Foundation Medicine, Inc., a genomics company committed to transforming cancer care, today announced a collaboration with Sumitomo Pharma America, Inc. (SMPA) to develop the FoundationOne®Heme platform as a companion diagnostic to identify patients with acute leukemia with a KMT2A rearrangement, also known as mixed lineage leukemia (MLL) rearrangement, or NPM1 mutations for potential treatment with SMPA’s enzomenib (DSP-5336), an investigational menin inhibitor.
Acute leukemia requires immediate treatment as the blood cells multiply rapidly, leading to a sudden onset of symptoms.1 Approximately 30% of acute myeloid leukemia (AML) patients have NPM1 mutations, 2 and 5-10% of AML patients have KMT2A (MLL) rearrangements.3
Menin inhibitors are emerging as a promising targeted therapy option for acute leukemia with KMT2A (MLL) rearrangements or NPM1 mutations.4 Menin is a protein that interacts with the KMT2A gene, playing a crucial role in regulating gene expression and protein interactions involved in hematopoiesis.5 Menin inhibitors are designed to disrupt this interaction, inhibiting the proliferation of leukemic cells.4
“Thanks to advancements in comprehensive genomic profiling, we have seen an increased focus on developing new targeted therapies for patients with hematological malignancies, which may help bring the promise of precision medicine to more patients,” said Foundation Medicine’s Chief Biopharma Officer Troy Schurr. “We’re excited to work with Sumitomo to advance our FoundationOne Heme platform as a companion diagnostic as they advance investigation of this promising potential treatment option for acute leukemia patients with a KMT2A rearrangement and NPM1 mutations.”
Foundation Medicine’s portfolio of tests offers 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 more than 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) testing in the United States and Japan.6
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.
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1 Chennamadhavuni A, Lyengar V, Mukkamalla SKR, Shimanovsky A. Leukemia. StatPearls [Internet]. January 17, 2023. Accessed November 11, 2024. https://www.ncbi.nlm.nih.gov/books/NBK560490/
2 Brandi ML, Agarwal SK, Perrier ND, Lines KE, Valk GD, Thakker RV. Multiple endocrine neoplasia type 1: latest insights. Endocr Rev. 2021;42(2):133-170. https://doi.org/10.1210/endrev/bnaa031
3 Borkin D, Klossowski S, Pollock J, et al. Complexity of blocking bivalent protein-protein interactions: development of a highly potent inhibitor of the menin-mixed-lineage leukemia interaction. J Med Chem. 2018;61(11):4832-4850. https://doi.org/10.1021/acs.jmedchem.8b00071
4 Thomas X. Small molecule menin inhibitors: novel therapeutic agents targeting acute myeloid leukemia with KMT2A rearrangement or NPM1 mutation. Oncol Ther. 2024 Mar;12(1):57-72. https://doi.org/10.1007/s40487-024-00262-x
5 Cierpoclo T, Grembecka J. Challenges and opportunities in targeting the menin-MLL Interaction. Future Med Chem. 2014; 6(4):447-462. doi:10.4155/fmc.13.214. https://doi.org/10.4155/fmc.13.214
6 Data on File, Foundation Medicine, Inc. 2024
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