iavi Imagine a world without AIDS HIV Vaccine Translational Research Laboratory International AIDS Vaccine Initiative

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1 HIV Vaccine Translational Research Laboratory Imagine a world without AIDS International AIDS Vaccine Initiative info@iavi.org Translational Health Science and Technology Institute info@thsti.res.in A Partnership for HIV Vaccine Design iavi International AIDS Vaccine Initiative

2 A Partnership for HIV Vaccine Design The HIV Vaccine Translational Research Laboratory, a joint venture of the Translational Health Science and Technology Institute (THSTI) and the International AIDS Vaccine Initiative (IAVI), is a new research facility at the THSTI, whose ultimate aim is to design vaccines to prevent HIV infection, particularly one that elicits an immune response capable of neutralizing a broad spectrum of the circulating genetic variants of HIV. The specific mission of the Laboratory is to develop strategies to accelerate the design and evaluation of HIV immunogens the active ingredients of vaccines in preclinical studies. It seeks to do so by developing, refining and adapting technologies for the systematic screening of thousands of candidate immunogens in massively parallel assays and their swift prioritization for further development. THSTI and IAVI expect that this ambitious endeavor will, by both harnessing and developing cutting-edge biomedical technologies, accelerate progress toward the creation of preventive AIDS vaccines. Beyond that, the research tools and strategies developed at the Programme could revolutionize the development of vaccines against other pathogenic viruses, including hepatitis C, dengue and influenza, among others. The Laboratory reflects an alignment of interests between the partners, allowing THSTI and IAVI to achieve objectives central to both their missions. IAVI harnesses the strengths of India s strong Bio-Pharma industry and the resources of an institute dedicated to translational research to advance AIDS vaccine development. The organization also gains access to India s deep pool of talent in the biomedical sciences, and an opportunity to build productive partnerships with the nation s vibrant biomedical industry. Vaccine manufacturers in the country are well positioned to support the global quest for an AIDS vaccine. They have in recent years played an important role in making vaccines for global infectious disease threats, such as swine flu and in Africa meningococcal disease. Since both THSTI and IAVI have an interest in bridging academic research and industrial innovation in pursuit of their missions, the Laboratory is open to collaboration with India s burgeoning biotechnology sector. THSTI, meanwhile, accesses IAVI s expertise in vaccine development and its global network of researchers and laboratories. This is in line with the Government of India s objective of stimulating technological innovation through a variety of policy mechanisms. The government has, for instance, declared the period between 2010 and 2020 to be India s Decade of Innovation. As part of this effort, it has stressed the cultivation of early stage research in a variety of scientific and technological fields an effort in which the government s Department of Biotechnology is an active participant and key facilitator. The government has also sought to promote international partnership in biomedical product development to address the nation s public health challenges. One of those challenges is HIV, and India has stepped up its response to its epidemic. The nation s public health policies support the development of new prevention tools, particularly vaccines, as part of an integrated programme for the treatment and prevention of HIV infection.

