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FUJOVEE (Abivertinib) (Cytokine Storm – STI 5656)

FUJOVEE (Abivertinib) is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK).  On May 21, 2020, Sorrento announced that it had entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ FUJOVEE (Abivertinib) across all indications for all territories outside of China.  The parties have since entered into an exclusive license agreement.

FUJOVEE (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 by inhibiting key pro-inflammatory cytokine production, including IL-1beta, IL-6 and TNF-alpha. These cytokines are associated with cytokine release syndrome (CRS) or cytokine storm and COVID-19 disease progression with poor outcomes in patients with acute respiratory distress syndrome (ARDS).

Since FUJOVEE (Abivertinib) targets multiple cytokines simultaneously, Sorrento anticipates that the effects of FUJOVEE (Abivertinib) will potentially superior to the initial published findings by others for IL-6 inhibitors targeted for COVID-19 trials, and the clinical benefits will be more pronounced given the broader range of anti-cytokine activity.

The trial, titled A Phase 2, Double Blinded, Randomized Study of the Efficacy and Safety of STI-5656 (FUJOVEE (Abivertinib) Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19 (NCT04440007), will be initially conducted in centers in the USA.