Business
PMV Pharmaceuticals Reports Second Quarter 2023 Financial Results and Corporate Highlights
Continued progress in ongoing Phase 1/2 PYNNACLE study of PC14586, a first-in-class precision oncology investigational therapy in patients with advanced solid
About this update from Pmv Pharmaceuticals, Inc.
[{"type":"text","content":"Continued progress in ongoing Phase 1/2 PYNNACLE study of PC14586, a first-in-class precision oncology investigational therapy in patients with advanced solid tumors with a p53 Y220C mutation; updated Phase 1 data expected in 2H 2023Concluded successful End-of-Phase 1 FDA meeting with alignment on recommended Phase 2 dose and key elements of single arm, Phase 2 registrational portion of PYNNACLE studyOngoing enrollment in combination arm of PYNNACLE study with PC14586 and KEYTRUDA® (pembrolizumab)Appointed Dr. Masha Poyurovsky as Vice President of Biology PRINCETON, N.J., Aug. 09, 2023 (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 reported financial results for the second quarter ended June 30, 2023, and provided a corporate update. PMV recently concluded an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) focused on gaining alignment with the Agency regarding the clinical and regulatory pathway for developing PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. Alignment with the FDA was obtained on the recommended Phase 2 dose as well as key elements of the Phase 2 registrational portion of the PYNNACLE trial. PMV plans to initiate the single arm, Phase 2 portion of the PYNNACLE study in early 2024. “Our ongoing PYNNACLE study of PC14586 in patients with advanced solid tumors continues to make good progress,” said David Mack, Ph.D., President and Chief Executive Officer. “The positive outcome of our recently held End-of-Phase 1 meeting positions us to initiate a registrational trial for PC14586 and is an important milestone in our goal of bringing PC14586 to advanced cancer patients with a p53 Y220C mutation. Furthermore, we look forward to sharing updated Phase 1 data in the second half of the year.” Dr. Mack added, “We are also very pleased to welcome Dr. Masha Poyurovsky to PMV as Vice President of Biology. Her scientific expertise in p53 biology and proven track record in translational drug development make her the ideal candidate to lead our biology team. I look forward to Masha’s leadership and contributions as we continue to leverage the potential of p53 targeted therapies.” Second Qu...