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

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.¹ There are currently no targeted treatments approved for patients with NPM1-mutated AML,² and the 5-year overall survival for patients with NPM1-mutated AML is approximately 50%.³ Menin inhibitors such as revumenib, currently under development by Syndax, are emerging as a promising targeted therapy option for NPM1-mutated AML.¹ To date, only six biomarkers associated with hematologic malignancies have approved targeted therapies,⁴ but more than 40 additional biomarkers are being studied in hematology clinical trials.⁵

“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.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.

About FoundationOne^®Heme

FoundationOne^®Heme is a laboratory developed test that was developed and its performance characteristics determined by Foundation Medicine. FoundationOne Heme has not been cleared or approved by the U.S. Food and Drug Administration. For more information on FoundationOne Heme, please see its Technical Specifications at foundationmedicine.com/heme.

The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions.

About Revumenib

Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed by Syndax Pharmaceuticals for the treatment of KMT2A-rearranged (KMT2Ar), also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and mutant nucleophosmin (mNPM1) AML. Revumenib was granted Orphan Drug Designation for the treatment of AML, ALL and MPAL by the FDA and for the treatment of AML by the European Commission, and Fast Track designation by the FDA and is currently under review for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. A New Drug Application (NDA) for revumenib for the treatment of adult and pediatric R/R KMT2Ar acute leukemia is currently under review by the U.S. FDA with a PDUFA action date of December 26, 2024.

¹ Swaminathan M, Bourgeois W, Armstrong SA, Wang ES. Menin inhibitors in acute myeloid leukemia—What does the future hold?. The Cancer J. 2022;28(1):62-66. https://doi.org/10.1097/PPO.0000000000000571

² Ranieri R, Pianigiani G, Sciabolacci S, et al. Current status and future perspectives in targeted therapy of NPM1-mutated AML. Leukemia. 2022;36(10):2351-2367. https://doi.org/10.1038/s41375-022-01666-2

³ Angenendt L, Röllig C, Montesinos P, et al. Chromosomal abnormalities and prognosis in NPM1-mutated acute myeloid leukemia: A pooled analysis of individual patient data from nine international cohorts. J Clin Oncol. 2019;37(29):2632-2642. https://doi.org/10.1200/JCO.19.00416

⁴ List of Cleared or Approved Companion Diagnostic Devices. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.

⁵ Multiple secondary sources used to cross validate information, including Trialtrove, clinicatrials.gov, EudraCT, ChiCTR; FDA approval timeline estimation based on Ph3 PCD + 8 months review; analysis based on current Phase 1/2, Phase 2 and Phase 3 trials with inclusion criteria requiring patient selection based on alterations to specific biomarkers.

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