Sorrento Therapeutics (NASDAQ:SRNE) hasn't released data from a phase 1 clinical trial testing STI-1499, which also goes by COVI-GUARD, its first-generation antibody treatment targeting the coronavirus that causes COVID-19.
But the biotech is already moving on to its next-generation version of the drug. Today, the company announced that the Food and Drug Administration cleared it to run a phase 1 clinical trial for STI-2020, which also goes by COVI-AMG.
Pre-clinical testing of the antibodies in laboratory studies showed STI-2020 was 50-fold more potent than STI-1499. The higher potency means that STI-2020 can be given in a small volume via an intravenous push with a syringe. Regeneron's (NASDAQ:REGN) coronavirus antibody treatments casirivimab and imdevimab and Eli Lilly's (NYSE:LLY) bamlanivimab have to be given via intravenous infusion, which requires a patient to be hooked up to a machine and takes longer to administer.
Sorrento has shown STI-2020 can bind to multiple variants of the novel coronavirus, making it potentially useful if drug-resistant variants become a serious problem.
The biotech plans to initially test the drug in healthy volunteers before moving on to patients with COVID-19. Sorrento has started the manufacturing process to produce up to 100,000 doses ahead of a potential Emergency Use Authorization (EUA).
While the potential for a stronger drug is great, Sorrento really needs to step on the gas and generate enough data to get an EUA before the population is largely vaccinated and the potential market for STI-2020 evaporates.