Regeneron Could Begin COVID-19 Clinical Trials in Summer for Newly Identified Antibodies
As companies continue to marshal their forces against COVID-19, the illness caused by the novel coronavirus, Regeneron announced this morning that its antibody program aimed at the virus could enter the clinic by early summer.
New York-based Regeneron said it has identified hundreds of virus-neutralizing antibodies and intends to begin large-scale manufacturing by mid-April. The antibody cocktail therapy is expected to be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as a treatment for those already infected, the company said. Regeneron aims to produce hundreds of thousands of prophylactic doses per month by the end of summer and hopes to have smaller quantities available for initial clinical testing at the beginning of the summer, the company said.
In its announcement this morning, Regeneron said the antibodies were isolated from mice that have been genetically-modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19, in order to maximize the pool of potentially potent antibodies, the company said. It’s from this pool of antibody candidates that Regeneron intends to select the top two that will be part of its “cocktail” treatment. The antibodies will be selected based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities, Regeneron said. All coronaviruses have a single glycoprotein on the virus surface called the spike protein, which is the protein on the virus cell surface that binds to the host cell and is required for infectivity. Regeneron's SARS-CoV-2 antibodies will target the spike protein in order to block its interaction with the host cell, and thus neutralize the virus. The company added that this was the same measure it took to develop a treatment for Ebola, which is currently awaiting a regulatory decision from the U.S. Food and Drug Administration.
George Yancopoulos, co-founder and chief scientific officer of Regeneron, said its 30-year investment in the company’s antibody technologies that accelerate and improve the traditional drug discovery process, “have hopefully prepared us for this critical time and to meet this important challenge.” Because the world is waiting for a treatment for COVID-19, Yancopoulos pledged that Regeneron would provide “regular and transparent updates” on its discovery and development programs.
The antibody program is in addition to Regeneron's separate ongoing clinical program with its development partner Sanofi evaluating Kevzara (sarilumab), an IL-6 receptor antibody, in severe COVID-19 patients. The companies opted to test the rheumatoid arthritis drug in COVID-19 patients following reports that some people who had been hit hard by the virus were experiencing an overactive immune response against the lungs and other healthy tissue. The idea is that Kevzara may calm that immune response in these patients.
On Monday, the two companies announced the beginning of a Phase II/III trial with Kevzara in those severely impacted patients. The role of IL-6 is supported by preliminary data from a study in China using Roche’s Actemra, a drug similar to Kevzara. John Reed, Sanofi's global head of research and development, pointed to the study in China that suggests Kevzara could be an important treatment in those severe COVID-19 cases.
"… this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 receptor inhibition with Kevzara is better than current supportive care alone,” Reed said in a statement. Sanofi is also working on a potential vaccine for the novel coronavirus. The company’s vaccine business, Sanofi Pasteur is leveraging previous development work for a SARS vaccine as part of our goal to quickly develop a COVID-19 vaccine.