On August 9, 2023 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 second quarter ended June 30, 2023, and provided a corporate update (Press release, PMV Pharma, AUG 9, 2023, View Source [SID1234634088]).
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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 Quarter 2023 and Recent Corporate Highlights:
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Ongoing enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA (pembrolizumab). PMV and Merck entered into a collaboration in 2022 under the terms of which Merck will supply KEYTRUDA for this study.
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Appointed Masha Poyurovsky, Ph.D., as Vice President of Biology. Dr. Poyurovsky has more than a decade of experience leading novel platforms and a track record of advancing therapies from concept to the clinic. From 2011 to 2023, she was employed at Kadmon (acquired by Sanofi in 2021) most recently as Vice President, Discovery Biology. Prior to working in industry, she was a Research Scientist and a Postdoctoral Research Fellow at Columbia University where she conducted studies on p53 in the laboratory of Professor Carol Prives. She is the author and co-author of numerous publications and patents in the area of cancer biology and drug discovery. Dr. Poyurovsky obtained a
doctorate in biochemistry from Columbia University and a bachelor of science in biochemistry and biophysics from the University of Pittsburgh.
Second Quarter 2023 Financial Results
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PMV Pharma ended the second quarter with $218.8 million in cash, cash equivalents, and marketable securities, compared to $277.4 million as of June 30, 2022. Net cash used in operations was $27.9 million for the six months ended June 30, 2023, compared to $31.7 million for the six months ended June 30, 2022.
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Net loss for the six months ended June 30, 2023, was $36.6 million compared to $35.7 million for the six months ended June 30, 2022.
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Research and development (R&D) expenses were $28.9 million for the six months ended June 30, 2023, compared to $23.3 million for the six months ended June 30, 2022. The increase in R&D expenses was primarily related to increased headcount and clinical expenses to advance research on PC14586, the Company’s lead drug candidate.
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General and administrative (G&A) expenses were $12.7 million for the six months ended June 30, 2023, compared to $13.2 million for the six months ended June 30, 2022. The decrease in G&A expenses was primarily due to facility related costs now allocated to research as our new laboratory building in Princeton, New Jersey began operations.
KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).