IAVI, a nonprofit scientific research organisation dedicated to addressing urgent, unmet global health challenges, and Serum Institute of India, a leading manufacturer of vaccines and biologics, have announced an agreement with Merck, a leading science and technology company, to develop SARS-CoV-2 neutralising monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.

"We're acutely aware of the tremendous potential for monoclonal antibodies to be used in COVID-19 response,” said Mark Feinberg, President, CEO, IAVI.

“I am extremely pleased that we have joined forces with IAVI and Merck in the fight against COVID-19 with the aim of developing monoclonal antibodies for global access,” said Adar Poonawalla, CEO, Serum Institute.

Scientists at IAVI’s Neutralising Antibody Center (NAC) based at Scripps Research, along with fellow immunologists at Scripps Research, were part of a team that identified antibodies from the blood of recovered COVID-19 patients that are capable of potently neutralising SARS-CoV-2, the virus that causes COVID-19. Animals that received these neutralising antibodies were protected against disease after challenge with SARS-CoV-2. The results were published in Science in June 2020.

Under IAVI’s agreement with Merck and Serum Institute, the partners will conduct an accelerated, integrated programme of preclinical and clinical research to evaluate the antibodies for treatment of COVID-19. A Phase I clinical trial is expected to start early in 2021.

Joining the partners in this development effort are two highly regarded companies with unique capabilities. Syngene International Ltd, based in Bengaluru, India, is Asia's largest contract research and manufacturing organisation. Through their innovation-focused research and development capabilities they are a collaborating partner for the development and conduct of assays to support clinical development of the SARS-CoV-2 mAb candidates. ATUM, a California-based bioengineering company, has utilised its Leap-In Transposase® Platform to develop stable cell lines needed for the manufacture of the SARS-CoV-2 antibody candidates being advanced via this collaboration.