Bazis Pharmaceuticals Updates Rezatapopt Clinical Trial Timeline, Plans NDA Submission

Bazis Pharmaceuticals is a biotechnology company developing rezatapopt, a potential treatment for platinum-resistant or refractory ovarian cancer. The company plans to submit a new drug application (NDA) to the FDA and is conducting a Phase 2 clinical trial, PYNNACLE, to evaluate the safety and efficacy of rezatapopt. The company expects to disclose clinical data updates from the trial and is targeting initial FDA approval for the indication.

PMV Pharmaceuticals (NASDAQ: PMVP) has announced interim data from its Phase 2 PYNNACLE trial, showcasing the potential of rezatapopt as a treatment for platinum-resistant or refractory ovarian cancer. The trial evaluated rezatapopt in patients with TP53 Y220C-mutated advanced solid tumors, yielding a 33% overall response rate (ORR) across 97 evaluable patients PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

The interim data highlight a 43% ORR in ovarian cancer patients, with a median duration of response of 7.6 months. This is particularly notable given that these patients had received a median of three prior treatment lines, demonstrating rezatapopt's potential for durable benefits. The safety profile was manageable, with predominantly Grade 1-2 adverse events and a low 3.7% discontinuation rate PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

The Phase 2 trial is a single-arm, expansion basket study comprising five cohorts, including ovarian, lung, breast, endometrial cancers, and other solid tumors. The primary objective is to evaluate rezatapopt's efficacy at the recommended Phase 2 dose (RP2D) in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The company plans to enroll an additional 20-25 platinum-resistant/refractory ovarian cancer patients and submit a New Drug Application (NDA) in Q1 2027 PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

The interim results position rezatapopt as a potentially first-in-class p53-targeting therapy with promising clinical validation. The observed efficacy across eight tumor types suggests a substantial addressable market beyond just ovarian cancer. The 33% overall response rate provides proof-of-concept for PMV's precision oncology approach, and the 43% response rate in ovarian cancer represents a compelling potential first approval pathway PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

The company's regulatory pathway appears clear, with the FDA providing feedback on the NDA submission strategy targeting platinum-resistant/refractory ovarian cancer, a population with significant unmet need. The median duration of response of 6.2 months across heavily pretreated patients suggests meaningful clinical benefit. The improvement in gastrointestinal tolerability with food administration represents a practical enhancement from Phase 1 PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

From an investment perspective, several metrics stand out. The 33% overall response rate, 43% response rate in ovarian cancer, and 60% response rate in endometrial cancer signal promising indications. The clear regulatory guidance from the FDA provides a defined pathway to market. The company's focused approach in a high unmet need population could potentially lead to an accelerated approval PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

PMV Pharmaceuticals is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The company's co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. PMV Pharma combines unique biological understanding with a pharmaceutical development focus, headquartered in Princeton, New Jersey PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

PMV Pharmaceuticals will host an investor webinar today at 8:00 AM ET to review the PYNNACLE Phase 2 interim data and provide a regulatory update. The event will feature presentations by PMV Pharma management and Ramez N. Eskander, M.D., Professor of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Diego. For more information, visit [www.pmvpharma.com](http://www.pmvpharma.com) PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

Forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties, including the Company's clinical development activities, plans and projected timelines for rezatapopt, and the overall timing and success of the Company's current and future clinical trials for rezatapopt PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].