The war on COVID-19 isn't being waged on a distant shore; it's being waged in laboratories. Drug manufacturer Regeneron is answering the call to action and is working closely with regulators to create a viable therapy for the novel virus. David Weinrich, head of global clinical development, describes the “shared sense of urgency” that is driving the work of international governments, agencies, and private companies to develop a way to curb the coronavirus.
Despite having their research and development team scattered across New York's suburb's due to working from home rules, Weinrich describes how the company is making it happen. After a lot of sleepless nights, an onslaught of video conferencing calls, and some creative problem-solving, the company put together a plan for doing their part.
“There isn’t a corner of the organization that hasn’t taken this in stride and really said, ‘We may be able to… do something here,'" Weinrich said. "We're going to make this work, and we're not going to compromise the way that Regeneron works."
Firstly, the company plans on repurposing its arthritis drug Kevzara that the firm created in conjunction with drugmaker Sanofi. When the IL-6 inhibitor started showing potential within weeks of beginning trials in China, the firm began recruiting candidates for its global phase 2/3 trials for the medication. Weinrich believes that sort of turnaround is only possible through the combined efforts of dedicated researchers and committed regulators.
“We were on the phone with the FDA on a Saturday, they reviewed the protocol we wanted to start (for a US Kevzara trial), and we were all clear on Sunday that same weekend,” Weinrich stated. “We’re all pulling together to find something that can help here.”
But the drugmaker isn't putting all its COVID-fighting eggs in one basket. It is also creating an antibody conjugate that could act as a vaccination or treatment. The antibody mixture is also well on its way, with the first human trials scheduled to start this summer. Weinrich added that the early summer deadline was likely but was still subject to the smooth running of the med's development.
Regeneron is using its proprietary VelociSuite technologies to create fully human antibodies to fight COVID-19 – all from genetically-altered mice. The technology provides for the speedy, high-scale, automated editing of mouse DNA with almost no limits on scale or sophistication of the manipulations. The benefits of the technology include the rapid processing for validation of therapeutic targets and the development of animal models for human illness.
The firm has focused on the manipulation of mouse genetics since 2006. Using the VelociGene solution, Regeneron worked as part of the National Institutes of Health (NIH) Knockout Mouse Project to crack the code on thousands of unknown genes. Additionally, the platform was also used to create REGN-EB3, an Ebola antibody concoction that it took to clinical trials a few months after the August 2018 outbreak.
Firms like Bayer, Novartis, Teva, and Mylan donated doses of their malaria drug chloroquine to the US government for coronavirus trials. As the work towards solving the COVID crisis continues, much of the responsibility will fall with drugmakers to make a cure possible.