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IAVI, Merck KGaA and Serum Institute partner to develop COVID-19 mAbs

The partnership aims to ensure access to a class of innovative therapies that have, to date, been out of reach in low- and middle-income countries (LMICs)

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IAVI and Serum Institute of India announced an agreement with Merck KGaA, Darmstadt, Germany 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.

The agreement builds on the advanced antibody discovery and optimisation expertise of IAVI and Scripps Research, gained from HIV broadly neutralising antibody research and development, and on Merck KGaA, Darmstadt, Germany’s and Serum Institute’s capabilities in design and scale up of accelerated manufacturing processes for mAb production. The global development plan is being led by the three organisations in partnership.

If the SARS-CoV-2 neutralising antibody candidates being advanced through this partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck KGaA, Darmstadt, Germany will lead commercialisation in developed countries. Serum Institute will lead global manufacturing as well as commercialisation in low- and middle-low-income countries, including India.

“By combining the scientific achievements of IAVI and Scripps Research with our partners’ development, manufacturing, and distribution expertise, we are hopeful that this partnership will result in globally accessible antibodies that are available to all who can benefit from them,” said Mark Feinberg, President and CEO of IAVI.

Belén Garijo, Vice Chair of the executive board and Deputy CEO, Merck KGaA, Darmstadt, Germany, as well as CEO, Healthcare, said, “Together with IAVI and Serum Institute, we look forward to demonstrating the potential application of these monoclonal antibodies in the management of COVID-19.”

“I am extremely pleased that we have joined forces with IAVI and Merck KGaA, Darmstadt, Germany in the fight against COVID-19 with the aim of developing monoclonal antibodies for global access. I am confident that we and our partners are on a productive path that will lead to a much-needed, globally available tool for COVID-19 treatment and possibly prevention,” said Adar Poonawalla, CEO, Serum Institute.

Neutralising mAbs against SARS-CoV-2 are widely considered to be promising candidates for COVID-19 treatment and prevention. mAbs have the potential to play an important complementary role to COVID-19 vaccines both for treatment and potentially for prevention, especially for those individuals who, due to age or medical conditions, may not benefit from vaccination.

Scientists at IAVI’s Neutralizing 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. The portfolio of mAbs identified by IAVI and Scripps Research scientists and their partners provides the foundation for a comprehensive program with potential application to COVID-19 treatment and prevention as well as to other coronaviruses that may arise or re-emerge in the future.

Under IAVI’s agreement with Merck KGaA, Darmstadt, Germany and Serum Institute, the partners will conduct an accelerated, integrated program 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. Should the mAb candidates being developed be shown to be safe and efficacious, Merck KGaA, Darmstadt, Germany and Serum Institute will help ensure that the therapy is rapidly and widely available and accessible.

Joining the partners in this development effort are Syngene International and ATUM, a California-based bioengineering company. Syngene is a collaborating partner for the development and conduct of assays to support clinical development of the SARS-CoV-2 mAb candidates. ATUM 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.

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