UPDATE – Sorrento Announces Encouraging Results From Two Phase 2 Studies of Abivertinib For Treatment Of Hospitalized Severe COVID-19 Patients

• Abivertinib is an oral capsule (100 mg QD or two 50-mg capsules a day) that potentially reduces cytokine storm associated with acute respiratory distress syndrome (ARDS) in severe hospitalized COVID-19 patients.
• Preliminary results from two completed Phase 2 studies: US study (N=96) and Brazil study (N=400) have identified an At-Risk COVID-19 Patient Population – Hospitalized COVID patients receiving oxygen support by non-invasive ventilation or high flow oxygen – which can potentially benefit from Abivertinib treatment.
• The At-Risk COVID-19 Patients show an improvement in the primary endpoint of avoiding death and respiratory failure at one month (20% improvement in the US study [78.3% vs. 58.3%] and 25% in the Brazil study [69.6% vs. 44.4%], respectively for Abivertinib vs. controls).
• The At-Risk Patients in the US study (who were a sicker population than those in the Brazilian study) were discharged on average 2 days sooner from the ICU.
• Abivertinib has the potential to fill the unmet need for the At-Risk COVID-19 Patients and significantly reduce progression to intubation, mechanical ventilation and death.

Excerpt from the Press Release:

SAN DIEGO, Oct. 27, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today positive preliminary results from two Phase 2 studies designed to identify the hospitalized patient population suffering from COVID-19-induced pneumonia and respiratory depression likely to respond to treatment with oral Abivertinib. Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) as well as Bruton’s tyrosine kinase (BTK). Abivertinib irreversibly binds to the BTK receptor, preventing the phosphorylation of the receptor. Due to this effect, it has shown potent immunomodulatory activities in vitro with potent inhibition of key pro-inflammatory cytokine production, including IL-1 beta, IL-6 and TNF-alpha. These cytokines are associated with acute respiratory distress syndrome (ARDS), and with cytokine release syndrome (CRS) or cytokine storm, and COVID-19 disease progression with poor outcomes in patients.

The US study, entitled “A Phase 2, Double Blinded, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19” (NCT04440007), recently completed enrollment (N=96 randomized 1:1). The Brazil study, entitled “A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19” also completed enrollment (N=400, randomized 3:1 active vs. placebo). Both studies were designed to assess the potential clinical benefits of Abivertinib’s ability to reduce inflammatory cytokine storm associated with COVID-19-induced respiratory depression. It was also important to identify the potential patient population most likely to respond to treatment based upon severity of COVID-19 respiratory depression at baseline. In both studies the clinical status was assessed using a 9-point (0 to 8) categorical scale, where 3=hospitalized with no oxygen therapy, 4=hospitalized with oxygen by mask or nasal cannulae, 5=non-invasive ventilation or high flow oxygen, 6=intubation and mechanical ventilation, 7=additional organ support such as extracorporeal membrane oxygenation, and 8=death.

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