T Cells SHORT COURSES *Separate registration required. TCR engineering The clinical effect of CART cells has been modest for the treatment of solid bypasses this process and can result in dangerous self-reactivity. Comprehensive immunity requires that each T-cell recognizes BIOCONJUGATES numerous peptides and thus be extremely cross-reactive.. Department of Medicine. antigen.D... Distinguished Research Professor and Wellcome Trust BIOASSAY STREAM 9:10 Chimeric Antigen Presenting T Cells That Change the Tumor Senior Investigator. The Children’s Hospital of Philadelphia Immune checkpoint inhibition results in immune-related adverse events. These toxicities THERAPEUTICS tumors due to several factors including the difficulty in identifying unique can be predicted and engineered out without loss of specificity for the target STREAM tumor associated antigens. presence on some vital normal tissues. Cancer Immunology and Virology. The glycolipid tumor antigen GD2 is an attractive antigen with which to study on-target/off-tumor and PD-1 immune checkpoint inhibitors have been combined and how clinicians and researchers can think differently about best strategies to deliver these toxicity owing to its shared expression between rodents and humans and its medications safely. M. Cancer Center. Immunocore Ltd.D. We will Register Online! On-target/off-tumor toxicity poses a major challenge in chimeric antigen receptor briefly review the spectrum of toxicities seen with these agents and how clinicians approach their treatment. We have developed an extended safety package which EXPRESSION Charles Sentman. STREAM of Medicine. Ph. Medical Oncologist. Center for Synthetic Immunity. 2017 DECEMBER 23 & SAVE UP TO $550 Preventing Toxicity in Immunotherapy Strategies to Advance Clinical Trials While Keeping Patients Safe COVER Recommended Short Courses* mutation into a GD2-specific CAR. syngeneic tumor models with intact immune systems.com (CAR) T cell immunotherapy. Cardiff University School of Medicine Microenvironment The αβ TCR repertoire is dwarfed by the vast array of potential foreign peptide- Wayne Marasco.

viruses and small Saad Kenderian. Management. PEGSummit.. for the Sequencing and Design ability to control the intrinsic activity of CAR-Ts with a small molecule definable Tim Whitehead. 2) Identifying receptors for protein ligands in 8:30 Toxicities after Chimeric Antigen Receptor T Cell Therapy: normal and disease processes. and TIL CONFERENCE-AT-A-GLANCE Jim Freeth. there is a concern that early ONCOLOGY introduction of immunosuppression can impair CART cell activity and therefore STREAM are reserved for severe CRS. Senior Vice President. Assistant Professor of Medicine and Oncology. Trinity College and Co-Founder and Treatment with CD19-directed CAR T cells can lead to durable clinical responses Director. REGISTER BY Preventing Toxicity in Immunotherapy DECEMBER 23 & 12:20 pm Sponsored Presentation (Opportunity Available) TUESDAY.. including oncology. The application of these systems in the clinic Next-generation sequencing has presented protein scientists with the will provide physicians with the ability to modulate safety issues like CRS and on/ HOTEL & TRAVEL ability to observe entire populations of molecules before. This presentation will describe both the Bicycle® and BDC platforms. Bicycle Therapeutics in lymphoma patients. proteins. 3) Off. The lack of relevant preclinical models for CRS after 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing CART cell therapy is a significant limitation for the development interventions IMMUNOTHERAPY to treat or prevent CRS. and BIOCONJUGATES have been used to develop Bicycle Drug Conjugates™ (BDCs). Retrogenix Limited Human cell microarray screening enables rapid discovery of the primary cell 8:25 Chairperson’s Remarks surface receptors and off-targets of antibodies. Hematology.. tunable exposure and chemical synthesis.com | 32 . target profiling of biotherapeutics including CAR T cell lines.D. My group leverages this REGISTRATION INFORMATION unprecedented wealth of sequence-function information to design and 10:00 Coffee Break in the Exhibit Hall with Poster Viewing engineer protein affinity.D. Bicycles® are a novel therapeutic class of constrained bicyclic peptides that Biomarker analysis implicated several immune programs in the cytokine release IMMUNOGENICITY & combine antibody-like affinity and selectivity with small molecule-like tissue syndrome and neurotoxicities associated with this therapeutic modality. Ph. M. Translational Medicine. their application is limited by the development of 1:50 Session Break cytokine release syndrome (CRS). While steroids and the IL-6 receptor blocker 2:20 Problem-Solving Breakout Discussions tocilizumab can generally reverse the syndrome. Mayo Clinic College of Medicine ENGINEERING 1:20 Luncheon Presentation II (Sponsorship Opportunity Available) Despite the impressive responses after chimeric antigen receptor T (CART) cells STREAM in hematological malignancies.. STREAM delivery platform which greatly improves toxin loading into tumour tissues. They have potential Elucidation of mechanisms differentially involved with toxicities but dispensable in many indications. 9:30 Controlling Specificity and Activity of Adoptive Cellular Therapies THERAPEUTICS Peter Emtage. Case studies from pharmaceutical partners will demonstrate how this Mayo Clinic College of Medicine SHORT COURSES unrivalled platform has been used for: 1) Uncovering novel targets from antibody phenotypic screening approaches. may allow rationale management of such toxicities.D.D.D. Managing Director. Assistant Professor of Medicine and Oncology. but they may be associated with reversible toxicities. Ph. a high-throughput screen or selection for function. TCR.. MAY 2 SAVE UP TO $550 12:50 Luncheon Presentation I: Identifying Critical Sponsored By 8:00 am Registration and Morning Coffee Receptor Targets and Off-Target Profiling Using Plasma COVER Membrane Protein Array Technology Safety in Cell Therapies: CAR. Cell Design Labs STREAM 4:55 Young Scientist Keynote: Programming Proteins by Deep Cell Design Labs THROTTLE Switch™ and synNotch™ technologies allow. specificity. we will review relevant preclinical STREAM PLENARY KEYNOTE SESSION models of human CRS after CART cell therapy and efforts to develop and optimize preventative strategies. My talk will present an overview of the above and detail Register Online! methodological improvements that enable the engineering work. In this presentation.. Research. SPONSORS molecules. and after off target toxicities while maximizing efficacy. BIOASSAY STREAM penetration. Master. Prevention and Preclinical Modeling TRAINING SEMINARS Saad Kenderian. during. Assistant Professor. Chemical Engineering and Materials mechanism in the case of THROTTLE-Switch™ and a logic gated decision SPONSOR & EXHIBITOR INFO Science..com 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing 6:55 End of Day A Division of Cambridge Innovation Institute PEGSummit. such as immune checkpoint interactions. M. and function and to infer structural complexes of proteins.D. Hematology. a novel toxin development of next generation T cell products. Vice President. Ph. FRS. EXPRESSION 4:00 Chairperson’s Remarks STREAM 9:00 Biomarker Correlates and Potential Mechanisms of CAR T Cell 4:10 Bicycles and Bicycle Drug Conjugates: Next-Generation Toxicities ANALYTICAL Therapeutics Adrian Bot.D. M. where Bicycles’ unique properties for clinical activity. Michigan State University paradigm in the case of synNotch™. Ph. Kite Pharma STREAM Sir Gregory Winter.

Associate Professor. Associate Professor. M. Senior Research Scientist.D. Assistant Professor.D. and Versartis. Department of Oncology. please see page 5-6 for course details. management. Despite mounting data. M. we have established an antibody-based control “switch” which affords refractory ALL. In this presentation. Research Fellow in Foundational Immunology & Head of Oncology 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing STREAM Biologics Discovery at Global Biologics. M. Diagnoses and Management of Immune-Related SC13: Phenotypic Screening Applications and Technologies Adverse Events *Separate registration required. Cytokine release syndrome (CRS) is the most significant and life- tunable CAR-T cell activity. This presentation will address immune related toxicities and side effects of STREAM Understanding Immune-Related Adverse Events checkpoint inhibitors and the best way to manage these side effects. Memorial Sloan Kettering Cancer STREAM development of multispecific antibody technology and how this technology could Center be used to design molecules to fine tune T cell functions for tumor killing. Amunix EXPRESSION neoantigens. Amunix is developing bispecific T cell activators based on our proprietary ProTIA directing T cells toward neoantigens that would result in tumor elimination. School of Medicine . Children’s Hospital of COVER Travis S. President and CEO. However.com A Division of Cambridge Innovation Institute PEGSummit.a pattern that is distinct from the tumor specific expression of mutated Volker Schellenberger. The universal design allows the same CAR to be threatening toxicity. discussed. Ph..D. Wayne State University/ BIOCONJUGATES 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or Karmanos Cancer Institute STREAM Enjoy Lunch on Your Own Many researchers believe that anti-cancer immunotherapy has the potential to eventually cure many types of cancer. Dramatic responses have been reported in patients with relapsed/ SPONSORS its use. and STREAM (Protease Triggered Immune Activator) platform.can lead to undesirable on-target. STREAM which maximizes anti-tumor effects while minimizing systemic toxicity (compared to other bispecific molecules such as BiTEs). along with the a highly effective novel immune therapy for relapsed/refractory hematologic need for a solution to adverse effects and long-term T cell aplasia associated with malignancies. REGISTER BY Preventing Toxicity in Immunotherapy DECEMBER 23 & SAVE UP TO $550 New Technologies to Prevent and Mitigate Toxicity 2:35 Cytokine Release Syndrome after CAR T Therapy for Acute Lymphoblastic Leukemia 10:50 Switch Mediated Control of CAR-T Cell Therapy David Teachey. Children’s Hospital of HOTEL & TRAVEL Philadelphia Recommended Dinner Short Course* REGISTRATION INFORMATION 2:05 Immunogenises. Understanding engineered for activation at the tumor site by tumor-associated proteases. SHORT COURSES retargeted to multiple tumor antigens to combat antigen-loss relapse mutations as well as.D. SPONSOR & EXHIBITOR INFO 2:00 Chairperson’s Remarks 5:30 Registration for Dinner Short Courses David Teachey..D. TRAINING SEMINARS 11:20 Harnessing T Cells to Fight Cancer with Novel Multispecific 3:05 Sponsored Presentation (Opportunity Available) Antibodies ENGINEERING Jijie Gu. Ph. Janssen. Lilly. the ability to predict which patients may develop severe CRS will be and to expand into multiple indications.D. Ph. AbbVie Bioresearch Center 4:25 Efficacy and Toxicity of Targeting Shared Tissue Differentiation Modulating T cells to kill tumor cells requires the better understanding of T cell Antigens versus Neoepitopes ONCOLOGY biology for both efficacy and safety.D. Pediatrics. we will discuss the Smita Chandran. Pediatrics. Principal Investigator. ProTIA therapeutics have been not tumor escape. Assistant Professor..com | 33 . and biology of CRS... BIOASSAY STREAM Ammar Sukari. success of cellular immunotherapies against these two classes of antigens.. The expression of nonmutated self-antigens on normal tissue. Head and Neck Multi-Disciplinary Team Roche. Young. ProTIA the balance between efficacy and toxicity will be critical to the widespread ANALYTICAL molecules release their highly selective payload in the tumor microenvironment. Immunological targeting of neoepitopes and shared tissue-differentiation IMMUNOTHERAPY 11:50 ProTIA – A Novel Format of Bispecific T Cell Engagers Designed antigens can mediate complete and durable tumor regression in patients with STREAM for Activation by Tumor-Associated Proteases metastatic melanoma. ProTIA molecules are based on 4:55 Cancer Immunotherapy and Immune Related Adverse Events Amunix’ proprietary XTEN™ polymer technology which has been validated in Oncologists’ New Frontier IMMUNOGENICITY & hundreds of patients and through partnerships with partners such as Biogen. California Institute for Philadelphia Biomedical Research Chimeric antigen receptor (CAR)-modified T cells with anti-CD19 specificity are CONFERENCE-AT-A-GLANCE Given the promising results for CAR-T cells in early clinical trials. Adi Diab. off-tumor toxicity. M. MD Anderson Cancer Center Register Online! PEGSummit. The clinical presentation. Biology. there are still many THERAPEUTICS 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing un-answered questions that require more research and clinical trials to answer. is critical to the efficacy of targeting mutations.. Leader. Ph.D..

Inc. Celyad S. Our studies have revealed that targeting REGISTRATION INFORMATION A2A at either the genetic or pharmacological level significantly enhanced CAR T 9:40 How Can We Utilize Neoantigens in Personalized Therapies for cell in immunocompetent mouse models. STREAM Neoantigens for the Treatment of Solid Tumors Philip M. Gritstone Oncology. 2017 DECEMBER 23 & SAVE UP TO $550 Adoptive T Cell Therapy Clinical Progress with CAR. them more efficacious in solid cancers.D..com | 34 .D. In my talk I will highlight several such mechanisms and novel ways in which we have turned our correlative sciences and 8:40 Fully Individualized Tumor Neoantigen-Based Vaccine Approaches product development studies in enhanced tumor targeting of CART cells. M. Senior Postdoctoral Researcher. ANALYTICAL been identified as the targets of new T cells in patients responding to checkpoint Thoracic Surgery. M. We hypothesized that targeting adenosine for sensitivity.. Inc. Cancer Immunotherapy. Register Online! Patients with Tumors Having Low Mutation Profiles? Dolores Schendel.. together with insights into how vaccine functional persistence. Ph. Joseph Melenhorst. and anti-tumor function.D. Center for Cellular ONCOLOGY Personalized Immunotherapies Immunotherapies. Medigene AG 12:25 pm Sponsored Presentation (Opportunity Available) PEGSummit.D.D. Director. 11:25 Overcoming CAR T Cell Checkpoint Blockade in Solid Tumors Genetic instability in tumors generates tumor-specific neo-antigens which have Prasad S. Medigene uses its immunotherapy platform CONFERENCE-AT-A-GLANCE technologies to investigate neoantigens as future targets for vaccines and SC3: Genomics in the Service of Cancer Immunotherapy adoptive T cell therapies exploring mutated targets in tumors with low mutational SPONSORS burden. and TIL COVER Recommended Short Courses* existing neoantigen-specific T cells. Antibodies were screened using this vaccine and tested clinical trials targeting this pathway. President and CEO. David Gilham. Ph.com One important challenge in the use of neoantigens for personalized 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or immunotherapies is to understand whether neoantigens are accessible as targets only for tumors of high mutational burden and/or limited to patients with pre- Enjoy Lunch on Your Own A Division of Cambridge Innovation Institute PEGSummit. F.D. Adusumilli.A. microenvironment can guide both cell-intrinsic and extrinsic strategies that can modulate the solid tumor microenvironment in addition to promoting CAR T-cell BIOCONJUGATES 9:10 Discovery and Development of Novel Immunogenic Tumor efficiency.C. Associate Attending and Deputy Chief. specificity. Research & Development... EXPRESSION to Cancer Therapy STREAM Karin Jooss. SC11: Adoptive Therapy with CAR T Cells SHORT COURSES *Separate registration required. Product Development & Correlative KEYNOTE SESSION: Neoantigens: A Framework for Sciences Laboratories (PDCS). Neoantigens were identified in may also enhance Chimeric Antigen Receptor (CAR) T cell function. TCR. CEO and CSO.. Membrane Paul Beavis.A.D. thus making colon cancer with these functional antibodies. Predicting neo-antigens by sequencing routine clinical biopsy CAR T-cell therapy for solid tumors is prone to the checkpoint blockade inhibition material and then incorporating them into therapeutic cancer vaccines is an similar to innate tumor-infiltrating lymphocytes. Arlen. Ph. 11:55 Enhancing Chimeric Antigen Receptor T Cell Therapy by Targeting THERAPEUTICS Immunogenic Neoantigens were derived from a membrane preparation of pooled Adenosine Mediated Immunosuppression STREAM allogeneic colorectal cancer from patients undergoing surgery. University of Pennsylvania STREAM Revamping a patient’s own failed T cell repertoire with engineered tumor-targeting 8:30 Chairperson’s Remarks receptors has demonstrated efficacy with some chimeric antigen receptors (CAR). Memorial Sloan Kettering Cancer Center STREAM inhibitor therapy. CSO. Cell-intrinsic strategies to IMMUNOGENICITY & attractive concept being developed by Gritstone Oncology. Precision Biologics. Vice President. Ph..S. Adjunct Associate Professor. please see page 5-6 for course details. It has become clear that T cell-intrinsic and -extrinsic factors contribute to the IMMUNOTHERAPY STREAM clinical efficacy of this form of therapy. REGISTER BY 4th Annual | May 3-4. Ph. 10:10 Coffee Break in the Exhibit Hall with Poster Viewing TRAINING SEMINARS WEDNESDAY. Understanding solid tumor type-specific immune vectors are selected and designed. The complexities of overcome this ‘Adaptive Resistance’ of infused CAR T cells can promote their BIOASSAY STREAM neo-antigen prediction will be discussed. MAY 3 Targeting Solid Tumors ENGINEERING 7:30 am Registration and Morning Coffee 10:55 New Targets in Hematologic Malignancies and Solid Tumors STREAM J. A Recent evidence indicates that targeting adenosine-mediated immunosuppression positive correlation was observed in patients who were able to mount and sustain enhances endogenous anti-tumor T cell responses and has resulted in several HOTEL & TRAVEL IgG responses to vaccine.. Peter fractions were isolated and tested for immunogenicity and utilized in a clinical MacCallum Cancer Centre SPONSOR & EXHIBITOR INFO trial in patients with chemotherapy refractory metastatic colorectal cancer.

Seth Ettenberg. current ACT strategy poses some limitations due to generation of sub- HLA-restricted and non-HLA restricted targets that are expressed by many other optimal TIL product for many patients which leads to poor survival. Inc. A Division of Cambridge Innovation Institute PEGSummit.. CONFERENCE-AT-A-GLANCE Thoracic Surgery.com 7:00 pm End of Day ACTR T cells with Rituximab. Pre-clinical studies of a NKG2D-CD3z CAR (NKR2) show potent anti-tumor activity and also suggest that T cells bearing the We describe a novel method utilizing phylogenetic and sequencing analysis to NKR2 receptor modulate the immune component of the tumor microenvironment visualize and quantify TCR repertoire diversity.S. Ph.D.. M. Director of Cell Therapy Research. Ph. ENGINEERING healthy tissue is minimal and provides a potential route to target a broad range Johns Hopkins University STREAM of hematological and solid tumors. Bridgeman.A. STREAM Andrew Sewell. We will Register Online! describe efforts specifically targeting B-cell malignancies using a combination of PEGSummit. utilization of a co-stimulatory signaling may play a critical role in 3:15 Adoptive Cell Therapy for Cancer Using Tumour Infiltrating restoring the survival. We have developed and demonstrated a novel method to meaningfully 2:45 New T Cell Targets by Dissection of Successful Tumor-Infiltrating parse and interpret TCR repertoire data and have applied it to yield a novel IMMUNOTHERAPY Lymphocyte Therapy for Melanoma understanding of CD8 T Cell responses to different types of antigens. and despite the success STREAM of novel immunotherapeutics. M.. Such cells have 5:45 Networking Reception in the Exhibit Hall with Poster Viewing potential utility as a therapy to treat a wide range of cancer indications. CSO. Ph. we have applied it to understanding the shaping of the CD8 T Cell STREAM translation of NKR2 technology into the early stage clinical trial setting.A. To demonstrate the utility of the ONCOLOGY and also potentially target tumor neo-vasculature.com | 35 . Cancer Immunotherapy. and lack of effective anti-tumor efficacy of these cells after adoptive transfer. by examining the dominant tumor-reactive T-cell clonotypes in the TIL infusion STREAM product and patient blood after ‘cure’ has revealed some surprising. response to self (TRP2) and foreign (SIY) antigens in naïve and tumor-bearing B6 mice. there exists an unmet need for new treatments. Cardiff University School of Medicine Adoptive T Cell Therapy STREAM Over 20% of melanoma patients that have been refractory to other treatments Abhishek Srivastava. Vice President. The results reported here support the 11:05 ACTR (Antibody Coupled T Cell Receptor): A Universal Approach SPONSOR & EXHIBITOR INFO success of melanoma TIL therapy seen in other centres worldwide and suggest to T Cell Therapy that this is a viable means of treating a disease which has few effective options.D.C. NIH undergo complete lasting remission after adoptive cell transfer of tumor- infiltrating lymphocytes (TILs). Distinguished Research Professor and Wellcome Trust 9:05 Exploitation of T Cell Co-Stimulation for the Improvement of EXPRESSION Senior Investigator. BIOASSAY STREAM Therefore.D.. MAY 4 SAVE UP TO $550 Emerging Treatments and Targets 8:00 am Morning Coffee COVER 2:10 Chairperson’s Remarks Improved Techniques and Technologies for Immuno- Prasad S. Off-the-Shelf T Cells: From One for Many We have established a protocol to generate Tumour infiltrating lymphocytes (TIL) from surgically resected melanoma lesions. persistence and antitumor efficacy of these TILs in ACT. Peter David Gilham.. Adusumilli.. SHORT COURSES MacCallum Cancer Centre The effector functions of Natural killer (NK) cells are controlled by a series of activating and inhibitory receptors that provides target discrimination for 8:35 ImmunoMap: A Novel Bioinformatics Tool to Visualize and Analyze TRAINING SEMINARS the NK cell. HOTEL & TRAVEL Fusing the ectodomain of CD16 to the co-stimulatory and signaling domains 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing of 41BB and CD3z generates an Antibody Coupled T cell Receptor (ACTR). National Cancer Institute. Senior Postdoctoral Researcher. Ph. Ph. F. Celyad S.D. Associate Attending and Deputy Chief. Dissection of these extraordinary successes Adoptive T cell therapy (ACT) involves the ex vivo stimulation and expansion of ANALYTICAL autologous tumor-infiltrating lymphocytes (TIL) and re-transfers into patients. Unum Therapeutics.. Professor.D.. REGISTER BY Adoptive T Cell Therapy DECEMBER 23 & 1:55 Session Break THURSDAY. Ph. Ltd.. These data have supported the approach. Pathology Medicine and Oncology. Cellular Therapeutics.. Research & Development. persistence IMMUNOGENICITY & tumour types.D. exciting new However.D. 10:05 Coffee Break in the Exhibit Hall with Poster Viewing THERAPEUTICS The prognosis for metastatic melanoma remains poor. REGISTRATION INFORMATION T cells expressing this receptor show powerful anti-tumor cytotoxicity when 4:45 Problem-Solving Breakout Discussions co-administered with an appropriate tumor-targeting antibody. BIOCONJUGATES Lymphocytes 9:35 Sponsored Presentation (Opportunity Available) STREAM John S.D. Ph. Memorial Sloan Kettering Cancer Center Oncology SPONSORS 2:15 Exploiting Natural Killer Receptors for CAR T Cell Therapy 8:30 Chairperson’s Remarks Paul Beavis. Surgery Branch. Fellow.D. NKG2D is an activating NK receptor that binds to 8 known stress T-Cell Receptor Repertoire Sequence Data ligands. These ligands are highly expressed on tumor cells while expression on Jonathan Schneck.

M.D.S. the aNK cell platform TRAINING SEMINARS has been bioengineered to incorporate a high-affinity antibody binding Fc- receptor (haNK).com | 36 . Canada and Europe. Ph. Research & Development. Vice President. Reprogramming Biology and Cancer Immunotherapy. MBA. persistence. we demonstrate a viable method for the derivation of efficacious engineered natural killer cells. Executive Director. 12:35 End of Adoptive T Cell Therapy IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. Harnessing the power of pluripotent cell technology represents a powerful IMMUNOTHERAPY approach to make cell-based immunotherapies available to a wide range of STREAM patients through the generation of a consistent “off-the-shelf” source of cellular therapeutics. Fate Therapeutics. targeting and STREAM safety mechanisms.. Both aNK and haNK cells can be equipped with chimeric antigen receptors (CARs) (called taNK) to further optimize targeting and potency in the ENGINEERING therapeutic setting.. Moreover. REGISTER BY Adoptive T Cell Therapy DECEMBER 23 & 11:35 Continuously Growing NK Cell Line as a Source for an Off-the- SAVE UP TO $550 Shelf. By coupling the unique capacity of our pluripotent cell platform to EXPRESSION efficiently facilitate multiple genomic modifications at the single cell level with our STREAM ability to accurately recapitulate the stages of hematopoiesis.D. STREAM 12:05 pm Off-the-Shelf Cancer Immunotherapy: Engineered Pluripotent ONCOLOGY Cell-Derived Natural Killer Cells STREAM Bahram (Bob) Valamehr.. COVER NantKwest.com A Division of Cambridge Innovation Institute PEGSummit.. Inc.D. ANALYTICAL genomically-engineered with augmented potency. NantKwest has developed the NK cell line NK-92 into an “off the shelf” activated CONFERENCE-AT-A-GLANCE NK (aNK) cell therapeutic. Ph. The cells can be expanded to 1010 within two weeks without feeder layer using FDA compliant medium. Inc. Engineered NK Cell Therapeutic in Cancer and Infections Hans Klingemann. The safety of aNK as well as SPONSORS their activity against a broad range of cancers have been confirmed in several Phase I clinical trials in the U. The aNK cells can be SHORT COURSES administered in the outpatient setting and serve as a universal cell-based therapy without need for individualized patient matching.

