Sorrento Therapeutics Inc SRNE shares, which are known for being volatile, are headed higher Thursday morning.
What Happened: The San Diego, California-based biopharma said the FDA has given its nod for initiating a Phase 1 trial for COVI-GUARD, its stand-alone antibody therapy aimed at blocking viral entry into host cells, in hospitalized COVID-19 patients.
COVI-GUARD, aka STI-1499, had previously demonstrated 100% in vitro neutralizing effect against SARS-CoV-2, preventing infection of healthy cells in preclinical studies, the company said.
Sorrento also noted that the evaluation of STI-1499 in multiple strains of SARS-CoV-2 in preclinical studies showed the antibody has been 100% effective against even against the highly contagious D614G variant strain.
The highest dose of 200mg per patient planned to be used in the Phase 1 study is lower than doses currently tested by rivals for their SARS-CoV-2 targeted antibodies or antibody cocktails.
"The potentially high potency of STI-1499 antibody may allow for rapid scaling up of manufacturing operations," the company said.
Why It's Important: Sorrento's coronavirus program has been mired in controversy, with short sellers calling out the company for dubious claims. This is despite the company standing its ground and reposing faith in its program.
The FDA approval for Phase 1 study initiation should vindicate the company.
Additionally, antibody treatment against COVID-19 has emerged as the new paradigm. Several companies, including Eli Lilly And Co LLY, GlaxoSmithKline plc GSK and Regeneron Pharmaceuticals Inc REGN, have dipped their heel into this arena.
What Next: Sorrento is planning a 33-participant randomized, double-blind, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of a single dose of STI-1499 administered via a single intravenous push injection, with the doses tested being 10mg, 30 mg, 10mg and 200mg.
The estimated completion date of the trial is fixed at February 2021.
The study is being designed for rapid adaptive expansion, including international sites in Brazil to supplement the U.S. program, Sorrento said.
At last check, Sorrento shares were jumping 17% to $9.86.
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