PMV Pharma Completes Enrollment in Phase 2 PYNNACLE Trial, Plans Rezatapopt NDA for Platinum-Resistant Ovarian Cancer in Q1 2027
核心洞察
PMV Pharma completed enrollment of platinum-resistant/refractory ovarian cancer (搜索) patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE trial.
The company plans to submit a New Drug Application for accelerated approval of rezatapopt in the first quarter of 2027.
Rezatapopt is a first-in-class p53 reactivator targeting the TP53 Y220C (搜索) mutation, with Fast Track and Orphan Drug Designations from the FDA.
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company focused on small molecule therapies targeting p53, announced the completion of enrollment of platinum-resistant/refractory ovarian cancer (搜索) patients for the primary analysis in the Phase 2 monotherapy portion of its PYNNACLE clinical trial. The company also confirmed plans to submit a New Drug Application (NDA) for accelerated approval of rezatapopt for this indication in the first quarter of 2027.
"The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer (搜索) in the first quarter of 2027."
PYNNACLE Phase 2 Monotherapy Update
The multicenter, single arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C (搜索) advanced solid tumors. PMV Pharma anticipates submitting an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer (搜索) patients with a TP53 Y220C mutation in the first quarter of 2027.
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C (搜索) mutation. The primary objective of the Phase 1 portion was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally. Safety, tolerability, pharmacokinetics, and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts — ovarian, lung, breast, and endometrial cancers, and other solid tumors — with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites. The trial is registered at www.clinicaltrials.gov under NCT identifier NCT04585750.
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 tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation, as well as Orphan Drug Designation for the treatment of TP53 Y220C (搜索) positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
TP53 mutations are found in approximately half of all cancers. PMV Pharma's co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979.
Second Quarter 2026 Financial Results
PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025.
Net loss for the quarter ended June 30, 2026, was $18.1 million, compared to $21.2 million for the quarter ended June 30, 2025. The decrease was primarily due to decreased contract research organization costs and reduced finance support costs. Research and development (R&D) expenses were $14.7 million for the quarter, compared to $18.4 million in the prior-year period, reflecting decreased contract research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.2 million, compared to $4.5 million in the prior-year period, primarily due to reduced personnel expenses and a decrease in finance support costs.