NEW DELHI: Non-profit scientific research organisation IAVI, vaccine major Serum Institute of India and global science and technology firm Merck KGaA have entered into an agreement to develop monoclonal antibodies to fight COVID-19 and to ensure their prompt and equitable global access.
The agreement is "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 partners said in a statement on Thursday.
The agreement builds on the advanced antibody discovery and optimisation expertise of International AIDS Vaccine Initiative (IAVI) and Scripps Research, and on Germany's Merck KGaA's and Serum Institute's significant capabilities in design and scale up of accelerated manufacturing processes for mAb production, it added.
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 will lead commercialisation in developed countries, the statement said.
Serum Institute will lead global manufacturing as well as commercialisation in low- and middle-low-income countries, including India, it added.
"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," IAVI President and CEO Mark Feinberg said.
On the agreement, Merck KGaA vice chair of the executive board and deputy CEO Belén Garijo 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", he added.
"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," Serum Institute of India CEO Adar Poonawalla said.
Under IAVI's agreement with Merck KGaA 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, the statement said.
Should the mAb candidates being developed be shown to be safe and efficacious, Merck KGaA and Serum Institute will help ensure that the therapy is rapidly and widely available and accessible, it added.
Joining the partners in this development effort are contract research and manufacturing firm Syngene International and bioengineering company ATUM, the statement said.