HomeInvestors & MediaNews
- New Givastomig/ABL111 combination data selected for Mini Oral presentation at ESMO GI, being held July 2-5 in Barcelona, Spain
- The Phase 1b trial is currently ongoing in the U.S., with data from the ongoing dose-expansion cohorts (n=40) expected to be released in 1H 2026
Seoul (South Korea) – June 24, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner I-Mab (NASDAQ: IMAB) will present Phase 1b clinical data of Givastomig/ABL111 in a Mini Oral presentation at the European Society of Medical Oncology (“ESMO”) Gastrointestinal (“GI”) Cancers Congress 2025, being held July 2-5 in Barcelona, Spain.
The oral presentation on Givastomig/ABL111 at ESMO GI 2025 is titled “Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)” and will cover data from the dose escalation cohort of the Phase 1b trial. The presentation will be delivered by Dr. Samuel J. Klempner, Associate Professor of Medicine, Massachusetts General Hospital, on Wednesday, July 2nd at 16:50 CEST (10:50 am EST).
The ongoing Phase 1b study is evaluating Givastomig/ABL111 for the treatment of gastric cancer in the first line setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). Data from the ongoing dose-expansion cohorts are expected to be released in 1H 2026. The study builds on positive Phase 1 monotherapy data.
Givastomig/ABL111 is a pipeline candidate co-developed by ABL Bio and I-Mab, and is one of the bispecific antibodies based on ABL Bio’s proprietary 4-1BB bispecific antibody platform, Grabody-T. The antibody is designed to activate immune T cells only within the tumor microenvironment where Claudin 18.2—an established tumor antigen—is expressed. The activated T cells selectively target and attack Claudin 18.2-positive cancer cells while sparing healthy tissue, thereby minimizing the risk of on-target, off-tumor toxicity.
Sang Hoon Lee, CEO of ABL Bio, stated, “The Phase 1b results of Givastomig/ABL111 mark the first clinical data from a combination therapy among our Grabody-T-based 4-1BB bispecific antibody pipelines. Going forward, we will continue to advance the global development of Givastomig/ABL111 in close collaboration with I-Mab, while also accelerating the research and development of other Grabody-T-based bispecific antibodies to further enhance their value as next-generation immuno-oncology therapeutics.”
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, will present data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy in ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).