Sorrento Gets FDA Nod for Phase I Study on Coronavirus Antibody

Sorrento Therapeutics, Inc. SRNE announced that it has received a clearance from the FDA to begin the phase I study on its proprietary antibody candidate STI-1499 (COVI-GUARD) for the treatment of hospitalized COVID-19 patients.

Per the company, this study will enroll patients rapidly, which will lay out a path for a larger study, data from which can be used for potential Emergency Use Authorization (EUA) filing before the end of this year. Sorrento already started cGMP manufacturing to deliver 50,000 doses of STI-1499 in anticipation of a potential EUA, if approved.

Notably, STI-1499 demonstrated 100% in vitro neutralizing effect against SARS-CoV-2 while preventing infection of healthy cells in pre-clinical in-vitro studies. Moreover, the antibody developed by the candidate has been 100% effective against the highly contagious strain of SARS-CoV-2, namely the D614G variant, in preclinical studies.

Shares of Sorrento were up 13.4% following the above announcement on Thursday. In fact, the stock has skyrocketed 180.4% so far this year compared with the industry’s increase of 2.9%.

Currently, there are no FDA-approved treatments for this severe illness caused by SARS-CoV-2. The pharma/biotech sector is racing against time to come up with treatments and vaccines to cure the contagion. Given the alarming levels of the spread and severity of the pandemic, quite a few biotechs are developing antibodies, which can treat COVID-19.

Regeneron REGN initiated studies on its novel investigational antibody "cocktail" treatment, REGN-COV2, which is designed to prevent and treat the SARS-CoV-2 virus. REGN-COV2 is currently being studied in two phase II/III studies for the treatment of COVID-19 and in a phase III study for the prevention of COVID-19 in household contacts of infected individuals.

Eli Lilly LLY is also making rigorous efforts to develop several potential neutralizing antibodies for the treatment of COVID-19. The company is developing an antibody therapy candidate LYCoV555 in mid-stage studies in collaboration with AbCellera.

Lilly also has a separate collaboration with China-based Junshi Biosciences to co-develop therapeutic antibodies for COVID-19. The companies completed dosing in a phase I study on LY-CoV016, the lead antibody from the alliance.

Meanwhile, Vir Biotechnology’s VIR investigational monoclonal antibody VIR-7831 entered the phase II/III study in August for the early treatment of COVID-19 patients who are at high risk of hospitalization. A phase II study on another monoclonal antibody VIR-7832 is expected to begin shortly.

Zacks Rank

Sorrento currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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