Business
PMV Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Progress Update on PYNNACLE Clinical Trial
Enrollment on track in Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced
About this update from Pmv Pharmaceuticals, Inc.
[{"type":"text","content":"Enrollment on track in Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors; more than 60% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis from Phase 2 monotherapy expected by mid-2025 Eligibility criteria in ongoing Phase 1b rezatapopt and pembrolizumab combination arm of PYNNACLE trial adjusted to align with Phase 2 TP53 Y220C and KRAS wild-type patient population Cash, cash equivalents, and marketable securities of $212.9 million as of June 30, 2024, providing expected cash runway to end of 2026 PRINCETON, N.J., Aug. 08, 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 reported financial results for the second quarter ended June 30, 2024, and provided an update on the Phase 2 monotherapy and Phase 1b combination portions of the PYNNACLE clinical trial. “We are encouraged by the pace of site activation and patient enrollment in the Phase 2 PYNNACLE trial,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “I would like to thank our team for their continued execution, and we look forward to providing an update on the PYNNACLE clinical trial next year.” PYNNACLE Phase 2 Monotherapy Update Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, 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 wild-type 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. Site activation is progressing well, with more than 60% of sites activated across the U.S., Europe, and Asia-Pacific. PMV plans to provide data from the interim analysis of the Phase 2 monotherapy portion of the PYNNACLE trial by mid-2025 and anticipates a New Drug Application (NDA) filing by the end of 2026. PYNNACLE Phase 1b Rezatapopt/Pembrolizumab Combination Update Enrollment continues in the Phase 1b combination arm of the PYNNACLE trial evaluating rez...