3 The Laboratory s Role A preventive AIDS vaccine would do much to reverse the tide of the HIV pandemic, including in India. But the stunning variability of HIV has so far hampered attempts to make such vaccines. This is because most viral vaccines work primarily by eliciting neutralizing antibodies, exquisitely precise molecules that prevent viruses from infecting cells. But HIV s mutability confers on it the ability to evade effective targeting by these weapons of the immune response. Devising a vaccine that can overcome this phenomenon, often referred to as the neutralizing antibody problem, is considered among the toughest scientific challenges of our day. IAVI launched the Neutralizing Antibody Consortium (NAC) in 2002 to take on that challenge. Leading research laboratories around the world, particularly the NAC and the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases, have since unraveled the structural and molecular secrets of a handful of previously isolated broadly neutralizing antibodies, which disable a broad variety of circulating HIV subtypes. Further, working with biotechnology companies, researchers in 11 countries and some 2,000 volunteers, NAC researchers have isolated and closely analyzed numerous new broadly neutralizing antibodies to inform the design of immunogens. NAC researchers two of whom lead IAVI s Medicinal Chemistry Program in India are racing to determine the precise molecular structures bound by each of these remarkably potent antibodies. They are also developing sophisticated biochemical and computational strategies to use this information to design entirely novel immunogens. India Needs an AIDS Vaccine HIV has spread relentlessly since the first cases were reported to health authorities in the United States in 1981, causing one of the most devastating pandemics ever recorded in human history. India has not been spared. According to the Joint United Nations Programme on HIV/AIDS: There were 2.4 million people living with HIV in India in 2009 Some 170,000 people in the country lost their lives to AIDS that year Women account for 39% of all people living with HIV in India Roughly 7,000 new HIV infections occur every day across the world, adding to the 34 million people living with HIV For every three people put on treatment globally, five more are newly infected with HIV This unique Laboratory at the THSTI, recently established under the auspices of the Department of Biotechnology (DBT), the Ministry of Science & Technology, the Government of India, aims to capitalize on recent advances in AIDS vaccine research. The aim is to accelerate vaccine R&D initiatives in the country by creating new scientific and technological platforms for the pre-clinical development and validation of vaccines against a variety of diseases. The Laboratory at THSTI, located at the Biotech Science Cluster in the National Capital Region, is part of the Government of India s efforts to create clusters of scientific excellence in the country. THSTI provides a platform for interdisciplinary research and education, including in engineering, medicine, chemistry, physics and agriculture to drive biotech innovation. The group of autonomous centers is focused on science for human health, addressing specific domains such as pediatric biology, vaccine design, health technologies, molecular diagnostics and bio-imaging. The Laboratory s operations are coordinated with those of IAVI s AIDS Vaccine Design and Development Laboratory in New York, which coordinates all IAVI-supported vaccine design efforts, and the IAVI Neutralizing Antibody Center at The Scripps Research Institute in California, which serves as the headquarters of the NAC.

4 IAVI s Global Research and Development Network The Laboratory is woven into IAVI s global research laboratory network through collaborations with the AIDS Vaccine Design and Development Laboratory, the IAVI 4 Neutralizing Antibody Center at The Scripps Research Institute and the Neutralizing Antibody Consortium. 1 2 The AIDS Vaccine Design and Development Laboratory New york, NEW YORK, u.s. This laboratory, established in 2008, connects IAVI s R&D efforts, linking design and development programs and providing scientific, material, logistical, technical and managerial support to our partners, other researchers and collaborating scientists. The IAVI Neutralizing Antibody Center at The Scripps Research Institute La Jolla, CalifORNIA, U.S. This facility, a partnership with Scripps launched in 2009, is dedicated to the structural, biochemical and genetic analysis of broadly neutralizing antibodies against HIV and the application of that information to the design of AIDS vaccine candidates. The center also serves as the headquarters of IAVI s Neutralizing Antibody Consortium. 3 The Human Immunology Laboratory London, U.K. Based at Imperial College London, this lab coordinates the IAVI-supported network of clinical trial centers in Africa. It trains and supports researchers and technicians, provides materials and quality assurance to the network, and plays a central role in generating the data that enables prioritization of vaccine candidates. The lab also is pioneering the development of standardized tests to improve the breadth, quality and detail of information researchers can collect on the interaction of HIV with the human immune system. 4 HIV Vaccine Translational Research Laboratory New Delhi, India Established in partnership with the Government of India as part of the newly created HIV Vaccine Design Programme, this laboratory will focus on conducting translational research in an effort to design effective immunogens based on clues provided by recently discovered broadly neutralizing antibodies to HIV. IAVI-SUPPORTED Clinical RESEARCH centers IAVI supports a web of partner laboratories across sub-saharan Africa to test AIDS vaccine candidates and conduct observational studies that inform the design of candidates and provide baseline information for future efficacy trials. LIST OF CENTERS Kenya AIDS Vaccine Initiative Kenya AIDS Vaccine Initiative Kenyatta National Hospital Kenya Medical Research Institute Centre for Geographic Medicine Research-Coast Uganda Virus Research Institute-International AIDS Vaccine Initiative Medical Research Council Projet San Francisco Zambia-Emory HIV Research Project Aurum Institute Kangemi, Kenya Nairobi, Kenya Kilifi, Kenya entebbe, Uganda Masaka, Uganda Kigali, Rwanda Lusaka, Zambia rustenburg, south Africa