REGISTER BY 3rd Annual | May 4-5, 2017

DECEMBER 23 &
SAVE UP TO $550
Agonist Immunotherapy Targets
Clinical Progress with CAR, TCR, and TIL

COVER
THURSDAY, MAY 4 Tom Davis, M.D., Executive Vice President and CMO, Celldex Therapeutics Inc.
CONFERENCE-AT-A-GLANCE The CD27 co-stimulation pathway for immune cells has shown potent
activity in pre-clinical models to eliminate tumors both as single agent and in
SPONSORS Case Studies with Agonist Antibodies
combination with checkpoint inhibitors. Clinical trials to date using varlilumab,
12:00 pm Registration an agonist anti-CD-27 antibody, confirm this specific immune activation without
SHORT COURSES significant immune toxicity. Single agent responses have been seen and multiple
12:35 Luncheon in the Exhibit Hall with Poster Viewing collaborative studies of varli in combination are ongoing.
TRAINING SEMINARS
1:40 Chairperson’s Remarks 4:50 JTX-2011: Development of an Agonist Antibody Targeting ICOS
Peter Ellmark, Ph.D., Principal Scientist, Research & Development, Alligator Jennifer Michaelson, Ph.D., Executive Program Leader, Senior Director of
ENGINEERING Bioscience Preclinical Development, Preclinical Development, Jounce Therapeutics Inc.
STREAM
JTX-2011 is an agonist antibody to the co-stimulatory molecule ICOS. Preclinical
studies demonstrated efficacy in syngeneic tumor models, with enhanced
ONCOLOGY efficacy in combination with PD-1 inhibitors. JTX-2011 induces T effector cell
STREAM 1:50 KEYNOTE PRESENTATION: Engineering of an ICOS Agonist activation and also preferentially reduces T regulatory cells in the tumors. This
Antibody for Cancer Therapy dual mechanism contributes to the significant anti-tumor response observed in
IMMUNOTHERAPY Axel Hoos, M.D., Ph.D., Senior Vice President, Therapeutic Area Head for Oncology preclinical models. A promising safety profile was revealed in preclinical studies.
STREAM R&D, GlaxoSmithKline Pharmaceuticals, Inc. JTX-2011 is in clinical development as a monotherapy and in combination with
anti-PD-1 therapy.
EXPRESSION 5:20 End of Day
STREAM 2:20 Tumor-Directed Immunotherapy – Tumor-Localized Immune
Activation Using TNFR-SF Agonistic Antibodies 5:20 Registration for Dinner Short Courses
ANALYTICAL Peter Ellmark, Ph.D., Principal Scientist, R&D, Alligator Bioscience
STREAM Alligator Bioscience develops mono and bispecific agonistic antibodies, targeting Recommended Dinner Short Course*
TNFR-SF members, for tumor-directed immunotherapy of cancer. This approach
IMMUNOGENICITY & provides new opportunities to generate an effective, immune-mediated, anti-tumor SC18: Clinical Prospects of Cancer Immunotherapy
response. Alligators pipeline projects will be presented, including ADC-1013, a *Separate registration required, please see page 5-6 for course details.
BIOASSAY STREAM human monospecific agonistic IgG1 antibody in clinical development and ATOR-
1015, a bispecific antibody targeting OX40 and CTLA-4 developed to deplete Tregs
BIOCONJUGATES FRIDAY, MAY 5
in the tumor microenvironment.
STREAM
2:50 OX40: From Bench to Bedside and Back Again 8:00 am Morning Coffee
THERAPEUTICS Brendan Curti, Director, Genitourinary Oncology Research, Immunotherapy Clinical
Program, Providence Medical Group Emerging Science
STREAM
Cancer immunotherapy is an evolving treatment that boosts the immune system 8:30 Chairperson’s Remarks
to recognize and destroy cancer cells. Head and neck squamous cell carcinomas Roland Kontermann, Ph.D., Professor of Biomedical Engineering, Institute of Cell
SPONSOR & EXHIBITOR INFO (HNSCC) produce suppressive factors that impair the immune system, thus Biology and Immunology, University of Stuttgart
limiting effective antitumor immunity. OX40 is a member of the tumor necrosis
HOTEL & TRAVEL factor (TNF) receptor family and a potent co-stimulatory pathway that when 8:35 Duokines: A New Class of Bifunctional Immunostimulatory
triggered can enhance T-cell memory, proliferation and anti-tumor activity in Molecules
REGISTRATION INFORMATION patients with metastatic cancer.
Roland Kontermann, Ph.D., Professor of Biomedical Engineering, Institute of Cell
3:20 Sponsored Presentation (Opportunity Available) Biology and Immunology, University of Stuttgart
Register Online! Duokines are bifunctional fusion proteins of TNF ligand superfamily members
3:50 Refreshment Break expressed either as homotrimer molecules or as single-chain derivatives. They act
PEGSummit.com either in cis or in trans and are capable of amplifying immune responses, e.g., as
4:20 Varlilumab, an Agonist Anti-CD27 Antibody, as Single Agent and in shown for the antitumor activity of T-cell retargeting bispecific antibodies.
Combination

A Division of Cambridge Innovation Institute PEGSummit.com | 37

REGISTER BY Agonist Immunotherapy Targets
DECEMBER 23 &
SAVE UP TO $550 9:05 The Tetravalent, Bispecific CD30/CD16A TandAb AFM13 is a Combinatorial Therapies: Using Antagonists and Agonists
Prototype NK-Cell Engager with Unique CD16A-Binding Properties to Maximize Response
Martin Treder, Ph.D., CSO, Affimed, NV.
COVER AFM13 is currently in Phase II clinical development in Hodgkin lymphoma (HL) 11:35 Enhancing Checkpoint Inhibitor Efficacy via Combination with
and other CD30+ malignancies. It engages NK-cells through CD16A with high CMP-001, a VLP Packaged TLR9 Agonist
CONFERENCE-AT-A-GLANCE affinity and specificity and confers significantly stronger NK-cell activation Aaron Morris, Senior Director, Research, Checkmate Pharmaceuticals, Inc.
compared to other therapeutic antibodies. We have previously shown synergistic Addition of TLR9 agonist CMP-001 to a standard checkpoint inhibitor regimen can
SPONSORS efficacy when NK-cell activation through AFM13 is combined with checkpoint induce a strong anti-tumor response when checkpoint inhibition alone has failed.
modulation such as anti-PD-1 treatment, which is known to unleash T-cell and NK- CMP-001 is a formulation of a CpG-A oligonucleotide, G10, within a Qb virus-
SHORT COURSES cell activity. Mechanism of action as well as mono- and combination therapeutic like particle (VLP). Preclinical studies and a phase Ib clinical trial have shown
approaches of an NK-cell engager will be discussed. induction of robust anti-tumor immunity and tumor regression when CMP-001 is
TRAINING SEMINARS combined with anti-PD-1 therapy.
9:35 Activation of Myeloid IL-27 Production Initiates 4-1BB Agonist
Hepatotoxicity 12:05 pm Clinical Safety and Efficacy Assessment of CD137 in
ENGINEERING Michael A. Curran, Ph.D., Assistant Professor, Immunology, MD Anderson Cancer Combination with Nivolumab
STREAM Center Erminia Massarelli, M.D., Ph.D., MS, Associate Clinical Professor, Medical Oncology
The clinical progression of 4-1BB agonist antibodies has been stymied by and Therapeutics Research, City of Hope
ONCOLOGY limited understanding of their underlying mechanism of action and the resulting
STREAM inability to separate off-target liver toxicity from on-target anti-tumor immunity. 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or
By analyzing the mechanisms underlying this toxicity, we have revealed novel Enjoy Lunch on Your Own
insights into 4-1BB biology which can inform design of novel antibodies or
IMMUNOTHERAPY combination strategies which favor tumor clearance over liver inflammation. 1:05 Refreshment Break
STREAM
10:05 Coffee Break Target Discovery Approaches in Immuno-Oncology
EXPRESSION
STREAM 10:35 Agonist Redirected Checkpoints for Cancer Immunotherapy 1:35 Chairperson’s Remarks
Taylor Schreiber, M.D., Ph.D., Scientific Founder, R&D, Shattuck Labs, Inc. Harpreet Singh, Ph.D., President & CEO, Immatics US, Inc.
ANALYTICAL This presentation will outline the production, pre-clinical characterization and
STREAM early GMP manufacturing for a lead ARC construct that simultaneously blocks 1:40 Exploring the Intracellular Proteome for the Identification and
signaling through PD-1 and activates signaling through OX40. This construct Validation of Novel Targets for Cancer Immunotherapy
demonstrates significantly superior tumor rejection in multiple pre-clinical models Yoram Reiter, Ph.D., Professor & Head, Laboratory of Molecular Immunology,
IMMUNOGENICITY & as compared to either PD-1/L1 or OX40 specific antibody therapy. Technion-Israel Institute of Technology
BIOASSAY STREAM
T-cell receptor-like (TCRL) antibodies bind HLA-peptide complexes on the surface
11:05 Selection of Fc for Antibody Therapeutics to Achieve Optimal of cells and can bind specifically to the cell surface of diseased cells, thus,
BIOCONJUGATES Antitumor Immunomodulating Activity transforming intracellular disease-specific targets expressed inside malignant
STREAM Jieyi Wang, Ph.D., CEO, Lyvgen Biopharma cells into targets that can be recognized on the cell surface by soluble TCRL
Therapeutic antibodies have become important biologics for cancer antibodies. These antibodies can be armed with various modalities or they can
THERAPEUTICS immunotherapy. Their modes of action not only rely on variable domains be used as naked molecules to modulate responses or environments associated
STREAM responsible for specificity but also involve the constant domains that can with immunity towards the target cells. This approach expands the pool of
interact with various Fc receptors. Blocking antibodies such as nivolumab and novel therapeutic targets and antibodies beyond the limits of currently available
pembrolizumab were successfully developed in the clinic as IgG4 molecules. antibodies.
SPONSOR & EXHIBITOR INFO However, it is not clear what IgG isotypes would be optimal for agonist antibodies
that are required to activate co-stimulatory targets such as CD40, OX40, CD27, 2:10 Novel Targets for Cancer Immunotherapies: The XPRESIDENT®
HOTEL & TRAVEL CD137, GITR, ICOS and HVEM. Approach
Harpreet Singh, Ph.D., President & CEO, Immatics US, Inc.
REGISTRATION INFORMATION Targeted adoptive cell therapies have been highly successful in achieving durable
clinical responses in B-cell malignancies based on targeting CD19. Novel T-cell
targets are required to expand this success to solid cancers. Here we present
Register Online! the outcome of the Human Immunopeptidome Program through applying our
PEGSummit.com proprietary XPRESIDENT® target discovery strategy which employs systematic
high-throughput and ultra-sensitive quantitative tandem mass spectrometry
combined with next-generation sequencing and T-cell receptor discovery.

A Division of Cambridge Innovation Institute PEGSummit.com | 38

REGISTER BY 3rd Annual | May 4-5, 2017

DECEMBER 23 & Agonist Immunotherapy Targets
SAVE UP TO $550 Clinical Progress with CAR, TCR, and TIL

COVER
2:40 Development and Validation of a Phenotypic Screening Platform 3:10 Emerging Innate Immune Targets for Enhancing Adaptive Anti-
CONFERENCE-AT-A-GLANCE for the Identification of Novel Immuno-Oncology Targets Tumor Responses
Christophe Quéva, Ph.D., CSO, iTeos Therapeutics SA Michael Rosenzweig, Ph.D., Executive Director, Oncology Discovery, Merck
SPONSORS A co-culture assay combining immune suppressive cells and T-cells has been Research Labs
set up to allow the identification of novel immune-oncology targets by screening Novel cancer immunotherapies targeting T cell checkpoint proteins have emerged
SHORT COURSES chemicogenomics, shRNA and cDNA libraries. Multi-parameter readouts are as powerful tools to induce profound, durable regression and remission of many
combined to assess both T cell activation and proliferation, through high content types of cancer. Despite these advances, multiple studies have demonstrated that
TRAINING SEMINARS imaging, complemented with detection of IFNγ secretion, as well as tumor cell not all patients respond to these therapies, and the ability to predict which patients
death, as assessed using a cytotoxicity assay. Application of this screening assay may respond is limited. Harnessing the innate immune system to augment
ENGINEERING to the identification of rationale combinations will be described. the adaptive anti-tumor response represents an attractive target for therapy,
STREAM which has the potential to enhance both the percentage and rate of response to
checkpoint blockade.

ONCOLOGY 3:40 End of Conference
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IMMUNOTHERAPY
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EXPRESSION
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ANALYTICAL
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IMMUNOGENICITY &
BIOASSAY STREAM

BIOCONJUGATES
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THERAPEUTICS
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SPONSOR & EXHIBITOR INFO

HOTEL & TRAVEL

REGISTRATION INFORMATION

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PEGSummit.com

A Division of Cambridge Innovation Institute PEGSummit.com | 39

REGISTER BY
DECEMBER 23 &
SAVE UP TO $550
EXPRESSION STREAM
COVER

CONFERENCE-AT-A-GLANCE

SPONSORS
Difficult to Express Proteins
SHORT COURSES

TRAINING SEMINARS Optimizing Protein Expression
ENGINEERING
STREAM
Protein Expression System Engineering
ONCOLOGY
STREAM

IMMUNOTHERAPY
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EXPRESSION
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ANALYTICAL
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IMMUNOGENICITY &
BIOASSAY STREAM

BIOCONJUGATES
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PEGSummit.com

A Division of Cambridge Innovation Institute PEGSummit.com | 40

CHO and We identified and characterized an epitope that reports correct protein BHK and this is an attractive alternative for glycosylation and biosafety concerns. Researcher. The epitope formation required the oxidation of four 11:20 Engineering High-Titer Heterologous Protein Secretion in cysteine residues located individually in the four separate extracellular regions of Bacteria IMMUNOGENICITY & GPR34. Associate Professor..D. Principal Scientist.6- sialyltransferase (ST6Gal1) was expressed in Chinese hamster ovary (CHO-K1) 11:50 Improving Membrane Protein Overexpression in Mammalian Cells SPONSOR & EXHIBITOR INFO cells. MAY 1 Engineering for Successful Expression ENGINEERING 7:00 am Registration and Morning Coffee 10:45 Chairperson’s Remarks STREAM Haruki Hasegawa. Biomolecular Engineering. on Membrane Protein Structure (NYCOMPS) IMMUNOTHERAPY STREAM The ease of use. Northwestern University BIOCONJUGATES Biomaterial production in bacteria would benefit greatly from a high-titer secretion 9:10 Glycoengineering of Chinese Hamster Ovary Cells for Enhanced strategy..D. SC8: In silico Immunogenicity Predictions (Hands-On) Workshop SHORT COURSES *Separate registration required.D..D. Ph. but are favourably expressed in a functional state in mammalian cells. Ph. membrane topology. the expression levels can often be too low for protein Register Online! 9:40 KEYNOTE PRESENTATION: Design of Water-Soluble Variants of structural studies requirements. Inc. Department of Chemical and preferred strategies for GPCR antigen design.. cost-effectiveness. REGISTER BY 12th Annual | May 1-2. please see page 5-6 for course details. Principal Scientist.. This system can be readily adapted for high- EXPRESSION Topology. called BacMam can be used to transduce mammalian cells like HEK. Using an optimised protocol of flow cytometric Membrane Proteins to Facilitate “Soluble Expression” sorting to generate stable-cell lines can significantly and sufficiently improve the PEGSummit. Therapeutic Discovery... expression and characterization of a water-soluble variant of a human GPCR. The modified pFastBac vector with mammalian promoter STREAM Haruki Hasegawa. We engineered the type III secretion system in Salmonella enterica for STREAM Erythropoietin N-Glycan Branching and Sialylation this purpose because it is non-essential for bacterial metabolism and allows Michael J. Ph. and post-translational machinery 8:40 Investigation of GPR34 Topogenesis and Cell Surface Trafficking make the baculovirus expression system a popular choice for production of by Monitoring a Unique Epitope That Is Simultaneously Sensitive to eukaryotic membrane proteins. Ph. robustness. Amgen.D. coordinated overexpression of these three glycosyltransferases by Flow Cytometric Sorting HOTEL & TRAVEL for the first time in model CHO-K1 cell lines provides a means for enhancing both Juni Andréll. Ph. 10:10 Coffee Break TRAINING SEMINARS MONDAY. N-glycosylation of recombinant erythropoietin (rEPO). but also suggested of Membrane Proteins and Protein Membranes. the human A Division of Cambridge Innovation Institute PEGSummit. New York Structural Biology Center. However.com | 41 . In this way.com Jeffrey G. University of Pennsylvania inducible expression of different membrane proteins in mammalian cells.D. Inc. Ph. Amgen. University of N-glycan branching complexity and sialylation with opportunities to generate Stockholm REGISTRATION INFORMATION tailored complex N-glycan structures on therapeutic glycoproteins in the future. Chemistry. Johns Hopkins University enables the high-titer production of a variety of challenging biomaterial-forming STREAM In order to examine the impact of glycosyltransferase expression on the proteins at titers >100 mg/l and >85% purity. Ph. Laboratory for the Engineering BIOASSAY STREAM only illustrated the challenges of raising mAbs against GPCRs. Therapeutic Discovery. Kalathur. Professor. which is involved in pain and addiction. a human α2.D. Solving Protein Expression Problems with Innovative ONCOLOGY Strategies 10:50 High-Throughput Baculovirus Expression System for Membrane STREAM Protein Production 8:30 Chairperson’s Remarks Ravi C. ANALYTICAL conformation. Department of Chemical and Biomolecular for target proteins to cross both bacterial membranes in one step. New York Consortium Haruki Hasegawa. Many membrane proteins from higher eukaryotic organisms cannot be expressed in bacterial or yeast systems.D. and cell surface trafficking competency of a STREAM GPCR family member GPR34.. Inc. 2017 DECEMBER 23 & SAVE UP TO $550 Difficult to Express Proteins Strategies for Taming “Finicky” Proteins COVER Recommended Short Courses* mu opioid receptor (MUR). Betenbaugh. and Redox Status throughput operations. Here we present the first study involving the computational design. The underlying biochemical properties of the conformational epitope not Danielle Tullman-Ercek. Principal Scientist. Amgen. Ph. Our platform THERAPEUTICS Engineering. This study CONFERENCE-AT-A-GLANCE exemplifies the potential of the computational approach to produce water- SC6: In-silico Protein Docking soluble variants of GPCRs amenable for structural and functionally related SPONSORS characterization in aqueous solution. Conformation. Therapeutic Discovery. Biochemistry and Biophysics. Saven.

penetration. They have potential BIOCONJUGATES in many indications. Trinity College and Co-Founder and metabolisms to stimulate reporter protein synthesis up to 2 mg/ml in batch Director. LMBB.D. Recent case studies will include secretion of functional antibody fragments and enzymes to the fermentation broth with up to 14 g/L. coli expression systems 8:00 am Registration and Morning Coffee CONFERENCE-AT-A-GLANCE ESETEC® and FOLDTEC®. Staff Scientist. but a limitation of the system has been the requirement for Sequencing and Design stable integration of heterologous genes that can result in high clonal variability SPONSOR & EXHIBITOR INFO Tim Whitehead.D. My talk will present an overview of the above and detail Designing Expression to Facilitate Purification PEGSummit.com | 42 . Post-Doctoral Senior Researcher. Ph. University of Minnesota In vitro transcription-translation (TX-TL) is becoming a highly versatile technology ANALYTICAL 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation for applications in synthetic biology and quantitative biology..com methodological improvements that enable the engineering work.D. Genome Sciences. coli refolding platform FOLDTEC®. Ph. a novel toxin Screens and Structural Studies in Pichia pastoris delivery platform which greatly improves toxin loading into tumour tissues. Selenocysteine high reactivity can be used to introduce site-specific chemistry into the protein scaffold. We have developed a new method to prepare IMMUNOTHERAPY 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing selenoproteins using expressed chemical ligation. Operations. We implemented novel Sir Gregory Winter. specificity.0: A Platform for Cell-Free EXPRESSION Synthetic Biology STREAM 4:00 Chairperson’s Remarks Vincent Noireaux. Large-Scale Affinity Purification of the Functional G 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing Protein-Coupled Receptors A Division of Cambridge Innovation Institute PEGSummit.. Ph. 1:50 Session Break They play a cardinal role in the management and regulation of reactive ONCOLOGY oxygen species. Wilburn. School of Physics and Astronomy. REGISTER BY Difficult to Express Proteins DECEMBER 23 & 12:20 pm New Solutions for Production of Sponsored By 6:55 End of Day SAVE UP TO $550 Difficult-to-Express Proteins Guido Seidel. including oncology. Ph. Chemical Engineering and Materials and limit high throughput screening. THERAPEUTICS presentation will describe both the Bicycle® and BDC platforms. Selenoproteins remain understudied because of the technical STREAM 2:20 Problem-Solving Breakout Discussions challenges associated with their production since the selenocysteine codon UGA also encodes a stop codon..D.. STREAM PLENARY KEYNOTE SESSION 9:00 The All E. during. This Damien B. NIH/ NIAAA 12:50 Luncheon Presentation I: Engineering of Antibodies forSponsored By 8:30 Utilizing Selenocysteine for Expressed Protein Ligation and TRAINING SEMINARS Humanization and Developability using Machine Learning Bioconjugations Speaker to be Announced Sharon Rosovsky. ENGINEERING University of Delaware STREAM 1:20 Luncheon Presentation II (Sponsorship Opportunity Available) Selenoproteins are enzymes that contain the rare amino acid selenocysteine. Bicycle Therapeutics mode reactions and 6 mg/ml in semi-continuous mode. where Bicycles’ unique properties 9:30 Applications of panARS-Based Vectors for High Throughput STREAM have been used to develop Bicycle Drug Conjugates™ (BDCs). Managing Director. I will present a STREAM Therapeutics unique TXTL system that my laboratory has developed. REGISTRATION INFORMATION a high-throughput screen or selection for function. and after protein yield in Pichia expression systems. Assistant Professor. MAY 2 COVER Wacker Biotech will present highly competitive solutions for production of difficult-to-express proteins based on its proprietary E. Ph. Assistant Professor. Chemistry and Biochemistry.D. Ph. Scaffolds and Synthetic Biology SPONSORS Together with its E.. coli TX-TL Toolbox 2. Here we describe expression of multiple Science. My group leverages this unprecedented wealth of sequence-function information to design and 10:00 Coffee Break in the Exhibit Hall with Poster Viewing engineer protein affinity. We use this experimental IMMUNOGENICITY & Bicycles® are a novel therapeutic class of constrained bicyclic peptides that platform for synthetic biology.D. Wacker Biotech GmbH TUESDAY. University of Washington STREAM Pichia pastoris is widely considered an industrial workhorse for expression of 4:55 Young Scientist Keynote: Programming Proteins by Deep recombinant proteins. Master. 10:50 High Yield. and function and to infer structural Register Online! complexes of proteins. from gene circuit prototyping to the cell-free BIOASSAY STREAM combine antibody-like affinity and selectivity with small molecule-like tissue synthesis of entire bacteriophages. tunable exposure and chemical synthesis. Michigan State University protein constructs using episomal vectors that include panARS: an autonomous HOTEL & TRAVEL Next-generation sequencing has presented protein scientists with the replicating sequence that enables stable plasmid maintenance and excellent ability to observe entire populations of molecules before. Wacker Biotech offers a novel and comprehensive approach to rapidly assess manufacturability of 8:25 Chairperson’s Remarks SHORT COURSES therapeutic proteins. FRS. Alexei Yeliseev.

. coli. offering important advantages 2:00 Chairperson’s Remarks in particular for difficult-to-express proteins. Randolph P. We present our work flow. Ph. Protein Engineering. growth media. temperature.g. Sponsored By BIOCONJUGATES 12:20 pm Luncheon Presentation I to be Announced 4:55 Stable Drosophila Cell Lines: An Alternative Approach to STREAM 12:50 Luncheon Presentation II (Sponsorship Opportunity Exogenous Protein Expression Available) or Enjoy Lunch on Your Own Thomas Krey. Scientist. Cuello. Spiders Do It? using those transfectants.Calponin Homology domain was purified but precipitated before crystallization trials. biophysical assessment of protein stability in overexpressed in colon cancer. maltose-binding protein and small affinity tags. Institute of Virology. Senior Scientist. with yields up to 2-3 mg/ L. and Detergent Optimization for Biophysical and Structural STREAM Characterization Expression Success Stories Raquel Lieberman. Mammalian (CHO) Cells and its Application in Therapeutic Proteins SPONSORS Production 11:20 A Systematic Approach to Improve the Expression and Gargi Roy. Here we present the methodology that is required for the generation of REGISTRATION INFORMATION stable Drosophila S2 cell transfectants and for production of recombinant proteins 2:05 Making Spider Silk: How Hard Can It Be... Intrexon Corporation membrane protein. protein ANALYTICAL studies. However. COVER demonstrate an efficient isolation of functional CB2 receptor labeled with stable isotopes in minimal medium. very large and composed 5:30 Registration for Dinner Short Courses of very few amino acids. Cell Physiology and Molecular for monitoring the UPR activation in IgG expressing cells. ImmunoOncology glycosylated multi-domain proteins that are stabilized by a complex disulfide Division. Staff Scientist. Lewis. This ENGINEERING We developed a method for the production of membrane proteins in E. a synchrotron beam was utilized to solve aspartyl proteases from archaeal organisms. The protocols developed in our laboratory can be 2:35 Development of a Dual Fluorescent Protein Reporter System CONFERENCE-AT-A-GLANCE applied to expression and purification of other membrane receptors for structural for Detection of Unfolded Protein Response Pathway Activation in and functional studies. reporter system with its ability to monitor the stress has a potential for devising STREAM The method consists in the systematic pipeline evaluation of different: E. coli We developed a reporter system that detects IRE1α mediated XBP1 splicing Luis G. Structural Virology Group.. therapeutics. School of Chemistry & Biochemistry. USTAR Professor. These each lead to complications when trying to express these proteins in quantities needed to develop commercial products.IQGAP1.. Georgia Institute of 4:25 IQGAP1 Protein Purification and X-Ray Crystallography EXPRESSION Technology Vinodh Kurella. Protein Engineering.. LMBB. Ph.coli solutions to some of these unique We purified the recombinant CB2 expressed in E. blockers or inhibitors. NIH/ NIAAA With a major focus on expression in E.D. inexpensive detergents for solubilizing the target membrane protein alongside Sponsored By ONCOLOGY optimizing the ionic strength. Health Sciences Center We demonstrate that it can be used to isolate high expresser clonal hosts.com Spider silk proteins are unique in being highly repetitive. coli.4 Å. protein STREAM purification and tag removal. We Brief discussions of other expression systems will be presented. Texas Tech University we show ER stress activation in stable IgG expressing cells during fed-batch.com | 43 . and detergent concentration determination using thin-layer IMMUNOGENICITY & stabilization and also yielded high-quality crystals. Senior Scientist. the structure to 2. e. coli cells as a fusion with problems will be discussed as well as identifying difficulties still to be overcome. Using this reporter TRAINING SEMINARS Biophysics and Center for Membrane Protein Research. ImmunoOncology STREAM We outline the protocol developed in our lab to produce a multipass α-helical Division. Ph. Intrexon Corporation pattern. Register Online! Utah State University 5:25 End of Difficult to Express Proteins PEGSummit.D. A Division of Cambridge Innovation Institute PEGSummit. REGISTER BY Difficult to Express Proteins DECEMBER 23 & SAVE UP TO $550 Alexei Yeliseev. MedImmune SHORT COURSES Purification of Membrane Proteins in E. IQGAP1. from ortholog selection to protein Protein purification process is a prelude to X-ray crystallography for certain purification. Biology / Synthetic Bio-Manufacturing. in-house diffraction chromatography. Ph.D.D. Hannover THERAPEUTICS Medical School STREAM 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing Among numerous expression systems. 3:05 Presentation to be Announced STREAM 11:50 Lessons from an α-Helical Membrane Enzyme: Expression. Ph.. chemical chaperones. including molecular biology for plasmid construction.D. Construct redesign lead to different detergents. We focus on results from our ongoing work with intramembrane BIOASSAY STREAM pattern revealed a fragile crystal.D. expression in E.. Ph. membrane proteins or heavily HOTEL & TRAVEL Vinodh Kurella. and temperature.D.D. Associate Professor. Ph. 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing IMMUNOTHERAPY Purification. pH. SPONSOR & EXHIBITOR INFO Building on Successful Expression Experience Stable expression in Drosophila S2 cells represents an attractive alternative to the widely used baculovirus expression system. coli strategies for the selection of high expressers and improved yields of bio- strains. A case study will be presented on a scaffold protein .. Finally. Ph. membrane isolation and detergent solubilization. insect cells provide the possibility to produce complex target proteins that require posttranslational modifications.

12:25 pm New Tools for Screening & Harvesting Solutions Sponsored By for CHO & HEK293 Cells. molecules for multi-pathway-inhibition or specific tumor-targeting will be given. PEGSummit. Vienna Ulrich Göpfert. HOTEL & TRAVEL challenges for technical development.com | 44 . We examined a EXPRESSION Demanding Protein Expressions: Protein Sciences the BioPharma Way variety of epigenetic modifications and identified molecular indicators which STREAM David Humphreys. A number of novel antibody formats have been advanced into clinics by Roche Technologies presented include well plates and culture tube systems with SPONSOR & EXHIBITOR INFO pRED. CHO cell lines are prone to production STREAM instability.. Roche Innovation Center that mimic large-scale bioreactors in non-controlled devices from 1mL-3L. Director and Head. and thorough comparison between Expi293 and ExpiCHO SC13: Phenotypic Screening Applications and Technologies will be presented. Morse.. Data will be presented on techniques and technology STREAM Development.D. Silencing of recombinant genes may be 8:40 KEYNOTE PRESENTATION: Protein Expression Demands and accompanied by DNA methylation and histone modification. Novartis Pharma AG STREAM Protein Expression Strategies 11:25 Prediction and Mitigation of Production Instability of ONCOLOGY Recombinant CHO Cell Lines 8:30 Chairperson’s Remarks STREAM Oliver Spadiut.D. Ph. Protein Sciences.. Protein expression in BioPharma can span from small quantity bespoke ANALYTICAL expression of antigenic proteins for immunisations and assays. Pharma Research and Early and HEK293 cell lines. which may be caused by promoter silencing. or post-transcriptional effects. coli to mammalian cells to meet Development BIOASSAY STREAM project and manufacturing demands. These will be highlighted in a general protein expression context.D. MAY 3 10:55 Deletion of a Telomeric Region on Chromosome 8 Correlates with Higher Productivity and Stability of CHO Cell Lines ENGINEERING 7:30 am Registration and Morning Coffee Thomas Jostock. Ph.D. Group Head. Associate Director.D. Principal Investigator.. Vice President & Biochemist. Process Research. 2017 DECEMBER 23 & SAVE UP TO $550 Optimizing Protein Expression Enhancing Expression Systems COVER Recommended Short Courses* antibodies. Ph. Examples on innovative therapeutic All of these tools will be presented with case studies from scientists. Principal Research Scientist. The selection of expression system for antibody therapeutics and CONFERENCE-AT-A-GLANCE ERTs will be discussed. CHO Expression TRAINING SEMINARS WEDNESDAY. Discovery Research.. Ph. In order to discover and develop differentiated monoclonal antibodies. REGISTER BY 7th Annual | May 3-4. please see page 5-6 for course details. A new direct harvesting technique will also be Roche’s strategy is based on engineering technologies that bear several introduced that eliminates centrifugation while maintaining 0. Roche Innovation Center University of Technology IMMUNOTHERAPY During expansion and maintenance.D. large numbers 11:55 Signal Peptide Processing of Material Produced in CHO Stable STREAM of antibodies to support project discovery needs through proteins for structural Cell Lines studies to therapeutic antibody manufacturing systems. for Both Transient and Stable Cell BIOCONJUGATES Sam Ellis. Principal Scientist. Cell Line & Molecular Development. Thomson Instrument STREAM 9:10 Early Development Strategies for Innovative Therapeutic Company Molecules Now and Then Evaluation of different transfection tools. UCB NewMedicines provide the opportunity to enrich stable producers. Ph.. UCB uses a whole range Barry A. Head. Ph. Ph. and titer for both CHO THERAPEUTICS Nicola Beaucamp. Cell Line Development.2um sterile filtration. Inc. 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or REGISTRATION INFORMATION 9:40 Alexion’s Protein Production Process and Platforms: Comparison Enjoy Lunch on Your Own of Expi293 and ExpiCHO Expression Systems 1:55 Session Break Register Online! Tadas Panavas. loss of transgene copies. Alexion Pharmaceuticals. product quality. SPONSORS SC17: Transient Protein Production in Mammalian Cells 10:10 Coffee Break in the Exhibit Hall with Poster Viewing SHORT COURSES *Separate registration required.com This presentation will showcase how Alexion has implemented streamlined Escherichia coli processes across multiple sites to automate our engineering and production 2:10 Chairperson’s Remarks of enzyme replacement therapeutics (ERTs) as well as single and multi-domain A Division of Cambridge Innovation Institute PEGSummit. incorporated filtration methodology. Biochemical Engineering.D. Janssen Research and IMMUNOGENICITY & of expression and purification systems from E..

