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Aeras and the Global Effort to Develop New TB Vaccines
Ann M. Ginsberg, MD, PhD
J2J Workshop, Kuala Lumpur 14 November 2012
Tuberculosis: A Devastating Epidemic
• Over 2 billion people or 1/3 of the world’s population is infected with M. tuberculosis
• Globally, 8.7 million new cases and 1.4 million deaths in 2011
• In SE Asia and Western Pacific, 5.2 million new cases and 610,000 deaths (excluding HIV) in 2011 • Globally, 13% of TB patients are HIVinfected. • MDR-TB = 3.7% of new cases, globally. XDR-TB identified in 84 countries. Surveillance inadequate in many countries.
Number of MDR-TB cases estimated to occur among notified pulmonary TB cases, 2011
XDR-TB: approximately 9% of MDR-TB cases are extensively drug-resistant TB (XDR-TB). As of Oct. 2012, 84 countries had reported at least one XDR-TB case.
Vaccines needed to turn the tide
The energy and approaches we have put into addressing TB over the past 20 years have led to insufficient progress.
Source: Christopher Dye, WHO
Global Plan will not eliminate TB by 2050
Projected incidence in 2050 >100x elimination threshold
Current trajectory -1.6%/yr Elimination -16% /yr Global Global Plan - 6%/yr -6% /yr
Current trajectory -1% /yr Elimination - 16%/yr
BCG – current TB vaccine
• BCG developed 90 years ago, not improved upon since. • Most widely delivered vaccine in the world. • Reduces the risk of severe pediatric TB disease, but:
− Unreliable protection against adult pulmonary TB, which accounts for most TB worldwide − Not recommended for use in infants infected with HIV − Many genotypes and phenotypes -- multiple BCGs − Inadequate impact on the global TB epidemic
The Need for Improved TB Vaccines
The Potential of New TB Vaccines
New, more effective TB vaccines could:
• Be safer and more effective in preventing TB in children, adolescents and adults, including people with HIV • Protect against all forms of TB – including MDR and XDR • Reduce the cost and burden of TB on patients, health care systems and national economies • Play a crucial role in global efforts to control TB
Save lives Break the cycle of transmission
A new vaccine
Reduce cost burden to health systems
• Located in Rockville, Maryland, USA, Cape Town, SA and Beijing, China • Nonprofit research organization operating as a product development partnership • Mission:
– Develop effective TB vaccines/biologics to prevent TB across all age groups in an affordable and sustainable manner.
• Fully integrated biotechnology organization
cGMP Clinical Manufacture
Clinical Trials Support
Aeras: a Product Development Partnership (PDP)
Collaborating, catalyzing, conducting…
Strategies for TB Vaccine Development
• Pre-infection: to prevent initial or latent infection or disease − Improved priming vaccines − Novel booster vaccines − Infants; LTBI(-)s
Block Initial Infection
• Post-infection: to prevent primary +/or reactivation disease Prevent Early − Novel booster vaccines to extend and Disease enhance immune protection − LTBI(+) adolescents and adults • Immunotherapeutic: to improve therapy − Shorten the course of chemotherapy for active TB or latent TB infection − Improve efficacy of MDR/XDR/TDRTB treatment
Prevent Latent Infection
Prevent Reactivation Disease
Global Clinical TB Vaccine Pipeline – 2012
VPM 1002 Max Planck, VPM, TBVI M72 + AS01 GSK, Aeras Hybrid-I + IC31 SSI, TBVI, EDCTP, Intercell RUTI Archivel Farma, S.L
Mw DBY, India, M/s. Cadila
Ad5 Ag85A McMaster CanSino
MVA85A/AERAS485 OETC, Aeras
ID93 + GLA-SE IDRI, Aeras Hyvac 4/ AERAS404 + IC31 SSI, sanofi-pasteur, Aeras, Intercell H56 + IC31 SSI, Aeras, Intercell MTBVAC TBVI, Zaragoza, Biofabri
AERAS-402/ Crucell Ad35 Crucell, Aeras M. Vaccae Anhui Longcom, China
Viral vector rBCG Protein/adjuvant Attenuated M.tb Immunotherapeutic: Mycobacterial – whole cell or extract
We work with partners to review and prioritize candidates with a goal of advancing at least two candidates to Phase III efficacy trials. With each advance, we collaborate to adjust site capacity, regimens, R&D, and regulatory approaches.
TB is complex and may require more than one vaccine to address geographic variations in the strains, stages of the disease, and populations. We continually invest in next-generation candidates, applying lessons learned and fostering novel partnerships and approaches.
In collaboration with partners, we evolve and standardize processes to focus on the most promising investigational vaccines. By using scientific approaches including challenge models, systems biology and innovative vaccine designs we accelerate advancement and cut costs.
We mobilize resources across public and private entities to sustain the growing costs of TB vaccine R&D efforts as we advance toward the finish line. Only by expanding our network of support and forging new partnerships can we address the immense scientific challenges and global need.
Vaccines that prevent adolescents and adults from TB would be the single greatest advance against the disease.
Vaccine – adol/adult
There is tremendous momentum in clinical development. Aeras and its global partners are currently testing six candidates in clinical trials.
Aeras partners globally to conduct epidemiological studies and clinical trials.
TB Vaccine Development: a decade of progress but much more to do
No new 2000 preventive TB vaccines in clinical trials
1st preventive 202 vaccine enters clinical trials (MVA85A)
1st Phase IIb 2009 proof-of-concept of preventive vaccine initiated
15 vaccines have 2011 entered clinical trials, 13 currently in clinical trials
• 15 novel TB vaccine candidates have been in clinical trials in the last decade; no ―winner‖ yet • First human efficacy data expected early 2013 (MVA85A/AERAS-485); major milestone • Pipeline of 2nd generation candidates, novel vaccine constructs and new delivery platforms continue to be explored • Substantial challenges remain; solutions will require global partnership and commitment. • With sufficient resources and positive results from current clinical trials, the first new TB vaccine could be approved within a decade.
The TB Vaccine Blueprint
Keys to Progress
Identifying five keys to progress • • • • Creativity in research and discovery Correlates of immunity and biomarkers for TB vaccines Clinical trials – harmonization and cooperation Rational selection of TB vaccine candidates
Building support through advocacy communications,
and resource mobilization
Collaboration is key in an unprecedented effort
Aeras serves as a catalyst by investing in the world’s most promisingTB vaccine candidates and coordinating a diverse community of global scientists, researchers, governments, and funders on a single mission:the development of effectiveTB vaccines.
Funding and collaboration needed to advance global TB vaccine efforts
The next phase of new vaccine development is the most critical—and
requires that the global community significantly scale efforts .
This cannot be the work of a single foundation or a small set of government or biotech partners, but of a much larger global community.
2010 global TB vaccine funding Global Plan annual target
AERASDRIVING INNOVATION 24
from TAG Report 2011
Aeras Gratefully Acknowledges the Volunteers in Our Clinical Trials, Hard Work of AERASDRIVING INNOVATION including Clinical Trial Sites, and Support of these Major Contributors 25 Many Partners
For more information: www.aeras.org firstname.lastname@example.org
Hello, my name is Mycobacterium tuberculosis! I am the king of the pathogens, killing more people than any other infectious agent except HIV From: http://ilovebacteria.com/
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