During the company’s first quarter financial results, Regeneron provided an update on how it is working to provide a treatment against COVID-19.
Previously, Regeneron and Sanofi had advanced an existing treatment, Kevzara (sarilumab), into Phase III clinical trials against the novel coronavirus.
However, separately from this, Regeneron had also developed an antibody cocktail, known as REGN-COV2, and the company stated that it has plans to initiate a clinical trial in June of this year, followed by the scaling up of manufacture to allow hundreds of thousands of doses to be available by August 2020.
In order to achieve these numbers, George Yancopoulos, CSO of Regeneron, said in an investor call that “we have made a huge commitment to enable our entire upstate New York manufacturing facility to be devoted to this effort, which on its own could supply hundreds of thousands, if not more over the course of time – maybe even in the order of a million or so doses per month.”
In terms of how quickly this scale up could occur, Leonard Schleifer, CEO of Regeneron, noted that the company will potentially have ‘a couple of hundred thousand doses’ by the end of the summer from its US facility.
Schleifer explained that should the cocktail prove to be successful in clinical trials then the company has already received enquiries from other companies about partnering on the manufacture of the treatment, as has been seen in the development of capacity for potential vaccines.
“That’s what probably will need to be done,” he added, in order to meet demand for the treatment.
In terms of the timeline of the treatment itself, Yancopoulos said that the company hopes to be able to see within one or two months whether the treatment is working, after the initiation of the trials.
Regeneron utilized its VelociSuite platform for the development of the cocktail that it previously used to develop its triple antibody treatment for the Ebola virus – recently provided US Food and Drug Administration (FDA) priority review, after trials showed that the cocktail met a superiority threshold on preventing death compared to standard of care.
Regeneron has selected two antibody cocktails from those discovered by the platform, with one acting as a lead and another as backup.
Yancopoulos outlined that the hope for a potential treatment is to prevent infection in those at risk, as well as acting as a treatment for those already infected and symptomatic.
The company also provided an update on the potential use of Kevzara as a treatment, noting that trials in China did not report a major benefit for severe patients. However, Yancopoulos noted that a separate Phase II trial indicated certain benefits in those patients deemed critical.