NEW YORK – Roche subsidiary Foundation Medicine said Wednesday that it has partnered with PMV Pharmaceuticals to develop the tissue-based FoundationOne CDx assay as a companion diagnostic for PMV's investigational solid tumor therapy rezatapopt.
Rezatapopt is designed for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation. The orally available small molecule is intended to reactivate the p53 function in patients harboring the mutation by binding to a pocket in the mutant protein, the companies said in a statement.
The mutation "creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA," the firms noted. By selectively binding to the pocket, rezatapopt restores the tumor suppressor function of wild-type p53. If the drug and test are approved by the US Food and Drug Administration, FoundationOne CDx would be used to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.
"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," Troy Schurr, Foundation Medicine's chief biopharma business officer, said in a statement. "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 test that detects substitutions, insertions and deletions, and copy number alterations in 324 genes, along with select gene rearrangements. It also detects genomic signatures such as microsatellite instability and tumor mutational burden from formalin-fixed, paraffin-embedded tumor tissue samples.