Core Insights - Foundation Medicine and PMV Pharmaceuticals have partnered to develop FoundationOne®CDx as a companion diagnostic for PMV Pharma's investigational therapy rezatapopt, targeting patients with locally advanced or metastatic solid tumors having a TP53 Y220C mutation [1][4]. Company Overview - Foundation Medicine is a pioneer in molecular profiling for cancer, focusing on improving clinical care and research through collaborations across the cancer community [6]. - PMV Pharma specializes in precision oncology, developing small molecule therapies targeting p53 mutations, which are prevalent in approximately 50% of all cancers [9]. Product Details - FoundationOne®CDx is a next-generation sequencing-based diagnostic tool that detects genomic alterations in 324 genes, intended to guide personalized treatment decisions [7]. - Rezatapopt (PC14586) is a first-in-class small molecule designed to reactivate p53 function in patients with the TP53 Y220C mutation, which is thermally unstable and unable to effectively interact with DNA [2][8]. Clinical Development - The FDA has granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and it is currently undergoing the registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial [3][8].
Foundation Medicine and PMV Pharma Announce Collaboration to Develop Companion Diagnostic for Rezatapopt, a First-In-Class, Investigational, Selective p53 Y220C Reactivator