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PMV Pharma Granted FDA Fast Track Designation of PC14586 for the Treatment of Advanced Cancer Patients that have Tumors with a p53 Y220C Mutation
CRANBURY, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc., (Nasdaq: PMVP) a precision oncology company pioneering the discovery and
About this update from Pmv Pharmaceuticals, Inc.
[{"type":"text","content":"CRANBURY, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc., (Nasdaq: PMVP) a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutations, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate PC14586, for the treatment of cancer patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. There are currently no FDA-approved medicines that target the p53 Y220C mutation.\n p53 plays a pivotal role in cellular function by preserving the integrity of DNA and preventing abnormal cells from entering or progressing through the cell cycle. Mutant p53 takes on oncogenic properties that endow cancer cells with a growth advantage and resistance to anti-cancer therapy. Mutant p53 proteins are very common and are found in approximately half of all human cancers. The p53 Y220C mutation is associated with many cancers including but not limited to breast, non-small cell lung cancer, colorectal, pancreatic and ovarian cancers. PC14586 is a first-in-class small molecule designed to structurally correct the p53 Y220C mutant protein. “Fast Track designation reflects the recognition by the FDA that PC14586 has the potential to address a significant unmet medical need for advanced cancer patients with a p53 Y220C mutation,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “While targeted therapies have improved outcomes for many patients with advanced cancers, those with tumors carrying a p53 mutation do not yet have precision treatment options for these mutations and often have poor outcomes. We look forward to working closely with the FDA as we advance PC14586 through the clinic as part of our mission to discover and develop novel, tumor-agnostic, precision oncology therapies.” PMV Pharma plans to conduct a Phase 1/2 open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, and anti-tumor activity of PC14586 in adult patients with a p53 Y220C mutation in locally advanced or metastatic solid tumors. Phase 1 is a first-in-human, open-label, dose-escalation study designed to up to 30 patients with solid tumors that have a p53 Y220C mutation using next-generation sequencing. Phase 2 is an open-label study...