BioNova Pharmaceuticals (Shanghai) Limited (hereinafter referred to as BioNova) is currently not providing BN104 Tablets for Expanded Access use.
BN104 is a novel, highly selective and potent oral menin inhibitor developed by BioNova and currently being investigated as a potential treatment for acute leukemias patients who harbor a mixed-lineage leukemia rearranged (MLLr) or nucleophosmin (NPM1) mutation. On October 23, 2023, BN104 was designated as a Fast Track product by the FDA.
A phase 1 clinical study constitutes the Part 1 dose-escalation and Part 2 dose-optimization will be conducted in eligible patients with acute leukemias. The study is designed to establish a safe and optimized dose and appropriate dosing schedule for BN104. Once RP2D established, and with agreement from the FDA, the company will initiate the phase 2 program in patients with acute leukemias who harbor a MLLr or NPM1 mutation.
BioNova will review its EA policy annually to determine if a change in policy is warranted and feasible.
BioNova will respond to all Expanded Access requests within 14 business days. All requests for Expanded Access or additional information may be sent by email to info@bionovapharma.com. For email requests, please indicate EXPANDED ACCESS REQUEST in the subject line.