IAVI and Scripps Research Join Efforts with NIH to Expedite Development of Globally Accessible and Affordable HIV Antibody Combination Products

HIV bnAb

NEW YORK – JULY 9, 2020 – Today during the global conference AIDS 2020: Virtual, IAVI, a scientific research organization dedicated to addressing urgent unmet health needs including HIV and tuberculosis, announced an innovative collaboration with Scripps Research and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). These leading scientific organizations are pooling their HIV broadly neutralizing antibody (bnAb) assets and expertise to develop a combination product specifically designed to be produced at scale to provide prompt, affordable, and sustainable global access, should bnAbs be shown to be efficacious for HIV prevention and possibly for treatment.

Through this collaboration, scientists from the IAVI Neutralizing Antibody Center (NAC), Scripps Research, and NIH will work together to expedite the development of a combination product, including their most potent and broadly neutralizing antibodies, that is designed to protect against the wide genetic diversity of circulating HIV strains. Via the partners’ joined efforts, highly promising bnAbs targeting distinct weaknesses on HIV will be optimized for potency, breadth, and manufacturability and for the most desirable product profile to foster ease of implementation and acceptance. The combination products will be rigorously compared in preclinical and clinical trials to determine which combination is optimal for HIV prevention and potentially for treatment. As part of its partnership with NIH, IAVI will in-license optimized bnAbs targeting the CD4 binding site on the HIV Envelope surface glycoprotein developed by scientists at the NIAID Vaccine Research Center (VRC) and other NIAID laboratories.

IAVI’s collaboration with Scripps Research and NIH will strengthen IAVI’s ongoing partnership with the Serum Institute of India Pvt. Ltd. (Serum Institute) to bring to licensure an affordable and globally accessible monoclonal antibody prevention product for HIV. These partnerships represent a unique collaboration framework in biomedical innovation, in which nonprofit, commercial, and governmental partners work to lower costs and enable delivery of a new HIV prevention product with the potential to profoundly change the trajectory of the HIV pandemic.

The potential efficacy of using bnAbs to prevent HIV is now being evaluated in the Antibody-Mediated Prevention (AMP) studies (HVTN 704/HPTN 085) sponsored by NIH. The results of these landmark studies are expected later this year. Should the AMP trial establish “proof of concept” of bnAbs as a new HIV prevention approach, it will be essential to develop bnAb combinations of optimal potency and breadth to bring to licensure and global access as quickly as possible. Further, it will be essential to create new pathways to enable promising bnAb combination products to be produced at sufficient scale to meet global needs and at a price that ensures availability and affordability to all who can benefit from them, especially people at risk of HIV in low-income countries. However, given that existing monoclonal antibody products targeting other diseases are available mainly in higher income countries at high prices, achieving this goal will require innovative science and innovative partnerships.

Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said, “We are profoundly gratified to be working with these leaders in the global fight against HIV/AIDS. Together, IAVI, Scripps Research, NIH, and Serum Institute can accomplish much more than we can working separately. In addition to the exciting scientific work that underpins our agreement with NIH, we are eager to advance an innovative partnership model with the goal of ensuring prompt global access to HIV bnAbs once we have positive efficacy results from HIV antibody trials. We and our partners are fully prepared to meet this challenge to ensure that the products we’re developing now will have widespread and affordable use should they be shown to be efficacious.”

Serum Institute is the world’s largest producer of vaccines and has a growing presence in biologics such as monoclonal antibodies. “As a global leader in vaccines and biologics manufacturing, Serum Institute is well-positioned to provide innovative solutions for antibody production. We are honored to work with IAVI, Scripps Research, and NIH to address the global HIV/AIDS problem, and I am confident that we will be able to make positive contributions in this important area,” said Adar Poonawalla, CEO, Serum Institute.

About 1.7 million new HIV transmissions occur each year, mainly in low- and middle-income countries (LMICs), even at a time when highly effective HIV prevention methods have been developed and approved. These new cases are not only a tremendous health burden for individuals, but they also represent a growing economic burden for governments, health systems, and families in LMICs as patients embark on a lifetime of taking HIV treatment medications. Alternatives to existing HIV prevention methods are urgently needed to reduce the number of new cases and reverse this unsustainable trend.

The discovery and development of IAVI’s bnAb candidates were enabled by generous and long-term investments made by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID). PEPFAR through USAID has funded IAVI and partners’ groundbreaking HIV epidemiological studies in which promising bnAbs were identified among people living with HIV/AIDS and has continued to support IAVI’s bnAb discovery and optimization science, translational research, and preparations for large-scale bnAb manufacturing.