D. Ph. ONCOLOGY University of Technology STREAM I will show our ongoing work. Manufacturing Sciences and Technology. as well as STREAM Body Processing in E. amount. Ph.D. coli position these novel systems within the available range of biopharmaceutical Oliver Spadiut.. IBA Lifesciences immunogenicity of our FDA-approved Trivalent and Quadrivalent Influenza STREAM IBA is focused on building a comprehensive product portfolio around its Vaccines. purity). Alexion Improving Production Pharmaceuticals. coli physiology and productivity. I will present the data on the production. Roche Innovation Center John Hunt. 2) demonstrate the effects Strategy in Large Scale Biotherapeutics Manufacturing IMMUNOTHERAPY of induction on inclusion body properties (size. allowing to customize these structures for particular ENGINEERING therapeutic functionality. oligomeric forms and proteins with its cognate 8:00 am Morning Coffee partners in very high quantities by multicopy integration. Biochemical Engineering. where we 1) understand the effect of lactose/ 9:05 Implement High Temperature Short Time (HTST) Viral Control IPTG induction on E. 12:35 End of Optimizing Protein Expression A Division of Cambridge Innovation Institute PEGSummit. CEO. Chemical. 4:45 Problem-Solving Breakout Discussions 12:05 pm Pichia-Based Recombinant Proteins: From Difficulty to HOTEL & TRAVEL Development 5:45 Networking Reception in the Exhibit Hall with Poster Viewing Chandrasekhar Gurramkonda. Lead Discovery. Ph. Our new codon-influence Glycosylation is the most common post-translational modification on metric differs significantly from prior expectations and permits generation of biopharmaceuticals produced in eukaryotic hosts. Vienna expression hosts. Pharma Research and Early COVER mRNA Levels Development. Process Research. REGISTER BY Optimizing Protein Expression DECEMBER 23 & SAVE UP TO $550 Tadas Panavas.. Srivastava.D. Ph. THERAPEUTICS assays. Associate Director.D. Verdant Therapeutics.. Kuhner Shaker. Developments over the past TRAINING SEMINARS diverse synonymous gene sequences that consistently drive high level protein decade have enabled to achieve higher levels of control over the glycan structures overexpression. Ph. Columbia University CONFERENCE-AT-A-GLANCE We have developed new computational gene-design algorithms based on 8:35 Pathway Engineering for Customizing Eukaryotic Protein multiparameter modeling of results from 6. Our analyses Nico Callewaert. and strategy to perform process improvements for yield improvement. and codon usage.. MAY 4 simple buffer and GRAS host for the expression of recombinant proteins such PEGSummit. proprietary Strep-tag® technology to provide solutions for protein production and Will also present the data on ZIKV vaccine development program. 8:30 Chairperson’s Remarks 2:15 Codon Influence on Protein Expression in E. REGISTRATION INFORMATION Biochemical and Environmental Engineering. Ph. density. Ph. and 3) Min Zhang..D.D. Protein Sciences Corp. Senior Scientist. Biological Sciences.D. Ph.348 experiments employing Glycosylation SPONSORS bacteriophage T7 polymerase to drive protein overexpression E. coli.D. including cloning. Because of its ability to reach high-cell densities. Professor. it can grow in THURSDAY. Senior Project Manager. Director.com | 45 .. Ghent define the relative influence of mRNA sequence parameters including predicted University SHORT COURSES folding energy. characterization and BIOCONJUGATES and Proteins. AstraZeneca/ STREAM finally show how induction and consequent inclusion body properties affect the MedImmune subsequent inclusion body processing (wash.com as disulphide bonded proteins. Ph. Protein Production. Head. In this talk. purification and immobilization. coli Correlates with Nicola Beaucamp. on biopharmaceuticals. Uwe Carl. Protein Titers in Green Algae SPONSOR & EXHIBITOR INFO 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing Miller Tran. Discovery Research. expression. Head. base composition. Strep-Tag Products In this talk. Inc. I will discuss Pichia pastoris GlycoSwitch 2:45 How Induction Impacts Inclusion Body Properties and Inclusion (TM) and mammalian cell/yeast/plant GlycoDelete technologies. Inc.D.. solubilization.D. Vice President. Principal Investigator. Inc. Ph. Especially STREAM our 3rd generation Strep-tag® system is superior to other systems due to its 11:35 Optimizing Genetic Tools and Production Strategies to Increase extreme high affinity and still reversible binding. VIB Medical Biotechnology Center. Product Realization. refolding). University of Maryland 7:00 End of Day Pichia pastoris emerged as a next door expression organism for many scientists Register Online! and engineers. Director. Sponsored By 9:35 Sponsored Presentation (Opportunity Available) EXPRESSION 3:15 Expression Flexibility at the 2-12L scale: SB10 STREAM 10:05 Coffee Break in the Exhibit Hall with Poster Viewing Orbital-Shaken SUB for High Density Cultivation in Multiple Cell Types ANALYTICAL David Laidlaw. Research Assistant Professor... Alternative Expression Systems STREAM 3:30 The 3rd Generation Strep-tag® System – Superior 11:05 Application of a Baculovirus Platform for the Production of Sponsored By IMMUNOGENICITY & Performance in Protein Purification and Assays with Vaccines BIOASSAY STREAM Strep-Tactin®XT Indresh K..

Technical University of Denmark IMMUNOGENICITY & Using high-throughput (HT) technologies.. The talk will describe design.. will be described. sophisticated Register Online! nanomachines that deliver proteins directly into the cytosol of mammalian cells. Synthesis. Professor. Associate REGISTRATION INFORMATION Professor. Ph. and phenotypic analysis of synthetic organisms. STREAM enhancing genomes with functions not commonly found in nature. assembly. University of Wyoming 4:20 KEYNOTE PRESENTATION: Enhanced Protein Production in ENGINEERING Mammalian and Insect Cells by Precise Genome Editing with the Cas9/ STREAM CRISPR Technology 1:50 FEATURED PRESENTATION: Lorenz M. M.D. REGISTER BY 3rd Annual | May 4-5. still • Case studies for difficult-to-express proteins and protein complexes EXPRESSION the downstream refolding process is variable by a low process robustness and • Summary and outlook STREAM varying quality of IBs. Microbiology and Immunobiology. Ph. Biotechnology. to engineer CHO cell lines optimised for the production of therapeutic proteins. as BIOCONJUGATES Recoding—the repurposing of genetic codons—is a powerful strategy for well as examples of the engineered improved cell lines. MAY 4 illustrates a potential new paradigm for the treatment of a variety of human diseases. Ph. Massachusetts General SC17: Transient Protein Production in Mammalian Cells Hospital/Harvard Medical School *Separate registration required. Therefore. Biological Reagents & Assay ONCOLOGY How Far Can We Go? Towards Automated Quality Analysis and Development. Research Fellow. CHO Cell Line Development..D. please see page 5-6 for course details. coli with a tunable type III secretion system capable of secreting therapeutic payloads directly into to mammalian cells as well as the extracellular milieu.com Here we report our advances in outfitting non-pathogenic strains of E.D. This work A Division of Cambridge Innovation Institute PEGSummit. Bjørn Voldborg. Ph. MSc. the CHO Cell Line Engineering project BIOASSAY STREAM 2:20 Design. The Novo Nordisk Foundation Center for Biosustainability.com | 46 .. synthesis. Bioprocess Engineering. This work underscores the feasibility 5:20 Registration for Dinner Short Courses of rewriting genomes and establishes a framework for design. CONFERENCE-AT-A-GLANCE Enhancing Escherichia coli 3:20 Sponsored Presentation (Opportunity Available) SPONSORS 12:00 pm Registration 3:50 Refreshment Break SHORT COURSES 12:35 Luncheon in the Exhibit Hall with Poster Viewing Engineering Breakthroughs TRAINING SEMINARS 1:40 Chairperson’s Remarks Donald Jarvis. 2017 DECEMBER 23 & SAVE UP TO $550 Protein Expression System Engineering Gene to Structure COVER THURSDAY.D.D. Many Gram-negative pathogens encode type III secretion systems. 5:20 End of Day THERAPEUTICS 57-codon E. Mayr..97-megabase. Director. Medicine. Harvard Medical School experimental and in silico generated data. Molecular Biology. The HT cell line engineering pipeline. coli genome in which seven codons were replaced with synonymous STREAM alternatives across all protein-coding genes. Ph. AstraZeneca R&D STREAM Mechanistic Model Supported Process Development for Recombinant • Overview of established protein expression technologies at AstraZeneca Inclusion Body-Based Processes • Optimization of transient gene expression (TGE) technologies IMMUNOTHERAPY Peter Neubauer. and Testing toward a 57-Codon Genome at the Center for Biosustainability is genetically modifying CHO cells based on Nili Ostrov. PEGSummit. Recommended Dinner Short Courses* SPONSOR & EXHIBITOR INFO 2:50 Engineering Escherichia coli into a Protein Delivery System for SC16: New USP Initiatives for Characterization and Release of HOTEL & TRAVEL Mammalian Cells Biologics Cammie Lesser. Professor. Vice President & Global Head. Here we present our ANALYTICAL 4:50 Engineering the CHO Cell approaches including a fluorescence-based quantitative detection of inclusion STREAM bodies and a mechanistic model-based analysis of process robustness. and progress toward assembly of a 3.. strategies for fast detection of inclusion bodies are of great interest as well as methods for a computer-based evaluation of how process changes affect the amount and quality of IBs.D. • Precise genome editing (PGE) with the Cas9/CRISPR technology STREAM Technische Universität Berlin (TU Berlin) • Use of PGE for the engineering of mammalian and insect cell lines Although inclusion bodies (IBs) are beneficial from the side of production. d’Arbeloff MGH Research Scholar. Genetics.

Institute of Bioprocess Engineering. Scientific Assistant. Research Chemist. IgG antibody libraries consisting of many millions of clones have been 8:35 Doxycycline Regulated Protein Expression in the Baculovirus constructed and binders selected. Boehringer Ingelheim Pharmaceuticals. Ph.. Molecular Biology. Quantitative Biology Center (QBiC). 12:05 pm Rapid Production in Milligram Quantities of a Hundred Kinds Friedrich-Alexander-University Erlangen-Nürnberg of Newly Generated Mutant Proteins ENGINEERING This is the first time the Tet-Off system was fully introduced in a baculovirus Takanori Kigawa. 9:35 Sponsored Presentation (Opportunity Available) BIOCONJUGATES 1:40 Codon Optimization: Lessons Learned from Recombinant Factor IX STREAM 10:05 Coffee Break Chava Kimchi-Sarfaty. One results in production of immature glycans that can be easily removed and the other results in production Codon Optimization and Innovative Processes of homogeneous insect-type paucimannosidic N-glycans more amenable to IMMUNOGENICITY & protein crystallization.D.. Principal Investigator.. Ph. Ltd. Ltd. Ph. MAY 5 11:35 Construction and Usage of Large IgG Antibody Libraries in Mammalian Cells 8:00 am Morning Coffee Michael Dyson. IONTAS. FDA/CBER/OBRR of antibody genes into a single genomic locus through the use of site-specific SHORT COURSES nucleases. together with the knob into hole principle. Our system is highly useful for protein engineering with IMMUNOTHERAPY rational design approaches because protein preparation steps can be dramatically STREAM 9:05 New Insect Cell Systems for Enhanced Structural Biology of accelerated without recombinant DNA technology.. RIKEN STREAM genome and used for regulated protein expression in Sf21 insect cells. Toxic proteins or proteins mutagenesis with high efficiency and robustness. Ph. Case studies PEGSummit.. Professor. 1:05 Refreshment Break STREAM both directed at simplifying glycosylation patterns. Team Leader. offering an insight into the SPONSOR & EXHIBITOR INFO mechanisms that may lead to altered protein structure. Inc. IONTAS. alter mRNA structure/stability and translation kinetics. Roche Innovation Center REGISTRATION INFORMATION We have established a platform for production of complex format CrossMab bispecific antibodies in stable CHO cell lines.com | 47 .. kinds of mutant proteins within a day without using recombinant DNA. 1:35 Chairperson’s Remarks BIOASSAY STREAM Michael Dyson. We continuously optimize our process in order to yield the maximal fraction of the main product. CTO. Senior Scientist. Division of Hematology Research and Review. Division of antibody gene/cell. Research Chemist. Recombinant Glycoproteins EXPRESSION Donald Jarvis. cell-free protein synthesis. Ph. Principal Investigator. MSc. The main limitation in achieving this 8:30 Chairperson’s Remarks has been the inability to construct sufficiently large libraries containing a single Chava Kimchi-Sarfaty. REGISTER BY Protein Expression System Engineering DECEMBER 23 & SAVE UP TO $550 FRIDAY. Ph. protein production without altering safety and efficacy. CH1-CL exchange in one of the Fab domains. A Division of Cambridge Innovation Institute PEGSummit. We have solved this problem by directing the integration SPONSORS Hematology Research and Review.D. Cell Line and Molecular Development. CTO. Our results suggest that codon optimization may Saurabh Sen. Regulation We have established a system to produce milligram quantities of a hundred of transgene expression will be crucial for a plethora of industrial applications.D. significantly improves correct Register Online! assembly by preventing undesirable side products.com showing the importance of the interplay of large clone statistics and high quality assays will be the focus of this presentation.D. COVER The availability of large libraries of binders expressed within mammalian cells Baculovirus/Insect Cells allows direct screening for function through simultaneous expression and CONFERENCE-AT-A-GLANCE functional reporting within the same cell.D. Principal Scientist.D. Knowledge gained from 11:05 Cell Line Development of Complex Therapeutic Antibodies these studies may be used to develop an optimization system that can increase HOTEL & TRAVEL Stella Tournaviti.. FDA/CBER/OBRR THERAPEUTICS Improving Production for Antibodies and Mutant Proteins We followed up on a large body of work showing that synonymous mutations can STREAM and do affect protein structure and function by studying codon optimized version 10:35 Best Practices towards High Titers for Antibody Expression of recombinant Factor IX (FIX).D. The One important issue to reach maximum protein yield will be the induction of system is composed of 1) newly developed PCR-based method for site-directed ONCOLOGY synthesis at the correct time-point of cultivation. Ph.D. and 2) fully automated protein STREAM interfering with the metabolism of the expression organism will gain more and preparation (expression and purification) using PCR-generated linear DNA-driven more importance in developing biotechnology. We used two diametrically opposed approaches. Ph.. Insect Cell Expression System TRAINING SEMINARS Ricarda Friebe. University of Wyoming 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or STREAM We produced new insect cell lines designed to enhance the utility of the Enjoy Lunch on Your Own baculovirus-insect cell system for use in studies on the structural biology of ANALYTICAL recombinant glycoproteins.

Chemistry. REGISTER BY Protein Expression System Engineering DECEMBER 23 & 2:10 Codon Usage Tables at the Peak of the Sequencing Era SAVE UP TO $550 Aikaterini Alexaki.D. taking advantage of the exponential growth of CONFERENCE-AT-A-GLANCE GenBank and the creation of NCBI’s RefSeq database. Ph.com A Division of Cambridge Innovation Institute PEGSummit. Hematology Research and Review.D. FDA/ CBER/OBRR COVER We have developed a new database to analyze and present codon usage tables for every organism available. and provides several new functionalities. University of Freiburg ANALYTICAL We invented and developed a device capable to take DNA in a PCR mix and STREAM generate a DNA microarray. resulting in a diverse panel of enzymes capable of performing the targeted reaction. This device can furthermore then copy a DNA microarray into additional DNA. Staff Fellow. We call this the device the biomolecule copier. Ph. Biochemistry & Molecular ENGINEERING Medicine. BIOCONJUGATES 3:40 End of Conference STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. This technology can be used in many applications IMMUNOGENICITY & including DNA in solution in and on demand DNA. The first approach combines bioinformatics STREAM and molecular modelling to mine sequence databases. SHORT COURSES 2:40 Discovering Novel Enzyme Function through Computational TRAINING SEMINARS Protein Design and Genomic Mining Justin B. Davis STREAM The ability to biosynthetically produce chemicals beyond what is commonly found in Nature requires the discovery of novel enzyme function.D. Group Head. The second approach uses STREAM computational enzyme design to reprogram specificity. such as the ability to view and compare codon usage across taxonomical clades as well as individual organisms. addresses concerns that limited the accuracy SPONSORS of earlier databases. Our database is more comprehensive than existing tools. Center for Biological Systems Analysis (ZBSA). Siegel. EXPRESSION 3:10 The Biomolecule Copier STREAM Günter Roth. Here.com | 48 . This integrative genomic mining approach establishes a unique avenue for enzyme function discovery IMMUNOTHERAPY in the rapidly expanding sequence databases. RNA or protein microarrays.. and BIOASSAY STREAM everything can be analysed directly label-free in real-time.. University of California. Assistant Professor. RNA or protein microarrays.. Ph. we utilize two ONCOLOGY approaches to discover enzymes.

com A Division of Cambridge Innovation Institute PEGSummit.com | 49 . REGISTER BY DECEMBER 23 & SAVE UP TO $550 ANALYTICAL STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Characterization of Biotherapeutics SHORT COURSES TRAINING SEMINARS Biophysical Analysis of Biotherapeutics ENGINEERING STREAM Protein Aggregation and Stability in Biopharmaceuticals ONCOLOGY STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.

More recently. show some new observations in product quality characterization that directly impact bioactivity and manufacturability. It improves our understanding for some A Division of Cambridge Innovation Institute PEGSummit.com dependent on the final application but also their manufacturability.D. REGISTER BY 7th Annual | May 1-2. Solvias REGISTRATION INFORMATION during Early Drug Development The Monocyte Activation Test was developed for cases where potential Zhimei Du. post-translational modifications. an inactive and non-toxic variant of diphtheria toxin. 12:20 pm Pyrogen Detection by Monocyte Activation Sponsored By HOTEL & TRAVEL Test in Antibody Formulations 9:40 Bioanalytical Strategies and Workstreams for Different Modalities Anja Fritsch.D. CSO. MAY 1 little is known about the impact of polymer conjugation geometry on protein STREAM interactions. CRM197’s physicochemical and immunochemical profiles from five initiated and is currently in clinical trials. The CrossMAb targeting Ang2 and VEGF was the first project that was stability. Senior Principal Scientist.D.. STREAM Zhimei Du. Inc. Register Online! There are many design formats for non-conventional biologics modalities. Development strategies to accommodate these novel demonstrate its utility in antibody discovery and engineering processes. Here we will rabbit pyrogen test. is a carrier 9:10 Insights in the Mode of Action of Angiopoietin 2 and VEGF Binding protein in many polysaccharide-conjugate vaccines on the market and in STREAM CrossMAbs clinical development. ENGINEERING MONDAY. 11:50 Physicochemical and Immunological Comparison of CRM197 IMMUNOGENICITY & from Different Manufacturers and Expression Systems BIOASSAY STREAM John Hickey. Roche manufacturing vaccines. purity. Eli Lilly and Company Challenges for New Immuno-Oncology Therapeutics and Combinations High concentration reversible self-association of biologics can result in significant EXPRESSION Tom Spitznagel. Ph.D. Head of Functional Characterization. MacroGenics. we demonstrate the utility of a variety of biophysical 7:00 am Registration and Morning Coffee measurements to understand both polymer and protein behavior in conjugated ONCOLOGY systems. reliable alternative to the PEGSummit. Merck & Company. Ph. Assistant Director.. Ph. researchers and manufacturers have produced CRM197 THERAPEUTICS The CrossMAb technology enabled the design and manufacturing of bispecific that varies in cost. and the best design choice is not only sample using human cells. Addition of polyethylene glycol (PEG) is an attractive strategy for the modification of proteins. In this study. However. and the importance of polymer geometry on the conjugate’s solution 8:30 Chairperson’s Remarks behavior. and STREAM antibodies... Inc. Ph. MAT provides a sensitive. SPONSORS Multi-Domain Biotherapeutics and New Modalities 10:10 Coffee Break SHORT COURSES 10:50 Biophysical Characterization of Structure and Interactions in Fab- SC10: Bioanalysis of Biomarkers: ADCs.com | 50 . Ph.. low-cost processes for Joerg Regula. Dickinson. Multi-domain PEG Conjugates Biotherapeutics and New Modalities Whitney Shatz. Genentech TRAINING SEMINARS *Separate registration required. 11:20 Mitigating Developability Risks by Application of Affinity-Capture IMMUNOTHERAPY Self-Interaction Nanoparticle Spectroscopy (AC-SINS) STREAM 8:40 KEYNOTE PRESENTATION: Development and Characterization Craig D. Senior Vice President. novel PEG geometries have become available. Merck & Company. contaminants other than endotoxin might be present in the antibody formulation. Initial experiments compared the in vivo different sources were comprehensively examined and compared in an analytical SPONSOR & EXHIBITOR INFO efficacy of these CrossMAbs to the originating antibodies.D.. please see page 5-6 for course details.. Senior Research Advisor. STREAM molecular entities and the speed at which clinical development often occurs will be presented. Macromolecule and Vaccine Stabilization Characterization of Novel Modalities Center. Inc.D. In attempts to develop efficient. such This test monitors the release of cytokines induced by pyrogens present in the as nanobodies and bispecific antibodies. Senior Scientific Researcher. with the in vitro functional characterization data to gain novel insights in the interaction of the CrossMAb with its two ligands. Senior Principal Scientist.D. AC-SINS is a remarkably sensitive STREAM Manufacturing. SC1: Preclinical and Clinical Immunogenicity Bioanalysis: ADCs. 2017 DECEMBER 23 & SAVE UP TO $550 Characterization of Biotherapeutics Optimizing the Analytical Function in an Era of New Product Formats COVER Recommended Short Courses* of these new modalities and might shed some light on protein engineering and CONFERENCE-AT-A-GLANCE selection at early stage. AME. MS. availability. Ph. BioPharmaceutical Development and viscosity and solubility issues in development. high-throughput screening tool that we show can be applied to any Fc containing Immuno-Oncology therapeutics and combinations are revolutionizing the way protein to rank self-association propensity. This data set is aligned biosimilarity assessment. University of Kansas BIOCONJUGATES CRM197. Ph. Examples will be provided that ANALYTICAL cancer patients are treated.

My group leverages this events occur during systemic circulation versus at the site of action are necessary REGISTRATION INFORMATION unprecedented wealth of sequence-function information to design and for understanding factors contributing to the observed in vivo PK/PD relationship. University of Missouri ENGINEERING Available) or Enjoy Lunch on Your Own We hypothesized that by covalently attaching these two antibodies to a single STREAM nanoparticle would accelerate the cancer cell death in lower concentrations of 1:50 Session Break antibodies. in many indications. Charles River for Tumor Therapy Raghuraman Kannan.com 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing 6:55 End of Day A Division of Cambridge Innovation Institute PEGSummit. This Characterizing in vivo Quality Attributes presentation will describe both the Bicycle® and BDC platforms. Associate Professor. MAY 2 SAVE UP TO $550 Mingjie Xie. Assistant Professor. They have potential vivo efficacy. Pearson. Chemical Engineering and Materials SPONSOR & EXHIBITOR INFO Science.. School of Medicine. FRS. Director. 9:30 Characterizing in vitro and in vivo Stability of Bispecifics. Bicycle Therapeutics and CD3zeta signaling domains were generated. and function and to infer structural This information is essential to guide engineering and for preclinical to clinical complexes of proteins. We will show covalent conjugation of two different antibodies to gold ONCOLOGY 2:20 Problem-Solving Breakout Discussions nanoparticle (AuNP) and characterization of the conjugates using Proteomics. specificity. A lead CAR (bb2121) was Bicycles® are a novel therapeutic class of constrained bicyclic peptides that IMMUNOGENICITY & selected for clinical development (NCT02658929). Rapid Novor Inc Many applications in antibody engineering require the direct sequencing of 8:00 am Registration and Morning Coffee COVER antibody proteins. including oncology. and after Combined with in vivo studies..D. and present our practices Development to ensure the correctness of every amino acid. Register Online! methodological improvements that enable the engineering work. tunable exposure and chemical synthesis. STREAM PLENARY KEYNOTE SESSION 9:00 Targeting B Cell Maturation Antigen (BCMA) Positive Multiple EXPRESSION 4:00 Chairperson’s Remarks Myeloma Cells with CAR T Cell Therapy STREAM Kathy Seidl. THERAPEUTICS and Immunocytokines STREAM 4:55 Young Scientist Keynote: Programming Proteins by Deep Josh T. Immunotherapy. during. Ph. Principal Scientist. Approaches for next-generation combine antibody-like affinity and selectivity with small molecule-like tissue BIOASSAY STREAM CAR T cell products. Ph. bluebird bio 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation We developed chimeric antigen receptors (CARs) targeting B cell maturation ANALYTICAL Therapeutics antigen (BCMA). At Rapid Novor (rapidnovor. 10:00 Coffee Break in the Exhibit Hall with Poster Viewing PEGSummit. Here we share the success Characterization Issues in Immuno-Oncology Drug CONFERENCE-AT-A-GLANCE experiences. Ultragenyx Pharmaceuticals SHORT COURSES Characterization of O-Linked Glycans from Therapeutic Glycoporteins using Porous Graphitized Carbon HPLC 8:30 Proteomics Characterization of Antibody-Nanoparticle Conjugates TRAINING SEMINARS Andrew Hanneman. Director. Associate Director.. My talk will present an overview of the above and detail translation. in vitro assays to elucidate whether degradative a high-throughput screen or selection for function.D. Fusions. a novel toxin STREAM delivery platform which greatly improves toxin loading into tumour tissues. Sequencing and Design Amgen Tim Whitehead. Senior Director. Pharmacokinetics & Drug Metabolism. STREAM We confirmed both the presence and the structural identity of antibodies 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing covalently attached to AuNP using proteomics. Ph.D. examine common mistakes novices make.D. Radiology and Biological 1:20 Luncheon Presentation II (Sponsorship Opportunity Engineering. Trinity College and Co-Founder and Lentivectors containing anti-BCMA single chain variable fragment (scFv).D. Master. Co-founder and CEO. Ph.D. 4-1BB. an antigen expressed on most multiple myeloma (MM) cells... such as ex vivo culture with a PI3K inhibitor that enhances in penetration. will be discussed. SPONSORS 8:25 Chairperson’s Remarks 12:50 Luncheon Presentation I: Profiling and Sponsored By Murali Bilikallahalli.com | 51 . Mass Spectrometry.. Ph. Ph. where Bicycles’ unique properties BIOCONJUGATES have been used to develop Bicycle Drug Conjugates™ (BDCs). STREAM Sir Gregory Winter. HOTEL & TRAVEL ability to observe entire populations of molecules before. The efficacy of this dual-antibody nanoconjugate and the mechanism of interaction with tumor cells will be IMMUNOTHERAPY presented. REGISTER BY Characterization of Biotherapeutics DECEMBER 23 & Sponsored By 12:35 Antibody Protein De Novo Sequencing with LC-MS/MS TUESDAY.com) we have developed a robust workflow and routinely sequenced antibody proteins. Michigan State University The presentation will cover strategies and workflows for characterizing potential Next-generation sequencing has presented protein scientists with the instabilities of dual targeting protein therapeutics during their in vivo trafficking. engineer protein affinity.

