ABL Bio announced in a regulatory filing on the 9th that it has received approval from the U.S. Food and Drug Administration (FDA) for amendments to the Phase 1 Investigational New Drug (IND) application for its bispecific antibody immuno-oncology agent, 'ABL503.'

The FDA confirmed both the approval date and the date of occurrence of the fact as July 9 for the amendment application submitted on June 4. The company explained that the disclosure was made based on the date it received notification of approval completion from its representative.

Clinical Overview... To Be Conducted at 8 Institutions in the U.S. and South Korea

ABL503 is a bispecific antibody immuno-oncology agent that simultaneously targets 4-1BB and PD-L1. It is a Phase 1 clinical trial evaluating the safety and efficacy of monotherapy and combination therapy in patients with advanced locally advanced (unresectable) or metastatic solid tumors, and will be conducted at eight or more institutions in the United States and South Korea. The expected clinical trial completion date is January 31, 2028.

Key Points of Amendment Approval... Monotherapy Maintained, Combination Therapy Newly Added

With this approval, the monotherapy dose escalation and dose expansion parts will proceed as originally planned. However, the monotherapy tumor expansion part has adjusted its target cancer types (cohorts), and combination therapy dose escalation and dose expansion parts have been newly added to conduct combination clinical trials.

The overall target number of subjects is as follows:

• Monotherapy dose escalation part: Approximately 36 patients
• Monotherapy dose expansion part: Approximately 6 to 20 patients per cohort
• Monotherapy tumor expansion part: Approximately 111 patients
• Combination therapy dose escalation part: Approximately 20 patients (newly added)
• Combination therapy dose expansion part: Approximately 20 patients (newly added, including patients who received the recommended Phase 2 dose (RP2D) during the dose escalation phase)

ABL Bio stated that it will disclose relevant information if the clinical trial plan receives additional approvals in other countries and institutions in the future.

Investment Precautions

The company noted that the probability of a clinical trial drug ultimately receiving final approval as a pharmaceutical product is statistically known to be around 10%. It added, "During the clinical trial and product approval process, results may fall short of expectations, and accordingly, there is always a possibility that we may change or abandon our commercialization plans. We urge investors to carefully consider the investment risks disclosed through periodic and current filings, including business reports, and invest prudently."