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- Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy
Seoul (South Korea) – July 2, 2025, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced its partner I-Mab published clinical data on ABL111/Givastomig, a bispecific antibody targeting Claudin18.2 and 4-1BB, in Clinical Cancer Research, a journal of the American Association for Cancer Research (CCR). The paper presents promising efficacy and safety data from a Phase 1 study of ABL111/Givastomig monotherapy in patients with Claudin18.2-positive gastric cancers.
Phase 1 data on ABL111/Givastomig monotherapy was previously presented in poster format at the European Society for Medical Oncology (ESMO) congresses in 2023 and 2024.
The study enrolled a total of 75 patients with solid tumors, including gastric cancers. Among them, 43 patients were efficacy-evaluable with CLDN18.2-positive advanced or metastatic gastroesophageal carcinoma (GEC) who received ABL111/Givastomig monotherapy at doses ranging from 5 to 18 mg/kg. Based on the data, seven out of the 43 patients achieved a partial response (PR), resulting in an objective response rate (ORR) of 16% (7/43) for ABL111/Givastomig monotherapy. Following the data cutoff presented at ESMO 2024, two additional patients were enrolled in the study, and one of them achieved a PR, raising the ORR to 18% (8/45).
The disease control rate (DCR) was 49% (21/43), including 14 patients who achieved stable disease (SD). Most adverse events were mild, categorized as Grade 1 or 2. Among patients who responded to ABL111/Givastomig monotherapy, Claudin18.2 expression levels ranged from 11% to 100%, suggesting that ABL111/Givastomig may offer therapeutic benefit even in patients with low Claudin18.2 expressions.
Sang Hoon Lee, CEO of ABL Bio, stated, “We are pleased to have the clinical data on ABL111/Givastomig monotherapy published for the first time in the prestigious international Clinical Cancer Research (CCR) journal. Moving forward, we will continue to work closely with I-Mab to successfully advance the global clinical development of ABL111/Givastomig and generate meaningful results from the combination therapy trials. Our goal is to provide a new treatment option for patients with gastric cancers.”
ABL111/Givastomig is a bispecific antibody that targets Claudin18.2-positive tumors and is designed to selectively activate T cells through the 4-1BB pathway only within the tumor microenvironment where Claudin18.2 is expressed. The antibody is currently being evaluated in a Phase 1b clinical trial in combination with the immune checkpoint inhibitor, nivolumab and chemotherapy, with the goal of developing it as a first-line treatment for gastric cancers. In the Phase 1 monotherapy study, ABL111/Givastomig demonstrated potent anti-tumor activity through the localized interaction between Claudin18.2 and 4-1BB, while minimizing the toxicity typically associated with conventional 4-1BB antibodies.
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, presents encouraging 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).