Aimedbio announced that it has received approval from the Ministry of Food and Drug Safety (MFDS) of Korea for its Phase 1 clinical trial plan for BI 4060107 (ODS025).

The company applied for approval of the clinical trial plan with the MFDS on June 15 and was notified by its agent that the plan had been approved. The date of confirmation of the domestic approval was August 18. Accordingly, Aimedbio filed a corrected disclosure adding the domestic approval details to its June 26 disclosure regarding the clinical trial plan approval.

■ FIH Trial in Solid Cancers... To Be Conducted at 13 Institutions in 5 Countries

This trial is an open-label, multicenter, first-in-human (FIH) Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of BI 4060107 administered intravenously in patients with unresectable advanced and/or metastatic solid tumors. The regulatory agencies approving the trial are the U.S. Food and Drug Administration (FDA) and Korea's MFDS.

The trial will be conducted at 13 institutions in 5 countries, and the participating countries and institutions may be adjusted according to the development strategy. The target number of subjects is approximately 90, which may change depending on future circumstances.

The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of BI 4060107 in patients with unresectable advanced and/or metastatic solid tumors, and the secondary objective is to evaluate safety, tolerability, and pharmacokinetic (PK) characteristics.

■ Trial Period Approximately 36 Months... Expected Completion Dates Differ Between Disclosure and Submission

The clinical trial period is planned to be approximately 36 months from the IND approval date and may change depending on the pace of subject enrollment. The expected completion date stated in the previous disclosure is June 26, 2029. However, the expected trial completion date Aimedbio submitted to the MFDS is February 2031.

■ Precautions for Investors

The company stated that the statistical probability of a clinical trial drug ultimately receiving approval as a medicine is known to be approximately 10%. It also cautioned investors that the clinical trial and product approval process may yield results that fall short of expectations, and that the company may modify or abandon its commercialization plans.