Foundation Medicine Partners with Syndax to Develop a Companion Diagnostic in Hematology and Support Efforts to Pursue Regulatory Approval for an Assay Based on the FoundationOne®Heme Platform

Original from: business wire

Foundation Medicine, Inc. today announced a collaboration with Syndax Pharmaceuticals (Nasdaq: SNDX) to develop a companion diagnostic for the identification of acute myeloid leukemia (AML) patients harboring an NPM1 mutation. As part of the collaboration, Syndax will also support Foundation Medicine’s efforts to pursue regulatory approval of an assay based on the FoundationOne®Heme platform.

NPM1 mutations are unique to AML patients and are the most frequently found genetic alteration at approximately 30% of newly diagnosed AML. There are currently no targeted treatments approved for patients with NPM1-mutated AML, and the 5-year overall survival for patients with NPM1-mutated AML is approximately 50%. Menin inhibitors such as revumenib, currently under development by Syndax, are emerging as a promising targeted therapy option for NPM1-mutated AML. To date, only six biomarkers associated with hematologic malignancies have approved targeted therapies, but more than 40 additional biomarkers are being studied in hematology clinical trials.

“Blood cancers have a devastating impact on the lives of so many patients and their families,” said Ashley Yocum, PhD, Executive Research Lead at The Leukemia & Lymphoma Society. “Thanks to advancements in comprehensive genomic profiling, and decades of scientific research for new treatments, we are seeing a paradigm shift in how many types of blood cancer are diagnosed and treated, allowing more patients to benefit from the promise of precision medicine with access to more personalized treatment options.”

If approved, the assay could be the first next-generation sequencing companion diagnostic to detect genomic alterations in hematologic neoplasms, including enhancing the identification of patients with NPM1 mutations who may be eligible for revumenib.

“As the number of biomarkers with targeted therapies in hematologic malignancies reaches a critical inflection point, it is essential for physicians to have access to high-quality tests to make informed treatment decisions for their patients,” said Troy Schurr, Chief Biopharma Officer at Foundation Medicine. “We are incredibly excited to work with Syndax to advance the FoundationOne Heme platform as a companion diagnostic, a potential first for the FoundationOne Heme platform, and if approved, help patients with AML access this potential therapy.”

Foundation Medicine’s portfolio of FDA-approved diagnostic tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. Foundation Medicine is the global leader in companion diagnostic approvals, with approximately 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.

Source: Foundation Medicine Partners with Syndax to Develop a Companion Diagnostic in Hematology and Support Efforts to Pursue Regulatory Approval for an Assay Based on the FoundationOne®Heme Platform