On May 29, 2024 Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; "PMV Pharma") reported a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, 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 (Press release, Foundation Medicine, MAY 29, 2024, View Source [SID1234643833]).
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Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.1 Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.2 TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.3 PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.
"The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option."
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. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
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.