Business
Onconova Therapeutics Announces Plans for a Phase 1/2a Trial of Narazaciclib Combined with Letrozole in Endometrial Cancer, Reports Third Quarter 2022 Financial Results, and Provides a Business Update
Initiation of Phase 1/2a endometrial cancer trial expected in 1Q23; preliminary data expected 4Q23 Conference call and live webcast at 4:30 p.m. ET today
About this update from Traws Pharma, Inc.
[{"type":"text","content":"Initiation of Phase 1/2a endometrial cancer trial expected in 1Q23; preliminary data expected 4Q23 Conference call and live webcast at 4:30 p.m. ET today NEWTOWN, Pa., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced plans for a Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). In addition, the Company reported its third quarter 2022 financial results and provided a business update. “Onconova’s upcoming Phase 1/2a trial has been thoughtfully designed to explore narazaciclib’s potential as a best-in-class therapy when combined with letrozole in recurrent LGEEC,” said Bhavana Pothuri, MD, Professor, Department of Obstetrics and Gynecology at NYU Grossman School of Medicine and Director, Gynecologic Oncology Research; Perlmutter Cancer Center and principal investigator of the trial. “Data from prior randomized and single-arm trials in LGEEC have validated the anti-cancer activity of letrozole combined with agents that, like narazaciclib, potently inhibit CDK 4/6. However, currently available CDK 4/6 inhibitors are hampered by limitations related to safety, tolerability, and treatment resistance. Moreover, none are currently FDA approved for endometrial cancer, creating an urgent need for improved treatment options for LGEEC patients. Clinical and preclinical data suggest narazaciclib’s differentiated inhibitory profile may allow it to address this unmet need, which is a hypothesis I look forward to evaluating with my colleagues in Onconova’s upcoming study.” Endometrioid Endometrial Cancer and the Upcoming Phase 1/2a TrialEndometrial cancer (EC) arises in the uterine lining and is the most common cancer of the female reproductive organs. Endometrioid endometrial cancer is the most common subtype of EC, accounting for approximately 75% of cases. Onconova expects to initiate a multi-center Phase 1/2a trial evaluating its multi-kinase inhibitor narazaciclib in combination with letrozole as a second- or third-line therapy for the treatment of recurrent metastatic LGEEC in 1Q23. Both narazaciclib and letrozole will be administered orally with a continuous daily dosing schedule i...