samples by combining fluorescence. is being Register Online! introduced. Mass Spectrometry. we and several other authors observed large differences in their pharmacokinetics which cannot be explained 2:05 Harness the Benefits of LC-MS and CE-MS for Multilevel mAb and by different Fc:FcRn interactions. Product Manager. We will demonstrate how THERAPEUTICS using an IMS QTOF Mass Spectrometry UNcle can thoroughly characterize more biologics and formulations quickly and STREAM Ying Qing Yu. Ph. A Division of Cambridge Innovation Institute PEGSummit. Ion Mobility-MS. Ph.D. Various parameters such as pharmacokinetics 2:35 Rapid Identification of Biotherapeutics with Label-Free Raman ONCOLOGY and stability with the respective methods will be discussed. REGISTER BY Characterization of Biotherapeutics DECEMBER 23 & SAVE UP TO $550 10:50 Assays for PK Prediction to Support Design and Selection of Spectroscopic Methods Next-Generation Biotherapeutics Hubert Kettenberger.D. Senior Science Manager. 12:50 Luncheon Presentation II (Sponsorship Opportunity Available) 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing SPONSOR & EXHIBITOR INFO 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing 4:25 Implementing QC-Level Mass Spectrometers HOTEL & TRAVEL Tatyana Mezhebovsky. Senior Scientist.. analytical and bioanalytical characterization by assessing several critical quality TRAINING SEMINARS attributes (CQAs). This presentation will describe our integrated approach of assessing the in vivo fitness of novel biotherapeutics. new generation of Mass Spectrometers (MS). We present predictive Elsa Wagner-Rousset. Principal Scientist. Pierre Fabre SHORT COURSES assays to identify mAbs with fast clearance during the lead selection and protein The development and optimization of mAbs and ADCs rely on improving their engineering phase. Novartis be presented. and aggregation data to be Characterizations of the NIST mAb Reference Standard obtained at the same time from the same sample. Ph. long in vivo half-life and thus long durability is desired.. Roche Innovation Center Penzberg Elsa Wagner-Rousset. Scientific Operations. Currently.D. and Sponsored By STREAM 12:20 pm Luncheon Presentation I: Comprehensive PTM allows for sizing. The UPLC-MS/UV/FLR PEGSummit..c. polydispersity. Spectrometry. Sanofi REGISTRATION INFORMATION Mass Spectrometry has become the major tool in protein biotherapeutics development.. Biotherapeutics represent a challenging cohort for testing product identity STREAM because of their similarity in chemical structure. This enables 10 different protein characterization applications. A case study will Spectroscopy STREAM illustrate how the individual parameters create a holistic picture of the in vivo Ishan Barman. ex vivo and in vivo methods were evaluated regarding the effect of Dina Finan. Screening models generate knowledge about the distribution and transport of biotherapeutics following these injections.D. facile tools.. Roche 2:00 Chairperson’s Remarks COVER Pharma Research & Early Development. we demonstrate that label-free Raman spectroscopy provides a Expectations of regulatory authorities are rising towards the demonstration of powerful method and offers excellent differentiation capability when used along ANALYTICAL a thorough understanding of the mechanisms and interactions taking place with partial least-squares-discriminant analysis derived decision algorithms. Analytical Chemistry & Mass For most biotherapeutics. however. Protein Analytics. Ph. They will be illustrated by extensive structural characterization of STREAM Pharma AG reference FDA and EMA approved therapeutic mAbs and ADCs. BTDM Integrated Biologics Profiling.com setup in our laboratory as well as the challenges we had to overcome to launch the system will be presented. 3:05 Let UNcle Tell You the Whole Stability Story Sponsored By In vitro. Injection for rapid. SLS.com | 52 . Top-Down Sequencing) will ENGINEERING Torsten Kuiper. Exploiting subtle differences in vibrational modes of STREAM Sabine Eichling. Principal Scientist. negatively impact PK. UNcle reduces these complications and conserves physicochemical properties. Unchained Labs IMMUNOGENICITY & Biologic stability characterization traditionally requires juggling disjointed data BIOASSAY STREAM molecule and formulation properties on systemic bioavailability. Ph. Senior Scientist. targeted for Mass Detection in routine application by non Mass Spectrometrists. Assistant Professor. Mechanical Engineering. This information complements current decisions which to date are focusing on optimizing from multiple instruments. BioFormulations Development..D. and DLS detection modes in one BIOCONJUGATES instrument. Ph. Johns Hopkins fitness that contributes to the developability risk assessment and lead selection University IMMUNOTHERAPY during the pre-clinical development phase. Progresses of multi-level state-of-the-art mass spectrometry 11:20 Testing for in vivo Fitness for the Development and Selection of methods combined with chromatographic and electrophoretic techniques Novel Biotherapeutics (2D-LC-MS. thermal melting. Traditional techniques employed 11:50 Tools in Formulation Development to Understand Biological for product identification are time and labor intensive leading to an unmet need EXPRESSION Performance of Biotherapeutics Following s. Pierre Fabre CONFERENCE-AT-A-GLANCE Comparing many different monoclonal antibodies. STREAM following subcutaneous injection. low-affinity interactions with highly ADC Structural Characterization SPONSORS abundant targets may. Native MS. Unspecific. Abbvie the biologics. Senior Scientist. Waters Corporation easily. CESI-MS. Senior Principal Scientist.D. These MS instruments rely on peak identification based on the methods transferred from the specialized MS laboratories.

Global Protein Sciences. we have implemented open-access software solutions to facilitate placing powerful mass spectroscopic techniques in the SPONSORS hands of a diverse user base. Research Scientist. Furthermore. REGISTER BY Characterization of Biotherapeutics DECEMBER 23 & 4:55 Implementation of Open-Access & Automated Analysis Mass SAVE UP TO $550 Spectrometry within Discovery Protein Generation Workflows David Winarta. AbbVie COVER Sample hand-offs. EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. we have developed an automated web script to intelligently analyze and annotate generated data.com | 53 . In line with efforts to build a world-class CONFERENCE-AT-A-GLANCE biologics generation platform.com A Division of Cambridge Innovation Institute PEGSummit. 5:25 End of Characterization of Biotherapeutics TRAINING SEMINARS 5:30 Registration for Dinner Short Courses ENGINEERING STREAM Recommended Dinner Short Courses* SC12: Study Design and Statistical Data Analysis of Flow Cytometry ONCOLOGY STREAM Assays SC16: New USP Initiatives for Characterization and Release of IMMUNOTHERAPY Biologics STREAM *Separate registration required. and manual data analysis are hallmarks of workflow bottlenecks. please see page 5-6 for course details. The observed benefits SHORT COURSES are presented with an eye on future improvements. information recapitulation.

D. 11:25 Biophysical Mechanism of Captisol-Induced Solubility of Protein Bristol-Myers Squibb Biologicals ANALYTICAL Increasing emphasis is placed for in-depth understanding of critical quality Murali Bilikallahalli. This platform brings together different applications into one IMMUNOTHERAPY unit: the automated handling of reagents and characterization.D.com | 54 . We will discuss our work in identifying the causes for these trade-offs as well as our development of new methods for Register Online! overcoming such trade-offs. Ph... REGISTRATION INFORMATION and/or bispecificity – often involves trade-offs between improvements in some properties and defects in other ones. as well as the SPONSOR & EXHIBITOR INFO Chemical & Biological Engineering. a protein solubilizer at high concentrations. STREAM Tapan Das. PEGSummit. Associate Professor. REGISTER BY 5th Annual | May 3-4. manufacturing. MAY 3 STREAM 10:55 High-Throughput Screening Platform for the Formulation of 7:30 am Registration and Morning Coffee Vaccines ONCOLOGY Vanessa Jully. Data management STREAM was fully integrated using an IT application to collect and process raw data by 8:40 KEYNOTE PRESENTATION: Criticality of Biologics Quality creating an output file that can be used in data analysis software. Ph. Career Development Professor. Merck SC12: Study Design and Statistical Data Analysis of Flow Cytometry Forced degradation studies are often used in biotherapeutics development to SPONSORS Assays determine possible biologic product degradation pathways under various stress conditions.D. This platform EXPRESSION Attributes and Integrated Analytical Control has the potential to accelerate significantly the development of new vaccines. University of A robust and rapid high-throughput screening (HTS) platform was developed for Kansas vaccine formulation. Principal Scientist. Rensselaer Polytechnic Institute stability of the candidate in one experiment. The process of engineering antibodies for improved properties – such as increased affinity.com A Division of Cambridge Innovation Institute PEGSummit. Research & Development. Ph. Different strategies on applying force TRAINING SEMINARS *Separate registration required.. 10:10 Coffee Break in the Exhibit Hall with Poster Viewing ENGINEERING WEDNESDAY. Ph. and pre-clinical molecules.D. it is capable of determining mechanism and extent of aggregation. Tessier.. Specificity. BIOCONJUGATES 11:55 An Innovative Method That Provides Direct Molecular Evidence STREAM Used to Decipher the Mechanism and Extent of Aggregation under Methods and Instruments Stress Conditions THERAPEUTICS Belinda Pastrana.D. Scientist. Professor. setting specifications. Results illustrate why and why not this BIOASSAY STREAM This session will cover phase-appropriate CQA assessments and establishing works with all kinds of proteins that differ in their physic-chemical properties.D. 2017 DECEMBER 23 & SAVE UP TO $550 Biophysical Analysis of Biotherapeutics Characterizing and Fine-Tuning the Physical Properties of Proteins in the Research and Development of Next Generation Protein Therapeutics COVER Recommended Short Courses* 9:40 Forced Degradation Strategies for Biotherapeutics Development CONFERENCE-AT-A-GLANCE Yite Robert Chou.. effector functions quantitative manner providing the much needed information to decision makers. Forced degradation also plays an important role in the development SHORT COURSES SC14: Overcoming the Challenges of Immunogenicity Assays. Risk of analytical methods. degradation at different stages and on increasing the workflow of biotherapeutics development will be presented. Ph. they can be analyzed in a often further engineered for therapeutic applications.. Link of CQAs to robust development. Pharmaceutical Chemistry. advanced analytical control. Biologics Characterization & Analytical Development. Ultragenyx Pharmaceuticals STREAM attribute and associated control strategy in biologics development and Captisol has been historically used to solubilize small hydrophobic drug production. Weis. HOTEL & TRAVEL Because the results are based on first principle.D. Ph. Senior Director. and design of formulations under Assessment and Regulatory Requirements the quality by design (QbD) paradigm. GlaxoSmithKline STREAM 8:30 Chairperson’s Remarks David D. please see page 5-6 for course details. Solubility and Stability The technology presented is transformative for the biopharma industry. Director. Ph. Richard Baruch M.D. The method is a label free method. because Peter M. This study for the first time establishes the mechanism of Captisol as IMMUNOGENICITY & and clinical outcomes is paramount to modern biologics development strategies.. Chemistry. Antibodies initially identified via immunization or in vitro display methods are and is independent of the protein therapeutic molecular weight or modification. STREAM 9:10 Understanding and Overcoming Trade-Offs between Antibody Puerto Rico Affinity. University of Puerto Rico Mayaguez.

We have used a wide range of biophysical analyses to HOTEL & TRAVEL Article resulting from USP’s recently convened roundtable of recognized experts characterize the aggregation landscape of proteins. Automated stability prediction and characterization by nanoDSF can help to significantly streamline development processes from early discovery to 8:30 Chairperson’s Remarks SHORT COURSES formulation development. Weis. many supra. Global Biologics.and 9:35 Sponsored Presentation (Opportunity Available) BIOASSAY STREAM macromolecular assemblies involved in key cellular processes cannot be studied in isolation.D. REGISTER BY Biophysical Analysis of Biotherapeutics DECEMBER 23 & Sponsored By 12:25 pm An Automated Platform to Predict and 7:00 End of Day SAVE UP TO $550 Characterize the Colloidal and Conformational Stability of Biologics THURSDAY. Biogen Characterization of PTMs is essential to understanding the structure-function EXPRESSION 2:15 Enabling and Doing Structural Biology in situ relationship in a protein and in the successful development of biopharmaceuticals. Scientist. Group Leader.D.. Science & Standards. As biological science Protein stability is a critical factor for the successful development of non- SPONSOR & EXHIBITOR INFO contributes to more advanced therapies. especially HDX-MS. Ph. University of Kansas ENGINEERING 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or Hydrogen exchange mass spectrometry (HX-MS) is gaining acceptance for its STREAM Enjoy Lunch on Your Own ability to monitor higher order structure in proteins. developing a molecular-level understanding of how protein- 1:55 Session Break ONCOLOGY excipient interactions alter physical stability. IMMUNOGENICITY & resolution obtained by single-particle cryo-EM. NanoTemper Technologies. Molecular Structural Biology. TRAINING SEMINARS 8:35 HX-MS in Formulation Development and Similarity Assessment 12:40 Sponsored Presentation (Opportunity Available) David D. Associate Professor.D. F. Ph.. These best practices may to inform better formulation design strategies. Professor of Biochemical Engineering and Biotechnology. Just Biotherapeutics reduced time to market. Second. Ph.com 4:45 Problem-Solving Breakout Discussions 5:45 Networking Reception in the Exhibit Hall with Poster Viewing A Division of Cambridge Innovation Institute PEGSummit. STREAM 2:45 New USP Initiatives for Biophysical Characterization of Biologics Computational Methods Maura Kibbey. Pharmaceutical Chemistry. Ph. Head of Research and Development – Biochemistry. Head.. resulting in better informed decisions and eventually Randal Ketchem.. exploring the limits of HX- STREAM MS to detect small changes in higher-order structure in similarity contexts. which calls for straightforward and precise analytical tools to increase research Applications of Mass Spectrometry in Biophysical Analysis SPONSORS efficiency. Technical Development. This talk highlights two areas of recent work. This talk will preview a USP Stimuli are therefore crucial. Molecular Design.com | 55 . TEM.. Ph.D. we elucidate the impact of methionine versus methionine and cysteine Juergen M.D. The USP is an independent scientific organization that protects public health University College London through standards for medicines and their ingredients.D. Ph. to guide protein engineering and formulation for improved shelf-life will be discussed. Director. Ph.) 9:05 Mass Spec Based Techniques for the Characterization of Protein IMMUNOTHERAPY 2:10 Chairperson’s Remarks Biopharmaceuticals STREAM Anacelia Ríos Quiroz. United States 11:05 Computationally-Guided Protein and Formulation Engineering THERAPEUTICS Pharmacopeial Convention STREAM Paul Dalby. Routes to predictably engineer protein stability role in drug development and manufacturing. Pharma Technical Development Europe (Biologics) Analytics. We have methods. Particle Lab. We selectively oxidize ANALYTICAL To visualize and analyse molecular structures in their native state and in their IFNβ-1a and characterize the products of each oxidation condition with various STREAM cellular context is the overarching aim of in situ structural biology. MAY 4 COVER Dennis Breitspecher.D. Hoffmann-La Roche Ltd.. However. The challenge for us is to apply cryo-EM to protein complexes and 10:05 Coffee Break in the Exhibit Hall with Poster Viewing BIOCONJUGATES other biological objects within their native environment within cells. Vice President. GmbH 8:00 am Morning Coffee CONFERENCE-AT-A-GLANCE Biopharmaceutical development projects become increasingly complex. STREAM Here. 3:15 Sponsored Presentation (Opportunity Available) Register Online! 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing PEGSummit. George Bou-Assaf. First. The use of molecular dynamics REGISTRATION INFORMATION lead to a new USP General Chapter..D.. Methods and Instruments (Cont. Plitzko. Ph. and used this understanding on higher order structure characterization of biologics. Max Planck Institute of Biochemistry oxidation on the HOS and structural dynamics of IFNβ-1a. standards continue to play a critical aggregating biopharmaceuticals. play a dominant role in seen stunning results of isolated molecular structures at atomic or near-atomic revealing the differential oxidation effects. MS-based techniques.

Roberts. Early molecular analysis enables an integrated approach ONCOLOGY to therapeutic design encompassing in silico tools.. Molecular Design. Ph. Pushing molecular design earlier in the therapeutic pathway increases the success and lowers the cost of therapeutics.com A Division of Cambridge Innovation Institute PEGSummit.. Vice President. Ph. 12:05 pm Computational Design and High-Throughput Characterization TRAINING SEMINARS to Predict and Repair Molecular Attributes Randal Ketchem. Hypermutation also leads to molecular issues as therapeutic candidates.D. It will illustrate examples where “simple” models can SPONSORS reasonably capture the high-concentration behavior if one uses low-concentration behavior to adjust the model. IMMUNOTHERAPY STREAM 12:35 End of Biophysical Analysis of Biotherapeutics EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. as well as challenges for systems with strong SHORT COURSES attractions and phase separation. COVER University of Delaware This presentation will show an example of combining “minimal” experimental data CONFERENCE-AT-A-GLANCE with molecular models to predict non-ideal interactions of monoclonal antibodies at high concentrations.D. and STREAM development of predictive tools coupled with large scale data capture. Chemical & Biomolecular Engineering. Just Biotherapeutics ENGINEERING Antibodies undergo somatic hypermutation to obtain their high levels of both STREAM antigen specificity and affinity. high-throughput screening. REGISTER BY Biophysical Analysis of Biotherapeutics DECEMBER 23 & 11:35 Interfacing Simulation and Experiment for Protein-Protein SAVE UP TO $550 Interactions Christopher J.com | 56 . Professor.

SC15: Critical Considerations for the Design and Development of PEGSummit.. University of Manchester SHORT COURSES Assessment and Regulatory Requirements Understanding the origins and factors contributing to the immunogenicity of *Separate registration required. Kildsig Chair and Department Head. including aggregation.com Antibody-Drug Conjugates *Separate registration required. Sanofi Genzyme 4:20 Understanding What Could Make Subvisible Protein Particles IMMUNOTHERAPY Immunogenic STREAM Anacelia Ríos Quiroz. Ph. Concentrated antibodies can lose their colloidal Understanding Aggregation Phenomena stability through various phase transitions. University of into a fast and convenient way to quantitatively evaluate colloidal stability of SPONSOR & EXHIBITOR INFO Kansas Medical School antibody solutions. we present solid-state This talk will help increase our understanding on the biological consequences of hydrogen deuterium exchange with mass spectrometric analysis (ssHDX-MS) as particulate matter. gelation THERAPEUTICS and crystallization. Ph. Professor. Perdue University literature together with the results of a study which evaluated the particle ANALYTICAL The lack of adequate methods to measure protein structure in the solid state has characteristics needed to break immune tolerance in an IgG1 transgenic mouse. Associate Director.D. I will also show how aggregation. Here I will discuss our recent work TRAINING SEMINARS in which we seek to investigate the roles of aggregation. Aggregation-Prone Proteins transformations.. EXPRESSION Structure in Lyophilized Solids and Impacts on Aggregation The likely immunogenic reactions that have been attributed to subvisible protein STREAM particles constitute a safety concern around the use of biotherapeutic proteins. affects the quality as well as the ENGINEERING 12:00 pm Registration amplitude of the immune response. Ph. Elizabeth M. PEG-induced liquid-liquid phase separation method has evolved Mark T.D. Risk Jeremy Derrick. Stabilizing the folded state of metastable and/or aggregation-prone proteins HOTEL & TRAVEL through exogenous ligand binding is an appealing strategy to decrease disease 5:20 End of Day pathologies brought on by protein folding defects or deleterious kinetic REGISTRATION INFORMATION transitions. Ph.. Fisher.. We also BIOASSAY STREAM show that ssHDX-MS results are highly correlated with the aggregation of a MAb 4:50 Precipitation Methods to Assess Colloidal Stability and of myoglobin during storage. please see page 5-6 for course details. F. Department The talk will give a comprehensive overview of the current status of the related of Industrial and Physical Pharmacy. Associate Director. Pharma Technical 1:50 KEYNOTE PRESENTATION: Measuring Changes in Protein Development Europe (Biologics) Analytics. Research & Development.D. in particular. This presentation describes an automated method for assessing 5:20 Registration for Dinner Short Courses the kinetic stability of folded proteins and monitoring the effects of ligand stabilization for metastable proteins using a GroEL chaperonin-based biolayer Recommended Dinner Short Course* Register Online! interferometry (BLI) denaturant-pulse platform.D. 10th Annual | May 4-5. Ph. Colloidal stability assessments are done to characterize 2:20 Chaperonin-Based Biolayer Interferometry to Assess the Kinetic the propensity of antibodies and their formulations to undergo such phase STREAM Stability of Metastable. Molecular Microbiology. Biochemistry and Molecular Biology. Ph.D. chemical modification THURSDAY. Sanofi Genzyme BIOCONJUGATES The use of precipitation methods to assess colloidal stability of antibodies STREAM has become widespread. 2017 REGISTER BY DECEMBER 23 & Protein Aggregation and Stability SAVE UP TO $550 in Biopharmaceuticals COVER Understanding and Controlling Protein Aggregation from Early Development to Manufacturing and Clinical Us CONFERENCE-AT-A-GLANCE Recommended Short Course* 2:50 Understanding the Causes of Immunogenicity in Biotherapeutic SPONSORS Proteins SC14: Overcoming the Challenges of Immunogenicity Assays. Topp. Here. Professor. IMMUNOGENICITY & a high resolution method to assess protein structure in lyophilized solids.com | 57 . biotherapeutic proteins remains a challenge. STREAM slowed the development of protein drug products. Research & Development.. Ramil Latypov. MAY 4 and host cell protein impurities on the immune response to selected proteins.. please see page 5-6 for course details. STREAM 12:35 Luncheon in the Exhibit Hall with Poster Viewing 3:20 Sponsored Presentation (Opportunity Available) ONCOLOGY 1:40 Chairperson’s Remarks 3:50 Refreshment Break STREAM Ramil Latypov. Hoffmann-La Roche Ltd. Group Leader. Particle Lab. Dane O.D. A Division of Cambridge Innovation Institute PEGSummit.

. National Institutes of Health COVER Non-ionic surfactants are commonly used in vaccine/protein formulations to Particle Characterization minimize instability induced by self-interaction and/or interfacial interactions CONFERENCE-AT-A-GLANCE occurring during manufacturing and long term storage. some of the newer unfibrillated insulin analogs (Tresiba®. across these regimes. Eli Lilly & Company REGISTRATION INFORMATION separations and how to properly screen and develop optimal modes of column 1:40 Profiling Molecular Feasibility for High Dose Biological operation using various strategies and modeling approaches. Scientist. Ph. spanning the subvisible and visible size range. Rensselaer Polytechnic Institute Controlling Stability in High Concentration Protein The propensity of downstream processing conditions for forming aggregates SPONSOR & EXHIBITOR INFO will be discussed along with strategies for avoiding these scenarios via high Formulations throughput screening.D. Flow cytometry has potential to bridge particle characterization Masaru Muraoka.. involving Chikungunya Virus Virus-Like 8:35 Protein Particle Standards: Use and Guidelines for Analyses Particles and Hemagglutinin-Ferritin Nanoparticles. are desired. AbbVie container adsorption. SHORT COURSES Srivalli Telikepalli. National Institute of Standards and Technology 11:35 Novel Biophysical Tools for the Study of Insulin Aggregates TRAINING SEMINARS New particle standards. This 9:35 Sponsored Presentation (Opportunity Available) BIOASSAY STREAM presentation will provide case studies covering these issues and discuss the 10:05 Coffee Break optimization strategies for protein engineering. These interactions may 8:30 Chairperson’s Remarks result in conformational changes leading to aggregation or material loss via Reema Raghavendra.D. but also into the Viscosity for High Concentration Subcutaneous Formulation STREAM sub-micron range.) show high background ThT fluorescence making it difficult to ONCOLOGY particles.com efficacious doses while maintain safety. STREAM screen for fibrils. Ph. etc. Techniques for removal of aggregates will then be discussed including how best to operate various chromatographic resin systems for these Shantanu Sule. AbbVie Immunogenicity concerns of therapeutic protein aggregates have necessitated 12:05 pm Optimization Strategy to Generate Antibody with Low EXPRESSION detailed particle characterization not only in the sub-visible range. which may be further enhanced by the low doses common SPONSORS to vaccine formulations. Therapeutics Shantanu Sule. Merck STREAM available standards. Vaccine 8:00 am Morning Coffee Research Center. Scientist. Scientist. Particle Developing high concentration formulations brings forth several challenges due STREAM responses were compared to micro-flow imaging and corrected for refractive to solubility limitations and increased viscosity.D.D. However. Ph. protein engineering has adverse effects IMMUNOGENICITY & on physicochemical properties of antibody. STREAM Reema Raghavendra. Here. We have developed a Flow Cytometry method using ThT that can distinguish between amorphous aggregates and fibrils in different stressed 9:05 Flow Cytometry: A Promising Tool for Sub-Visible Particle commercial insulins.D. New A Division of Cambridge Innovation Institute PEGSummit. are being and Their Ability to Distinguish between Fibrillar and Amorphous developed using ethylene tetrafluoroethylene (ETFE) polymer and a photoresist Aggregates ENGINEERING because they have desirable properties that make them better than currently Gayatri Ganeshan.. Ph. BIOCONJUGATES 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or STREAM Formulation and Process Control Enjoy Lunch on Your Own 10:35 Improvements in Downstream Processes to Minimize and THERAPEUTICS 1:05 Refreshment Break Mitigate Aggregation STREAM Steven Cramer. ANALYTICAL novel protein-like standards and therapeutic proteins by flow cytometry.D.com | 58 . Here we outline state-of-the-art approaches to develop high dose/high concentration biologics. Professor. MAY 5 11:05 The Role of Surfactants in Phase I Vaccine Formulations Sashikanth Banappagari. Its sensitivity and turnover time are valuable as a design tool IMMUNOTHERAPY Characterization to de-risk key attributes. Two case studies. Formulation Development. even with a single mutation.. Senior Research Scientist. Research Chemist. Eli Lilly & Company Register Online! Developing biological therapeutics often faces challenges from the high PEGSummit. molecular engineering and excipient technologies that address such challenges. protein property analyses and appropriate use of mobile 1:35 Chairperson’s Remarks HOTEL & TRAVEL phase modifiers. in some cases.. Ph. Research Scientist. Biologics and Vaccines. These particles can be used to 1) standardize subvisible Fluorescent dyes including Thioflavin-T are typically used to measure fibrils in particle measurements. we present quantitative particle measurements of LTD. High solubility and low viscosity index biasing. Chugai Pharmabody Research PTE. allowing accurate particle quantitation. develop a semi-quantitative method for monitoring visible proteinaceous Levemir®. Scientist.. Senior Research Scientist. will be discussed. Ph. REGISTER BY Protein Aggregation and Stability in Biopharmaceuticals DECEMBER 23 & SAVE UP TO $550 FRIDAY. primarily through correcting instrument bias and 2) insulins. However.

