Advancing TB Vaccines for the World

Advancing TB Vaccines for the World

Aeras Leadership EXECUTIVE STAFF Jacqui Shea, PhD Chief Executive Officer Ann Ginsberg, MD, PhD Chief Medical Officer BOARD MEMBERS Lota S. Zoth, CPA (Chair) Former CFO of MedImmune, Inc. Aeras is a nonprofit biotechnology organization developing new, effective tuberculosis (TB) vaccines that are affordable and accessible to all who need them. Aeras works through partnerships in both the public and private sectors, with individuals, research organizations, academic institutions, funders, policymakers and other stakeholders around the world to advance TB vaccine science and development. Founded in 1997 as a U.S. 501(c)(3) nonprofit biotechnology organization Offices in Rockville, USA (HQ); Cape Town, South Africa; Beijing, China Governed by an independent Board of Directors, with external technical advisory groups incorporating global expertise Executive leadership team with decades of experience developing and commercializing new vaccines and biologics Barry Bloom, PhD Distinguished Service Professor at Harvard University David L. Blumberg, MBA Former Life Sciences Sector Leader of KPMG Jim Connolly Former President & CEO of Aeras Marja Esveld, MSc Senior Advisor, Global Health and Innovation Marian Eslie Jacobs, MD Former Dean, Faculty of Health Sciences, University of Cape Town Professor Michel Kazatchkine, MD Senior Fellow, Global Health Programme, Graduate Institute of International and Development Studies Wayne F. Pisano President and CEO, VaxInnate Regina Rabinovich, MD, MPH Exxon Mobil Malaria Scholar in Residence, Harvard School of Public Health Jacqueline E. Shea, PhD CEO of Aeras Gerd Zettlmeissl, PhD Former CEO of Intercell AG

Building support to solve a global crisis Surveillance data for 2016 showed that TB killed more people than any other infectious disease in the world. With 10.4 million new cases and 1.7 million deaths, TB was more deadly than Ebola, malaria, or even HIV. 1 We will not eliminate TB with the current vaccine and vaccination strategies available. In fact, the World Health Organization s End TB Strategy states that a new TB vaccine is essential to ending the TB epidemic. 2 A new vaccine will also be critical in the fight against antimicrobial resistance (AMR). If left unchecked, by 2050 AMR will kill 10 million people and a quarter of those deaths will come from drug resistant TB. 3 These statistics are staggering, but we know there is hope: A widely used, more effective TB vaccine would be the single most costeffective tool in mitigating this epidemic and would make a major impact on efforts to control AMR. 3 5 Aeras is working diligently to build coalitions among stakeholders, raise awareness with governments across the globe, and move TB vaccine research into the forefront of global health discussions. Deaths in 2016 TB 1.7 million Coinfection (TB and HIV/AIDS) 400,000 HIV/AIDS 1 million 1

Innovating to ultimately end TB Together with our partners, Aeras is successfully advancing TB vaccine science. Moving promising vaccines into clinical trials Global clinical pipeline of tb vaccine candidates Viral Vector Protein/Adjuvant Mycobacterial Whole Cell or Extract Mycobacterial Live Fifteen years ago, there was only one vaccine candidate in the clinical trial pipeline. Since then, Aeras has helped develop 9 TB vaccine candidates and conducted over 35 Phase 1-2b clinical trials. Of the 12 vaccine candidates currently in human clinical trials globally, four are supported by Aeras. We expect results from two current clinical trials in the first half of 2018: The first is evaluating the ability of Sanofi Pasteur vaccine candidate H4:IC31 and BCG to prevent sustained infection (POI) in adolescents in a high TB-burden setting. POI is a new study design that can be used to evaluate the biologic effect of a candidate before advancing to larger, longer and more costly prevention of disease studies. Primary results from another novel late-stage clinical trial for GSK vaccine candidate M72/AS01E testing prevention of disease are expected to follow. Phase 1 MTBVAC Biofabri, TBVI, Zaragoza Ad5 Ag85A McMaster, CanSino ChAdOx1.85A/MVA85A (ID/IM/Aerosol) Univ of Oxford Phase 2a RUTI Archivel Farma, S.L H56: IC31 SSI, Valneva, Aeras H4: IC31 Sanofi Pasteur, SSI, Aeras ID93 + GLA-SE IDRI, Wellcome Trust TB/FLU-04L RIBSP Continuing to explore a diverse range of vaccine candidate types will be critical to success since scientists don t yet fully understand what type of immune response will protect people from TB. Each study conducted offers an unprecedented opportunity to apply learnings to optimize TB vaccine development. 2

