Healthcare Business

Why This FDA Clearance Is a Big Deal For Sorrento Therapeutics

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) stock jumped on Monday after the company announced that the U.S. Food and Drug Administration (FDA) had cleared its Phase 2 study in hospitalized patients with moderate to severe COVID-19.

The study will be focused on the safety and efficacy of once-weekly injections of STI-5656 (abivertinib maleate) in hospitalized COVID-19 patients who have a high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).

Back in May, Sorrento announced that it had entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ Abivertinib across all indications for all territories outside of China. The parties have since entered into an exclusive license agreement.

Essentially, abivertinib works to inhibit pro-inflamatory cytokine production. These cytokines are associated with cytokine release syndrome (CRS) or cytokine storm and COVID-19 disease progression with poor outcomes in patients with ARDS.

Because abivertinib targets multiple cytokines simultaneously, Sorrento expects that the effects of Abivertinib will be incremental to the initial published findings by others and that the clinical benefits will be more pronounced given the broader range of anti-cytokine activity.

So far, abivertinib has been studied in over 600 patients worldwide in various oncologic indications, including one registration trial in non-small cell lung cancer.

Most treatment-related adverse events observed were grade 1 or 2. Other common treatment-related adverse included anemia, neutropenia and thrombocytopenia, each of which are generally considered typical with long-term use of tyrosine kinase inhibitors. No unexpected adverse effects were reported.

Sorrento stock was last seen up about 17% at $8.13, with a 52-week range of $1.39 to $10.00. The consensus analyst price target is $23.00.