The International AIDS Vaccine Initiative (IAVI), a non-profit scientific research organisation dedicated to addressing urgent global health challenges, and Serum Institute of India on Thursday announced an agreement with Merck, a 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.
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, and on Merck’s and Serum Institute’s significant 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 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 commercialisation of the effort in developed countries.
The Serum Institute has a proven track record of more than 50 years in developing affordable medicines and it is the world’s largest producer of vaccines. Serum Institute will lead global manufacturing as well as commercialisation in low and middle-low-income countries, including India.
“We are 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, in a statement released on Thursday.
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 of 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.
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. 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.
Given that many experts speculate that Covid-19 will become an endemic, or permanently circulating, disease, and given the severity of symptoms in a significant proportion of people affected, effective therapies will be necessary to treat those who remain unvaccinated or whom vaccination does not protect.
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