IAVI Serum Institute to Develop Affordable Antibody Products for HIV

"IAVI is committed to translating scientific innovation into public health solutions, and we are collaborating with Serum Institute to enable global access to broadly neutralizing monoclonal antibodies (bNAbs) against HIV if they are proven effective at preventing HIV infection. Through this partnership, we will work to pioneer a viable and sustainable pathway toward accessible, low-cost, antibody-based products for HIV, which if successful, may also be applied more broadly to innovative monoclonal antibody therapeutics targeting other disease areas," said

Mark Feinberg, M.D., Ph.D., president and CEO, IAVI.

"We have a proven record of developing and delivering vaccines and pharmaceutical products globally, and we are already applying this expertise in the field of antibody development. I am extremely pleased that Serum Institute and IAVI have joined forces in the fight against HIV with the aim of making cost-effective monoclonal antibodies for HIV, and in the fields of antimicrobial resistance and anti-snake venom. Provided the breadth of our technology, I am confident that we will be able to make positive contributions in these important areas," said Adar Poonawalla, CEO, Serum Institute of

India. "Monoclonal antibodies are providing significant therapeutic benefit in the treatment of a growing number of serious diseases. However, due to their high cost, the availability of current products is limited to wealthier countries. In light of the demonstrated efficacy of monoclonal antibodies and their future promise as globally relevant tools for disease treatment and prevention, this must change. Serum Institute is committed to developing high quality, affordable, monoclonal antibodies with the potential to treat and prevent HIV and other diseases in

India and across the globe."

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.

IAVI and its partners are pursuing 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 between IAVI and Serum Institute 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. IAVI and Serum Institute will simultaneously define a pathway for sustainable access and delivery of these antibodies in developing countries, in collaboration with other stakeholders. The goal for this partnership is to be of broad benefit to the field and to enable the most promising antibodies to be developed in the most promising combinations to maximize chances of success.

New HIV prevention methods are desperately needed, as the rate of new infections has not declined significantly in more than a decade.

"It is essential that we develop new ways to stop the spread of HIV. Antibody prophylaxis has the potential to provide a valuable, new tool for HIV prevention while the work to develop an efficacious HIV vaccine continues," said Feinberg.

"Serum Institute is proud to apply its expertise as a global supplier of affordable, high-quality vaccines to developing and delivering biomedical innovations toward HIV," added Poonawalla.