PMV Pharmaceuticals Announces First Patient Dosed in Global Tumor-Agnostic Phase 2 PYNNACLE Trial for Rezatapopt in TP53 Y220C-Positive Solid Tumors

• Rezatapopt is a first-in-class precision oncology investigational therapy for patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type (WT)
• First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS WT advanced solid tumors
  

PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that the first patient has been dosed in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of rezatapopt (PC14586) in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type (WT). Rezatapopt is a first-in-class precision oncology small molecule investigational therapy that selectively targets mutated p53 Y220C proteins in solid tumors.

“Building upon our promising Phase 1 data, we are pleased to announce the dosing of our first patient in the global Phase 2 PYNNACLE trial of rezatapopt as a monotherapy in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type,” said Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma. “This pivotal trial is a testament to PMV’s commitment to developing new treatment options for patients with advanced solid tumors with a significant unmet medical need.”

The multi-center, single-arm, registrational, tumor-agnostic Phase 2 trial will assess rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS WT advanced solid tumors. The primary endpoint of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites across the U.S., Europe, and Asia-Pacific.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.