A COVID-19 first: Regeneron pushes mAb cocktail into clinic
Less than two weeks after the first COVID-19 mAbs entered human testing, Regeneron became the first company to bring a COVID-19 mAb cocktail into the clinic.
Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) announced on Thursday the start of its clinical REGN-COV2 program.
REGN-COV2 comprises two mAbs, REGN10933 plus REGN10987, that bind different parts of the spike’s receptor-binding domain (RBD) -- the part of SARS-CoV-2 that interacts with host cells. The company believes that combining mAbs with non-competing epitopes will reduce the risk that SARS-CoV-2 evolves resistance mutations (see “Different Scientific Paths to COVID-19 Antibody Therapies”).
Regeneron will evaluate the mAb cocktail in four cohorts: hospitalized COVID-19 patients, non-hospitalized patients, uninfected individuals who have been exposed to a COVID-19 patient and uninfected individuals at high risk of exposure.
The first two studies are placebo-controlled, adaptive Phase I/II/III trials in the COVID-19 patient populations. A Regeneron spokesperson told BioCentury the first hospitalized patients have been dosed, and that the company expects dosing of non-hospitalized, symptomatic patients to begin imminently.
The Phase I portions will assess safety and the Phase II parts will have clinical endpoints. Phase I and II data will inform Phase III endpoints and population size.
The spokesperson said Phase I data could read out this summer, and that preventative Phase III trials will begin after safety has been established in patients in Phase I testing.
This month also saw two other COVID-19 antiviral mAb monotherapies begin randomized, placebo-controlled Phase I studies.
The first is testing Ly-CoV555 from AbCellera Biologics Inc. and Eli Lilly and Co. (NYSE:LLY) in hospitalized COVID-19 patients, and the second is evaluating JS016 from Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877) and Lilly in healthy volunteers (see “Lilly’s Junshi-partnered Program Becomes China’s First COVID-19 mAb in Clinic”).
At least three other COVID-19 mAb developers -- AstraZeneca plc (LSE:AZN; NYSE:AZN), Vir Biotechnology Inc. (NASDAQ:VIR) and Celltrion Inc. (KSE:068270) -- plan to begin human testing by August. Like Regeneron, AZ is combining two mAbs that bind different parts of the spike RBD (see “AstraZeneca Eyes August Trial Start”).