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Servier To Acquire a Potential Best-in-Class Precision Therapy for Acute Leukemias, from BioNova Pharmaceuticals

Suresnes (France), May 23, 2025 Servier, an independent global pharmaceutical group governed by a non-profit foundation, and BioNova Pharmaceuticals, a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative medicines for the treatment of diseases with unmet medical needs, today announce that the companies have entered into a definitive agreement under which Servier will acquire BN104, a potential best-in-class menin inhibitor currently in Phase 1/2 development for the treatment of acute leukemias.

In line with its 2030 strategy, Servier aims to accelerate the global clinical development of BN104 in mutated AML as well as acute lymphoblastic leukemia (ALL) where the unmet medical need is high, especially for safer therapies in relapse/refractory conditions. This asset will enable Servier to further expand its hematological oncology franchise and build on its leadership with a targeted and differentiated portfolio of medicines in this field.

BN104 is a novel, potent and highly selective small molecule designed and discovered by BioNova Pharmaceuticals. BN104 is uniquely positioned to be a potential best-in-class menin inhibitor for the treatment of acute leukemias with a KMT2A gene rearrangement or NPM1 mutation. Results presented at the 2024 American Society of Hematology (ASH) Annual Meeting demonstrated that patients with relapse refractory Acute Myeloid Leukemia (AML) had a CR/CRh (complete response/complete response with partial hematologic recovery) rate of 60.9% for the KMT2A rearranged subgroup and 40% for the NPM1 mutation subgroup, with a tolerable safety profile1 (no QTc prolongation nor differentiation syndrome ≥G3). KMT2A rearrangements are found in 5 to 10%2 of patients with AML and NPM1 mutations in 20 to 30%3 of patients with AML. BN104 was granted Orphan Drug Designation (ODD) in April 2023 and Fast Track Designation in October 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of acute leukemia.

Under the terms of the agreement, BioNova Pharmaceuticals will receive a cash payment for its sale of BN104 with development and regulatory earn-outs. The transaction is subject to customary closing conditions.


[1] https://ashpublications.org/blood/article/144/Supplement%201/2879/533203/A-First-in-Human-Phase-1-2-Study-of-the-Menin and ASH 2024 poster 2879
[2] Zhang R., et al., Outcomes of acute myeloid leukemia with KMT2A (MLL) rearrangement: a multicenter study of TROPHY group. Blood Cancer J. 2025 May 2;15(1):84. doi: 10.1038/s41408-025-01293-x – https://doi.org/10.1038/s41408-025-01293-x
[3] Falini B., Dillon R., Criteria for Diagnosis and Molecular Monitoring of NPM1-Mutated AML. Blood Cancer Discov. 2023 Dec 7;5(1):8–20. doi: 10.1158/2643-3230.BCD-23-0144 – https://doi.org/10.1158/2643-3230.BCD-23-0144