Sorrento Therapeutics, Inc. (NASDAQ:SRNE, &ldquo, Sorrento&rdquo, )) and ACEA Therapeutics, Inc. (“ACEA”) have entered into a binding term sheet for an exclusive license to ACEA’s Abivertinib across all indications for all territories outside of China. The final terms of the license will be set forth in a definitive agreement to be entered into between the parties.
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).
More than 600 patients have been treated with Abivertinib at different oral doses up to 300 mg bid in multiple trials through registration trial (NCT03856697) in patients with non-small cell lung cancer (NSCLC) and B cell malignancies (Phase 1) conducted in China. Favorable safety, tolerability and efficacy in patients with NSCLC or relapsed/refractory B-cell malignancies were demonstrated in separate studies.
At the American Society of Clinical Oncology (ASCO) meeting in 2019, the results of an interim analysis of 209 response-evaluable patients (n=227 total) with NSCLC was presented. Of the 209 patients, the investigators determined that 90% (188/209) had tumor size reduction, with 52% of the patients (109/209) demonstrating a confirmed partial response, 5% (11/209) of the patients demonstrating an unconfirmed partial response, 30% of the patients (64/209) demonstrating stable disease and 12% of the patients (25/209) demonstrating progressive disease. The progression free survival (Kaplan-Meier) was 7.5 months at the time. An estimate of the median overall survival was 25 months at the time of the presentation with the study still ongoing. All patients (n=227) experienced at least one adverse event (AE). Grade 3/4 (in severity) AEs were reported in 46% of the patients (104/227), of which treatment related grade 3/4 AEs were reported in 30% of the patients (67/227). None of the grade 5 AEs (4%, 9/227) were deemed treatment-related. 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.
Promptly following the execution of the definitive license agreement, Sorrento expects to meet with the FDA to discuss the data and the path forward to seek approval for oncologic indications.