Benzinga | Aug 2, 2021 07:31AM EDT

Zentalis Pharmaceuticals Announces First Patient Dosed in Potentially Registrational Phase 2 Study of ZN-c3 in Patients with Uterine Serous Carcinoma

Zentalis Pharmaceuticals, Inc. (NASDAQ:ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the first patient has been dosed in the Phase 2 trial of ZN-c3, the Company's oral WEE1 inhibitor product candidate, in adult women with recurrent or persistent uterine serous carcinoma (USC). Following an end-of-Phase 1 meeting, the U.S. Food and Drug Administration agreed in principle that ZN-c3 has the potential for an accelerated approval pathway based on the Phase 2 global study design in USC.

"This trial, with its potential accelerated approval pathway, underscores our potential ability to efficiently develop and advance promising therapeutic candidates in hopes of delivering them to patients quickly," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "Dosing the first patient in this Phase 2 trial is an important next step toward our goal of developing a safe and effective therapy for the thousands of women in the U.S. diagnosed with USC annually. Despite current treatment options, USC -- a highly aggressive form of endometrial cancer -- has an extremely poor prognosis, with survival rates ranging between 30-50%. We believe that our potentially first- and best-in-class oral WEE1 inhibitor, ZN-c3, represents one of the most promising clinical advances in DNA damage response and synthetic lethality to date, and if successfully developed and approved, has the potential to redefine the USC treatment landscape."

The Phase 2 trial (ZN-c3-004) is an open-label, multicenter study evaluating the clinical activity, safety, pharmacokinetics, and related biomarkers of ZN-c3 in patients with recurrent or persistent USC. The primary efficacy endpoint is a measure of the antitumor activity of ZN-c3 based on the objective response rate as defined by RECIST criteria. Secondary endpoints include duration of response and progression-free survival. More information about the trial is available at www.clinicaltrials.gov: NCT04814108.