Aimed Bio(0009K0)'s Antibody-Drug Conjugate (ADC) new drug candidate "BI 4060107 (development code name ODS025)," which was licensed out to C. H. Boehringer Sohn AG & Co. KG, received approval for a phase 1 investigational new drug (IND) application in Japan. With clinical approval in Japan following the United States and Korea, the global phase 1 trial is expected to gain speed.
Aimed Bio said on the 21st via a revised filing that it received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the phase 1 IND of BI 4060107. The company applied for the IND to the PMDA on the 22nd of last month and was notified of the approval by its agent that day.
In this trial, BI 4060107 will be administered intravenously to patients with unresectable advanced or metastatic solid tumors to evaluate safety, tolerability, and pharmacokinetics (PK).
The primary endpoint is to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of BI 4060107. Safety and tolerability and pharmacokinetic characteristics are set as secondary endpoints.
The target enrollment is about 90 patients, and the trial is planned to be conducted at 13 institutions in a total of five countries. The trial period is about 36 months from the IND approval date.
After Aimed Bio licensed out BI 4060107, C. H. Boehringer Sohn AG & Co. KG took charge of subsequent development. Phase 1 approval has now been obtained in the United States, Korea, and Japan, and the IND approval process is underway in France and Australia. The scheduled completion date for the domestic trial is Feb. 2031.