Covid-19: IAVI, Merck, Serum join hands to develop monoclonal antibodies

IAVI, a non-profit scientific research organisation dedicated to addressing urgent and unmet global health challenges, and Pune-based Serum Institute of India Pvt Ltd, have announced an agreement with Merck to develop SARS-CoV-2-neutralising monoclonal antibodies (mAbs) to address the pandemic.

In a joint press statement, the stakeholders said that the agreement builds on the advanced antibody discovery and optimisation expertise of IAVI and Scripps Research, gained from years of experience in HIV-neutralising antibody research and development. Merck’s and Serum Institute’s significant capabilities in design and scale-up of accelerated manufacturing processes for mAb production will facilitate the process.

The global development plan is being led by the three organisations in partnership.

The two companies have broad networks across complementary geographic areas that will be crucial to reach, given the worldwide spread of Covid-19. If the highly potent and broadly cross-reactive 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 will lead the commercialisation in developed countries. Serum Institute will lead the global manufacturing as well as commercialisation in low- and middle-low-income countries, including India, the statement added.

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 the 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 and Serum Institute will help ensure that the therapy is rapidly and widely available and accessible.

Joining the partners in this development effort are two other companies. Syngene International Ltd, based in Bengaluru, India, is Asia’s largest contract research and manufacturing organisation. Through their innovation-focussed 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.

“We’re acutely aware of the tremendous potential for monoclonal antibodies to be used in Covid-19 response. 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, 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. We share a common purpose to accelerate this promising science and deliver effective solutions that address global challenges presented by this pandemic.”

“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. Given the breadth and scale of our technology and our long-standing devotion to improving health, especially in low-income countries, 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. Encouraging results for Covid-19 antibody treatment have emerged from preclinical research and from initial clinical trials” the press note added.

According to the companies not only are innovative therapies such as SARS-CoV-2-neutralising antibodies urgently needed for immediate pandemic response, they will likely also, continue to be needed even after an effective vaccine is available.

Dennis Burton, professor and chair of the Department of Immunology and Microbiology at Scripps Research and scientific director of the IAVI NAC said: “The accelerated discovery of highly potent SARS-CoV-2-neutralising antibodies by IAVI and Scripps Research scientists was achieved by a tremendous collaborative effort of a team committed to translating state-of-the-art monoclonal antibody science into public health interventions that we all hope will have an important role in ameliorating the individual and societal impact of the Covid-19 pandemic.”

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