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- At the 8 mg/kg and 12 mg/kg dose levels currently being evaluated in ongoing dose expansion studies, an ORR of 83% (10/12) was observed
- Phase 1b dose expansion data for Givastomig/ABL111 combination therapy is expected to be disclosed in the first quarter of 2026
Seoul (South Korea) – July 7, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that its partner I-Mab (NASDAQ: IMAB) successfully completed a Mini Oral presentation on new Givastomig/ABL111 Phase 1b clinical data at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 (ESMO GI 2025), held on July 2.
Givastomig/ABL111 is a bispecific antibody co-developed by ABL Bio and I-Mab that simultaneously targets Claudin 18.2 and 4-1BB. Givastomig/ABL111 is currently being evaluated in combination with standard-of-care therapies—nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy—as a potential first-line treatment for patients with metastatic gastric cancers.
At ESMO GI 2025, I-Mab presented encouraging data from the dose escalation portion of the Phase 1b study evaluating Givastomig/ABL111 in combination with nivolumab plus chemotherapy.
According to the Mini Oral presentation at ESMO GI 2025, Givastomig/ABL111 combination therapy demonstrated promising efficacy, with an objective response rate (ORR) of 71% (12/17) and a disease control rate (DCR) of 100% (17/17) across the three dose levels. Notably, in the 8 mg/kg and 12 mg/kg cohorts—currently being evaluated as optimal doses in the dose expansion arms—an ORR of 83% (10/12) was observed. In addition, Givastomig/ABL111 showed favorable tolerability across the 5 mg/kg, 8 mg/kg, and 12 mg/kg cohorts, with limited Grade 3+ TRAEs and no events of Grade 3+ nausea or vomiting.
The ongoing Phase 1b study is underway in the United States, targeting patients who are HER2-negative, Claudin 18.2-positive (defined as >1+ intensity in >1% of tumor cells) regardless of PD-L1 expression levels. The study consists of three dose escalation cohorts and two dose expansion cohorts. The primary endpoint is safety, while secondary endpoints include objective response rate (ORR), pharmacokinetics/pharmacodynamics (PK/PD), and duration of response (DoR). Enrollment for the 8 mg/kg cohort in dose expansion has been completed.
Sang Hoon Lee, CEO of ABL Bio, stated, “Currently, the monoclonal antibody zolbetuximab is the only Claudin 18.2-targeted therapy approved in key global markets for gastric cancer patients. Considering that the ORR of zolbetuximab in combination with mFOLFOX6 chemotherapy was 40.3% in the SPOTLIGHT trial, the 83% ORR observed with Givastomig/ABL111 at the doses selected for expansion studies is highly encouraging.” He added, “Among our bispecific antibodies based on the Grabody-T platform, Givastomig/ABL111 is the most advanced in clinical development. The ESMO GI 2025 presentation highlights its potential as a first-line treatment for gastric cancers; we hope that other Grabody-T-based bispecific antibodies will also demonstrate strong outcomes in combination settings.”
Givastomig/ABL111 is a bispecific antibody developed using ABL Bio’s proprietary 4-1BB bispecific antibody platform, Grabody-T, and is the most advanced candidate within the Grabody-T pipeline. It is designed to activate immune T cells only within the tumor microenvironment where Claudin 18.2 is expressed. The activated T cells selectively attack Claudin 18.2-positive cancer cells while sparing healthy tissue, thereby minimizing the risk of on-target, off-tumor toxicity.
Virtual KOL Webinar:
Register for the post-ESMO GI 2025 Webinar here. A replay of the webinar will be accessible on the News & Events page of the I-Mab website (www.i-mabbiopharma.com) for 90 days.
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, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy at ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
About I-Mab
I-Mab (NASDAQ: IMAB) is a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer. The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, bispecific antibody (Claudin 18.2 x 4-1BB) designed to treat Claudin 18.2-positive gastric cancers. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. Givastomig is being developed for first-line metastatic gastric cancers, with additional potential in other solid tumors. In Phase 1 trials, givastomig was observed to maintain strong tumor-binding and anti-tumor activity, attributable to a potential synergistic effect of proximal interaction with Claudin 18.2 and 4-1BB, while minimizing toxicities commonly seen with other 4-1BB agents.