Among the drugmakers seeking an answer for COVID-19, Regeneron once showed promise in its quest to repurpose an older therapy as a treatment and develop a novel antibody cocktail, too. Now, thanks to disappointing data, that first path appears blocked. But the second is looking up, to the tune of $450 million.
Regeneron and the Trump administration signed a $450 million pact for U.S. supply of the drugmaker's investigational antibody cocktail for COVID-19, which entered a late-stage human trial as a preventive earlier this week and is rolling ahead in two phase 2 treatment trials.
As part of the agreement, Regeneron will amp up manufacturing to produce up to 1.6 million doses of the cocktail, dubbed REGN-COV2, as early as the end of summer, the company said.
Because Regeneron is still investigating dosing for possible treatment and prevention uses, the drugmaker said the order covers anywhere between 70,000 to 300,000 treatment doses and 420,000 to 1.3 million preventive doses.
Regeneron will provide bulk, unfinished lots of the cocktail as well as finished doses through 2020. If the FDA eventually grants an emergency authorization for either use, the government would make doses available at no cost and handle distribution.
Regeneron CEO Len Schleifer touted the drugmaker's early decision to begin scaling the antibody cocktail's manufacturing at risk as a move that could help it get into patients' hands faster.
"This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic," Schleifer said in a release.
The pact is the latest major investment made as part of the administration's Operation Warp Speed, with funding from the U.S Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Department of Defense.
Monday, Regeneron said it would take REGN-COV2 into a phase 3 human trial as a possible preventive for novel coronavirus infections. The prevention study comes after a data monitoring committee's recommendation based on early data.
The drugmaker already started the cocktail in phase 2/3 human trials as a treatment for hospitalized and non-hospitalized COVID-19 patients. Those studies will aim to enroll nearly 3,000 patients across 150 sites in the U.S., Brazil, Mexico and Chile and will assess virologic and clinical endpoints.
In early May, Regeneron said it had begun manufacturing doses of the as-yet-unproven antibody cocktail with the goal of making hundreds of thousands of doses available by the end of summer if clinical data persuade the FDA it's worth introducing. To design the dual-antibody combo, Regeneron researchers selected from hundreds of neutralizing antibodies against SARS-CoV-2 from a mouse model and from humans who have recovered.
The major U.S. investment in the cocktail could also go a long way toward getting the bitter taste out of Regeneron's mouth from pulling rheumatoid arthritis Kevzara out of a major clinical trial for critically ill COVID-19 patients.
Monday, Regeneron and Sanofi shut down a stateside study of their partnered med in mechanically ventilated patients after the drug failed to prevent deaths or get patients off ventilation, among other key endpoints.
Kevzara, added to standard-of-care therapy, not only failed to better patients' condition after 22 days, but the drug's "minor positive trends" in ventilated patients were also offset by poor results in a partially enrolled subgroup that had not been ventilated at the start of treatment, the companies said.