NEW YORK – Roche subsidiary Foundation Medicine said Wednesday that it has partnered with Syndax Pharmaceuticals to develop a companion diagnostic based on the FoundationOne Heme platform for a leukemia drug under development by Syndax.
The assay will identify acute myeloid leukemia (AML) patients with an NPM1 mutation, and Syndax will support Foundation's efforts to gain regulatory approval for the test. There are currently no targeted treatments approved for patients with NPM1-mutated AML, but menin inhibitors are a potential targeted therapy option. Syndax is currently developing revumenib, a small molecule inhibitor of the menin-KMT2A binding interaction, for various leukemia types including AML.
A new drug application for revumenib is under review by the US Food and Drug Administration for the treatment of adult and pediatric R/R KMT2A-rearranged acute leukemia, Foundation said.
"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," Troy Schurr, Foundation's chief biopharma officer, said in a statement. "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."
FoundationOne Heme uses both RNA and DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations, chromosomal rearrangements, and gene fusions.
If approved, the test could be the first next-generation sequencing-based companion diagnostic to detect genomic alterations in hematologic neoplasms, Foundation added.