Serum Institute of India, IAVI, and Merck join race to develop antibodies for Covid-193 min read . Updated: 22 Oct 2020, 07:30 PM IST
- As per a joint statement by IAVI and Serum Institute, the two monoclonal antibodies were co-invented by IAVI and Scripps Research as an innovative intervention to curb the pandemic
- Under IAVI’s agreement with Merck and SII, the partners will conduct an accelerated, integrated program of preclinical and clinical research to evaluate the antibodies for treatment of Covid
To develop SARS-CoV-2 neutralising monoclonal antibodies (mAbs) that could help keep people healthy after they have been infected with the novel coronavirus, the Serum Institute of India has entered into an agreement with German pharmaceutical giant Merck KGaA and IAVI, a non-profit health research organisation.
Monoclonal antibodies are synthesised proteins that act like human antibodies in the immune system in battle against a particular infection.
The agreement builds on the advanced antibody discovery and optimisation expertise of IAVI and Scripps Research, gained from years of experience in HIV broadly 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 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 commercialisation in developed countries.
Serum Institute to lead global manufacturing
Meanwhile, Serum Institute will lead global manufacturing as well as commercialisation in low- and middle-low-income countries, including India.
“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, M.D., Ph.D., 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.
Dennis Burton, Ph.D., 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 neutralizing 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."
Under IAVI’s agreement with Merck 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 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 highly regarded companies with unique capabilities. Syngene International Ltd., based in Bengaluru, India, is Asia's largest contract research and manufacturing organization. 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 utilized 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. This effort is enabling the rapid and robust transition from research to clinical development.
Meanwhile, the overall number of global coronavirus cases has increased to 41.1 million, while the deaths have soared to more than 1,130,400, according to the Johns Hopkins University.
As of Thursday morning, the total number of cases stood at 41,148,042, while the death toll surged to 1,130,405, the University's Center for Systems Science and Engineering (CSSE) revealed in its latest update.
The US is the worst-hit country with the world's highest number of cases and deaths at 8,333,591 and 222,063, respectively, according to the CSSE.
India comes in second place in terms of cases at 7,651,107, while the country's death toll soared to 115,914.