ABL Bio, a bispecific antibody specialist company, announced on the 30th that it has received approval from the Ministry of Food and Drug Safety for the domestic Phase 1 clinical trial plan (IND) of the bispecific antibody immuno-oncology drug 'ABL503.'
Accordingly, ABL503 will expand the ongoing Phase 1 clinical trial in six clinical institutions in the United States to also conduct a Phase 1 trial domestically. Through the expanded part of the clinical trial, additional safety data in monotherapy will be secured, and the recommended phase 2 dose (RP2D) and the optimal target cancer types will be determined for Phase 2 clinical trials.
ABL503, a bispecific antibody targeting PD-L1 and 4-1BB simultaneously, selectively activates T cells only in the tumor microenvironment because 4-1BB can be activated only in immune cells surrounding cancer cells expressing PD-L1. ABL Bio explained that this mechanism minimizes the side effects of 4-1BB, which shows high hepatotoxicity when used as a single antibody.
The company emphasized that since only 20-30% of patients respond to immune checkpoint inhibitor mechanism anticancer drugs in existing treatments, and there were no new mechanism immuno-oncology drugs to administer upon relapse even if effective, ABL503 could be a new alternative.
Sanghoon Lee, CEO of ABL Bio, said, "ABL Bio's pipelines are designed to have clear differentiation from existing treatments," adding, "If positive clinical results continue to be supported, we are confident that their value will naturally be recognized."
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