Developing TB Vaccine Clinical Trial Capacity Aeras Perspective. Vicky Cardenas, PhD, JD

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1 Developing TB Vaccine Clinical Trial Capacity Aeras Perspective Vicky Cardenas, PhD, JD ASEAN-EU STI Days January 2014

2 Aeras Founded in 2003 Mission: Develop improved TB vaccines that are affordable and accessible to all who need them Offices o Rockville, MD (headquarters) o Cape Town, South Africa o Beijing, China Governed by a Board of Directors Technical advisory groups incorporating expertise from around the world ~ 170 total employees with annual budget of approx. USD $50 million 2

3 Fully Integrated R&D Capabilities Preclinical Research Staff expertise in vaccine design, assay development, immunology, animal studies, antigen selection, platform development, patent and regulatory filings Process Development & Manufacturing Fully integrated BSL-2 compliant biopharmaceutical manufacturing facility Clinical Research Network of clinical trial partner sites in North America, Europe, Africa and Asia Diagnostic and mycobacteriology lab capacity at sites Highly trained and skilled clinical research infrastructure with offices in USA, South Africa & China 3

4 Collaboration is key in an unprecedented effort Aeras serves as a catalyst by investing in the world s most promising TB vaccine candidates and coordinating a diverse community of global scientists, researchers, governments, and funders on a single mission: the development of effective TB vaccines. 4

5 TB is a Global Epidemic with an Urgent Need for Action Nearly 9 million new cases globally every year 11 countries in the Asia Pacific are among the 22 countries that carry 80% of the global TB disease burden 5

6 Disease burden in Asia Asia Pacific HBCs Pacific Active TB cases 2012 India 2,800,000 China 1,400,000 Indonesia 730,000 Bangladesh 670,000 Pakistan 670,000 Philippines 450,000 Myanmar 260,000 Vietnam 200,000 Cambodia 110,000 Afghanistan 110,000 Thailand 110,000 AP Total 7,510,000 (63%) Global Total 11,908,057 Source: WHO, Global Tuberculosis Control Report

7 TB will not be eliminated by 2050 Current rate of decline -2%/yr (globally) Today TB incidence >100x higher than elimination target for 2050 Elimination target:<1 / million / yr -20%/yr China, Cambodia -4%/yr (the best observed nowadays) W Europe after WWII -10%/yr (Historical example) 7

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9 Vaccine development approach where to focus 9

10 Aeras Discovery Portfolio 10

11 The Global Pipeline of TB Vaccine Candidates PHASE I PHASE IIa PHASE IIb PHASE III Ad5 Ag85A McMaster CanSino VPM 1002 Max Planck, VPM, TBVI, SII MVA85A/AERAS-485 Oxford, Aeras M. Vaccae Anhui Longcom, China MTBVAC TBVI, Zaragoza, Biofabri H1 + IC31 SSI, TBVI, EDCTP, Intercell M72 + AS01E GSK, Aeras ID93 + GLA-SE IDRI, Aeras RUTI Archivel Farma, S.L Crucell Ad35/MVA85A Crucell, Oxford, Aeras H4/AERAS IC31 SSI, Sanofi-Pasteur, Aeras, Intercell H56/AERAS IC31 SSI, Aeras, Intercell Crucell Ad35/AERAS-402 Crucell, Aeras VIRAL VECTOR rbcg PROTEIN/ADJUVANT ATTENUATED M.Tb IMMUNOTHERAPEUTIC: Mycobacterial Whole Cell or Extract AERAS SPONSORED 11

12 Clinical Trials Ongoing and Completed Since 2003 Numerous clinical trials in Africa, Asia, Europe, and North America Phase I 21 trials Phase II 6 trials Phase IIb 3 trials Phase IV 1 trial 12

13 Historically circa 2000 Aeras focus on South Africa high TB incidence 576/100k in /100k in 2013 Report large population ~45 M in 2000 ~52.5M in 2013 Report TB Control program sites requiring some TB capacity building experienced researchers 13

14 Expansion Period IPHCR Pune, India Makerere University Iganga, Uganda KEMRI/CDC Siaya, Kenya CHC Svay Rieng, Cambodia UCT/SATVI; Worcester, South Africa 14

15 Strategy shift circa 2009 Funder interest in bricks and mortar development, and longitudinal cohort studies diminished BMGF funding for cohort studies stopped Sites sought different funding streams to complete follow up 15

16 Methods shift (I) Expand search to regions traditionally unexplored for conduct of TB vaccine clinical trials Identify high incidence pockets in medium incidence countries Network to identify TB researchers working in the area Identify established experienced clinical trial sites requiring no/little infrastructure development 16

17 Methods shift (II) Determine TB and TB/HIV epidemiology through focused review of extant data (global, national, local, published, etc.) If appropriate, collaborate on collection of data through conduct of epidemiological studies Conduct assessment of capacity needs for participation on TB vaccine trials (refer to Pre- Qualification Visit questionnaire) 17

18 Clinical Study Sites Aeras partners globally to conduct epidemiological studies and clinical trials. 18

19 Recent Partnership Efforts in Epidemiology and Site Capacity Papua New Guinea Indonesia Bangladesh Vietnam Mongolia Timor Leste China 19

20 Aim: Add ASEAN countries Thailand Philippines Brunei 20

21 Major Funders and R&D Partners

22 Thank you.