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*Immudicon Executive Summary*

Company Overview Immudicon LLC exploits the interworkings of the human immune system to innovate solutions to improve current cancer therapeutic strategies. The company has developed a new technology platform for the intracellular delivery of tumor-associated antigens to enhance immune cell recognition and destruction of cancerous cells without the need for expensive, invasive surgeries. The initial therapeutic development focus of the company is a breast cancer vaccine: however, the platform technology has the potential to address unmet needs in other diseases with new antigen discoveries. Cancer is not only the second major cause of death, but breast cancer affects over 2.5 million patients, which is over 26% of all patients battling cancer. In addition, breast cancer is associated with a high rate of recurrence of 85%. Immudicons therapeutic cancer vaccine utilizes an immunoprotein directly from the blood serum of the patient to design a nanoparticlebased delivery vehicle to antigen-presenting cells of the immune system. Immudicon was established by Riley Ennis, who conceived of the cancer vaccine strategy while conducting research at the University of Pennsylvania and Georgetown University. He focused on a protein in the human body that he believes is the ancestral link to the immune systems of invertebrates and that could be incorporated in the design of a novel cancer vaccine. As a young company in the pharmaceutical industry, Immudicon is quickly establishing its delivery system and vaccine pipeline, and searching for partnerships in order to expand the company to reach its goal of improving current breast cancer therapies. Technology Summary Immudicons platform technology is based on an intracellular delivery system that targets dendritic cells (DCs) and other primary antigen-presenting cells (APCs) of the immune system. Our vaccine construct falls under the class of APC technologies within the therapeutic vaccine market segmentation, and is considered a standardized vaccine because no ex vivo extraction of the immune cells is necessary; which lowers costs and extraneous procedures significantly. In contrast, current APC approaches in the field of immunotherapeutics and vaccine development technologies involve the ex vivo infusion of APCs with the antigen of interest. This involves costly and painful invasive procedures to obtain the APCs. In addition, this ex vivo process can lead to lack of APC potency and therefore the ability to mount an effective immune response in vivo. Immudicons vaccine construct delivers the antigen intracellularly to APCs in vivo, both protecting and maintaining the immunological integrity of the internal components of the vaccine complex. The APC intracellular delivery system is initially constructed of poly(lactic-co glycolic acid) (PLGA) biodegradable nanoparticles that are internalized with tumorspecific antigens (TSA) prepared specifically from tumor biopsy material. The TSA/PLGA particles are then bioconjugated with CpG oligodeoxyribonucleotide (CpG ODN) and granulocyte macrophage-colony stimulating factor (GM-CSF). CpG ODN has

been demonstrated to act as an immunostimulatory adjuvant and GM-CSF has been shown to increase both precursor and mature APCs. The TSA/PLGA/CpG/GM-SCF nanoparticles maintain the chemical functional groups that can be later activated for the bioconjugation of a patient-derived immune protein that is novel in the field of immunotherapies. The vaccine delivery system is a smart complex and responds to changes in the microenvironment of the particle. In the pH medium of the DC endosome, the vaccine complex begins to degrade, releasing the CpG, GM-CSF, PLGA, and antigen components into the cell. The binding and endocytosis of the vaccine complex initiates maturation of the APCs, antigen processing, and appropriate MHC II class protein association. The TSA-MHC II complex is transported to the surface of the DC where it is presented to both T and B lymphocytes to begin the activation of a humoral and cellmediated immune response. This allows for immune cells to be created that can not only kill the target cells (bacterial, viral, or diseased), but also can be stored by the immune system if the target cells ever return (long term immunization). The proposed intracellular delivery system technology platform creates a patient specific, effective, and safe way of transporting antigens to dendritic cells in order for target cell recognition by the patients immune system in order to improve disease treatment. Technology Advantages Immudicons technology is not only an advanced intracellular delivery system that can respond to the microenvironment inside of the body, but also displays a variety of advantages when compared to competitor technologies. There are two broadly different types of therapeutic cancer vaccines, personalized (autologous immune cell extraction) and standardized vaccines, and MacroVax encapsulates principles from both types. MacroVax is personalized in that the components of the vaccines are taken from the body, but without the need for expensive immune cell extraction. MacroVax is standardized in that it is cheaper to construct and can be manufactured in high quantities because of the conserved delivery platform. - - - - - - - - - - - Novel technology Tumor specific therapy Patient specific Cost effective Does not require expensive extraction of patients immune cells Short duration of vaccine synthesis Activation of immune cells inside the patient to improve vaccine effectiveness Low cytotoxicity profile Fewer FDA clinical hurdles compared to competitors Procedures not limited to special facilities Technology platform allows for expansive partnership opportunities