Phase 2b Phase 3 DAR-901 VaccaeTM Dartmouth, GHIT Anhui Zhifei Longcom M72 + AS01E GSK, Aeras VPM 1002 SII, Max Planck, VPM, TBVI (Phase 2/3) 3

Advancing the understanding and speed of TB vaccine science Aeras follows globally developed criteria for selecting, assessing and advancing only the most promising vaccine candidates through the research and development pipeline, which helps ensure the best stewardship of the limited funds available for TB vaccine development. Further steps taken by Aeras to accelerate vaccine development include: The AerasSHARE Biorepository, launched in September 2016, which allows investigators from the broader research community to access clinical specimens collected by Aeras and its research partners in an effort to facilitate state-of-the-art TB vaccine science and promote world-wide collaboration among researchers. Incorporation of the latest data within TB vaccine research and development (R&D) stage gate criteria. These criteria, developed with the TuBerculosis Vaccine Initiative (TBVI), help inform and align vaccine developers on the key steps in TB vaccine development. Creation of improved animal models of disease to facilitate and enhance initial screening for promising TB vaccine candidates. We also worked with partners to initiate the R&D program to develop a controlled human infection model for TB, which has evolved to the Human Challenge Consortium with support from the Bill & Melinda Gates Foundation. Co-organizing the biennial Global Forum on TB Vaccines, which brings the global TB vaccine field together to accelerate progress. 4

Building clinical trial capacity in high-burden countries for lasting impact Aeras fosters knowledge sharing and research capacity strengthening in multiple countries with a high TB burden. The value of collaborating with Aeras goes beyond the immediate benefits of successful TB vaccine research. Aeras has helped establish and support clinical research capacity throughout Africa, including trial sites in South Africa, Tanzania, and Zambia. Collateral benefits to clinical trial sites include equipment and facilities, skills development, high-quality jobs for local researchers, healthcare workers and other staff, and generally a higher standard of healthcare for trial participants. And Aeras worked with the AIDS Vaccine Advocacy Coalition, clinical trial site staff, community advisory boards, TB Alliance and Treatment Action Group to draft Good Participatory Practice Guidelines for TB vaccine clinical trials. 5

Advocating for resources to match the scale of the problem TB research and development is significantly underfunded. Investments in TB vaccine R&D have averaged $95 million per year over 2011 2016, less than half of the $250 million per year needed to advance TB vaccines. 6 Aeras advocates for an expanded and diversified funding base to help ensure long-term financial support for urgently needed TB vaccine research and development. We know that new, effective vaccines are both essential to the fight against TB and ultimately achievable but only with sustained global investment and support. number of deaths in 2016 Amount of research & Development Investment TB 1.7 million $95.4 million HIV 1 million $894 million Ebola 11,310 for the entire outbreak up to 2016 $244.6 million from start of outbreak REFERENCES 1. WHO. Global Tuberculosis Report 2017. (World Health Organization, 2017). 2. WHO. The End TB Strategy Factsheet. (2015). Available at: http://www.who.int/tb/post2015_strategy/en/. (Accessed: 9th September 2016) 3. The Review on Antimicrobial Resistance. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. (2016). 4. Harris, R. C., Sumner, T., Knight, G. M. & White, R. G. Systematic review of mathematical models exploring the epidemiological impact of future TB vaccines. Hum. Vaccines Immunother. 12, 2813 2832 (2016). 5. World Bank. Drug-Resistant Infections: A Threat to Our Economic Future (Discussion Draft). (World Bank, 2016). 6. TAG. 2017 Report on Tuberculosis Research Funding Trends, 2005 2016: The Ascent Begins. (Treatment Action Group, 2017). aeras.org