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- ABL103 in combination with KEYTRUDA® (pembrolizumab) and Taxane will be evaluated for safety and efficacy in South Korea and the United States
Pangyo (South Korea) – May XX, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has received MFDS clearance of IND application for the Phase 1b/2 study of ABL103 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and Taxane as a triple combination therapy.
ABL103 is a bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio’s 4-1BB based bispecific antibody platform ‘Grabody-T’ has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, potentially reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. A Phase 1 clinical trial evaluating ABL103 monotherapy is currently underway in the United States and South Korea, and with the recent IND clearances in South Korea and the U.S., a Phase 1b/2 study of the triple combination therapy is expected to follow.
The Phase 1b/2 study consists of two safety lead-in parts to determine the optial dose for the triple combination therapy, as well as one dose expansion part. Through this study, ABL Bio aims to evaluate the safety and efficacy of the ABL103 triple combination therapy.
Sang Hoon Lee, CEO of ABL Bio, stated, “We have received MFDS and FDA clearance to proceed with a clinical trial evaluating the safety and efficacy of ABL103 in a triple combination therapy in South Korea and the United States. We hope that the combination of ABL103, KEYTRUDA, and Taxane will offer a new treatment option for patients with difficult-to-treat solid tumors.” He added, “Clinical development of our 4-1BB-based bispecific antibodies, including ABL103, is progressing smoothly. We will continue to do our utmost in R&D to deliver more positive updates like today’s IND clearance for the Phase 1b/2 trial of ABL103.”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.