On May 9, 2024 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, PMV Pharma, MAY 9, 2024, View Source [SID1234643013]).
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"Dosing the first patient in the registrational, tumor-agnostic Phase 2 portion of the PYNNACLE trial is an important milestone for PMV. Our team has worked diligently to initiate this global trial and I would like to thank them for their efforts," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "Rezatapopt offers the potential to provide a new treatment option for patients with a TP53 Y220C mutation and KRAS wild-type advanced solid tumors."
Corporate Highlights:
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First patient dosed in Phase 2 portion of the PYNNACLE trial. 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 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 across the U.S., Europe, and Asia-Pacific.
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Phase 1 data of rezatapopt in advanced ovarian cancer was featured in a late-breaking oral presentation at the 2024 SGO Annual Meeting on Women’s Cancer. Of the 15 heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation, seven patients achieved a confirmed partial response with a seven-month median duration of response and a favorable safety profile.
First Quarter 2024 Financial Results
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PMV Pharma ended the first quarter with $213.1 million in cash, cash equivalents, and marketable securities, compared to $228.6 million as of December 31, 2023. Net cash used in operations was $16.2 million for the three months ended March 31, 2024, compared to $15.0 million for the three months ended March 31, 2023.
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Net loss for the quarter ended March 31, 2024, was $15.3 million compared to $19.1 million for the quarter ended March 31, 2023.
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Research and development (R&D) expenses were $13.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023. The decrease in R&D expenses was primarily related to decreased contractual research organization costs, offset by increased personnel related costs and stock-based compensation.
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General and administrative (G&A) expenses were $5.0 million for the quarter ended March 31, 2024, compared to $6.4 million for the quarter ended March 31, 2023. The decrease in G&A expenses was primarily due to reduced spend for facility and operational expenses.
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 (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.
About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. 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 and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).