5 The Translational Health Science and Technology Institute (THSTI) The Translational Health Science and Technology Institute (THSTI) part of the emerging biotech science cluster in the National Capital Region of Delhi and was established by the Department of Biotechnology, Ministry of Science & Technology, the Government of India is an ambitious initiative that is creating a unique institutional environment for the conduct of multidisciplinary research that translates scientific and technological advancements into medical innovation that will ultimately help improve healthcare in India and around the world. Focus of the THSTI THSTI s research activities are focused on three broad areas, namely, vaccine and infectious diseases; pediatric biology; and bio design and diagnostics development. THSTI has the following centers: 1 Vaccine and Infectious Disease Research Centre (VIDRC) MISSION: The VIDRC was set up by the Department of Biotechnology, Ministry of Science and Technology, Government of India in early 2009 as a niche center of the newly established Translational Health Science and Technology Institute (THSTI). The aim of VIDRC is to study infectious diseases and pathogens with a view to develop effective vaccines and therapeutics. Activities: Vaccine development (Rotavirus 116E-Phase III trial) Novel vaccine delivery platforms (Animal adenoviruses, HPV) Respiratory infection (tuberculosis) Enteric infection (Rotavirus, HEV) Mosquito-borne infection (JE, dengue) Paediatric Biology Centre (PBC) MISSION: Translate mechanistic and causal understanding into development of robust and sustainable interventions for clinical and public health policies in reducing neonatal and child morbidity and mortality. Activities: Immunobiology of perinatal period & early infancy Nutritional regulation of immunity & infection Biology of specific pediatric diseases, Pathobiology of pediatric renal disease Program on biology of birth with specific reference to prematurity & intrauterine growth retardation Biology of sepsis Centre for Bio Design and Diagnostics (CBDD) MISSION: The primary mission of the CBDD is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics. Activities: Protein & Antibody Engineering Detection technologies and concepts New clinical markers Nucleic acid diagnostics Decentralized diagnostics (POC) Therapeutic proteins Clinical Development Services Agency (CDSA) MISSION: The Clinical Development Services Agency (CDSA) was established as an extramural unit of the THSTI and has been established to provide cost-effective, high quality preclinical and clinical product-development support services to meet the country s growing healthcare needs. It will tend to enterprises, particularly small and medium enterprises, involved in new technology innovation and facilitate translation of scientific know-how into viable products. Activities: The early focus of the CDSA mandate is to promote the enhancement of clinical trial capacity in India as per international standards. It will: Create centers of excellence in clinical research Conduct training programs in clinical research Monitor public health trials for their Good Clincial Practices compliance

6 At the HIV Vaccine Translational Research Laboratory The Laboratory s primary focus is the development of strategies for the highthroughput analysis of potential immunogens to elicit broadly neutralizing antibodies to HIV. Advances in the new field of proteomics over the past decade have made it possible to delicately probe protein molecules by the thousands, so that their interactions with other molecules can be rapidly assessed. The Laboratory seeks to build upon these technologies to screen potential protein immunogens on a massive scale, evaluating the ability of thousands of distinct proteins derived from variants of HIV to bind to neutralizing antibodies. Those that do so best can be modified and refined in parallel, and then prioritized for further evaluation. Researchers at the Laboratory will further accelerate vaccine design and development by devising cell culture-based strategies to hasten the preclinical evaluation of immunogens. This will help them to better hone the selection of candidate immunogens, and could significantly improve the efficiency of preclinical development. Finally, the Laboratory is also working with the NAC and researchers in India to screen sera collected from HIV-positive volunteers for their ability to neutralize HIV. The samples that do so most effectively are further analyzed for the possible detection and isolation of new broadly neutralizing antibodies. Such discoveries can expand the repertoire of targets on HIV that are available for structure-based immunogen design. The Laboratory supports both the NAC and a broader HIV vaccine design programme in a variety of ways: The immunogen evaluation core: Responsible for the screening of blood serum samples against a panel of viruses. The panels of viruses used for the assay are chosen to include viruses from different clades, geographical locations and general neutralization sensitivity. Further pre-clinical studies would screen neutralizing antibody induction. The protein production core: Responsible for the production and standardization of all HIV env, scaffolds, peptides and antibodies to support discovery activities of the program. It would also entail development of expression systems and biochemical and biophysical analysis to ensure consistency of reagents.

