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- 8 mg/kg selected as the dose for further clinical development of givastomig, with an ORR of 79% observed in the 8 mg/kg cohort of the Phase 1b study
Seoul (South Korea) – October 26, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has successfully concluded the presentation of clinical data on givastomig (ABL111) and ragistomig (ABL503), two 4-1BB-based bispecific immuno-oncology therapies, at the European Society for Medical Oncology (ESMO) Congress 2026.
Givastomig and ragistomig are both developed using Grabody-T, ABL Bio’s proprietary 4-1BB-based bispecific antibody platform. Givastomig targets Claudin18.2, which is overexpressed in certain cancers, including gastric and pancreatic cancers, while ragistomig targets the immune checkpoint PD-L1. Both candidates are being co-developed with NovaBridge Biosciences, a U.S.-based biotechnology company.
At this year's ESMO Congress, the two companies presented additional analyses of data from a total of 71 patients enrolled in the Phase 1b study of givastomig, including 31 patients treated at 8 mg/kg and 40 patients treated at 12 mg/kg. Based on a comprehensive evaluation of efficacy, safety, and long-term follow-up data from the Phase 1b study, 8 mg/kg was selected as the dose for further clinical development of givastomig.
In the 8 mg/kg cohort, givastomig demonstrated an objective response rate (ORR) of 79% (23/29) and a disease control rate (DCR) of 97% (28/29). An analysis of patients in the 8 mg/kg cohort by Claudin18.2 expression level also showed encouraging antitumor activity. The ORR was 82% (14/17) in patients with Claudin18.2 expression of 75% or higher and 75% (9/12) in those with expression levels ranging from 1% to 74%.
In terms of safety, the additional Phase 1b analysis confirmed that givastomig demonstrated a manageable safety profile, with no Grade 4 or Grade 5 treatment-related adverse events reported. Immune-related adverse events were infrequent, except for gastritis, which was predominantly Grade 2 in severity.
ABL Bio and NovaBridge have been engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the further clinical development of givastomig and have reached alignment on key elements of the design of a global registrational Phase 3 study. Givastomig has previously received Orphan Drug Designation and Fast Track Designation from the FDA, and the two companies plan to leverage these designations to advance its clinical development.
Ragistomig, which was also featured in a poster presentation at this year's ESMO alongside givastomig, demonstrated an improved safety profile and sustained antitumor activity in a Phase 1 monotherapy study when the dosing interval was extended from every two weeks (Q2W) to every six weeks (Q6W). The incidence of Grade 3 or higher treatment-related adverse events was lower in the Q6W group compared to the Q2W group. Despite reduced drug exposure resulting from the extended dosing interval, activation of key CD8+ T cells was sustained.
Meanwhile, immunosuppressive regulatory T cells (Tregs) remained at baseline levels, suggesting the potential to create an immunological environment favorable for antitumor immune responses. The objective response rate (ORR) was 11.8% (2/17) in the ragistomig 3 mg/kg Q6W group and 21.1% (4/19) in the 5 mg/kg Q6W group.
Ragistomig demonstrated antitumor activity across various solid tumors, including in patients who had failed prior immune checkpoint inhibitor therapy. Notably, 84.6% (11/13) of patients who responded to treatment were refractory to prior PD-(L)1 inhibitor therapy or had experienced disease recurrence following treatment. ABL Bio and NovaBridge expect ragistomig to emerge as a new treatment option for patients with high unmet medical needs who are refractory to or have relapsed following prior immune checkpoint inhibitor therapy.
Sang Hoon Lee, CEO of ABL Bio, said, “The long-term follow-up data presented at this year's ESMO Congress have further strengthened our confidence in the durability of givastomig's efficacy and its safety profile. We have also made meaningful progress in our discussions with the FDA, laying the groundwork for further clinical development. We will work closely with NovaBridge to accelerate preparations for the Phase 3 study of givastomig. At the same time, we plan to actively advance the ongoing clinical development of ragistomig in combination with a PD-1 inhibitor, building on the dosing schedule optimization results demonstrated in this study.”
About ABL Bio
ABL Bio is developing a variety of preclinical and clinical-stage pipelines utilizing its BBB shuttle platform Grabody-B and its 4-1BB-based bispecific antibody platform Grabody-T, among others. Clinical projects for pipelines such as ABL111 (Givastomig), ABL503 (Ragistomig), ABL103, ABL105 (Nesfrotamig), ABL104 (YH32364), ABL206 (NEOK001), ABL209 (NEOK002), ABL202 (CS5001/LCB71), and ABL301 (SAR446159) are underway across various countries, including the US, China, Australia, Japan, and South Korea. ABL301 has completed its Phase 1 clinical trial in the US, with subsequent trials to be conducted by Sanofi. ABL111 is being co-developed with NovaBridge and has received Fast Track Designation and Orphan Drug Designation from the FDA. ABL111 is currently undergoing Phase 2 clinical trial for combination therapy with nivolumab and chemotherapy in patients with 1L metastatic gastroesophageal cancer. In addition, several preclinical pipelines, including bispecific antibody ADCs and dual-payload ADCs, are continuously under research and development.