ABL Bio Applies for Phase 1 Clinical Trial of Bispecific Antibody Immuno-Oncology Drug in Korea

US Phase 1 Clinical Trial Dose Escalation Part Officially Begins

[Asia Economy Reporter Myunghwan Lee] ABL Bio announced on the 7th that it has submitted an Investigational New Drug (IND) application for the domestic Phase 1 clinical trial of the bispecific antibody immuno-oncology drug 'ABL503' to the Ministry of Food and Drug Safety.

This comes about two years after the Phase 1 clinical trial application to the U.S. Food and Drug Administration (FDA) in 2020. ABL Bio explained that this is to proceed with the expansion part, the next stage following the dose escalation part of the ongoing Phase 1 clinical trial in the U.S.

ABL Bio plans to secure additional safety data from monotherapy through the expansion part clinical trial conducted at domestic clinical institutions in collaboration with six clinical institutions in the U.S., and to determine the recommended dose and optimal target cancer types for Phase 2 clinical trials.

ABL503, which applies the Grabody-T platform technology, is a bispecific antibody immuno-oncology drug that simultaneously targets PD-L1 and 4-1BB. It is currently being co-developed with iMab, a Nasdaq-listed company.

4-1BB, which helps activate T cells, is known for its excellent anticancer effects, but high toxicity side effects when administered as a single antibody have been pointed out as a limitation. However, in the case of the bispecific antibody ABL503 composed of two antibodies, 4-1BB can be activated in immune cells surrounding cancer cells expressing PD-L1. Therefore, ABL Bio explained that it is possible to minimize the toxic side effects of 4-1BB through selective T cell activation only in the tumor microenvironment.

Lee Sang-hoon, CEO of ABL Bio, said, "Starting with ABL503 and ABL111, the Grabody-T based pipeline including ABL103 will gain new attention," adding, "Through this, we can advance as a leading company in the field of T cell engager bispecific antibodies."