Foundation Medicine and PMV Pharma Partner to Develop Companion Diagnostic for Rezatapopt
BOSTON and PRINCETON, NJ – May 29, 2024 – Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; “PMV Pharma”) today announced a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.
Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases. TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors. PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.
Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 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 TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial.
Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.
About Rezatapopt Rezatapopt (PC14586) is an investigational, first-in-class, small molecule, p53 reactivator designed to selectively bind to a pocket in the p53 Y220C mutant protein leading to the restoration of the wild-type p53 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 PMV Pharma PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus.