By Fineline Cube 
French pharmaceutical firm Servier announced a definitive agreement to acquire BN104 from BioNova Pharmaceuticals (Shanghai) Ltd. The transaction includes an undisclosed upfront payment and additional development and regulatory milestone payments, contingent upon standard delivery conditions. This acquisition underscores Servier’s commitment to expanding its oncology portfolio.
BN104 Development and Clinical Data
BN104 is a novel, highly selective small-molecule inhibitor of menin, currently in Phase I/II development for the treatment of acute leukemia. Clinical data presented at the 66th Annual American Society of Hematology (ASH) Annual Meeting highlighted impressive results. In patients with relapsed and refractory acute myeloid leukemia (AML), the complete remission rate with partial hematological recovery was 60.9% in the KMT2A rearrangement subgroup and 40% in the NPM1 mutation subgroup. The drug demonstrated tolerable safety, with no QTc interval prolongation or differentiation syndrome ≥ grade 3 observed.
Regulatory Milestones
BN104 received Orphan Drug Designation in the US in April 2023 and Fast Track designation in October 2023 for the treatment of acute leukemia. These designations highlight the drug’s potential to address significant unmet medical needs in this patient population.-Fineline Info & Tech