SRNE - Sorrento on go with early-stage COVID-19 antibody trial
The FDA has signed-off investigational new drug application for Phase 1 study with Sorrento's ([[SRNE]] -13.5%) intravenous ((IV)) COVI-AMG (STI-2020) for the treatment of COVID-19 patients with mild symptoms and a separate study to evaluate safety and pharmacokinetics in healthy volunteers.STI-2020 is an affinity-matured version of the parent antibody COVI-GUARD (STI-1499) and IND for 1499 was signed-off by the FDA in September.As previously announced, in preclinical studies, both STI-2020 and STI-1499 demonstrated neutralizing effect and ST-1499 at a very low dose prevented SARS-CoV-2.The company has initiated manufacturing to produce 100,000 doses, expected to be available early next year, in anticipation of a potential Emergency Use authorization.
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Sorrento on go with early-stage COVID-19 antibody trial