High-throughput screening EXPRESSION (HTS) techniques can be used to screen solution conditions for early formulation STREAM development.com A Division of Cambridge Innovation Institute PEGSummit. MedImmune IMMUNOTHERAPY Selection of optimal formulation conditions for monoclonal antibodies can be STREAM challenging due to short timelines and reliance on predictive assays to ensure product quality and adequate long term stability. and differential scanning fluorescence (DSF) were evaluated ANALYTICAL as early formulation screening techniques.com | 59 . Formulation Sciences.D. Biologics. The implications of high concentration processing and delivery devices will then be summarized for the current clinical and commercial landscape. Senior Scientist.. and will present a test case demonstrating that AC-SINS successfully predicted high ENGINEERING viscosity variants from an antibody engineering panel. Ph. differential scanning light scattering (DSLS). maximum packing fraction. REGISTER BY Protein Aggregation and Stability in Biopharmaceuticals DECEMBER 23 & findings on the impact of manufacturing operations on biologic quality will be SAVE UP TO $550 shared. AbbVie BIOCONJUGATES Changes in Simha shape.D. Ph. The utility of using accelerated stability. Senior Scientist. Therapeutic Discovery.. COVER 2:10 Affinity Capture Self-Interaction Nanoparticle Spectroscopy (AC- SINS) Measurements of Weak Interactions in Dilute Solution Support CONFERENCE-AT-A-GLANCE Early Assessment of Antibody Manufacturability Marissa Mock. 3:10 Using Viscosity-Derived Parameters and Thermal Analysis to IMMUNOGENICITY & Evaluate the Solution Properties of Bispecific Dual Variable Domain BIOASSAY STREAM Antibodies Ralf Joe Carrillo.D. Amgen SPONSORS Methods to identify molecules with potential manufacturability liabilities are desired during the preclinical selection of large molecule therapeutics. Physical Chemistry. This talk highlights the correlation STREAM between data from these techniques and predictability to real time stability. STREAM Long Term Stability Prediction ONCOLOGY 2:40 Evaluation of Early Stage Formulation Development Strategies for STREAM Monoclonal Antibodies Hardeep Samra. 3:40 End of Conference SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. Current SHORT COURSES techniques are often impractical in early pipelines because they require large amounts of highly pure material.. Peter Tessier at RPI. Senior Scientist. intrinsic viscosity and DSC STREAM thermal stability for mAbs and bi-specific Dual Variable Domain Immunoglobulins DVD-Ig proteins have been studied and analyzed to ascertain how the viscoelastic THERAPEUTICS properties for mAbs and DVD-Igs differ and how these properties can predict long STREAM term stability. developed by Prof. Ph. We evaluated and implemented the high- TRAINING SEMINARS throughput AC-SINS assay.

com A Division of Cambridge Innovation Institute PEGSummit. REGISTER BY DECEMBER 23 & IMMUNOGENICITY SAVE UP TO $550 & BIOASSAY STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Immunogenicity: Regulatory and Clinical Relevance SHORT COURSES TRAINING SEMINARS Strategies for Immunogenicity Assay Assessment ENGINEERING STREAM Optimizing Bioassays for Biologics ONCOLOGY STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.com | 60 .

yet pre- clinical animal models often fail to detect the potential of drugs to cause these Biologics reactions. QPD. Principal Investigator. Clinical Pharmacology. go through the latest advances in the field. Ph. Group Head. Novartis 11:20 Latest Advances in T Cell and B Cell Epitope Prediction EXPRESSION As the number of Immuno-Oncology (IO) therapies in development continues Paolo Marcatili. and compare antibodies from different patient sera by in silico data analyses. epitopes from a single selection experiment.D.. MAY 1 Hypersensitivity: Humanized Mice 7:00 am Registration and Morning Coffee Michael Oropallo. Ph.D.. Using examples. Avelumab is in clinical for Cell Therapy and Immunology THERAPEUTICS development for the treatment of metastatic Merkel cell carcinoma. Priya Sriraman. please see page 5-6 for course details. Ph... a rare form A new way to analyse the NGS data from peptide phage display experiments in STREAM of skin cancer. ProImmune REGISTRATION INFORMATION Pharmaceuticals An immunogenicity strategy is proposed based on the regulatory perspectives 12:50 Luncheon Presentation (Sponsorship Opportunity Available) or and scientific considerations on utilization of mRNA product for a broad range Enjoy Lunch on Your Own Register Online! of protein-replacement applications.D. Safety ENGINEERING Assessment & Laboratory Animal Resources. it is important for immunogenicity scientists and related departments University of Denmark to prepare themselves for the unique challenges ahead.com development of Alexion immunogenicity strategy for mRNA programs. Executive Director.D. and describe the latest developments concerning IMMUNOGENICITY & the inclusion of antibody and TCR information in epitope prediction. Goletz.D. EMD Serono NGS STREAM Avelumab binds PD-L1. Associate Scientist. Shefali Kakar. The risk-based approach is used in the 1:50 Session Break PEGSummit. Senior Director. Bio and Health Informatics. or efficacy.com | 61 . safety. Immunology Sales Specialist. Non-Clinical Safety. 2017 REGISTER BY DECEMBER 23 & Immunogenicity: Regulatory SAVE UP TO $550 and Clinical Relevance COVER Pre-Clinical and Clinical Risk Assessment to Ensure Product Safety CONFERENCE-AT-A-GLANCE Recommended Short Course* Predictive Models and De-Risking Strategies SPONSORS SC8: In silico Immunogenicity Predictions – A Hands-On Workshop 10:45 Chairperson’s Remarks *Separate registration required. as well as data comparing various commercially available 1st IMMUNOTHERAPY and 2nd generation models.. Merck STREAM Immunogenicity for Immuno-Oncology and Complex Drug induced hypersensitivity reactions pose a significant safety risk. Oncology. Alexion Emilee Knowlton. Head. blocking the interaction with PD-1 to subsequently Michael Szardenings. risk STREAM years. Non-Clinical Safety. Ph. This discussion will summarize current first and second generation ONCOLOGY STREAM 8:30 Chairperson’s Remarks humanized mouse models and their potential to predict clinically relevant immunogenicity. This is allowing to efficiently map Progress towards obtaining neutralizing antibody data will also be presented. Ph. Postdoctoral Fellow. Ph.D. BIOASSAY STREAM 9:10 KEYNOTE PRESENTATION: Immunogenicity of Avelumab . NBE Drug Disposition.D. 10:10 Coffee Break 2:20 Problem-Solving Breakout Discussions A Division of Cambridge Innovation Institute PEGSummit. Ligand Development..D. Ph.An Immune Checkpoint Inhibitor for Oncology 11:50 Broad Mapping of the Immunome with Peptide Phage Display and BIOCONJUGATES Theresa J. It will also discuss the potential of humanized mice to STREAM 8:40 Immunogenicity Assessment of Immunotherapies be combined with other techniques in the pre-clinical pipeline. SPONSOR & EXHIBITOR INFO 12:20 pm An Integrated Approach to Managing Sponsored By HOTEL & TRAVEL 9:40 Risk Based Immunogenicity Strategy for mRNA Programs Immunogenicity Risk and Drug Immune Modulation Mark Ma. Global Head.. Ph. Assistant Professor..D. We will mitigation and combination therapies. Celgene human physiology. Ph. 10th Annual | May 1-2. It will share methods to determine if these mice recapitulate Priya Sriraman. Celgene SHORT COURSES 10:50 Developing Tools for De-Risking Immune Mediated Drug TRAINING SEMINARS MONDAY. see the strengths and limitations of the available computational tools. Technical STREAM to grow. The incidence of immunogenicity with avelumab was found to combination with a proprietary library allows the identification of multiple potential be low with no apparent impact on clinical pharmacokinetics. Fraunhofer Institute potentiate T-cell cytotoxicity against tumor cells. thanks to novel machine learning algorithms and larger datasets. this ANALYTICAL The prediction of B and T cell epitopes has substantially improved in the last few presentation will review the key challenges in IO immunogenicity assessment.. Principal Investigator. Bioanalytical Development.

D.D. This proof-of-principle study presents Lysostaphin is a highly potent antibacterial lysin and a promising lead in the Register Online! search for next generation therapies to treat infections by MRSA superbugs.D. SHORT COURSES Director. however.. However. My talk will present an overview of the above and detail University of California. Trinity College and Co-Founder and Julio Delgado. Principal Investigator. A functional. lysostaphin has proven to be immunogenic due to its microbial origins. Senior Manager. tunable exposure and chemical synthesis. THERAPEUTICS Bayer HealthCare STREAM Preclinical and Clinical Immunogenicity Monitoring 11:50 Engineering Less Immunogenic and Antigenic FVIII Proteins 8:25 Chairperson’s Remarks SPONSOR & EXHIBITOR INFO Kathleen Pratt. Ph. TUESDAY. Ph. Ph.. Pharm. a strategy for designing less immunogenic FVIII proteins targeted to specific hemophilia A subpopulations. Master. BR US Lead Discovery.. Ph. REGISTER BY Immunogenicity: Regulatory and Clinical Relevance DECEMBER 23 & 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing subjects. during. Bicycle Therapeutics ARUP Laboratories..D. Chemical Engineering and Materials IMMUNOTHERAPY STREAM Science. Associate Professor. Department of Medicine. Medical Director and Section Chief. Immunoassay/Immunoprofiling Group. Uniformed Darshana Jani. and detection of delivery platform which greatly improves toxin loading into tumour tissues. Thayer School of Engineering.D. San Diego STREAM methodological improvements that enable the engineering work.com | 62 .. STREAM 4:55 Young Scientist Keynote: Programming Proteins by Deep Sequencing and Design 10:00 Coffee Break in the Exhibit Hall with Poster Viewing Tim Whitehead. Pfizer Services University HOTEL & TRAVEL 8:30 Preclinical Immunogenicity Assessment of Engineered Lysins: Development of antibodies that interfere with factor VIII (FVIII) pro-coagulant Next-Gen Antibiotics activity (“inhibitors”) can complicate the treatment of hemophilia A. specificity. Our REGISTRATION INFORMATION laboratory has identified an immunodominant epitope in FVIII.D. PLENARY KEYNOTE SESSION 9:00 Preclinical Assessments of Immunogenicity COVER Zuben Sauna. Ph. and function and to infer structural Niels Vande Casteele. Ph. Associate Professor.D. Associate Professor. where Bicycles’ unique properties ENGINEERING contributes to therapeutic failure.. Michigan State University Immunogenicity in Haemophilia Patients Next-generation sequencing has presented protein scientists with the ability to observe entire populations of molecules before. and after 10:50 Implementation of Therapeutic Drug Monitoring in Clinical EXPRESSION a high-throughput screen or selection for function. it is important to distinguish IMMUNOGENICITY & transient from persistent ADA and how this covariate (continuous or categorical) BIOASSAY STREAM 6:55 End of Day is included in pharmacological models. Division of Plasma Protein Therapeutics 4:00 Chairperson’s Remarks and Office of Tissues and Advances Therapies. ANALYTICAL complexes of proteins.. FRS. My group leverages this Practice as a Reactive or Proactive Tool to Optimize Treatment STREAM unprecedented wealth of sequence-function information to design and Outcomes of Biologics engineer protein affinity. Global Assay Lead. Gastroenterology. Using advanced biotherapeutic design algorithms. ADA are typically used in a reactive setting to support treatment decisions.. Griswold. Ph. tested its potential Karl E. MAY 2 STREAM 11:20 Immunogenicity in Haemophilia Patients 8:00 am Registration and Morning Coffee Pedro Paz. we have 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or reengineered lysostaphin to evade T cell mediated immune recognition in human Enjoy Lunch on Your Own A Division of Cambridge Innovation Institute PEGSummit. PEGSummit. University of Utah School of Bicycles® are a novel therapeutic class of constrained bicyclic peptides that Medicine TRAINING SEMINARS combine antibody-like affinity and selectivity with small molecule-like tissue TNF antagonists are used for the treatment of inflammatory diseases. developed in the clinical laboratory for measuring the biological activity and ONCOLOGY neutralizing antibody response to TNF antagonists. This drugspecific antibodies. Anti-drug antibodies (ADA) can impair the treatment effect of biologics and have 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing been associated with adverse events. including oncology. FDA/CBER (invited) CONFERENCE-AT-A-GLANCE 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation 9:30 Immunogenicity Assessment of Tumor Necrosis Factor SPONSORS Therapeutics Antagonists in the Clinical Laboratory Sir Gregory Winter. whereas drug concentrations can be used in a BIOCONJUGATES proactive setting to guide dosing based on exposure. Assistant Professor.D. Immunology Division.D. and generated amino acid substitutions in FVIII peptides and proteins Dartmouth to abrogate or reduce its immunogenicity. penetration. a novel toxin STREAM therapeutic failure includes measurement of drug levels. Rational and cost-effective evaluation of have been used to develop Bicycle Drug Conjugates™ (BDCs).. Postdoctoral Fellow. Pathology. Here we describe preclinical efficacy and immunogenicity analysis of SAVE UP TO $550 one high-performance variant.com Like most lysins. Ph.. cell-based reporter gene assay (RGA) was presentation will describe both the Bicycle® and BDC platforms.. They have potential Development of antibodies against these drugs is a major impediment that in many indications. Ph. promiscuity.D.

Ph. 5:30 Registration for Dinner Short Courses STREAM MedImmune LLC Immunogenicity is an important part of clinical development for biologics Recommended Dinner Short Course* EXPRESSION as it impacts drug PK. IMMUNOGENICITY & Sponsored By 3:05 Considerations for Development Projects: BIOASSAY STREAM Combination Therapy Josefin-Beate Holz. Ph. adverse events. ENGINEERING mesothelin expressing tumors. Pfizer Technology.. Global Assay Lead. STREAM antibodies for domain specificity.. NIH antibody requires well-designed immunogenicity assays. In this presentation. Teva CONFERENCE-AT-A-GLANCE Unwanted immunogenicity of a biologic may result in decreased drug 2:05 Strategies to Reduce the ADA Response to Immunotoxin Therapy SPONSORS concentrations. Clinical Pharmacology & DMP. Ph. Biologics Assays and Darshana Jani. part of NDA Group Network BIOCONJUGATES Considerations of an integrated development plan for a product as part of a STREAM combination regimen impact on candidate selection impact on non-clinical development impact on translational research impact on first-in-human strategy THERAPEUTICS impact on assessment of “clinical Proof-of-Concept”. Co-Chief.. which include identification and removal of B and T cell 4:55 Are ADA Results Reflecting the Impact on Pharmacokinetic epitopes and the induction of tolerance using novel approaches. SS1P is an immunotoxin targeting define ADA clinical relevance.D. National Cancer Institute.. Molecular Biology. STREAM 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.D. REGISTER BY Immunogenicity: Regulatory and Clinical Relevance DECEMBER 23 & SAVE UP TO $550 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing Defining ADA Clinical Relevance Immunotoxins 4:25 Conduct of Clinically Meaningful Immunogenicity Assessment for COVER Defining ADA Clinical Relevance 2:00 Chairperson’s Remarks Linglong Zou. We have pursued several strategies to reduce the STREAM immunogenicity of SS1P. Boehringer Ingelheim GmbH 2:35 Challenges and Solutions in Immunogenicity Assessment of STREAM Moxetumomab Pasudotox.D.D. and parallel measurement of clinical efficacy. please see page 5-6 for course details. adequate sampling SHORT COURSES Recombinant immunotoxins are anti-cancer agents composed of an Fv targeting schedule.com A Division of Cambridge Innovation Institute PEGSummit. They have good anti-cancer or drug concentrations. Risk challenging because of pre-existing anti-toxin antibodies of high prevalence. Head. Biosciences. two domain structure of the drug required characterization of anti-drug *Separate registration required.com | 63 . In Assessment and Regulatory Requirements ANALYTICAL addition. Immunogenicity assessment of STREAM moxetumomab pasudotox. a Recombinant Immunotoxin with Two 5:25 End of Immunogenicity: Regulatory and Clinical Relevance Functional Domains IMMUNOTHERAPY Inna Vainshtein. Ph. Director of Experimental Immunology. a strategy and case studies will be TRAINING SEMINARS activity in hematologic malignancies. Principal Scientist. impaired clinical efficacy and/or lead to severe adverse events of Cancer such as hypersensitivity reactions. an anti-CD22 recombinant immunotoxin. Exposure? ONCOLOGY Niklas Czeloth. where the immune system is suppressed illustrated for conducting clinically meaningful immunogenicity assessment to and neutralizing antibodies do not develop. Senior Manager. efficacy and safety. was SC14: Overcoming the Challenges of Immunogenicity Assays. and/ a protein on a cancer cell fused to a bacterial toxin. Ph.D. Bioneer-Consulting. Biosimilars. This talk will present challenges and solutions to obtain the most accurate assessment of drug immunogenicity. Clinical impact assessment of anti-drug Ira Pastan..

D. STREAM Immunogenicity Assessment of Multi-Domain Therapies 11:25 KEYNOTE PRESENTATION: The Use of Population Specific ADA ONCOLOGY STREAM 8:30 Chairperson’s Remarks Assay Cut Points Wendy White. Ph. Senior Principal Scientist. This presentation will WEDNESDAY. please see page 5-6 for course details. Ph. Principal Scientist.com A Division of Cambridge Innovation Institute PEGSummit. 10th Annual | May 3-4. Risk 10:55 Setting Targets for Relative ADA Assay Performance SHORT COURSES Assessment and Regulatory Requirements Theo Rispens. Clinical Assays. Here. Enjoy Lunch on Your Own HOTEL & TRAVEL 9:40 Assays for Multi-Domain Immunogenicity Assessment 1:55 Session Break REGISTRATION INFORMATION Cheikh Kane. Senior Scientist. Pfizer discuss case studies where baseline samples from different clinical studies were EXPRESSION Many biotherapeutics currently in development have complex mechanisms of evaluated to determine the appropriateness of the established assay cut points. Sanquin *Separate registration required. Manager.. and SPONSOR & EXHIBITOR INFO assess their utility in proof-of-concept studies of a simulated anti-drug-antibody 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or (ADA) assay. In general. the use of standards in determining assay performance and pitfalls in doing so. each with a specific role or function. Celldex Therapeutics BIOASSAY STREAM 9:10 Development and Characterization of Neutralizing Anti-Idiotype Pre-existing antibodies and other interfering matrix components can confound BIOCONJUGATES anti-drug antibody screening assay cutpoint calculations and increase the risk of Antibodies Directed against Mirvetuximab Soravtansine STREAM false negative results for patients. STREAM action and contain more than one domain.. Cutpoints IMMUNOGENICITY & as discussed in this presentation. patient background responses in an ADA assay IMMUNOTHERAPY can vary significantly.D.D. 2017 REGISTER BY DECEMBER 23 & Strategies for Immunogenicity SAVE UP TO $550 Assay Assessment COVER Improving Assay Detection Performance. Biomedicine Design. Fellow and Scientific Director. Boehringer Ingelheim 10:10 Coffee Break in the Exhibit Hall with Poster Viewing Register Online! PEGSummit. and when necessary.. This variability in the background response may require STREAM 8:40 Immunogenicity Assay Strategies for Multi-Domain Products the establishment of population specific assay cut points. Strategies for mitigating the impact of these Sven Loebrich.. MAY 3 address comparability of ADA assays. Albert Torri. Immunogen factors on the assay cutpoint are dependent on both the nature and prevalence of The antibody-drug conjugate Mirvetuximab soravtansine represents a potential the interfering substance. STREAM tools in the development of sensitive and specific bioassays for monitoring patient immune responses. DMPK. This presentation will Seema Kumar. Executive Director. Ph. Ph. Development Scientist III.com | 64 .. the tiered immunogenicity assay strategy may benefit and Interfering Substances on Anti-Drug Antibody Screening Assay from additional characterization such as domain specificity of immune response. LLC In various disease populations. Ph. One factor that hampers our understanding of immunogenicity is the difficulty TRAINING SEMINARS in unambiguously generating and interpreting ADA data. Regeneron MedImmune. Anti-idiotypic antibodies are powerful study to reduce the risk of false-negative responses in-study. A variety of approaches exist that can be employed pre- THERAPEUTICS new treatment for ovarian cancer patients. Depending 11:55 Strategies for Mitigating the Impact of Pre-Existing Antibodies on the specific risk factors. the presence of a domain with high immunogenicity risk or presence ANALYTICAL of a domain with high endogenous protein homology may result in an overall high STREAM immunogenicity risk level for the entire multi-domain biotherapeutic. we report the generation and characterization 12:25 pm Sponsored Presentation (Opportunity Available) of highly specific anti-idiotypic antibodies against Mirvetuximab soravtansine. Bioanalytical Sciences. Ph.. Ph..D. Department of Immunopathology.D.D.D. Translational Sciences. Jason DelCarpini. Sensitivity and Relevance CONFERENCE-AT-A-GLANCE Recommended Conference Short Course* Interpreting ADA Data SPONSORS SC14: Overcoming the Challenges of Immunogenicity Assays. how alternative cut points were established. as well as the relationship between technical ENGINEERING 7:30 am Registration and Morning Coffee and clinical performance.

Matrix interference to induce immunogenicity. UCB A Division of Cambridge Innovation Institute PEGSummit. Ph. MedImmune IMMUNOTHERAPY Research Laboratories Immunogenicity assessment is a requirement for biopharmaceutics registration. therefore. Director. Biologics and Vaccines Bioanalytics. The goal of our work is immunogenicity assessment. Methods for maintenance Managing Drug and Target Interference STREAM of critical reagents and ensuring consistent long-term performance of ADA methods will be discussed. COVER Wendy White. Clinical Immunology and Bioanalytics Group. antibody or derivatives of such. Ph. Ph. We developed a THERAPEUTICS procedure that used magnetic beads to specifically remove therapeutic drug from STREAM 7:00 pm End of Day assay samples. LLC biotherapeutics both in terms of safety and efficacy. Amgen PEGSummit.com | 65 . In detection of the neutralizing STREAM anti-drug antibodies (ADA)..D. it is critical to perform an immunogenicity is a common challenge for immunogenicity testing. Understanding the potential CONFERENCE-AT-A-GLANCE impact on a project early in the life cycle is preferred. Small amounts of aggregates present in preparations of conjugated reagents may 10:05 Coffee Break in the Exhibit Hall with Poster Viewing lead to a spurious increase of ADA positive classifications creating an appearance ENGINEERING of immune response developing in certain individuals. It STREAM Biotherapeutic drugs such as monoclonal antibodies (mAbs) have the potential is often evaluated in clinical studies as a secondary endpoint..D. With this procedure.D.. Principal Scientist. Merck Sciences. Thus we developed a 2:15 Storage Conditions of Conjugated Reagents Can Impact Results of method to better characterize the circulating immune complexes in preclinical SPONSORS Immunogenicity Assays: Lessons Learned species in terms of their size. Luminex and Delfia for ADA characterization. Ph.. we will use case examples to discuss innovative STREAM anti-drug antibodies (ADA).D. characterization approaches to overcome various matrix interferences to ensure accurate of ADA for neutralizing drug activity and isotyping. Ph. SPONSOR & EXHIBITOR INFO THURSDAY. Fellow and Scientific Director.D. MAY 4 12:05 pm Drug Target Interference in Immunogenicity Assays Zhandong Zhong. Translational Sciences. Teva Viewing BIOCONJUGATES Neutralizing antibodies against therapeutic proteins can potentially impact patient 4:45 Problem-Solving Breakout Discussions safety and directly mediate loss of drug efficacy. In general. Translational Shuangping Shi. Ph. Ph..) 9:05 SEC Based Method for Size Determination of Immune Complexes of Therapeutic Antibodies in Animal Matrix 2:10 Chairperson’s Remarks Mario Richter. Senior Scientist. SHORT COURSES MedImmune LLC Integrity of conjugated reagents used for measurement of anti-drug antibody 9:35 Sponsored Presentation (Opportunity Available) TRAINING SEMINARS (ADA) in study samples is critical for generation of reliable immunogenicity data.. Bioanalytical Scientist. an method development. Inc.D. 11:05 Innovative Approaches to Overcome Matrix Interference for Anti- ONCOLOGY Drug Antibody Detection STREAM 2:45 New Technology on Multiplex ADA Isotyping Meina Liang. Principle Scientist. titer assessment. Senior Manager. Ph. the interference could lead to inaccuracy in immunogenicity EXPRESSION immunogenicity assessment is performed in a multi-tiered approach: screening of reporting. the remaining therapeutic protein drug can inhibit the 5:45 Networking Reception in the Exhibit Hall with Poster Viewing neutralizing activity of the antibody and prevent the detection. In this presentation.D.. we can detect the neutralizing ADA in the presence of high levels of drug. Immunogenicity Biologics Assays and 3:45 Refreshment Break in the Exhibit Hall with Poster Technology.. Director. Associate Director.D.com 8:35 Effect of ADA on PK Assays Pérez Tosar Luis. Senior Scientist. Immunogenicity is a constant point of concern in the development in MedImmune. AbbVie. If not addressed during assessment to ensure drug efficacy and patient safety. The method can be applied to any humanized Robert Kubiak.. Ph. confirmatory test. Amgen HOTEL & TRAVEL 8:00 am Morning Coffee 12:35 End of Strategies for Immunogenicity Assay Assessment REGISTRATION INFORMATION Effect of ADA on PK Assays 8:30 Chairperson’s Remarks Register Online! Zhandong Zhong. DMPK-BA. REGISTER BY Strategies for Immunogenicity Assay Assessment DECEMBER 23 & SAVE UP TO $550 Interpreting ADA Data (Cont. ANALYTICAL to develop multiplex approaches on various platforms including Meso Scale STREAM Discovery (MSD).D. 11:35 Elimination of Drug Interference in Detection of Neutralizing Anti-Drug Antibodies in Samples Containing High Levels of Therapeutic 3:15 Presentation to be Announced Sponsored By IMMUNOGENICITY & Protein BIOASSAY STREAM Sheng Dai. Clinical Pharmacology and DMPK.

INSERM Director.D.D. MAY 4 cancer treatment by targeting the delivery of cytotoxic agent to tumor cell type of TRAINING SEMINARS interest.D. locate degradations and initiate the identification of critical Therapies and Points to Consider for Regulatory Compliance quality attributes.. Develop and Optimize MOA Reflective Potency Assays for Michael Tovey. development and optimization of mechanism of PEGSummit. This presentation will highlight general We have developed an alternative SPR-based assay principle. Roche Pharmaceutical Research and Early autoimmune diseases.D. Novartis reporter gene assays have been implemented to assess the potency of a kλ-Body as part of product quality analysis and characterization studies. 8:30 Chairperson’s Remarks SPONSOR & EXHIBITOR INFO 2:50 Design. Bioassay plays an important role in the development Development. Results obtained development and optimization of 8:00 am Morning Coffee THERAPEUTICS commercially available bioassays for cancer immunotherapy drugs will be STREAM presented. please see page 5-6 for course details.. please see page 5-6 for course details. cell based. Head. Comparison of data between immunomodulatory biologics.. Roche Innovation Register Online! of product and manufacture process. Novartis Biologics R&D. Manager. Ecole Normale Supérieure de Cachan HOTEL & TRAVEL Shihua Lin. REGISTER BY 3rd Annual | May 4-5. Bioassay Development. Bristol-Myers Squibb 5:20 End of Day Combination therapies are currently under consideration for cancer therapy. Large Molecule Research. Molecular and Analytical STREAM Development. Ph. Senior Scientist. Director. ADCs are generally complex heterogeneous mixtures of multiple in vivo drug species and present unique challenges to bioassay development. ImmunoGen SHORT COURSES Antibody-drug conjugates (ADCs) represent an increasingly important approach to THURSDAY.. Novartis Biologics R&D. We will Bioassay Strategies for Cancer Therapies present some examples from our experience in the development of bioassays for ENGINEERING 12:00 pm Registration the measurement of a new class of payloads from biological matrices. Laboratory of Biotechnology & Immunomodulatory Biologics Applied Pharmacology.D. Laboratory Head. Ph.com | 66 .D.com action (MOA) reflective and QC-suitable bioassays for potency determination of individual assessment of both targets in solution. NovImmune STREAM 1:40 Chairperson’s Remarks A comprehensive suite of highly sensitive and complementary binding and Natko Nuber. Laboratory Head. Hence.. MAY 5 STREAM An ideal bioassay should mimic the MoA and be able to detect changes in the integrity of the drug.. Senior Scientist. bioassays to detect stressed material was Bioassay Strategies for Bispecifics assessed in comparison to standard binding assays. Ph. This is further compounded by a variety of ratio and formulation presentations. Ph. Analytical Biotechnology Development.. Ph. STREAM 12:35 Luncheon in the Exhibit Hall with Poster Viewing 4:50 Implementing Bioassays for a kλ-Body ONCOLOGY Anaëlle Dos Santos. 5:20 Registration for Dinner Short Courses ANALYTICAL Independent and synergistic mechanisms of action contribute to feasibility of STREAM combination therapies but also to control strategy complexity. Research. Bioanalytical Development. and revealed a good correlation. BTDM-BPD. Novartis FRIDAY. Recommended Dinner Short Course* IMMUNOGENICITY & SC19: Strategic Bioassay Design and Analysis BIOASSAY STREAM 2:20 Development and Optimization of Cell-Based Bioassays for Novel *Separate registration required. Development and Validation of Biological Assays COVER Recommended Short Course* 3:50 Refreshment Break CONFERENCE-AT-A-GLANCE 4:20 Bioassay Development and Validation Strategies for Antibody-Drug SC16: New USP Initiatives for Characterization and Release of Biologics Conjugates SPONSORS *Separate registration required. Results obtained IMMUNOTHERAPY using the different assays were correlated to demonstrate the assays’ stability STREAM 1:50 KEYNOTE PRESENTATION: Potency Methods for Combination indicating properties. which allows the consideration on the design.D.D. Bioanalytical Science. Ph.. BTDM-BPD. Cancer Immunotherapy BIOCONJUGATES Natko Nuber. Ph. EXPRESSION Isam Qahwash. both SPR-based 3:20 Sponsored Presentation (Opportunity Available) assay principles allow a “full” functional analysis of a bispecific CrossMab in only A Division of Cambridge Innovation Institute PEGSummit. 2017 DECEMBER 23 & Optimizing Bioassays for Biologics SAVE UP TO $550 Improving the Speed. the assays showed that simultaneous binding can be calculated based on both individual readouts. 8:35 SPR-Based Assays Enable the Full Functional Analysis of REGISTRATION INFORMATION MedImmune LLC Bispecific Molecules Immunotherapy is now a promising approach for the treatment of cancer and Joerg Moelleken. Ph. Michelle Palmer. Ability of these.