7 About THSTI The Translational Health Science and Technology Institute (THSTI) is an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India, and is a part of the interdisciplinary Biotech Science Cluster, located in the National Capital Region. THSTI seeks to create a unique institutional environment for the conduct of truly multidisciplinary research that translates scientific and technological advancements into medical innovations that will improve human health. The other members of the cluster include the Regional Centre for Biotechnology (RCB) under the aegis of UNESCO and the NII with which THSTI will collaborate seamlessly in its interdisciplinary approach to solving scientific problems. The cluster institutions will have access to a state-of-the-art experimental animal facility and the platform technology center for sophisticated instrumentation. About IAVI IAVI is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates. In addition, IAVI conducts policy analyses and serves as an advocate for the AIDS vaccine field. IAVI supports a comprehensive approach to addressing HIV and AIDS that balances the expansion and strengthening of existing HIV-prevention and treatment programs with targeted investments in the design and development of new tools to prevent HIV. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it. IAVI relies on the generous donations from governments, private individuals, corporations and foundations to carry out its mission.

8 With Thanks THSTI and IAVI are confident that the HIV Vaccine Translational Research Laboratory will contribute to the quest to develop preventive AIDS vaccines of relevance to people in India and elsewhere. The strategies and technologies that are being developed here are also likely to find application in the prevention of other infectious diseases. This ambitious laboratory program would not be possible without the support of our many generous donors. We are thankful for the confidence they have placed in us and for their continued faith in the global AIDS vaccine effort. avi International AIDS Vaccine Initiative IAVI gratefully acknowledges the generous support provided by the following major donors The Laboratory and its activities are supported by: The Department of Biotechnology, the Government of India; THSTI and IAVI For additional information on IAVI s donors, please visit our website For additional information about THSTI, please visit our website Design by Padraic Design. All photos by Charlotte Raymond Photography International AIDS Vaccine Initiative. All rights reserved. International AIDS Vaccine Initiative, IAVI and the IAVI logo are trademarks of the International AIDS Vaccine Initiative, Inc The Translational Health Science and Technology Institute Basque Autonomous Government (Spain) Becton, Dickinson and Company (BD) Bill & Melinda Gates Foundation Bristol-Myers Squibb Broadway Cares/Equity Fights AIDS Canadian International Development Agency The City of New York, Economic Development Corporation Foundation for the National Institutes of Health The Gilead Foundation GlaxoSmithKline Google Inc. Government of Japan The Hearst Foundations Institut Mérieux Irish Aid James B. Pendleton Charitable Trust Ministry of Foreign Affairs and Cooperation, Spain Ministry of Foreign Affairs of Denmark Ministry of Foreign Affairs of The Netherlands Ministry of Science & Technology, Government of India National Institute of Allergy and Infectious Diseases Norwegian Royal Ministry of Foreign Affairs The OPEC Fund for International Development Pfizer Inc The Starr Foundation Swedish International Development Cooperation Agency Thermo Fisher Scientific Inc. U.K. Department for International Development The U.S. President s Emergency Plan for AIDS Relief through the U.S. Agency for International Development United Continental Airlines The World Bank through its Development Grant Facility And many other generous individuals from around the world As of July 2012