Regeneron, Vir Prepare for COVID-19 Antibody Trials, Warn of Manufacturing Challenges

Regeneron Pharmaceuticals and Vir Biotechnology said they will soon begin clinical trials of monoclonal antibodies they hope will be able to prevent or treat COVID-19 patients.

Regeneron is “just a few days away” from beginning monoclonal antibody cocktail trials in early and hospitalized COVID-19 patients, said George Yancopoulos, the company’s president and chief scientific officer, in a June 8 presentation at the Biotechnology Innovation Organization’s  international convention, which is being held online this week due to the pandemic.

Vir Biotechnology CEO George Scangos said the company will begin its first three antibody trials “in very short order,” covering the same indications as Regeneron’s studies.

Scangos said that there will be supply hurdles if an antibody is approved, but that the company is securing manufacturing deals with large-scale manufacturers.

“Manufacturing will be an issue and being able to provide sufficient quantities of the antibodies, should they work, will be an issue,” he said. “We’ve signed manufacturing agreements with WuXi [Biologics], with Samsung [Biologics], with Biogen, and so we’ll be able to bring forward tens of millions of doses, so I think we’re in a good place.”

Yancopoulos echoed that producing the antibodies in sufficient amounts may be a daunting task. “This could be a situation … where the need is going to far exceed the total world manufacturing capacity,” he said. “We are one of the world’s largest antibody producers … [but] of course we have other important [medicines] to continue to make, so we can’t devote all of it to this no matter how important this challenge is.”

As a result, Regeneron is seeking partners to assist it in U.S. and foreign antibody manufacturing.

Yancopoulos said the monoclonal antibodies being developed could be more beneficial than a COVID-19 vaccine. “Essentially, these will be immediately acting vaccines in terms of protecting people with a much higher chance of having universal prevention than a vaccine,” Yancopoulos said. “Of course, you will have to keep giving these antibodies … but they can also be given to people who are already infected. You can’t do that with vaccines.” — James Miessler