BOSTON - Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP) have announced a partnership to develop a genomic profiling test as a companion diagnostic for an investigational cancer therapy, rezatapopt, targeting a specific mutation found in various solid tumors.
The collaboration aims to leverage Foundation Medicine’s comprehensive genomic profiling test, FoundationOne®CDx, to identify patients with TP53 Y220C mutations eligible for rezatapopt treatment.
TP53, the most frequently altered gene in human cancers, is mutated in about 50% of all cancer cases. The TP53 Y220C mutation, which occurs in roughly 1% of solid tumors, has historically been considered challenging to target therapeutically. PMV Pharma’s rezatapopt is a small molecule designed to reactivate p53 function in advanced cancer patients with this mutation.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors carrying the TP53 Y220C mutation. The therapy is currently being evaluated in the PYNNACLE Phase 2 clinical trial.
If approved, FoundationOne CDx would be the first companion diagnostic for identifying patients with the TP53 Y220C mutations potentially benefiting from rezatapopt. Foundation Medicine’s test is a next-generation sequencing-based in vitro diagnostic device that detects genetic alterations in 324 genes and genomic signatures such as microsatellite instability (MSI) and tumor mutational burden (TMB) from tumor tissue specimens.
Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine, expressed pride in providing their genomic test and real-world data to support the development of PMV Pharma’s treatment option in an area of high unmet medical need.
PMV Pharma is a precision oncology company focused on discovering and developing small molecule therapies targeting p53, a protein pivotal in tumor suppression. The partnership with Foundation Medicine represents a significant step toward addressing the therapeutic challenges associated with TP53 mutations.
This news is based on a press release statement from PMV Pharmaceuticals, Inc.
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