Foundation Medicine and PMV Pharma Partner to Develop Rezatapopt Companion Diagnostic

BOSTON and PRINCETON, N.J., May 29, 2024 — Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; "PMV Pharma") have announced a collaboration to create a tissue-based genomic profiling test to be used as a companion diagnostic for PMV Pharma's innovative treatment, rezatapopt. This investigational therapy targets patients suffering from locally advanced or metastatic solid tumors with the TP53 Y220C mutation.

TP53 is the most frequently altered gene found in approximately 50% of all cancer cases, making it a significant focus for cancer research. Historically, TP53 mutations have been challenging to target therapeutically, despite their prevalence. Among these mutations, TP53 Y220C is notably common, occurring in about 1% of all solid tumors.

The investigational therapy, rezatapopt (PC14586), is a small molecule designed to reactivate p53 function in cancer patients with the TP53 Y220C mutation. This specific mutation results in a thermally unstable p53 protein that fails to interact properly with DNA. Rezatapopt aims to stabilize the p53 Y220C protein by binding to a unique pocket created by the mutation, thereby restoring its tumor-suppressing function. This therapy has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treating patients with advanced or metastatic solid tumors harboring the TP53 Y220C mutation. The ongoing PYNNACLE Phase 2 clinical trial is evaluating its efficacy.

Foundation Medicine's portfolio includes FDA-approved comprehensive genomic profiling tests, providing both blood- and tissue-based testing options to help guide personalized treatment decisions. If approved, FoundationOne CDx could become the first companion diagnostic test to identify patients with the TP53 Y220C mutation who may benefit from rezatapopt.

Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine, emphasized the collaboration's significance: "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. 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."

FoundationOne®CDx is a next-generation sequencing-based in vitro diagnostic device designed to detect various genetic alterations, including substitutions, insertions, deletions, copy number alterations, and certain gene rearrangements. Additionally, it assesses genomic signatures like microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. It is prescribed to identify patients who may benefit from targeted therapies.

PMV Pharma is a precision oncology company focused on discovering and developing small molecule therapies that target p53, a protein involved in tumor suppression. Established by Dr. Arnold Levine, a pioneer in p53 biology, PMV Pharma leverages decades of research to create tumor-agnostic treatments. Based in Princeton, New Jersey, the company aims to revolutionize cancer treatment by addressing the most common genetic mutations found in cancer.

Foundation Medicine continues to be a leader in molecular profiling for cancer, collaborating across the cancer care community to advance clinical care and research. Their comprehensive understanding of cancer biology aids physicians in making informed treatment decisions and empowers researchers to develop new therapies.

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