First Patient Receives Dose in Phase 2 PYNNACLE Trial of Rezatapopt for TP53 Y220C Tumors

PMV Pharmaceuticals, a leading company in the field of precision oncology, has initiated a significant clinical trial for a novel treatment known as rezatapopt. This therapy is specifically designed for patients battling advanced solid tumors that possess a TP53 Y220C mutation and KRAS wild-type status. The PYNNACLE Phase 2 trial marks a crucial step in the development of this groundbreaking drug, which is a first-of-its-kind small molecule that targets mutated p53 Y220C proteins.

The first patient has now received a dose of rezatapopt as part of this global, registrational trial. The company's Chief Development Officer, Deepika Jalota, expressed her enthusiasm for this advancement, highlighting the importance of developing new treatment options for patients with advanced solid tumors who have a significant unmet medical need.

The PYNNACLE trial is a multi-center, single-arm study that will evaluate the efficacy of rezatapopt administered as a monotherapy at a dosage of 2000 mg once daily. The primary goal of the trial is to measure the overall response rate through a blinded independent central review. The study plans to include 114 patients across five different cohorts, and it will be conducted at approximately 60 sites in the U.S., Europe, and the Asia-Pacific region.

Rezatapopt (PC14586) is a first-in-class small molecule p53 reactivator. It is engineered to selectively bind to the p53 Y220C mutant protein, restoring its normal structure and function, which are essential for suppressing tumors. The U.S. Food and Drug Administration (FDA) has recognized the potential of this therapy by granting it Fast Track designation for the treatment of patients with locally advanced or metastatic solid tumors featuring a p53 Y220C mutation.

The ongoing Phase 1/2 PYNNACLE clinical trial is assessing the safety, tolerability, pharmacokinetics, and biomarker effects of rezatapopt in patients with advanced solid tumors that have the TP53 Y220C mutation. The Phase 2 portion of the trial is an expansion basket clinical trial that includes five cohorts and aims to evaluate the efficacy of rezatapopt at the recommended Phase 2 dose in patients with the specified genetic mutations.

PMV Pharma, with its headquarters in Princeton, New Jersey, is dedicated to pioneering the discovery and development of small molecule, tumor-agnostic therapies that target the p53 protein. Dr. Arnold Levine, a co-founder of the company, is credited with establishing the field of p53 biology after discovering the p53 protein in 1979. PMV Pharma combines deep biological knowledge with pharmaceutical development expertise to address the needs of cancer patients.