Servier Acquires BN104, a Novel Oral Menin Inhibitor for Acute Leukemia, from BioNova Pharmaceuticals

On May 23, Servier（Servier）Bionova Pharmaceuticals Announces Agreement with Servier for AcquisitionSmall Molecule Menin Inhibitor BN104The final agreement. The drug, developed by Bionova Pharmaceuticals, is intended for the treatment of acute leukemia and is currently in Phase 1/2 clinical development.

Acute leukemia is caused byKMT2AGene RearrangementOrNPM1Driven by mutations, and the abnormal gene expression caused by these two variations depends onMEN1Maintenance of Menin protein encoded by genes.Research has found,Disrupting the Menin-MLL interaction can preventMLLGrowth of Gene Rearrangement Leukemia Cells. Therefore,Menin inhibitors are currentlyConsidered to be another potential breakthrough in targeted therapy for acute leukemia, especially for those carryingKMT2AGene Rearrangement orNPM1Patients with gene mutations.

BN104 is a novel, highly active, and highly selective small molecule drug independently developed by Bionova Pharmaceuticals and is expected to become a treatment for patients carryingKMT2AGene Rearrangement orNPM1New Treatment Options for Acute Leukemia with Mutations.

According to an earlier press release from BioNova,BN104 has demonstrated potent anticancer activity in preclinical animal models of acute myeloid leukemia xenografts.The study also found that the productWhile maintaining therapeutic effectiveness, it has almost no inhibitory effect on hERG (an ion channel)., the predicted clinical risk of prolonging cardiac QTc (QT interval corrected for heart rate) is low, indicating better safety.

Data from the BN104 trial presented at the 2024 American Society of Hematology (ASH) Annual Meeting showed,In relapsed/refractoryAcute Myeloid Leukemia (AML)Among the patients,KMT2AThe complete response rate with partial hematologic recovery in the rearranged subgroup was 60.9%.NPM1Mutation subgroup accounts for 40%，BN104 demonstrated a tolerable safety profile (no QTc prolongation or ≥Grade 3 differentiation syndrome was observed).

BN104 was granted Orphan Drug Designation by the U.S. FDA in April 2023 and received Fast Track Designation for acute leukemia treatment from the FDA in October 2023. In China, the product has also been included in the Breakthrough Therapy designation by the NMPA.The proposed indication is for the treatment ofCarryKMT2AReorganization and/orNPM1Relapsed/Refractory Acute Leukemia with Mutations。

According to the terms of the agreement, Bionova Pharmaceuticals will receive an upfront payment for BN104 as well as subsequent development and registration milestone payments. Servier will accelerate the global clinical development of BN104 in mutated AML and acute lymphoblastic leukemia (ALL). There is a significant unmet medical need in these treatment areas, especially for relapsed/refractory patients who urgently require therapies with higher safety and better tolerability.