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- ABL103 in combination with KEYTRUDA and Taxane will be evaluated for safety and efficacy in South Korea, the United States, and Australia
Pangyo (South Korea) – March 20, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has submitted an additional clinical trial amendment for the Phase 1b/2 study of ABL103 in combination with MSD’s (a subsidiary of 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. ABL Bio plans to amend the investigational new drug (IND) application for this Phase 1 trial to include a Phase 1b/2 study assessing combination therapy in South Korea, the United States, and Australia. The Phase 1b/2 study will consist of two safety lead-in parts to determine the appropriate dosage 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 said “with the submission of this clinical trial amendment, the journey to evaluate ABL103 combination therapy in solid tumor patients has officially begun. We hope that ABL103 will demonstrate strong efficacy in combination with KEYTRUDA and Taxane. Along with ABL103, clinical trials for 4-1BB-based bispecific antibodies, including ABL111/Givastomig, ABL503/Ragistomig, and ABL105, are progressing smoothly. Among them, ABL111/Givastomig is advancing the fastest in clinical development and is expected to announce the top-line results of its Phase 1b combination study this year. We appreciate your continued interest and support in our progress.”
Meanwhile, ABL Bio entered a clinical trial collaboration and KEYTRUDA supply agreement with MSD in October last year to evaluate ABL103 combination therapy in patients with advanced or metastatic solid tumors.
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001, ABL111/givastomig, ABL503/ragistomig, ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001, 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. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. 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.