Sorrento Therapeutics Inc. (NASDAQ: SRNE) shares jumped on Thursday after the company announced that it received approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 treatment.
The long and short of it was that the FDA issued a letter to Sorrento that it may proceed with its Phase 1 clinical trial for Covi-Guard (STI-1499) in hospitalized COVID-19 patients.
As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in such preclinical in vitro studies.
Separately, STI-1499 was further evaluated using multiple strains of SARS-CoV-2, including the highly contagious D614G variant. In these preclinical studies, the antibody has been 100% effective against the highly contagious D614G variant strain at similar doses to those observed in experiments with the USA-WA1/2020 strain.
At the same time, animal data generated in Syrian Golden hamsters infected with SARS-CoV-2 was presented to the FDA in support of a post-exposure human treatment dose for the IND.
The highest proposed dose (200 mg per patient) in the Phase 1 trial is a lower dose than currently being tested for other known SARS-CoV-2 targeted antibodies or antibody cocktails in active clinical studies. The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations.
Sorrento Therapeutics stock traded up about 19% on Thursday, at $9.95 in a 52-week range of $1.39 to $19.39. The consensus price target is $24.00.