FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients With Moderate to Severe COVID-19

SAN DIEGO, July 17, 2020 — ACEA Therapeutics, Inc. today announced that on July 16, 2020, the FDA cleared the IND to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms. The Trial, 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 USA.

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). ACEA announced an exclusive license of abibvertinib to Sorrento across all indications outside of China on 21MAY2020. ACEA will continue developing abivertinib all indications in China.

Abivertinib irreversibly binds to the BTK receptor, preventing the phosphorylation of the receptor.  Due to this effect, it has shown potent immunomodulatory activities by inhibiting key pro-inflammatory cytokine production, including IL-1beta, IL-6 and TNF-alpha. These cytokines are associated with COVID disease progression and poor outcomes in patients with acute respiratory distress syndrome (ARDS).

Since abivertinib targets multiple cytokines simultaneously, we anticipate the effects with Abivertinib will be incremental to the initial findings of others which primarily reduce IL-6, and the clinical benefits more pronounced given the broader range of anti-cytokine activity.

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 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, and all 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 China to support its long-term growth. This infrastructure provides ACEA greater control over drug supply chain to make sure products are delivered to patients on-time and at the highest quality. ACEA is well positioned to deliver on its promise to bring innovative treatments to patients living with life-threatening diseases while creating value for shareholders, employees, and society.

For more information visit aceathera.wpengine.com

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir®”).  Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MABTM, COVI-MABTM, COVI-GUARDTM, COVI-SHIELDTM and COVI-KILLERTM. 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 February 28, 2018.

For more information visit www.sorrentotherapeutics.com