Antibody Products for HIV globally

On October 22, 2018, the International AIDS Vaccine Initiative (IAVI) and Serum Institute of India (SII), the world's largest vaccine manufacturer, announced a strategic partnership to develop and manufacture affordable and accessible monoclonal antibody products for HIV and other global health challenges6.

Serum Institute of India was founded to address the shortage of life-saving vaccines in India. Its vaccines are now in used in 170 countries. IAVI has worked in India since 2001, and partners with the Government of India on its network of clinical research centers and laboratories engaged in cutting-edge HIV research, including the Translational Health Science and Technology Institute. The collaboration between IAVI and Serum Institute brings together partners with complementary expertise and a shared public health commitment to expedite the introduction of affordable, accessible, and sustainable global health solutions, particularly in countries with the highest disease burden.

About HIV

Globally, 36.9 million people were living with HIV in 2017. The world is facing a prevention crisis with 1.8 million new infections occurring in 2017. More alarming is that certain groups are being left behind. New infections are particularly high among adolescent girls and young women in sub-Saharan Africa, people who use drugs in Eastern Europe and parts of Asia, and globally, populations of men who have sex with men, transgender people and sex workers.

HIV prevention and management

In recent years, researchers, including those at IAVI, have identified hundreds of broadly neutralizing monoclonal antibodies (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 towards 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 are 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.

Note - 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.

Footnote

6 https://www.iavi.org/newsroom/press-releases/2018/iavi-and-serum-institute-of-india-to-develop-and-manufacture-globally-affordable-and-accessible-antibody-products-for-hiv

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