. I will discuss the lessons learned and pitfalls to avoid from our IMMUNOTHERAPY 10:35 FEATURED PRESENTATION: Conformationally Selective NAb assay transfer experience. Eli Lilly 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or and Company Enjoy Lunch on Your Own CONFERENCE-AT-A-GLANCE We developed a synergy cell-based assay for one of our bispecific antibodies as 1:05 Refreshment Break we have seen in vivo synergy with this molecule in our preclinical animal model.D. GSK Vaccines Michael Tovey. Ph.com been quantified in serum samples from patients with Crohn’s disease and that of adalimumab and etanercept in patients with rheumatoid arthritis with a high We will present different ways how robustness can be assessed and which statistical methods are employed. We demonstrate that trypsin digestion. BIOASSAY STREAM 11:05 Development and Automation of Cell-Based Assays for Biologics Natalia Kozhemyakina. Case study will go through the method development journey: from the reduces variability and facilitates assay development and validation. In practice. and prompt communication. Protein Chemistry. degree of precision and with minimal interference from human serum. Novel target cells. SPONSORS We were able to identify the optimum conditions to achieve our goal where we were able to determine the response from both the targets in a single cell-based Lifecycle Management and Statistical Analysis SHORT COURSES assay. The assay principles can be qualified and enable an efficient drug 12:05 pm Bioassays Design. Laboratory of Biotechnology & Robustness is an important aspect for analytical methods.. have been developed robustness studies have often been included in a not-too-rigorous manner during for the quantification of the ADCC activity of rituximab. 3:40 End of Conference A Division of Cambridge Innovation Institute PEGSummit. This talk will development itself to the tools implemented to monitor the method performance present case studies of potency assays for bispecific and monoclonal antibodies using the latest recommendations from the USP. understood as a systematic approach that begins with predefined objectives and to pre-select immunologically active HA. Principal Science & Standards Liaison.. STREAM including but not limited to work cell bank preparation and qualification. Bioassays. Ph. Development Scientist II. Alexion Pharmaceuticals 9:05 Development of Synergistic Cell-Based Assay for Bispecifics COVER Piyush M. Research.. Bioassays. sample pretreatment to increase drug tolerance. Guidelines have always REGISTRATION INFORMATION Applied Pharmacology. proper analyst training. Bioassay Laboratory. Senior Research Investigator. Associate Director..D.. Director. spread across different stages of method development. BIOCAD the USP Approach STREAM Main problems of cell-based potency assays are variability and complexity. Seqirus 2:10 Lifecycle Management for Bioassay Development and Validation EXPRESSION Influenza vaccines are the primary intervention for reducing the health burden Steven Walfish. Senior Research Scientist. Inactivated Lifecycle management for bioassay development starts with procedure influenza vaccines are formulated. The use of automatic station for cell-based assays allows reduction and relative potency bioassays are generally used to accurately determine this STREAM of procedure time and implementation of complex designs. Head. UCB Classical potency assay presents a lot of drawbacks that could be overcome by Biological activity is a critical quality attribute for biopharmaceutical products. Manager. USP STREAM from influenza. INSERM Director. Vyas. Ph. 1:40 Challenges When Transferring NAb Assays to CROs 9:35 Sponsored Presentation (Opportunity Available) ENGINEERING Linlin Luo. PEGSummit. BMS STREAM 10:05 Coffee Break Cell-based neutralizing antibody (NAb) assay posts many challenges in assay development. REGISTER BY Optimizing Bioassays for Biologics DECEMBER 23 & one assay.. Gael Debauve. THERAPEUTICS automation.com | 67 . Analytical Sciences. sound science and quality risk management (ICH Q8). and tested for stability design and continues through validation based on QbD. 3:10 Statistical Considerations regarding Assay Robustness Studies HOTEL & TRAVEL 11:35 A Novel System for Improved Quantification of ADCC Activity Walter Hoyer. Novel mathematical approach is used to determine TRAINING SEMINARS Gael Debauve. cetuximab assay validation.D.. validation and execution. we have revisited the concept Register Online! and TNFα antagonists. Ecole Normale Supérieure de Cachan encouraged assessing robustness before method validation.D. It significantly activity. together with homologous control cells. Extra considerations need to be given ONCOLOGY Optimizing Assay Development and Determining Potency during a NAb assay transfer to contract research organization (CRO) labs. Ph. however. Data analyses of such efficacy data was challenging as the traditional 1:35 Chairperson’s Remarks model cannot fit such data. Ph. followed by quantification by RP-HPLC is emphasizes product and process understanding and process control. Head. Ph. STREAM Biophysical Assay for Influenza Vaccine Potency Determination Yingxia Wen. based on STREAM a promising alternative in vitro potency assay for influenza vaccines. Ph. John Garza.D..D. trastuzumab. SRID. Ph. Ph. HA is the most important influenza vaccine antigen. With an increased focus on QbD. UCB the synergy of such bispecific antibodies. Statistics. Ph. released for clinical use.D. An overview of variability and measurement uncertainty to align decisions with results generated by a IMMUNOGENICITY & procedure. The concept of QbD is ANALYTICAL based on an in vitro potency assay. Development and Validation SAVE UP TO $550 development. Bioassay Development. Associate Director. The ADCC activity of the TNF antagonist infliximab has of method robustness.D. SPONSOR & EXHIBITOR INFO with the use of automation.D.D.. Analytical Development 2:40 Tips and Tricks to Develop and Validate a Bioassay According to BIOCONJUGATES Department.

com | 68 . REGISTER BY DECEMBER 23 & SAVE UP TO $550 BIOCONJUGATES STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Fusion Protein Therapeutics SHORT COURSES TRAINING SEMINARS Antibody Drug Conjugates I : ENGINEERING New Targets.com A Division of Cambridge Innovation Institute PEGSummit. Payloads and Alternative Formats STREAM ONCOLOGY Antibody Drug Conjugates II: Advancing Toward the Clinic STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.

REGISTER BY 3rd Annual | May 1-2. in contrast.B. Professor.D... Here I highlight the current strategies to generate SHORT COURSES SC9: Target Selection for Biologics biobetters with these superior properties while describing their benefits and limits *Separate registration required.com | 69 .and THERAPEUTICS 9:10 FEATURED PRESENTATION: Fusion Proteins: Case Studies from CD27-agonists. Case studies and Skeletal Diseases TFA. Ph. Lastly. Regeneron Pharmaceuticals.D. Inc. a common 8:40 KEYNOTE PRESENTATION: From Cytokine Traps to Antibody. Process Science and Production. M. 2017 DECEMBER 23 & Fusion Protein Therapeutics SAVE UP TO $550 Engineering Next-Generation Biologics COVER Recommended Short Courses* Next-generation biologics with enhanced properties are one of the fastest CONFERENCE-AT-A-GLANCE growing protein classes. CSO..D. GITR-. Ala. STREAM Roche’s Research & Early Development Pipeline Stefan Weigand. multi-functional therapeutics that allow for tailored solutions for 12:20 pm Sponsored Presentation (Opportunity Available) the biological problem at hand. Antibody Discovery & Protein Engineering. Lu Shan. Enjoy Lunch on Your Own Register Online! 1:50 Session Break 9:40 Fusion Protein Approaches to Generate Biobetters – Current PEGSummit. Technische Universität Munich.. their agonistic activity does not rely on secondary crosslinking applications for the generation of therapeutics will be discussed. Executive Director. Scientist II. Vice President. this is achieved by SPONSORS Process Development fusing the therapeutic entity to other protein modules influencing plasma half-life or reducing off-target toxicity. PAS sequences are strongly EXPRESSION Based Protein Therapeutics: A Scientific Journey hydrophilic. Ph.D. uncharged biological polymers with biophysical properties surprisingly STREAM Aris N. Rentschler Biotechnology 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing A Division of Cambridge Innovation Institute PEGSummit. We will present the modular engineering concept and the current results obtained for the hexavalent CD40-. MedImmune/ SPONSOR & EXHIBITOR INFO This talk will briefly introduce the concept of fusion proteins and provide AstraZeneca HOTEL & TRAVEL examples from Roche’s pipeline how to discover. Large Molecule Research. and/or Ser (PAS) is a beneficial way to enlarge the hydrodynamic volume and retard kidney clearance.. Technological advances TNFRSF targeting compounds with a solely agonistic activity on immune cells in monoclonal antibody generation and production have largely supplanted are still rare. Apogenix’s single-chain-based fusion proteins mimic the three- cytokine trap technology and have also enabled the engineering of antibody-based dimensional organization of the natural ligands (the TNFSF-proteins). Examples of these technologies and their STREAM to antibodies. Genome Engineering Technologies. Molecular Biology. Vice President. develop and deliver differentiated.. Co-Founder & Head of Functional Modeling. and in as much as they are potent and highly specific. similar to PEG while. MAY 1 ENGINEERING Engineering to Improve Properties STREAM 7:00 am Registration and Morning Coffee 10:50 PASylation: The Biological Alternative to PEGylation for Plasma ONCOLOGY Next-Generation Therapeutic Fusion Proteins Half-Life Extension and Beyond STREAM Arne Skerra. events in vitro nor in vivo. Economides. Regeneron on the route to clinical development will be presented. please see page 5-6 for course details.D. HVEM. Ph. Ph. 4-1BB-. design. 8:30 Chairperson’s Remarks Pieris AG Fredrik Frejd.com Status and Future Outlook 2:20 Problem-Solving Breakout Discussions Stefan Schmidt. Head. In many cases. Roche Pharma Research 11:50 Monomeric Fc Platform for Monomeric Fusion Proteins and Early Development (pRED).D.. APOGENIX AG BIOASSAY STREAM also present engineering and production challenges. drawback during biological drug development. they Oliver Hill. in examples from the present development pipeline. In contrast BIOCONJUGATES therapeutics with novel properties. allowing traceless metabolization.. Ph. Ph.A. Ltd. TRAINING SEMINARS 10:10 Coffee Break MONDAY. and Co-Founder. Hoffmann-La Roche. ANALYTICAL Genetics Center. These biobetters typically demonstrate improved SC4:The Multi-Attribute Method (MAM) for Improving Product and pharmacokinetics or more selective targeting. STREAM Engineered proteins such as receptor ectodomain-Fc fusions and cytokine traps 11:20 Hexavalent Agonists Targeting Co-Stimulatory Receptors of the are complex fusion proteins comprised of two different receptor ectodomains TNFR-Superfamily IMMUNOGENICITY & fused to human Fc. Ph.D. Affibody AB Fusion of proteins or peptides with conformationally disordered polypeptides IMMUNOTHERAPY STREAM comprising the L-amino acids Pro. I will raise challenges and opportunities for REGISTRATION INFORMATION 12:50 Luncheon Presentation (Sponsorship Opportunity Available) or future applications of fusion proteins. F.

Head. tunable exposure and chemical synthesis. Biochemistry and Physiology & Biophysics. FRS.. Assistant Professor.D. strongly synergizes with Maraviroc inhibiting R5 HIV. Ph.. Institute of Human Virology. IMMUNOGENICITY & 6:55 End of Day BIOASSAY STREAM 11:20 Engineering Novel General Amyloid Interaction Motif (GAIM)- Immunoglobulin Fusions for Targeting Misfolded Protein Aggregates in TUESDAY. Michigan State University IMMUNOTHERAPY but purification was challenging.com shown in man. Phase Ib clinical trial. inhibiting R5 HIV entry in SPONSORS Sir Gregory Winter. specificity. Ultee. Chemical Engineering and Materials acid alpha glucosidase enzyme (GAA). An Affibody® based 18. Science. populations by covalently linking single chain peptide-MHC (sc-pMHC) and costimulatory molecules in a manner that recapitulates the proximity.. Hoffmann-La Roche. HOTEL & TRAVEL 8:30 Engineering an Affibody Fusion Protein Trap towards Therapeutic Blocking of IL-17 in Humans 11:50 New Strategies for Immunotherapy REGISTRATION INFORMATION Fredrik Frejd. We demonstrate SHORT COURSES Bicycles® are a novel therapeutic class of constrained bicyclic peptides that that (FLSC) IgG1.D.. ability to observe entire populations of molecules before. We reported that treatment with the CCR5 antagonist Maraviroc Director. Ph.. Albert Einstein College of Psoriasis is an IL-17 driven disease.. Senior Director. They have potential studies are warranted. My talk will present an overview of the above and detail Transfusion Burden in Patients with Low or Intermediate-1 Risk ANALYTICAL methodological improvements that enable the engineering work. Cell Biology and Protein Chemistry. Senior Scientist. where Bicycles’ unique properties have been used to develop Bicycle Drug Conjugates™ (BDCs). The trivalent bispecific fusion Register Online! protein blocks IL-17 with unparalleled affinity and display long plasma half-life as We describe a novel platform for the clonal specific expansion of disease-relevant T cells. These A Division of Cambridge Innovation Institute PEGSummit..D. This finding combine antibody-like affinity and selectivity with small molecule-like tissue suggests that this combinatorial treatment has potential merit. Myelodysplastic Syndromes (MDS) STREAM 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing Asya Grinberg. specifically binds cellular coreceptor CCR5.D. Ph.D. Principal. Early development and data from Phase I/II will be presented.D. Trinity College and Co-Founder and primary cells. and function and to infer structural 10:50 Luspatercept (ACE-536) Increases Hemoglobin and Reduces complexes of proteins. Bicycle Therapeutics increased exposure of the (FLSC) IgG1 binding sites on CCR5.6 kDa ligand trap was Medicine engineered to block IL-17 with femtomolar affinity. Inc. Acceleron Pharma.. amyloidogenic aggregates in a conformation-dependent STREAM manner.D.e. Research. Ph. Ph. Ltd. Ulteemit BioConsulting. Biochemistry.. F. Large Molecule Research. VAL-1221. orientation and overall organization experienced at the immunological synapse. Assistant Professor.. a fusion protein containing gp120BAL Therapeutics and CD4. including oncology. Roche Pharma Research GAIM with a human immunoglobulin (hIgG1Fc). CSO. and after a high-throughput screen or selection for function. University of Maryland CONFERENCE-AT-A-GLANCE 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation We have previously shown that (FLSC) IgG1. Chairman. Ph. We describe the design.D. LLC STREAM presentation will describe both the Bicycle® and BDC platforms. during. Ph. CHO-cell production was straightforward. School of Medicine. displays 2 copies of GAIM. retains binding and remodeling activities towards amyloid fibrils in vitro and ex vivo. The fusion protein.D. Microbiology and Immunology. Proclara Biosciences STREAM The tip protein g3p of the filamentous bacteriophage M13 was previously Conquering Disease identified as a General Amyloid Interaction Motif (GAIM) that binds and remodels THERAPEUTICS a variety of fibrillar. REGISTER BY Fusion Protein Therapeutics DECEMBER 23 & SAVE UP TO $550 PLENARY KEYNOTE SESSION 9:00 Synergistic Inhibition of R5 HIV-1 by the Fusion Protein (FLSC) IgG1 Fc and Maraviroc in Primary Cells: Implications for Prevention and Treatment COVER 4:00 Chairperson’s Remarks Olga S. My group leverages this 10:00 Coffee Break in the Exhibit Hall with Poster Viewing EXPRESSION unprecedented wealth of sequence-function information to design and STREAM engineer protein affinity. contains a humanized anti-dsDNA Fab genetically linked to the Tim Whitehead. in many indications. clonal) lymphocyte PEGSummit. The final process overcame these challenges for Next-generation sequencing has presented protein scientists with the STREAM production of clinical material at the 500L scale. a novel toxin 9:30 A New Fab-Fusion Protein Therapeutic for Enzymatic Targeting ENGINEERING delivery platform which greatly improves toxin loading into tumour tissues. Ph. Montefiore Medical Center. MAY 2 Neurodegenerative Diseases BIOCONJUGATES 8:00 am Registration and Morning Coffee Ming Proschitsky. Ph. Master. To prolong the half-life of this molecule in the blood. Our approach manipulates antigen-specific (i. and Professor. Latinovic. currently in a SPONSOR & EXHIBITOR INFO and Early Development (pRED). Affibody AB Steven Almo. Future in vivo TRAINING SEMINARS penetration.com | 70 . a preclinical product candidate for glycogen- STREAM Sequencing and Design storage diseases. we genetically fused 8:25 Chairperson’s Remarks Stefan Weigand. This Michiel E. development and manufacture of a unique antibody- 4:55 Young Scientist Keynote: Programming Proteins by Deep fusion protein consisting of a Fab-linked enzyme rather than the more typical ONCOLOGY Fc-linked fusion protein.

D. Ph. M. Senior Director and Venture Leader. University CONFERENCE-AT-A-GLANCE of Stuttgart 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing Engineering of multivalent antibody-scTRAIL (single-chain derivatives of TRAIL) SPONSORS by introducing different homodimerization modules leads to a novel platform Harnessing Albumin of therapeutic molecules for cancer therapy. STREAM 5:25 End of Fusion Protein Therapeutics Bioorthogonal labeling of antibodies enables the conjugation of compounds to expand targeting capacity or enhance cytotoxicity. Ph. Antibodies or other scaffold Dirk Spitzer. exchanging the specificity Rentschler Biotechnology of the antibody moiety facilitates the treatment of a broad spectrum of different cancer entities. Sorrento Therapeutics.com | 71 . which resulted in a STREAM Conjugation better understanding of targeted drug design but also offered new insight into the James Patterson. REGISTER BY Fusion Protein Therapeutics DECEMBER 23 & SAVE UP TO $550 constructs are generated as Fc-fusion proteins (i. the possibility of creating biomarker-targeted variants under strict stoichiometric EXPRESSION control. A detailed characterization of the improved activity profile of mesothelin- 2:35 A Human Serum Albumin Domain I Fusion Protein for Antibody targeted scFv-TR3 revealed unexpected drug properties. Ligand COVER 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or 4:25 Multivalent Antibody-TRAIL Fusion Proteins for Cancer Therapy Enjoy Lunch on Your Own Oliver Seifert. Washington University School of proteins can provide the cellular address for delivering a covalently linked. ANALYTICAL and Chemical Biology. Inc.e.. Recommended Dinner Short Course* BIOCONJUGATES Conjugation via HSA domain I fusion should therefore have broad utility for STREAM making antibody conjugates. genetically stabilized and constitutively trimerized TRAIL- STREAM components on the path to developing a therapeutic candidate. Risk Assessment and Meeting Regulatory Requirements 3:05 Sponsored Presentation (Opportunity Available) *Separate registration required..A. Assistant Professor. Post-Doc.com A Division of Cambridge Innovation Institute PEGSummit.. Janssen R&D Translational Cancer Research with Fundamental Concepts of Native ONCOLOGY Targeted delivery of therapeutic payloads to specific tissues is an important TRAIL Biology STREAM component of modern pharmaceutical development.D. Ph. Vice President. Ph. Medicine IMMUNOTHERAPY Optimization of bioconjugate properties and exposure profile are important The newly designed. Centyrex. Ph.. please see page 5-6 for course details. SC11: Overcoming the Challenges of Immunogenicity Assays. This presentation based fusion protein TR3 has tremendous potential as a cancer therapeutic due to will focus on current efforts to optimize Centyrins for payload delivery. Surgery.B. This combined targeting modulation construct is referred to as synTac TRAIL: Tumor Necrosis Factor-Related Apoptosis-Inducing (artificial immunological Synapse for T-cell Activation). Antibody Technologies ligand/receptor biology of the native TRAIL cytokine. TRAINING SEMINARS Stefan Schmidt. we demonstrate that domain I of HSA can be used as a fusion protein for the preparation of serum-stable antibody conjugates. THERAPEUTICS STREAM 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.D. Institute of Cell Biology and Immunology. Due to the modular composition of this novel platform. Project Leader. Process Science and Production. ENGINEERING 2:05 Fusion to a Highly Stable Consensus Albumin Binding Domain STREAM Allows for Tunable Pharmacokinetics 4:55 Functional Characterization of Mesothelin-Targeted TR3 Connects Karyn O’Neil.D. Senior Scientist.D... Our results show that both tumor SHORT COURSES targeting and enhancing the valency of scTRAIL fusion protein provides enforced 2:00 Chairperson’s Remarks apoptosis induction together with good anti-tumoral activity and tolerance in vivo. Taking advantage of a IMMUNOGENICITY & 5:30 Registration for Dinner Short Courses cyclohexene sulfonamide compound that site-selectively labels Lys64 in human BIOASSAY STREAM serum albumin (HSA). IgG) for enhanced avidity and stability.

with sub-nanomolar potency against a large panel of tumor cell lines has been BIOCONJUGATES established as a versatile new payload class for the generation of potent and 9:10 Abdurin-Drug Conjugates: A New Generation of Targeted STREAM selective ADCs against different targets. the inhibition of RNA polymerase II. SarcinDI. generated with a chemical scaffold.. Therapeutics Kurt Gehlsen. MAY 3 10:55 HDP-101 – A BCMA-Targeted Amanitin-Based ADC STREAM Andreas Pahl.D. Ph. This payload introduces a novel mode of action into STREAM Alternative Formats and Effector Moieties oncology therapy. Vice President and CSO. to be displayed on the AG STREAM surface of viable bacteriophage. demonstrated 8:30 Chairperson’s Remarks safety profile and biomarker. Sponsored By 9:40 Small is Beautiful – Humabodies Drug Conjugates. 7th Annual | May 3-4. Vice President.D.D. Small IMMUNOGENICITY & avoids liver and GI toxicity often associated with other drug modalities. bicyclic Hans-Georg Lerchen. The technology platform around ATACs includes Amanitin supply. AzymetricTM (bispecific) enhanced payload delivery to solid tumors compared to standard antibody-drug and AlbuCORETM (multispecific) platforms for the development of next-generation conjugates. Therapeutics. linkers and site-specific conjugation technologies designed a monoclonal antibody and have been conjugated to MMAE and a deimmunized for the targeted delivery of therapeutics with optimal efficacy and safety profiles. Ph.. Ph. A BCMA-ATAC has been selected based on favorable IMMUNOTHERAPY Ravi Chari. Research Corporation 11:55 Expanding the Therapeutic Window of ADCs with Zymelink™ THERAPEUTICS Technologies. The smaller size and longer half-life of Abdurins may facilitate It is compatible with traditional monoclonal antibodies. MedChem.D.. Bayer ANALYTICAL peptides (Bicycles®).com Engineering. Bicycle Therapeutics Payload Class The Bicycle® platform allows hugely diverse libraries of constrained. Preclinical Development and Protein 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or PEGSummit.. Abdurins are amenable to high-throughput screening to isolate binders to targets ZymelinkTM is a novel drug-conjugate platform consisting of a modular suite of SPONSOR & EXHIBITOR INFO of interest. A new pyrrole subclass of KSP inhibitors development of BT1718. Oncology Research. Ph. Ph. Vice President. site-specific conjugation. Ph. Abdurins have demonstrated improved tumor penetration compared to proprietary payloads.D.. Chemistry & Biochemistry. ImmunoGen. 2017 REGISTER BY DECEMBER 23 & Antibody-Drug Conjugates I: SAVE UP TO $550 New Targets.. Inc. Senior Vice President. Inc. STREAM 8:40 BT1718.D. HDCs a Real 12:25 pm Presentation to be Announced Register Online! Alternative to ADCs Thomas Sandal. Heidelberg Pharma 7:30 am Registration and Morning Coffee Antigen-Targeted Amanitin-Conjugates (ATACs) represent a new class of ADCs ONCOLOGY using the payload Amanitin. renal clearance increase therapeutic options and potentially help to overcome resistance. Ph. Novel Linkers and Payloads STREAM Abdurins are a small antibody-like scaffold that retains a long circulating half-life. please see page 5-6 for course details. Novel Payloads ENGINEERING WEDNESDAY. CSO. a potent Bicycle Drug Conjugate targeting MT1-MMP.. REGISTRATION INFORMATION biotherapeutics. Principal Scientist. HOTEL & TRAVEL ribotoxin. Crescendo Biologics Ltd. Zymeworks Inc. preclinical data to start the clinical development of the first ATAC. This molecule inhibitors of kinesin spindle protein (KSP/Eg5) have generated interest BIOASSAY STREAM presentation will exemplify the Bicycle platform and describe the discovery and due to their high antitumor potency.5-2 kDa) delivers The identification of ADC payload classes with a novel mode of action will advantages in tumor penetration and extravasation and the fast.D. Discovery Research. Vice President. John Babcook. Their relatively small size (1. Payloads & Alternative Formats COVER Innovative Engineering and Creative Chemistry to Optimize Therapeutic Impact CONFERENCE-AT-A-GLANCE Recommended Short Courses* • Humabodies enable plug and play engineering allowing simple exploration of limitless format options SPONSORS SC9: Target Selection for Biologics • The versatility of the Humabody™ platform enables creation of optimal HDC format and half-life with improved Therapeutic Index SHORT COURSES SC15: Critical Considerations for the Design and Development of 10:10 Coffee Break in the Exhibit Hall with Poster Viewing TRAINING SEMINARS Antibody-Drug Conjugates *Separate registration required. A Bicycle Drug Conjugate (BDC) Targeting MT1-MMP for 11:25 Development of Potent and Selective Antibody-Drug Conjugates EXPRESSION Treatment of Solid Tumors Targeting Different Antigens with Pyrrole-Based KSP Inhibitors as Novel STREAM Peter Park. Enjoy Lunch on Your Own • HDCs demonstrate exceptionally fast tumour penetration • HDCs facilitate low systemic exposure 1:55 Session Break A Division of Cambridge Innovation Institute PEGSummit. Drug Discovery.com | 72 .

