Regeneron says depending on trial data it could be producing hundreds of thousands of doses of an antibody cocktail against COVID-19 by the end of summer.
Regeneron was one of the first to announce its intentions to develop monoclonal antibodies (MAbs) against COVID-19, caused by the novel coronavirus (SARS-CoV-2).
Using its VelociSuite discovery and development technologies and experience garnered to develop its investigational triple antibody cocktail treatment for Ebola REGN-EB3, the firm has is focused on developing a multi-antibody ‘cocktail’ treatment based on potency and binding ability to the SARS-CoV-2 spike protein.
“We have selected two distinct antibody cocktails from this collection, our initial cocktail as well as the backup,” chief scientific officer George Yancopoulos told investors this week.
“And we have already begun large-scale manufacturing and anticipate initiating clinical trials with elite cocktail in June. With Ebola, we set the record of nine months from initiating the project to starting human trials. Now, we hope to break that record with five months from project initiation to the clinic.”
Manufacturing at risk
The firm is hopeful it can produce (hopefully positive) data within a month or two, based on Ebola experience, supporting a commitment to produce the antibody at risk.
“We have been working to clear manufacturing capacity in our New York plant so that we can make it at large scale,” CEO Leonard Schleifer explained. “We hope to be able to have a couple hundred thousand doses by the end of the summer and then continue to manufacture from there. In terms of pricing, donations, and fair values and all that sort of stuff that’s just got to come down the road a little bit.”
Regeneron’s130-acre site in East Greenbush has been subject to numerous expansions over the past decade, the latest an $800 million expansion announced in 2018.
Such expedited trial and manufacturing timelines have never been seen before, Yancopoulos added.
“On the other hand, I don’t think we ever had quite a pandemic like this before. And I think that, some companies like ours have really put themselves in a position with the technologies, the commitments, the investments that we’ve made to put ourselves in a position, to maybe help out and make a difference here.
“And regulators like the FDA, BARDA everybody is coming together to try to help us in this situation to meet the urgency and meet the dire need that we might have here. And so the hope is yes, it might be possible by the end of the summer or the fall that, our antibody treatment could be available. A lot of risks, a lot of concerns, but we are working as hard as we can with so many collaborators to try to turn that into a reality.”