In a few short weeks, the novel coronavirus pandemic has upturned countries around the world, presenting new and complex workplace challenges. That shift is also true for drugmakers working to combat COVID-19.
For New York-based Regeneron––at the forefront of the COVID-19 hunt––those challenges are unprecedented and extraordinary, but it’s still mostly business as usual.
After two weeks of sleepless nights, growing comfort with conference calls and “esprit de corps,” Regeneron researchers are making headway toward a COVID-19 therapy with the backing of international regulators and a “shared sense of urgency,” David Weinreich, Regeneron’s head of global clinical development, said Friday.
“There isn’t a corner of the organization that hasn’t taken this in stride and really said, ‘We may be able to work do something here,” Weinreich said. “We’re going to make this work, and we’re not going to compromise the way that Regeneron works.”
With much of its R&D team working from home, Regeneron has laid out its battle plan for a COVID-19 therapy: repurposing Sanofi-partnered arthritis med Kevzara and crafting an antibody conjugate that could be used as a vaccine or treatment.
On both fronts, Weinreich said, Regeneron has been met with a “shared level of urgency” from international regulators and hospitals looking for answers.
Take Kevzara, for example: Within weeks of the IL-6 inhibitor showing promise in a single-arm comparator trial in China, Regeneron began enrolling global phase 2/3 trials for the drug earlier this week. That sort of speed could only be achieved through a combination of regulator dedication and hard work by researchers.
“We were on the phone with the FDA on a Saturday, they reviewed the protocol we wanted to start (for a U.S. Kevzara trial), and we were all clear on Sunday that same weekend,” Weinreich said. “We’re all pulling together to find something that can help here.”
The two-part U.S. arm of the Kevzara program will evaluate the drug as an add-on to supportive care in around 400 patients across 16 states. With trials picking up, Weinreich said Regeneron has had to scrap to meet an unexpected uptick in Kevzara prescriptions but so far hasn’t run into any shortage concerns.
On the second front––developing a COVID-19-fighting antibody cocktail––Regeneron is also speeding ahead, hoping to dose the first human patients in early summer as researchers rapidly screen for the two best antibodies for the combo. Weinreich said that early summer target date was a “likely” timeline barring any unforeseen barriers in the development process.
Regeneron used its proprietary VelociSuite technologies to produce fully human antibodies against the novel coronavirus from genetically edited mice. It’s the same platform the company used to design the Ebola antibody cocktail, called REGN-EB3, that it advanced into clinical studies four months after the August 2018 outbreak.
As Regeneron researchers work furiously, countries around the globe are scrambling for solutions as infection counts and death tolls spike. In the U.S., that pressure for a solution has fallen squarely on drugmakers to come up with novel solutions.
In the last two days, major players including Bayer, Novartis, Teva and Mylan agreed to donate vast quantities of malaria med chloroquine, which President Donald Trump highlighted in a press conference Thursday as a possible treatment. Other companies including Merck KGaA, with multiple sclerosis med Rebif, and AbbVie, with HIV therapy Kaletra, have also pitted their existing drugs against the virus.
At all levels of Regeneron’s global operations, Weinreich said, researchers grasp the vastness of the pandemic’s fallout and the challenge ahead of them. Their solution? Find comfort in the work.
“There’s no escaping that it’s not business as usual, but the work is still business as usual,” Weinreich said. “We’re not compromising on the science.”