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IAVI and Serum Institute of India to Develop and Manufacture Globally Affordable and Accessible Antibody Products for HIV

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The International AIDS Vaccine Initiative (IAVI) and Serum Institute of India, the world’s largest vaccine manufacturer, today announced a strategic partnership to develop and manufacture affordable and accessible monoclonal antibody products for HIV and other global health challenges.

Antibodies are an essential component of the immune response to infection and are largely responsible for the protection conferred by vaccination. While vaccines stimulate the human immune system to make protective antibodies, these infection-fighting proteins can also be administered directly to treat or prevent disease.

In recent years, researchers, including those at IAVI, have identified hundreds of bNAbs that are both potent and broadly cross reactive against the majority of HIV variants circulating globally. Some of these bNAbs are now being explored for their potential ability to prevent, treat, and cure HIV infection. The results of the first study of the efficacy of a bNAb for prevention of HIV infection are expected within the next two years, and additional bNAb combinations are advancing toward efficacy testing. It is still unknown whether antibody prophylaxis will be effective in blocking HIV infection, but defining a pathway to access at the outset will hasten the introduction of new products, should they work. There is a pressing need to develop a sustainable model to ensure that bNAb products can be widely available and affordable to protect individuals at high risk of HIV infection in low-income countries where HIV incidence is highest.

The  development of optimized versions and combinations of some of the most promising bNAbs as a new HIV prevention approach. This includes working with scientific collaborators to rapidly select and optimize a combination of the most potent antibodies available. The partnership will focus on developing large-scale, low-cost manufacturing processes to produce these optimized antibodies, evaluate them in clinical trials, and, if effective, register and commercialize an antibody-based HIV prevention product globally.
New HIV prevention methods are desperately needed, as the rate of new infections has not declined significantly in more than a decade.

Some HIV-specific bNAbs are already being tested in clinical trials, both for prevention and treatment. IAVI scientists and their partners are working to optimize HIV-specific bNAbs, develop low-cost manufacturing processes to produce them, and eventually test their ability to prevent HIV infection.

Antibody immunoprophylaxis, if effective, could augment existing HIV prevention strategies and help limit the spread of the virus until a vaccine is developed.

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