D. Massachusetts Institute of IMMUNOTHERAPY We will review the development of Mylotarg & Inotozumab Ozogamicin. Ph. To overcome 2:15 KEYNOTE PRESENTATION: Antibody Drug Conjugates with Novel resistance. Ph. This talk Technology will explore the next generation of Pfizer DNA-damaging ADCs STREAM Here we report a robust bioconjugation method using cysteine arylation. Kadcyla® (ado-trastuzumab SPONSORS DNA Alkylating Agents: Design and Preclinical Evaluation emtansine) was developed by Genentech.D. Duocarmycin as payload STREAM for antibody drug conjugates has been explored by several companies. Ph. Ph. Chemistry. Inc. Ph. MAY 4 in the clinical trial was not successful due to the toxicity. Ph. will PEGSummit. effect both disulfide reduction and functional re-bridging). Chemistry & Biochemistry. Ph. Oncology Research. But the 8:00 am Morning Coffee linker design for duocarmycin has been challenging. 10:05 Coffee Break in the Exhibit Hall with Poster Viewing STREAM 2:45 KEYNOTE PRESENTATION: Novel DNA-Targeting Payloads for Optimizing Linker and Conjugation Chemistry ONCOLOGY ADCs 11:05 Site Selective Antibody Drug Conjugates Enabled by Cysteine STREAM Puja Sapra.. Target Therapeutics Unit. Duocarmycin as small molecule BIOCONJUGATES THURSDAY.. Nutritional Biochemistry. • HuMax-AXL-MMAE shows efficacy in AXL-expressing melanoma CDX and PDX models 12:35 End of Antibody-Drug Conjugates I: New Targets.D. Associate Director of Chemistry.D. Ambrx Duocarmycin is very potent DNA alkylating agent. Chari. Nutritional Sciences. Tz) with Covalent Attached Redox A Division of Cambridge Innovation Institute PEGSummit. • AXL is overexpressed in many types of cancer. 5:45 Networking Reception in the Exhibit Hall with Poster Viewing 11:35 Novel Lysosoma Cleavage Linker Leads to Potent and Stable IMMUNOGENICITY & Duocarmycin Conjugates BIOASSAY STREAM 7:00 End of Day Ying Sun. and antibodies.D. we have designed a new class of potent DNA-alkylating agents.. “indolino.D. Ph. Formation of Homogeneous Antibody Conjugates and Explore Novel University College London ADC Avenues through PDT and Bispecifics HOTEL & TRAVEL Vijay Chudasama. Inc. Lecturer. Vice President. Director. resistant and Kadcyla® treated Herceptin® resistant JIMT-1 BC cells.. and an update our first-in-class reagents that Register Online! associated with EMT and increased invasiveness of tumors. Lecturer. redox selenium moiety (Mab-SeCN) that redox cycles and increases intracellular SHORT COURSES There are currently over 50 Antibody-Drug Conjugates (ADCs) in clinical BC oxidative stress. Ph. Payloads & Alternative Formats DECEMBER 23 & SAVE UP TO $550 KEYNOTE PRESENTATIONS Selenium is More Cytotoxic to Tz Resistant JIMT-1 Breast Cancer Cells than Tz Alone by Generating Intracellular Superoxide and H2O2 2:10 Chairperson’s Remarks Julian Spallholz. which leads to potent and STREAM Overcoming Drug Resistance stable duocarmycin conjugates. ImmunoGen. and a novel oft-used BRAF and MEK inhibitors in melanoma strategy for making DAR 2 constructs from a native antibody scaffold. Also presented. Vice President. Recently. Organic Chemistry and Chemical Biology. Organic Chemistry and Chemical Biology. including melanoma.. Tz) treated women with Her/2 + breast cancer (BC) CONFERENCE-AT-A-GLANCE often relapse with their cancer becoming Herceptin resistant. TRAINING SEMINARS As part of our effort to expand the available toolbox of cytotoxic payloads. we report a new linker THERAPEUTICS design with novel lysosomal cleavage mechanism. 8:35 Elimination of Multidrug-Resistant Melanoma by Humax-AXL University College London REGISTRATION INFORMATION MMAE Our latest data on next generation maleimide and pyridazinedione reagents for the David Satijn. This chemistry enables site-specific conjugation at cysteine residues within peptides.D. Pfizer. in vivo efficacy. Bicycle Therapeutics Texas Tech University Herceptin® (Trastuzumab.. Professor. Payloads and Alternative Formats 9:05 Herceptin® (Trastuzumab. EXPRESSION proteins.com • AXL is also upregulated upon resistance to a variety of therapies including the be how we have been able to use our platforms to create bispecifics.. 9:35 Sponsored Presentation (Opportunity Available) benzodiazepine dimers” (termed IGNs). and is in vitro selectivity. Genmab site-selective modification of antibodies will be detailed (robust serum stability. reflecting the growing interest in ADCs for the treatment of cancer. COVER Peter Park. an ADC. New Antibody Products. Bradley L. The chemical design and preclinical data ENGINEERING for representative IGN ADCs will be discussed. REGISTER BY ADCs I: New Targets.com | 73 .. Vice President and CSO. The Se-Herceptin® ADC is more cytotoxic to Herceptin® development.D. antibody-drug conjugate. Our two developed approaches use either perfluoroaryl- 3:15 Sponsored Presentation (Opportunity Available) STREAM cysteine SNAr chemistry or organometallic palladium reagents. Pentelute. Oncology Arylation Research & Development. Here. 8:30 Chairperson’s Remarks 12:05 pm Fine-Tuning Functional Disulfide Re-Bridging to Enable the SPONSOR & EXHIBITOR INFO Vijay Chudasama. we 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing discovered a self-labeling four-residue sequence that enables regioselective conjugation at only one cysteine residue within an intact antibody containing ANALYTICAL STREAM 4:45 Problem-Solving Breakout Discussions natural amino acids.D. Professor. We replace Emtansine with a small Ravi J..

characteristics and function of the MPS affect the PK and PD of ADCs. Biomedicine Design. to optimize clinical trial design and determine SHORT COURSES likelihood of success versus clinical standard of care. Senior Director. Inc. Novel THERAPEUTICS Biomedical Research. to Eradicate Tumor-Initiating Cells University of North Carolina at Chapel Hill EXPRESSION Scott J. STREAM ImmunoGen 4:20 Relationship between the Mononuclear Phagocyte System and the Pharmacokinetics and Pharmacodynamics of Antibody Drug Conjugates IMMUNOTHERAPY in Patients STREAM 1:50 KEYNOTE PRESENTATION: Leveraging Antibody-Drug Conjugates William C..D. characteristics and function of the MPS and the IMMUNOGENICITY & PK and PD of ADCs in patients.. Additionally.com | 74 . 5:20 Registration for Dinner Short Courses 2:50 Predicting Clinical Success of ADCs using a Mechanistic Modeling Register Online! & Simulation Approach Recommended Dinner Short Course* PEGSummit. Ph.. 7th Annual | May 4-5. Informing Biomarker Strategy Since ADCs are generally complex heterogeneous mixtures of multiple species.D. can be used to select the best ADC. Oncology Biotherapeutics. Clinical efficacious dose Antibody-Drug Conjugates *Separate registration required. Ph. Novartis Institutes for these novel therapeutic products present unique bioanalytical challenges. AbbVie The PKPD of carrier-mediated agents (CMA) and ADC agents are dependent on STREAM Stemcentrx. Bioanalytical Services. please see page 5-6 for course details. and 3) relationship between mediators. Pfizer Quantitative modeling and simulation was used to analyze data on 10 ADCs SC15: Critical Considerations for the Design and Development of in patient trials or approved for oncology indications. MAY 4 3:20 Sponsored Presentation (Opportunity Available) 12:00 pm Registration 3:50 Refreshment Break ENGINEERING STREAM 12:35 Luncheon in the Exhibit Hall with Poster Viewing PKPD and Bioanalytics of ADCs in Support of Clinical 1:40 Chairperson’s Remarks Development ONCOLOGY John Lambert. Pharm. Associate Research Fellow. HOTEL & TRAVEL murine tumor models to profile ADC activity in immune-competent settings and characterized pharmacodynamic changes in the tumor microenvironment to 5:20 End of Day REGISTRATION INFORMATION inform rational combination approaches. Ph.. Celerion. TOND2I Lab. 2) MPS variability across patient populations. Director. Monte Carlo clinical trial SPONSORS simulations were performed to predict objective response rate. 2017 REGISTER BY DECEMBER 23 & Antibody-Drug Conjugates II: SAVE UP TO $550 Advancing Toward the Clinic COVER Lessons Learned from Preclinical and Early Trials to Drive Clinical Success CONFERENCE-AT-A-GLANCE Recommended Short Course* was predicted from preclinical PK/PD studies and compared with clinical MTD.D.D. This information SC9: Target Selection for Biologics *Separate registration required. TRAINING SEMINARS THURSDAY. Director. Dylla. Ph. Ph.D. It is important ANALYTICAL findings in the lab translate into drugs providing clear clinical benefit to patients to evaluate how mediators. This presentation will examine the different methodologies such SPONSOR & EXHIBITOR INFO response data with molecular features across these models. Zamboni. Executive Vice President and Distinguished Research Fellow. Carl Uli Bialucha. we are building a as LBAs and LC-MS/MS methods for the bioanalysis of ADCs using Kadcyla® rich dataset for biomarker analysis. we have begun to generate population-based assays (LBA) and LC–MS-based platforms are needed to overcome challenges in vivo activity datasets on several emerging ADC programs. CSO. bioanalytical approaches and strategies including a combination of ligand-binding STREAM Using PTX mouse clinical trials.D. A Division of Cambridge Innovation Institute PEGSummit. Vice President. please see page 5-6 for course details.. BIOASSAY STREAM Modeling and Simulation Approaches 4:50 Challenges and Solutions Associated with Bioanalysis of Antibody BIOCONJUGATES Drug Conjugates in Support of Clinical Studies STREAM 2:20 Novel Approaches for Modeling Pre-Clinical Activity of ADCs and Rafiq Islam. Ph.D. recommended Phase II and clinically approved doses..com Alison Betts. By integrating unique to ADCs. LLC their recognition and interaction with the mononuclear phagocyte system (MPS) • Tumor-initiating cells (TICs) remain controversial and will remain so until where the conjugated drug is cleared via interactions with the MPS. Inc. Associate Professor.. We will discuss: 1) pharmacologic methods to characterize STREAM • Antibody-drug conjugates are a promising class of drugs able to target and specifically reduce the frequency of TICs ADCs ex vivo and in vivo. Research & Development. we are employing fully syngeneic (ado-trastuzumab emtansine) as a case study.

D. Ph. Oncology Discovery. I will present preclinical and clinical data on antibody. Senior Director.. MedImmune.. MAY 5 11:05 Update on Mersana’s Antibody-Drug Conjugates: Progress into the Clinic 8:00 am Morning Coffee Donald A. developed including protein. XMT-1536 Christopher D. II clinical development for the treatment of Non-Hodgkin lymphoma. CMO. Swiss Federal Clinical Trials Institute of Technology (ETH Zurich). Senior Research Fellow. it may be possible to identify patterns that will help guide future radionuclide conjugate (ARC). Philogen Ed Reilly. Updated STREAM clinical and pre-clinical data will be presented. In this lecture. Bergstrom.D.D.. Ph. RNA and gene amplification detection methods. Ph. Thanos. Nordic Nanovector ASAc STREAM both hematologic malignancies and solid tumors.. Chemistry and Applied Biosciences. Several of these ADCs have advanced to conditions. Seattle Genetics Anti-CD37 Antibody Radionuclide Conjugate Betalutin® ENGINEERING Antibody-drug conjugates are emerging as an important therapeutic option for Jostein Dahle.D. REGISTER BY ADCs II: Advancing Toward the Clinic DECEMBER 23 & SAVE UP TO $550 FRIDAY. CTO.. Lessons learned from different antigens. Research and 11:35 Treatment of Non-Hodgkin Lymphoma with the Beta-Emitting Development. AbbVie
1:40 Synergistic Potential of Combining Antibody-Drug HOTEL & TRAVEL Conjugate and Immunotherapy for Cancer Treatment Herren Wu. REGISTRATION INFORMATION • Race to develop combinatory cancer therapy of ADC and IO • Promising preclinical results • Opportunities and challenges Register Online! PEGSummit. Halozyme is a Dolaflexin ADC targeting NaPi2b that is highly active in models of NSCLC SPONSORS Therapeutics adenocarcinoma and epithelial ovarian cancer. Ph. Ph. ImmunoGen Novel ADC Concepts with Promising Preclinical Results THERAPEUTICS STREAM 1:35 Chairperson’s Remarks SPONSOR & EXHIBITOR INFO Ed Reilly.D. M. Executive Vice President and Distinguished Research Fellow. IMMUNOGENICITY & BIOASSAY STREAM 10:05 Coffee Break 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or 10:35 ImmunoGen’s ADC Platform Technologies: Current Progress and Enjoy Lunch on Your Own BIOCONJUGATES STREAM Future Prospects 1:05 Refreshment Break John Lambert. AbbVie EXPRESSION Antibodies represent ideal vehicles for the delivery of cytokines to the site of Abbvie has multiple antibody drug conjugate (ADC) programs encompassing STREAM disease and for the selective modulation of the immune system in pathological various linker payload combinations. Appropriate patient selection biomarker strategies have been STREAM in patients with cancer or with chronic inflammatory conditions. LLC.D. as well as breast and non- CONFERENCE-AT-A-GLANCE small cell lung cancer (NSCLC) without HER2 gene amplification and lower HER2 8:30 Chairperson’s Remarks expression. Senior Research Fellow.com A Division of Cambridge Innovation Institute PEGSummit. XMT-1536 will enter clinical development in late 2017.D.. CSO. Betalutin is currently in Phase I/ ONCOLOGY early trial design will be discussed. and Co-Founder.D.com | 75 .D. Again TRAINING SEMINARS Jonathan Drachman. Mersana Therapeutics COVER XMT-1522 is a HER2-targeting ADC that induces complete regressions in models Preclinical and Clinical Updates of heavily-pretreated HER2-positive breast tumors. Ph. CMO and Executive Vice President.D. Professor... M. This presentation will focus on the development of a tumor-target specific ADC from 9:35 Sponsored Presentation (Opportunity Available) discovery to clinical trials. 9:05 Antibody-Cytokine Fusion Proteins for the Therapy of Cancer and IMMUNOTHERAPY of Chronic Inflammation 12:05 pm Development of a Tumor-Specific ADC: From Discovery to STREAM Dario Neri. payloads. XMT-1522 entered clinical development in October 2016. CD37 is an internalizing transmembrane antigen technological advances. XMT-1536 has significantly SHORT COURSES improved efficacy and tolerability compared to a monomethyl auristatin E ADC 8:35 Clinical Development of ADCs: From Bench to Clinic and Back against the same target. clinical trials where objective responses in patients with different solid tumors ANALYTICAL cytokine fusion proteins that we have moved to advanced controlled clinical trials have been observed. Ph. Oncology Discovery.. As more clinical trials are 177Lu-satetraxetan-lilotomab (Betalutin®) is a novel CD37-binding antibody completed. and highly expressed on most B-cell malignancies. Ph. Senior Vice President. Biotherapeutics Discovery..

Here we screened a panel of over 70 tumor cell lines derived from SPONSORS various solid tumor malignancies..D. including those with downstream TRAINING SEMINARS activating mutations in the KRAS/BRAF pathway. This talk will therefore describe a new level of therapeutic precision that depends on protein-protein proximity and not simply expression. Prudent.com | 76 . Evaluations in several human xenograft tumor models and patient derived tumor models in mice demonstrated potent tumor SHORT COURSES regression. Ph. Halozyme Therapeutics CONFERENCE-AT-A-GLANCE We have previously described HTI-1511. Demonstrates Significant SAVE UP TO $550 Activity against KRAS. Thanos. STREAM 3:10 Probody Drug Conjugates for the Treatment of Cancer EXPRESSION Jason Sagert.D. Centrose The talk will review the development of EDCs to multiple cancer-related targets ONCOLOGY and describe their extracellular mechanism which resembles necrosis. CytomX Therapeutics STREAM Probody™ Drug Conjugates (PDCs) are a class of antibody-based therapeutics that remain in a substantially inert. masked form until activated proteolytically in ANALYTICAL the tumor microenvironment. REGISTER BY ADCs II: Advancing Toward the Clinic DECEMBER 23 & 2:10 HTI-1511. an ADC in pre-clinical development that targets EGFR. STREAM data using cynomolgus monkey models will be discussed. Preclinical data supporting the IMMUNOGENICITY & development of PDCs will be presented. Ph. Ph.com A Division of Cambridge Innovation Institute PEGSummit. Senior Director. These results support further development of HTI-1511 as a possible treatment for EGFR overexpressing tumors. A Novel Anti-EGFR-ADC. 2:40 Novel Medicines that Exploit Extracellular Protein-Protein ENGINEERING Interactions STREAM James R. In addition. President & CEO. BIOASSAY STREAM 3:40 End of Conference BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.. where a CD20-specific EDC was able to eliminate all CD20+ B-cells while having no effect on other cells IMMUNOTHERAPY or tissues.. Biotherapeutics Discovery.or BRAF-Mutated Tumors of Various Types In Preclinical Studies COVER Christopher D. Senior Scientist II. Oncology. This platform allows the targeting of antigens that STREAM are highly expressed on tumor cells with high prevalence across multiple types of cancer regardless of normal tissue expression.D.

com | 77 .com A Division of Cambridge Innovation Institute PEGSummit. REGISTER BY DECEMBER 23 & SAVE UP TO $550 THERAPEUTICS STREAM COVER CONFERENCE-AT-A-GLANCE SPONSORS Drug Discovery for Autoimmunity and Inflammation SHORT COURSES TRAINING SEMINARS Biologics and Vaccines for Infectious Diseases ENGINEERING STREAM Agonist Immunotherapy Targets ONCOLOGY STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit.

Ph. Cell Migration 9:10 IL33 in Lung Inflammation STREAM Group.. The significance of Type-2 cytokines.D. where many trials have efficacy and side effects. Therapeutic Strategies and Product Formats for a Growing Market CONFERENCE-AT-A-GLANCE Recommended Short Courses* by tackling efficacy ceilings and to expand into underserved smaller indications while facing challenges of biosimilar entry. ENGINEERING 10:50 New Targets and Pathways to Treat Unmet Medical Need in STREAM MONDAY. THERAPEUTICS atopic diseases. IgE and eosinophils in but clinical trials of broad spectrum MP inhibitors were all failed due to lack of STREAM disease pathophysiology is most appreciated in asthma. These data novel therapeutic strategies for RA will be discussed. MAY 1 Scleroderma and Fibrotic Diseases Tony Manning. We have now the 3:20 Refreshment Break in the Exhibit Hall with Poster Viewing opportunity to apply the knowledge gained to further improve treatment outcomes A Division of Cambridge Innovation Institute PEGSummit.D. Vice President.D. Immunology & Inflammation. Senior Scientist.. in addition I will discuss how translational medicine is being before any overt cartilage damage. Queen Mary University of London EXPRESSION We have developed a panel of human scFvs that bind specifically to collagen type 8:40 Targets and Pathways for Airway Diseases STREAM II post-translationally modified by oxidants present in arthritic joints. 12:20 pm Sponsored Presentation (Opportunity Available) HOTEL & TRAVEL 12:50 Luncheon Presentation (Sponsorship Opportunity Available) or REGISTRATION INFORMATION 9:40 KEYNOTE PRESENTATION: Opportunities and Challenges for Enjoy Lunch on Your Own Biotherapeutics in Autoimmunity and Inflammation Christian Antoni. Research. Immunology & Inflammation. Ph.D. anti-ROS-CII: Matthew Sleeman. Associate Professor and Principal Investigator.D. Vice President. Senior Scientist. Ph. Ph. high CMC costs and the need to SPONSORS demonstrate added value for new drugs. Antibody and Therapeutic Engineering. Inc. IMMUNOGENICITY & used to find biomarkers to improve response rates and how newly described BIOASSAY STREAM phenotypes of airway disease such as ACOS (asthma COPD overlap syndrome) 11:50 Old Target Revives: Potential Novel Therapeutic Strategy for are being used to develop new biological therapies. University of Oxford Rajita Pappu. Rajita Pappu.. Momenta Pharmaceuticals ONCOLOGY 7:00 am Registration and Morning Coffee STREAM 11:20 Antibodies Specific to Damaged Arthritic Cartilage as Imaging Emerging Targets and Pathways Probes and for Targeting Payload Drugs to Joint with Rheumatoid IMMUNOTHERAPY Arthritis and Osteoarthritis STREAM 8:30 Chairperson’s Remarks Ahuva Nissim. 4th Annual | May 1-2. Ph. However. Associate Professor. please see page 5-6 for course details. Executive Director. ANALYTICAL In this talk I will present an overview of pathways and the new targets that are b) enhance resolution of inflammation by targeting payload drugs specifically STREAM being considered in respiratory disease and the underlying data that supports to inflamed arthritic joints..com diseases and greatly enhanced our understanding of the underlying immune- 2:20 Problem-Solving Breakout Discussions pathology but rarely achieved complete disease control. We demonstrate selective inhibition of some MPs may provide significant benefits in RA.D. recent studies have indicated that highly demonstrated clinical benefit from blocking Type-2 cytokines. MPs were considered to be therapeutic targets..D. and c) detect disease activity in osteoarthritic joints these mechanisms. Kennedy Institute of Rheumatology. SC2: Translational Considerations for Development of Monoclonal SHORT COURSES Antibodies Part I: Focus on Early Discovery SC7: Translational Considerations for Development of Monoclonal 10:10 Coffee Break TRAINING SEMINARS Antibodies Part II: Focus on Nonclinical Development to the Clinic 10:45 Chairperson’s Remarks *Separate registration required. 2017 REGISTER BY DECEMBER 23 & Drug Discovery for Autoimmunity SAVE UP TO $550 and Inflammation COVER Emerging Targets. Potential IL33 regulates multiple pathogenic pathways including IL5 and IL13. a) bind specifically to human rheumatoid arthritic and osteoarthritic cartilage Regeneron Pharmaceuticals.. and to cartilage from murine models of inflammatory arthritis and osteoarthritis. Ph..com | 78 . Ph. Genentech Rheumatoid arthritis (RA) is characterized by destruction of joint tissues by Dysregulated Type-2 inflammation is associated with a number of allergic and metalloproteinases (MPs). Genentech William Harvey Research Institute. SPONSOR & EXHIBITOR INFO suggest blocking IL33 signaling in asthma may provide clinical benefit due to inhibition of multiple pathogenic pathways. Sanofi 1:50 Session Break Register Online! Biotherapeutics have revolutionized the treatment outcome for major autoimmune PEGSummit. Rheumatoid Arthritis BIOCONJUGATES Yoshi Itoh.

Associate Director.. and after 10:00 Coffee Break in the Exhibit Hall with Poster Viewing a high-throughput screen or selection for function.. SHORT COURSES Bicycles® are a novel therapeutic class of constrained bicyclic peptides that combine antibody-like affinity and selectivity with small molecule-like tissue 9:30 Parallel Aspects of the Microenvironment in Cancer and TRAINING SEMINARS penetration.D.D. CSO.. AstraZeneca IMMUNOGENICITY & 6:55 End of Day We have identified that co-blockade of the ectonucleotidase that generates BIOASSAY STREAM adenosine CD73 and the A2A adenosine receptor (A2AR) that mediates adenosine signaling in leukocytes. conditions. Assistant Professor. Ph. Sachsenmeier. My group leverages this EXPRESSION unprecedented wealth of sequence-function information to design and Talk Protein Engineering and Emerging Product Formats STREAM engineer protein affinity. Ph. tunable exposure and chemical synthesis. The underlying principle and data REGISTRATION INFORMATION Tariq Ghayur. specificity.Sc. VIB SPONSOR & EXHIBITOR INFO AstraZeneca IL-33 and TSLP are two cytokines that are released from epithelial surfaces and HOTEL & TRAVEL 8:30 Modulating T Cell and Myeloid Cell Functions for Treatment of which control the fate of downstream allergic immune responses in asthma and Autoimmune Diseases and Cancer atopic dermatitis. Early clinical data demonstrate B cell inhibition in patients and Director..D. Translational Sciences. Master. Inflammation Research Center. Understanding these parallels may help Tim Whitehead. Vice Department Director.com and/or target combinations and to design the right therapeutic modalities to modulate immune functions to achieve the desired outcome. Rudi Beyaert.. Sachsenmeier. THERAPEUTICS Controlling Immune Response STREAM 11:20 Non-Antibody Based Cytokine Trapping Molecules for the 8:25 Chairperson’s Remarks Treatment of Asthma and Atopic Dermatitis Kris F. We have developed a new type of biologics that function as high affinity decoy receptors for IL-33 and TSLP. Technion. some intriguing similarities. Ph. MAY 2 that target these molecules. Michigan State University direction to regain balance and homeostasis. Associate Director. engineering provides novels ways to modulate immune functions for treatment of Register Online! a variety of disease states. Research have been used to develop Bicycle Drug Conjugates™ (BDCs). as the immune response is suppressed and unable to eradicate tumor cells in the former. Translational Sciences. Distinguished Research Fellow. FRS. Ph. Immunology. and function and to infer structural complexes of proteins. Director. A Non-Depleting B Cell Inhibitor for the Treatment of PLENARY KEYNOTE SESSION Autoimmune Diseases John Desjarlais.com | 79 . CONFERENCE-AT-A-GLANCE 4:10 Bicycles and Bicycle Drug Conjugates: Next Generation XmAb5871 is an anti-CD19 antibody whose Fc domain was engineered to increase Therapeutics affinity for FcγRIIb dramatically. Assistant Professor. Trinity College and Co-Founder and suppression. My talk will present an overview of the above and detail 10:50 Adenosine and the Inflammatory Microenvironment: Turning the ANALYTICAL methodological improvements that enable the engineering work. Bicycle Therapeutics promising activity in rheumatoid arthritis and IgG4 related disease (IgG4-RD). Chemical Engineering and Materials identify new therapeutic targets that might skew the microenvironment in the right Science. Xencor COVER 4:00 Chairperson’s Remarks FcγRIIb is an inhibitory receptor that regulates B cell responses through a negative feedback loop that requires co-localization of FcγRIIb to the BCR complex.. by using compound gene-targeted mice or therapeutics TUESDAY. Heat Off or On? STREAM 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing Kris F. particularly in aspects relating to the STREAM Sequencing and Design microenvironments exist between the two. limits tumor initiation. The challenges now will be to identify the right target PEGSummit. Ph.D. AbbVie Bioresearch Center showing their potent antagonistic activity in vitro and in murine models of allergic Advances in T cell and myeloid cell biology coupled with advances in protein disease will be presented.. Ph. A Division of Cambridge Innovation Institute PEGSummit. growth. REGISTER BY Drug Discovery for Autoimmunity and Inflammation DECEMBER 23 & SAVE UP TO $550 9:00 XmAb5871. In vitro and in vivo studies show potent B cell SPONSORS Sir Gregory Winter. ONCOLOGY 4:55 Young Scientist Keynote: Programming Proteins by Deep Nevertheless. including oncology. where Bicycles’ unique properties Miki Rahat. This Cancer and autoimmune diseases are fundamentally opposite pathological STREAM presentation will describe both the Bicycle® and BDC platforms.D. They have potential Autoimmune Disease: Possible New Therapeutic Targets? in many indications. D. These data STREAM 8:00 am Registration and Morning Coffee are presented in light of experiments showing that adenosine also plays a role in shaping inflammation associated with autoimmunity.D. Carmel Medical Center ENGINEERING delivery platform which greatly improves toxin loading into tumour tissues. This BIOCONJUGATES tumor control requires effector lymphocytes and interferon-gamma. IMMUNOTHERAPY Next-generation sequencing has presented protein scientists with the STREAM ability to observe entire populations of molecules before. during.D. while it is hyper-activated against self-antigens in the latter. a novel toxin Laboratories. and metastasis.. Ph.

. Inflammatory.D. Senior Scientist Respiratory. and celiac disease. and When Is It Not Right.v infusion of antigen-encapsulating PLG STREAM nanoparticles (Ag-NP) for therapy of Th1/Th17-mediated autoimmune disease models of MS. BIOCONJUGATES Antigen-Encapsulating PLG Nanoparticles STREAM Stephen D. This approach is being tested in a phase 1 trial in celiac HOTEL & TRAVEL disease. Advances are needed if improved drugs are to be SHORT COURSES developed.D. CD11chi B cells may serve as an important Tolerance in Autoimmune Diseases pharmacodynamic marker in clinical trials that target inflammatory processes. please see page 5-6 for course details. Ph. histologic phenotyping. Neurology. FcRL5. Professor.com | 80 . REGISTRATION INFORMATION 3:05 Sponsored Presentation (Opportunity Available) 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing Register Online! PEGSummit. and 12:20 pm Luncheon Presentation (Sponsorship Opportunity Available) or cellular analysis of RA synovial samples that have revealed different pathological TRAINING SEMINARS Enjoy Lunch on Your Own phenotypes of RA with differential association with disease activity. and Autoimmune of systemic lupus erythematosus (SLE) patients. Consequently. Senior Scientist Respiratory.D. Ph. Francisco Quintana. Immunology Portfolio. These NPs induce STREAM tolerogenic DCs through the AhR-dependent induction of Socs2. NP-induced tolerogenic DCs induced antigen-specific Tregs. UCB 4:25 Disease Heterogeneity and Drug Response Subsets in Rheumatoid COVER Direct targeting of Fc receptors (activating and inhibitory FcγRs and FcRn) is Arthritis considered an attractive concept to treat autoimmune diseases and how the Michael Townsend. BIOASSAY STREAM SC14: Overcoming the Challenges of Immunogenicity Assays 2:35 Tolerogenic Immunotherapy for Autoimmune Disease Using *Separate registration required. 1:20 Ice Cream Break in the Exhibit Hall with Poster Viewing ENGINEERING 4:55 Altered B Cell Subsets in SLE STREAM Tolerance Induction Rachel Ettinger. clinical progression. other Rheumatoid arthritis (RA) is a heterogeneous autoimmune disease and the SPONSORS drugs are being developed which have been designed to avoid FcR engagement relationship between drivers of disease in RA and therapeutic outcome is and this will also be discussed by reference to specific examples in the clinic. MedImmune ONCOLOGY 2:00 Chairperson’s Remarks Here. Associate Scientist. inhibiting Recommended Dinner Short Courses* nuclear factor kB (NF-kB) activation. Harvard Medical School 5:25 End of Drug Discovery for Autoimmunity and Inflammation STREAM Here we describe nanoparticles (NPs) that co-administer the aryl hydrocarbon receptor (AhR) agonist ITE and T-cell epitopes to dendritic cells (DCs) in vivo 5:30 Registration for Dinner Short Courses ANALYTICAL to reestablish immune tolerance in autoimmune disorders. Associate Director. incompletely understood. These B cells displayed a Diseases.D. and T-bet. Director.. Inflammatory. we describe an unusual subset of B cells highly expanded in a large cohort STREAM Rachel Ettinger.com A Division of Cambridge Innovation Institute PEGSummit. In contrast. and Autoimmune Diseases. Ph. Brigham and Women’s Hospital. CONFERENCE-AT-A-GLANCE pharmaceutical industry is approaching this will be discussed by focusing on Genentech specific examples of biotherapeutics in clinical development. REGISTER BY Drug Discovery for Autoimmunity and Inflammation DECEMBER 23 & SAVE UP TO $550 11:50 When Is It Right. suppressed pathogenic T cells and arrested the SC13: Phenotypic Screening Applications and Technologies IMMUNOGENICITY & development of experimental autoimmunity. Northwestern University THERAPEUTICS We have demonstrated the utility of i. including high densities IMMUNOTHERAPY of CD11c. T1D. These CD11chi B cells significantly correlate with 2:05 Nanoparticles for the Therapeutic Induction of Antigen-Specific STREAM SLEDAI. I will discuss our work using genomics. and response to drug therapy. Microbiology-Immunology and Dermatology. Miller. EXPRESSION Associate Professor. MedImmune unique phenotype not noted on other B cell populations..D. Ph. Ph. Ag-NP-induced tolerance is mediated by both PD-L1/PD1 anergy and Treg activation and dependent on particle uptake and SPONSOR & EXHIBITOR INFO antigen re-presentation by splenic marginal zone and liver APCs via the MARCO scavenger receptor. autoantibodies and IL-21. Biomarker Discovery OMNI. Ph.D. for Therapeutic Biomarkers and Patient Stratification Antibodies to Engage Fc Receptors? Anthony Shock.