USAID and PEPFAR have emphasized the need for an effective product that would provide additional prevention options for adolescent girls and young women (AGYW), who, in many parts of the world, shoulder the largest burden of HIV acquisition risk. IAVI’s longstanding research and advocacy partnerships in communities hardest hit by HIV, also made possible by years of support by and partnership with USAID, will enable IAVI and NIH to understand the challenges facing people vulnerable to HIV acquisition and why some populations are not being served by existing HIV prevention products. Analysis of this information will help determine how to ensure acceptability of the new HIV antibody products.

The use of bnAbs could be a promising low-cost HIV prevention approach for people in LMICs. In particular, this prevention method may be especially suitable for use by AGYW in LMICs. Nearly 1,000 girls and young women acquire HIV each day, and in sub-Saharan Africa, there are twice as many new HIV acquisitions in girls and young women than in boys and men the same age. Existing HIV prevention methods, such as daily HIV prevention pills or condoms, can be stigmatizing or difficult for AGYW to use or negotiate in sexual encounters. Infection-blocking antibodies have several advantages over daily prevention pills for at risk AGYW: they can be given discreetly via subcutaneous injection and at the same medical visit as injections of long-acting contraceptives, a widely used method of birth control among AGYW in under-resourced settings.

“We have arrived at hopeful moment in the battle against the HIV/AIDS pandemic. The IAVI/Scripps Research/NIH HIV antibodies in the research pipeline could be a game-changer in particular for African girls and women, who are so vulnerable to HIV and to whom we must offer prevention tools that suit their particular needs,” said Kundai Chinyenze, M.D., executive medical director at IAVI.

IAVI’s HIV antibody program and work at the NAC is made possible by the generous support of IAVI’s donors, including the Bill & Melinda Gates Foundation, the Governments of Denmark (through Danida), Ireland (through Irish Aid), The Netherlands (through the Ministry of Foreign Affairs), Norway (through the Norwegian Agency for Development Cooperation and GLOBVAC), the United Kingdom (through Department for International Development), and through the generous support of the American people from the President’s Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID), among others.

BACKGROUND

• bnAbs develop naturally in some people after many years of HIV infection.
• bnAbs have been shown to neutralize a wide range of HIV variants in the lab.
• Scientists are making HIV bnAbs in the lab with monoclonal antibody technology and engineering them to extend how long they last and make them more potent.
• The IAVI-Scripps Research-NIH bnAb candidates are more potent than earlier versions being tested in ongoing clinical trials. The increased potency of these optimized bnAbs could also enable the delivery of lower bnAbs doses that are administered by simple subcutaneous injection rather than intravenous infusion
• The partners will select the best candidates from their pipelines to develop and combine into a combination antibody product.
• The goal is for a single dose to provide protection from HIV acquisition for three to six months.

About IAVI
IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions..

Through 2026, project ADVANCE, supported by USAID through PEPFAR, and designed by IAVI in collaboration with African and Indian clinical research center partners, will move the world closer to a safe and globally effective HIV vaccine. ADVANCE aims to ensure African scientists fully participate in a product development pathway that reflects African realities and considers key regional priorities.

About Scripps Research
Scripps Research is an independent, nonprofit biomedical institute ranked the most influential in the world for its impact on innovation. With campuses in La Jolla, California, and Jupiter, Florida, we are advancing human health through profound discoveries that address pressing medical concerns around the globe. Our drug discovery and development division, Calibr, works hand-in-hand with scientists across disciplines to bring new medicines to patients as quickly and efficiently as possible, while teams at Scripps Research Translational Institute harness genomics, digital medicine and cutting-edge informatics to understand individual health and render more effective healthcare. Scripps Research also trains the next generation of leading scientists at our Skaggs Graduate School, consistently named among the top 10 U.S. programs for chemistry and biological sciences. Learn more at scripps.edu.

About Serum Institute of India Pvt. Ltd. (Serum Institute)
Serum Institute is now the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). Vaccines manufactured by Serum Institute are accredited by the World Health Organization and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world.

Serum Institute is developing biosimilars of existing antibody immunotherapies for a range of diseases, and in 2017 launched a novel monoclonal antibody against rabies.

About USAID
USAID administers the U.S. foreign assistance program providing economic and humanitarian assistance in more than 120 countries worldwide. This project is made possible by the support of the American people through USAID and PEPFAR. The contents of this announcement are the responsibility of IAVI and do not necessarily reflect the views of USAID, PEPFAR, or the United States government.