[Edaily Reporter PARK MIN ] ABL Bio Inc.(298380)announced on the 28th that it had received additional approval from the South Korean Ministry of Food and Drug Safety (MFDS) regarding amendments to the Investigational New Drug (IND) application for its bispecific antibody immunotherapy ABL503.
According to the company, the key point of this amended disclosure is that the Ministry of Food and Drug Safety (MFDS) has been added as a clinical trial regulatory authority, in addition to the existing U.S. Food and Drug Administration (FDA). The company stated that it received approval for the amendment to the clinical trial plan from the MFDS on July 28, 2026, and was notified of this fact through its representative.
ABL503 is a bispecific antibody immunotherapy that simultaneously targets 4-1BB and PD-L1. The company is currently conducting a Phase 1 clinical trial evaluating the drug as a monotherapy or in combination therapy for patients with advanced or metastatic solid tumors. The clinical trial is being conducted at more than eight institutions in the United States and South Korea.
A company official stated, “The countries where the clinical trial is being conducted, the participating institutions, the trial methodology, the trial period, the target number of participants, and the expected completion date are subject to change depending on the progress of the trial,” adding, “We plan to immediately file a related disclosure if additional approvals are granted at other institutions where clinical trial protocols have been submitted.”
According to the company, the key point of this amended disclosure is that the Ministry of Food and Drug Safety (MFDS) has been added as a clinical trial regulatory authority, in addition to the existing U.S. Food and Drug Administration (FDA). The company stated that it received approval for the amendment to the clinical trial plan from the MFDS on July 28, 2026, and was notified of this fact through its representative.
ABL503 is a bispecific antibody immunotherapy that simultaneously targets 4-1BB and PD-L1. The company is currently conducting a Phase 1 clinical trial evaluating the drug as a monotherapy or in combination therapy for patients with advanced or metastatic solid tumors. The clinical trial is being conducted at more than eight institutions in the United States and South Korea.
A company official stated, “The countries where the clinical trial is being conducted, the participating institutions, the trial methodology, the trial period, the target number of participants, and the expected completion date are subject to change depending on the progress of the trial,” adding, “We plan to immediately file a related disclosure if additional approvals are granted at other institutions where clinical trial protocols have been submitted.”