MAY 3 donor and model Env interactions of antibody CAP256-VRC26 from a third donor. coli OM. Associate Professor. Inc. aims to Chlamydia elementary body (EB).com | 81 . Molecular Biosciences. There E2 protein used in candidate vaccines displays far too many other binding-site was significant induction of innate immune response by vaccine microparticles IMMUNOGENICITY & conformations--and thus elicits antibodies that mostly do nothing to stop the which was observed in vitro when compared to blank microparticles. The ontogeny-based design of vaccine antigens STREAM described here may provide a general means for eliciting antibodies of a desired 8:30 Chairperson’s Remarks class. Ph. and Leishmaniasis to clinical trials with the goal of protecting people in the poorest Register Online! countries from these debilitating NTDs. in principle. please see page 5-6 for course details. The OM expressed and purified recombinant MOMP for many NTDs proceed towards deployment slowly. PAI Life Sciences IMMUNOTHERAPY 10:10 Coffee Break in the Exhibit Hall with Poster Viewing STREAM 8:40 New Research Uncovers Why Hepatitis C Virus Vaccine Has Been Difficult to Make Novel Approaches for Vaccine Success EXPRESSION Mansun Law. Institute for Cellular and Molecular Biology. Infectious Diseases and Vaccines Discovery. which is a BIOCONJUGATES 9:10 Strategies to Improve Expression of Outer Membrane Proteins in prerequisite for Th1 and Th2 immune responses. *Separate registration required. MRL. Ph. Scientist I. and glycan ONCOLOGY Breaking News in Vaccine Design & Science interactions mature over time. REGISTER BY 2nd Annual | May 1-5.. Risk Broadly Neutralizing Antibodies Reveal Commonalities that Enable SPONSORS Assessment and Meeting Regulatory Requirements Vaccine Design SHORT COURSES Jon R. University of Texas at Austin TRAINING SEMINARS Here we report the cocrystal structure of V1V2 with antibody CH03 from a second WEDNESDAY.. Washington. and often fail to enter human HOTEL & TRAVEL is immunogenic in mice and elicits antibodies that react to the native antigen. PEGSummit... trachomatis major outer membrane protein (NTD) Vaccines (MOMP). The BIOASSAY STREAM actual virus. Merck & Co. Ph. Scripps STREAM Research Institute 10:55 Physicochemical and Preclinical Evaluation of a Novel Buccal Prior studies have shown that HCV’s receptor binding site adopts a narrow range Measles Vaccine ANALYTICAL of conformations (shapes) when bound by virus-neutralizing antibodies. A vaccine Tuhin Bhowmik. Georgiou Laboratory.D. ENGINEERING These V1V2-directed bNAbs used strand-strand interactions between a protruding STREAM 7:30 am Registration and Morning Coffee antibody loop and a V1V2 strand but differed in their N-glycan recognition. Ph. we are working to move promising vaccine candidates for Schistosomiasis. Immunology & Microbial Science. Biomedical SC17: Transient Protein Production in Mammalian Cells Engineering.. located in Seattle. Ph. bridge the gap between research and clinical testing by performing translational REGISTRATION INFORMATION research on NTDs.D. clinical trials. McDaniel. candidate vaccines MOMP to the E.D..D. 2017 DECEMBER 23 & SAVE UP TO $550 Biologics & Vaccines for Infectious Diseases Novel & Emerging Strategies for Clinical Success COVER Recommended Short Courses* CONFERENCE-AT-A-GLANCE 9:40 KEYNOTE PRESENTATION: Structures of HIV-1 Env V1V2 with SC14: Overcoming the Challenges of Immunogenicity Assays.D. Chemical Engineering. Senior Scientist. C. PAI Life Sciences. By partnering with research organizations.com A Division of Cambridge Innovation Institute PEGSummit. provide effective protection. Ph. The results suggest that the ODF STREAM Vaccine Research measles vaccine formulation is a viable dosage form alternative to noninvasive Lan Zhang. THERAPEUTICS Inc. microparticles also significantly increased the antigen presentation and co- stimulatory molecules expression on antigen presenting cells. Sean Gray. STREAM A safe and efficacious vaccine against Chlamydia trachomatis infection 11:25 Translational Activities to Enable Neglected Tropical Disease remains an unmet medical need. PAI Life Sciences SPONSOR & EXHIBITOR INFO antigen in the OM of the bacterium. is the most abundant Sean Gray.. Senior Scientist. Onchoceriasis. But this study suggests that the biodegradable bovine serum albumin (BSA) and processed by spray drying.. Ontogeny analysis indicated that protruding loops develop early. Formulation. We targeted the recombinant expression of Despite significant promise to address global health needs. Takeda Vaccines STREAM that elicited high levels of antibodies against only these key conformations The measles vaccine microparticles were made with biocompatible and would.D. a β-barrel integral outer membrane (OM) protein. immunization.

Professor.. Department of Microbiology and Immunobiology. Co-Founder. Tulane Medical IMMUNOTHERAPY School.com 4:45 Problem-Solving Breakout Discussions 5:45 Networking Reception in the Exhibit Hall with Poster Viewing A Division of Cambridge Innovation Institute PEGSummit. Zalgen Labs in a species because of an exceptionally long CDR3H (~61 amino acids). Associate Professor.. and illustrate these concepts with specific examples of therapeutic 3:45 Refreshment Break in the Exhibit Hall with Poster Viewing antibodies derived from the B cells of survivors of virus infections. Ph. Crowe. and West Nile virus. Medicine. Ph. D. Ph. Harvard Center TRAINING SEMINARS 12:55 Luncheon Presentation (Sponsorship Opportunity Available) or for Aids Research Immunology Core Enjoy Lunch on Your Own 8:35 Natural Infection-Inspired Monoclonal Antibody Design ENGINEERING Galit Alter. Associate Professor.D. Director. and have applied these to investigate the mechanism by which monoclonal antibodies increasingly hold promise as the most rapid mode vaccine adjuvants generate an effective antibody response. Microbiology & Immunology. Understanding the impact James E. Jr.D. Infectious Disease Research Institute Promising & Emerging Biologics THERAPEUTICS STREAM Effective vaccine development for emerging and pre-pandemic diseases often 11:05 Human Monoclonal Antibodies for Viral Diseases requires the use of complex adjuvant formulations. DVM. anthrax protective antigen. Kristine & Bob Higgins MGH STREAM 1:55 Session Break Research Scholar. These Combinations of potent broadly neutralizing monoclonal antibodies (mAbs) ‘Megabodies’ offer an opportunity to develop new therapeutics and vaccines. This study highlights the flavivirus coding sequences needed for efficient assembly of Breakthroughs in Biologics SPONSORS virus-like particles.D... Harvard Medical School THURSDAY. Ragon Institute Imaging Core. REGISTER BY Biologics & Vaccines for Infectious Diseases DECEMBER 23 & SAVE UP TO $550 11:55 Vaccine Vectors for Zika and Other Viruses 7:00 End of Day David M. These results point to the potential utility of human mAbs against hemorrhagic vaccines. 8:00 am Morning Coffee CONFERENCE-AT-A-GLANCE influenza. BIOASSAY STREAM production with lower potential for adverse events than chimeric mouse-human mAbs. Human HOTEL & TRAVEL sequence data. Director. Robert F.D. Harvard Center for Aids Research Immunology Core ONCOLOGY Emerging Therapeutics The presentation will discuss new methods that utilize natural infection-inspired STREAM 2:10 Chairperson’s Remarks antibody design. An ANALYTICAL evidence for structural optimization of bovine scFvs to enhance viral neutralization isolated from survivors of Lassa fever or Ebola protect in animal models even STREAM potency will be presented. M.D. Associate Professor. Co-Founder. This information will facilitate generation of additional vaccine vectors against other flaviviruses including the recently emerged Zika virus. Professor. Ragon Institute Imaging Core. Ph.. Knipe. including HIV. Director. Ph.com | 82 . 9:35 Sponsored Presentation (Opportunity Available) BIOCONJUGATES 10:05 Coffee Break in the Exhibit Hall with Poster Viewing STREAM 2:45 The Impact of Adjuvants on Antibody Sequence Diversity and Protective Capacity in an Arboviral Disease Vaccine Neal Van Hoeven.. University of Guelph STREAM Robert F. Medicine. and development. Microbiology & Immunology. MAY 4 COVER We have utilized herpes simplex virus recombinant viruses as vectors for expression of various microbial antigens as vaccine candidates. Kristine & Bob Higgins MGH 12:25 pm Sponsored Presentation (Opportunity Available) Research Scholar. Microbiology & Immunology. Zalgen Labs 9:05 Exploiting Large Sized Cow Antibodies for Developing Novel STREAM Therapeutics and Vaccines 2:15 Human Monoclonal Antibodies for Immunotherapy of Ebola and Azad Kaushik. Director.. a ‘proof of concept’ for developing novel if treatment is delayed until after clinical signs of these diseases manifest.D. Pathology. as well as our current outcomes using this technique. Senior Scientist. of therapy that can be developed and deployed for such outbreaks. Ph. that these adjuvants have on the development of a complex anti-pathogen Vanderbilt University SPONSOR & EXHIBITOR INFO polyclonal antibody response is important to both refine and accelerate vaccine Viral pathogens already cause a significant proportion of human diseases. will IMMUNOGENICITY & fever viruses as improved immunotherapeutic drugs that can reduce costs of be presented.D. Tulane Medical Our laboratory discovered that bovine antibodies are the largest known to exist School. Garry. We have developed methods for analysis of antibody repertoire emerging pathogens now regularly cause major unexpected outbreaks. In addition.Sc. via antigenization of bovine scFv with an exceptionally long CDR3H. SARS.. Register Online! PEGSummit. Professor. 8:30 Chairperson’s Remarks SHORT COURSES Galit Alter. College of Biological Science. Garry. We will REGISTRATION INFORMATION review general principles of molecular recognition of viral pathogens by human 3:15 Sponsored Presentation (Opportunity Available) antibodies.. EXPRESSION Lassa Fever Department of Molecular and Cellular Biology.

Here. Ph.. Principal Investigator. costing the ONCOLOGY global economy $100 trillion. Postdoctoral Associate.. and evaluate cocktails derived from them as immunotherapeutics potentially capable of combating outbreaks caused by any known ebolavirus. REGISTER BY Biologics & Vaccines for Infectious Diseases DECEMBER 23 & 11:35 Human Antibody Cocktails for Universal Immunotherapy against SAVE UP TO $550 Ebolaviruses Kartik Chandran. but suffer from lack of breadth. Current-generation immunotherapeutics like the ZMappTM mAb cocktail show promise. Biological Engineering. Albert Einstein School of Medicine Three ebolaviruses cause outbreaks of a lethal viral disease for which no CONFERENCE-AT-A-GLANCE approved treatments are available.D. TRAINING SEMINARS 12:05 pm Bioinspired Peptide Engineering to Combat Infectious Diseases ENGINEERING Cesar de la Fuente. 12:35 End of Biologics and Vaccines for Infectious Diseases IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. MIT/ STREAM Broad Institute of MIT and Harvard Antibiotic resistance will kill 10 million people annually by 2050. Ph. we describe pan-neutralizing mAbs isolated from a human survivor of the 2014–16 Ebola epidemic in West SHORT COURSES Africa. Microbiology & COVER Immunology.com | 83 .com A Division of Cambridge Innovation Institute PEGSummit. I will discuss our ongoing work engineering peptide STREAM therapeutics to counter biofilms and other difficult-to-treat infections.D. Professor. SPONSORS targeting only one of five known ebolaviruses.

Preclinical studies demonstrated efficacy in syngeneic tumor models. FRIDAY. Head and neck squamous cell carcinomas SPONSOR & EXHIBITOR INFO Roland Kontermann. University of Stuttgart Register Online! Duokines are bifunctional fusion proteins of TNF ligand superfamily members 3:50 Refreshment Break expressed either as homotrimer molecules or as single-chain derivatives. with enhanced ONCOLOGY efficacy in combination with PD-1 inhibitors. This Antibody for Cancer Therapy dual mechanism contributes to the significant anti-tumor response observed in IMMUNOTHERAPY Axel Hoos.D. JTX-2011 is in clinical development as a monotherapy and in combination with anti-PD-1 therapy. M.com | 84 . as Single Agent and in shown for the antitumor activity of T-cell retargeting bispecific antibodies. Senior Vice President. please see page 5-6 for course details.D. TRAINING SEMINARS 1:40 Chairperson’s Remarks 4:50 JTX-2011: Development of an Agonist Antibody Targeting ICOS Peter Ellmark..D.. University of Stuttgart limiting effective antitumor immunity. 12:00 pm Registration an agonist anti-CD-27 antibody. EXPRESSION 5:20 End of Day STREAM 2:20 Tumor-Directed Immunotherapy – Tumor-Localized Immune Activation Using TNFR-SF Agonistic Antibodies 5:20 Registration for Dinner Short Courses ANALYTICAL Peter Ellmark. a bispecific antibody targeting OX40 and CTLA-4 developed to deplete Tregs BIOCONJUGATES in the tumor microenvironment.g. M. R&D. JTX-2011 induces T effector cell STREAM 1:50 KEYNOTE PRESENTATION: Engineering of an ICOS Agonist activation and also preferentially reduces T regulatory cells in the tumors. Genitourinary Oncology Research. a BIOASSAY STREAM *Separate registration required.. Ph. Alligator Bioscience STREAM Alligator Bioscience develops mono and bispecific agonistic antibodies.D. Single agent responses have been seen and multiple 12:35 Luncheon in the Exhibit Hall with Poster Viewing collaborative studies of varli in combination are ongoing. Ph. Professor of Biomedical Engineering. Institute of Cell (HNSCC) produce suppressive factors that impair the immune system.D. Celldex Therapeutics Inc. Therapeutic Area Head for Oncology preclinical models.. Providence Medical Group Emerging Science Cancer immunotherapy is an evolving treatment that boosts the immune system 8:30 Chairperson’s Remarks to recognize and destroy cancer cells. They act PEGSummit. Ph. Roland Kontermann. GlaxoSmithKline Pharmaceuticals. Jounce Therapeutics Inc. Ph. Executive Vice President and CMO. Ph. Ph.. human monospecific agonistic IgG1 antibody in clinical development and ATOR- 1015. 2017 DECEMBER 23 & SAVE UP TO $550 Agonist Immunotherapy Targets Stepping on the Gas with Costimulatory Agents COVER THURSDAY. an Agonist Anti-CD27 Antibody. Director. MAY 5 STREAM 2:50 OX40: From Bench to Bedside and Back Again 8:00 am Morning Coffee THERAPEUTICS Brendan Curti. REGISTER BY 3rd Annual | May 4-5. immune-mediated. Research & Development. OX40 is a member of the tumor necrosis HOTEL & TRAVEL factor (TNF) receptor family and a potent co-stimulatory pathway that when 8:35 Duokines: A New Class of Bifunctional Immunostimulatory triggered can enhance T-cell memory. STREAM JTX-2011 is an agonist antibody to the co-stimulatory molecule ICOS.com either in cis or in trans and are capable of amplifying immune responses. thus Biology and Immunology. Institute of Cell 3:20 Sponsored Presentation (Opportunity Available) Biology and Immunology. anti-tumor SC18: Clinical Prospects of Cancer Immunotherapy IMMUNOGENICITY & response.. targeting Recommended Dinner Short Course* TNFR-SF members.D. CONFERENCE-AT-A-GLANCE The CD27 co-stimulation pathway for immune cells has shown potent activity in pre-clinical models to eliminate tumors both as single agent and in SPONSORS Case Studies with Agonist Antibodies combination with checkpoint inhibitors. Preclinical Development. Combination A Division of Cambridge Innovation Institute PEGSummit. STREAM R&D. Immunotherapy Clinical STREAM Program. Alligators pipeline projects will be presented.D.. MAY 4 Tom Davis. This approach provides new opportunities to generate an effective. for tumor-directed immunotherapy of cancer. proliferation and anti-tumor activity in REGISTRATION INFORMATION Molecules patients with metastatic cancer. confirm this specific immune activation without SHORT COURSES significant immune toxicity. Principal Scientist.. Alligator Jennifer Michaelson. as 4:20 Varlilumab. including ADC-1013. Senior Director of ENGINEERING Bioscience Preclinical Development. A promising safety profile was revealed in preclinical studies. Clinical trials to date using varlilumab. Executive Program Leader. Professor of Biomedical Engineering. Inc.. Principal Scientist.D. e.

within a Qb virus. Erminia Massarelli. Bispecific CD30/CD16A TandAb AFM13 is a 12:05 pm Clinical Safety and Efficacy Assessment of CD137 in SAVE UP TO $550 Prototype NK-Cell Engager with Unique CD16A-Binding Properties Combination with Nivolumab Martin Treder. Scientific Founder. Research. President & CEO. shRNA and cDNA libraries.. Professor & Head. Associate Clinical Professor.D. OX40. Multi-parameter readouts are induction of robust anti-tumor immunity and tumor regression when CMP-001 is combined to assess both T cell activation and proliferation. Inc. Ph..and combination therapeutic approaches of an NK-cell engager will be discussed. Christophe Quéva. as well as tumor cell Register Online! death.D. pre-clinical characterization and Technion-Israel Institute of Technology STREAM early GMP manufacturing for a lead ARC construct that simultaneously blocks T-cell receptor-like (TCRL) antibodies bind HLA-peptide complexes on the surface signaling through PD-1 and activates signaling through OX40. IMMUNOTHERAPY demonstrates significantly superior tumor rejection in multiple pre-clinical models transforming intracellular disease-specific targets expressed inside malignant STREAM as compared to either PD-1/L1 or OX40 specific antibody therapy. Blocking antibodies such as nivolumab and Approach IMMUNOGENICITY & pembrolizumab were successfully developed in the clinic as IgG4 molecules. cells into targets that can be recognized on the cell surface by soluble TCRL antibodies. Application of this screening assay PEGSummit.D.D. CMP-001 is a formulation of a CpG-A oligonucleotide. Laboratory of Molecular Immunology.D. This approach expands the pool of Jieyi Wang. CEO. complemented with detection of IFNγ secretion. iTeos Therapeutics SA Addition of TLR9 agonist CMP-001 to a standard checkpoint inhibitor regimen can HOTEL & TRAVEL A co-culture assay combining immune suppressive cells and T-cells has been induce a strong anti-tumor response when checkpoint inhibition alone has failed. Ph. REGISTER BY Agonist Immunotherapy Targets DECEMBER 23 & 9:05 The Tetravalent. A Division of Cambridge Innovation Institute PEGSummit. Inc. Ph. ANALYTICAL immunotherapy. STREAM 11:35 Enhancing Checkpoint Inhibitor Efficacy via Combination with 2:40 Development and Validation of a Phenotypic Screening Platform CMP-001. These antibodies can be armed with various modalities or they can 11:05 Selection of Fc for Antibody Therapeutics to Achieve Optimal be used as naked molecules to modulate responses or environments associated EXPRESSION STREAM Antitumor Immunomodulating Activity with immunity towards the target cells. a VLP Packaged TLR9 Agonist SPONSOR & EXHIBITOR INFO for the Identification of Novel Immuno-Oncology Targets Aaron Morris. M. Yoram Reiter. clinical responses in B-cell malignancies based on targeting CD19..D. ICOS and HVEM.. ONCOLOGY This presentation will outline the production. City of Hope and other CD30+ malignancies. set up to allow the identification of novel immune-oncology targets by screening REGISTRATION INFORMATION like particle (VLP). which is known to unleash T-cell and NK- 1:05 Refreshment Break SHORT COURSES cell activity. Shattuck Labs. targets are required to expand this success to solid cancers. Ph. ENGINEERING 10:05 Coffee Break 1:40 Exploring the Intracellular Proteome for the Identification and STREAM 10:35 Agonist Redirected Checkpoints for Cancer Immunotherapy Validation of Novel Targets for Cancer Immunotherapy Taylor Schreiber. BIOASSAY STREAM However. We have previously shown synergistic Enjoy Lunch on Your Own SPONSORS efficacy when NK-cell activation through AFM13 is combined with checkpoint modulation such as anti-PD-1 treatment. Affimed. Their modes of action not only rely on variable domains STREAM responsible for specificity but also involve the constant domains that can 2:10 Novel Targets for Cancer Immunotherapies: The XPRESIDENT® interact with various Fc receptors.. Novel T-cell BIOCONJUGATES CD137. CSO. Inc. Ph. it is not clear what IgG isotypes would be optimal for agonist antibodies Targeted adoptive cell therapies have been highly successful in achieving durable that are required to activate co-stimulatory targets such as CD40. President & CEO.com to the identification of rationale combinations will be described. M. G10..D. Checkmate Pharmaceuticals.D. Preclinical studies and a phase Ib clinical trial have shown chemicogenomics. Target Discovery Approaches in Immuno-Oncology TRAINING SEMINARS 1:35 Chairperson’s Remarks 9:35 Sponsored Presentation (Opportunity Available) Harpreet Singh. CD27. thus. Immatics US. It engages NK-cells through CD16A with high affinity and specificity and confers significantly stronger NK-cell activation 12:35 Luncheon Presentation (Sponsorship Opportunity Available) or CONFERENCE-AT-A-GLANCE compared to other therapeutic antibodies.D. Mechanism of action as well as mono... Lyvgen Biopharma novel therapeutic targets and antibodies beyond the limits of currently available Therapeutic antibodies have become important biologics for cancer antibodies.com | 85 . Inc. R&D. imaging. This construct of cells and can bind specifically to the cell surface of diseased cells. Here we present STREAM the outcome of the Human Immunopeptidome Program through applying our Combinatorial Therapies: Using Antagonists and Agonists proprietary XPRESIDENT® target discovery strategy which employs systematic high-throughput and ultra-sensitive quantitative tandem mass spectrometry THERAPEUTICS to Maximize Response combined with next-generation sequencing and T-cell receptor discovery.. through high content combined with anti-PD-1 therapy. as assessed using a cytotoxicity assay. Medical Oncology COVER AFM13 is currently in Phase II clinical development in Hodgkin lymphoma (HL) and Therapeutics Research. Harpreet Singh. Ph. Ph. GITR. MS. NV. Senior Director. CSO.. Immatics US. Ph.D.

and the ability to predict which patients may respond is limited. Oncology Discovery. Ph. Executive Director. Despite these advances.com | 86 . ONCOLOGY 3:40 End of Conference STREAM IMMUNOTHERAPY STREAM EXPRESSION STREAM ANALYTICAL STREAM IMMUNOGENICITY & BIOASSAY STREAM BIOCONJUGATES STREAM THERAPEUTICS STREAM SPONSOR & EXHIBITOR INFO HOTEL & TRAVEL REGISTRATION INFORMATION Register Online! PEGSummit. Harnessing the innate immune system to ENGINEERING augment the adaptive anti-tumor response represents an attractive target for STREAM therapy.D. which has the potential to enhance both the percentage and rate of response to checkpoint blockade. 2017 DECEMBER 23 & SAVE UP TO $550 Agonist Immunotherapy Targets Stepping on the Gas with Costimulatory Agents COVER 3:10 Emerging Innate Immune Targets for Enhancing Adaptive Anti- CONFERENCE-AT-A-GLANCE Tumor Responses Michael Rosenzweig. REGISTER BY 3rd Annual | May 4-5. Merck SPONSORS Research Labs Novel cancer immunotherapies targeting T cell checkpoint proteins have emerged SHORT COURSES as powerful tools to induce profound..com A Division of Cambridge Innovation Institute PEGSummit. durable regression and remission of many types of cancer. multiple studies have demonstrated TRAINING SEMINARS that not all patients respond to these therapies.

ENGINEERING your talk. STREAM Additional Opportunities Available for Invitation-Only Dinner/Hospitality Suite Sponsorship Include: ONCOLOGY Sponsors will select their top prospects from the conference pre-registration • Poster Awards • Hotel Room Keys STREAM list for an evening of networking at the hotel or choice local venue. quality leads STREAM Exhibitors will enjoy facilitated networking opportunities with qualified throughout the year.100+ conference participants with a mobile app to facilitate STREAM Looking for additional ways to drive leads to your sales communication and navigation of various event features. We will mine our database of over 800.SOLD • …and More! Mobile App Sponsorship EXPRESSION PEGS provides all 2.000 life science delegates. Business Development 781-972-5471 | dinerstein@healthtech. service.com A Division of Cambridge Innovation Institute PEGSummit. The evening will • User Group Meetings • Footprints IMMUNOTHERAPY be customized to meet with your specific objectives. CHI will • Focus Groups • Conference Notebook extend invitations. • White Papers • Custom Market Research Survey • Web Symposia • Podcasts BIOCONJUGATES STREAM THERAPEUTICS STREAM For sponsorship. conferences attendees will be seated and ready to listen to meetings. conduct follow-up and confirm attendees. team? ANALYTICAL Exhibit CHI Lead Generation Programs will help you obtain more targeted.com Companies L-Z Carol Dinerstein Senior Manager. Speak face-to-face with prospective clients and showcase your professionals to your specific needs. during. We guarantee a minimum of 100 leads IMMUNOGENICITY & per program! Opportunities include: BIOASSAY STREAM latest product. SPONSOR & EXHIBITOR INFO please contact: HOTEL & TRAVEL Companies A-K REGISTRATION INFORMATION Jason Gerardi Business Development Manager 781-972-5452 | jgerardi@healthtech. All sponsorship packages can be customized to meet your company’s needs and budget. Whether over lunch or part of list.com | 87 . SHORT COURSES Podium Presentations — Available within Main Agenda! One-on-One Meetings Reach your target audience by presenting in the main session room as part of Sponsors will select their top prospects from the conference pre-registration TRAINING SEMINARS the conference program in your track of choice. Presentations will sell out quickly! Sign on early to secure your talk. exhibit space. branding CONFERENCE-AT-A-GLANCE and networking with specific prospects. Sponsorship allows you to achieve your objectives before. and CHI will organize a guaranteed minimum number of face-to-face the main agenda. and long SPONSORS after the event. REGISTER BY DECEMBER 23 & SPONSOR & EXHIBITOR INFORMATION SAVE UP TO $550 COVER CHI offers comprehensive sponsorship packages which include presentation opportunities.com Register Online! PEGSummit. STREAM • Conference Tote Bags • Program Guide Advertisement • Badge Lanyards . or solution. exhibit & lead generation information.

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