Regeneron Pharmaceuticals said Tuesday that it hopes to enter clinical studies by early summer for a multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as treatment for those already infected. The company indicated that it plans to initiate large-scale manufacturing by mid-April, having previously said it aimed to have hundreds of thousands of doses ready for human testing in late summer.
"Our three decades of investment in our VelociSuite antibody technologies, which accelerate and improve the traditional drug discovery process, have hopefully prepared us for this critical time and to meet this important challenge," commented chief scientific officer George Yancopoulos.
Regeneron noted that it has isolated hundreds of virus-neutralising, fully-human antibodies from its VelocImmune mice, which are genetically engineered to have human-like immune systems, and that it has also isolated antibodies from humans who have recovered from COVID-19. The company explained that it will select the top two antibodies from this pool of candidates for a "cocktail" treatment based on potency as well as binding ability to the SARS-CoV-2 spike protein in order to block its interaction with the host cell.
"Using a multi-antibody approach allows for targeting of different parts of the virus and may help protect against multiple viral variants," Regeneron said, noting that it had previously used these technologies to rapidly develop its Ebola virus infection treatment REGN-EB3, which is currently under review by the FDA.
Meanwhile, Regeneron said it is applying its VelociMab technology to prepare manufacturing-ready cell lines as lead antibodies are selected, so that clinical-scale production can begin immediately. The company is also collaborating with the US Biomedical Advanced Research and Defense Authority to boost production capacity even more.
Yancopoulos indicated that the dose needed for prevention is a lot less than for treatment after someone is infected, and that "for every hundred people you 'prophylax,' you can probably treat like five or 10 people." The duration of protection that Regeneron's antibodies could provide is unknown before clinical studies are run, but based on earlier experience, Yancopoulos said they "expect one dose to last at least a month." He added that the first people likely to receive the prophylactic treatment would be healthcare workers and others at high risk for the disease, administered via a monthly dose until a vaccine that provides longer-term immunity becomes available.
The latest news follows plans announced earlier this week by Regeneron and partner Sanofi to initiate Phase II/III global testing on the IL-6R antibody Kevzara (sarilumab), which is already approved for rheumatoid arthritis, in patients hospitalised with severe COVID-19. The companies suggested that IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.
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