FDA clears Abivertinib for Phase 2 safety and efficacy study in hospitalized patients with moderate to severe COVID-19
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
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 Abivertinib targets multiple cytokines simultaneously, Sorrento anticipates that the effects of Abivertinib will be incremental 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 (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
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 (AEs) were grade 1 or 2, the most common of which were transaminase elevations and diarrhea, which are generally considered common for TKIs. Other common treatment-related AEs included anemia, neutropenia and thrombocytopenia, each of which are generally considered typical AEs with long-term use of TKIs. No unexpected AEs were reported.
About ACEA Therapeutics
ACEA Therapeutics is committed to developing and delivering innovative treatments to improve the lives of patients with life-threatening diseases. ACEA has expanded drug discovery efforts to encompass development in both targeted cancer therapy and immunotherapy areas. Alongside a robust R&D organization, ACEA has established drug manufacturing in
For more information visit www.aceatherapeutics.com
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ("G-MAB™ library"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T™"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir™", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on
For more information visit www.sorrentotherapeutics.com
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