Regeneron doesn’t give up easy, a persistent group on a mission. Fresh from failure with the last study (with Sanofi) repurposing Kevzara to COVID-19 patients, the company managed to launch the Phase 3 clinical trial for a brand new advanced monoclonal antibody (REGN-COV2) as an Independent Data Monitoring Committee (IDMC) offered a thumbs up. This was made possible because the company and the U.S. Food and Drug Administration (FDA) agreed in advance that an initial group of patients would serve as a ‘sentinel population.’ Now the company’s relentless deal making led to the securing of $450 million in government money for this next research initiative: part of the Operation Warp Speed. The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020 in addition to fill/finish and storage activities. Hence, the current REGN-COV2 clinical program is evaluating multiple dosages and will at some point establish the exact number of possible treatment doses equaling up to 300,000 treatment doses or up to 1.3 million prevention doses at no cost to the American people. With 330 million people in the U.S. it would be interesting to uncover what pricing may look like after this initial gratis batch.
Regeneron received $450 million from the federal government to manufacture and supply this advanced novel monoclonal antibody called REGN-COV2. Actually a double antibody cocktail as they announced in the recent press release, it is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19 infection. TrialSite News covered that brand new study with a focus on a new research site in Mesa, Arizona.
REGN-COV2 at Risk
Regeneron has been active since the advent of the pandemic, expending great energy and capital in a search for therapies or treatments targeting the novel coronavirus. Noting this “business risk,” the company scaled up manufacturing so that the product could be made available immediately for use in the United States if clinical trials prove successful. If that were to be the case then they would depend on the FDA to grant Emergency Use Authorization (EUA) or full product approval—this would be a big deal.
This Operation Warp Speed (via BARDA/ASPR/US HHS & DOD) agreement covers a fixed number of built lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities. The ongoing REGN-COV2 clinical program evaluates multiple dosages and is designed, the assumption is, to establish the exact number of potential treatment doses (estimated range from 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1.3 million) available from these lots in total. They disclose in their news release that the initial dose may be ready as early as the end of summer.
The company and government agreement leads to making the first doses from the lots available to the American people at no cost. The American government would cover the distribution costs. But the way the press release reads that would be only the lots from this first group. There are 330 million people in America so TrialSite News will search for some clarity on the rest of the deal terms—what can Regeneron charge for everything above and beyond these first lots?
IDMC Gives Greenlight
TrialSite News finally received clarity on a pressing question in regards to data from a preliminary study that triggered regulatory approval for the Phase 3 clinical trial of healthy volunteers. According to Regeneron’s July 6 press release:
“This clinical progress follows a positive review from the Independent Data Monitoring Committee of REG-COV2 Phase 1 safety results in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19.”
As it turns out, a very open and helpful spokeswoman from the company explained that the data is still blinded; however, the IDMC gave the company the greenlight to proceed. This must equate to a safety signal. As mentioned, the company and the FDA apparently established an agreement in advance that this initial group of patients would serve as a ‘sentinel population.’ Hence, this at least clarified for TrialSite News where the “Phase 1” patient data was that justified immediately proceeding to a large Phase 3 clinical trial.
Leonard S. Schleifer, MD, PhD, President and Chief Executive Officer of Regeneron, commented this breakthrough was possible due to over three decades of investment in the “VelociSuite ”antibody discovery and development platform as well as large-scale manufacturing facilities combined with exceptional company human capital. Now with the government injected $450 million, some of that risk is absorbed while the company works tirelessly and furiously to “help REGN-COV2 reach many people more quickly” with the hopes of changing “the course of this deadly and still-raging pandemic.”