ABL Bio and NovaBridge Confirm Positive Data for ABL111 in Phase 1b Dose Expansion Cohort

ABL Bio, a company specializing in bispecific antibodies, announced on January 7 that ABL111 (Givastomig), which is being co-developed with the US biotech firm NovaBridge Biosciences, has demonstrated positive anti-cancer efficacy in the Phase 1b dose expansion cohort. The latest results are based on data from patients with HER2-negative, Claudin18.2-positive, first-line metastatic gastric cancer.

ABL111 (Givastomig) is a bispecific antibody that simultaneously targets Claudin18.2 and 4-1BB. It is currently undergoing a Phase 1b clinical trial in the United States in combination with the PD-1 inhibitor Nivolumab and the chemotherapy regimen mFOLFOX6. The Phase 1b study of the ABL111 (Givastomig) combination therapy targets patients with Claudin18.2-positive gastric cancer and consists of a dose escalation cohort and a dose expansion cohort.

The newly announced data are the results of an integrated analysis of patients who received either 8 mg/kg or 12 mg/kg doses of ABL111 (Givastomig) in both the dose escalation and dose expansion cohorts. The analysis showed an objective response rate (ORR) of 77% (20 out of 26) at 8 mg/kg and 73% (19 out of 26) at 12 mg/kg.

The ABL111 (Givastomig) combination therapy demonstrated consistent responses regardless of patients’ PD-L1 and Claudin18.2 expression levels. The safety profile was also similar to the current first-line standard therapy, indicating overall good tolerability. The median progression-free survival (PFS) was confirmed to be 16.9 months at the 8 mg/kg dose, while the 12 mg/kg group had a relatively short follow-up period, with data to be disclosed in the future.

Lee Sanghoon, CEO of ABL Bio, stated, "The data presented this time confirm the potential of ABL111 (Givastomig) to become a best-in-class, potential first-line standard therapy. Since gastric cancer represents a global market opportunity of approximately 12 billion dollars, both companies will continue to accelerate the clinical development of ABL111 (Givastomig) through collaboration." He added, "We also plan to expand clinical trials of other 4-1BB bispecific antibodies under development, such as ABL503 (Ragistomig), as combination therapies."

Philip Dennis, Chief Medical Officer of NovaBridge, commented, "The dose expansion cohort data reconfirm the strong anti-cancer efficacy observed in the dose escalation phase." He further explained, "It is particularly encouraging that a high ORR was observed even among patients with low PD-L1 and Claudin18.2 expression at the 8 mg/kg dose." He added, "While the 12 mg/kg group had a shorter follow-up period due to later patient enrollment and thus the PFS data are not yet mature, we are optimistic about future data as treatment efficacy continues to be observed without an increase in side effects at higher doses."

The full data from the Phase 1b clinical trial of ABL111 (Givastomig) are scheduled to be presented at a global academic conference in 2026. ABL Bio and NovaBridge plan to initiate a global randomized Phase 2 clinical trial in the first quarter of 2026, comparing both 8 mg/kg and 12 mg/kg doses of ABL111 (Givastomig) against the existing standard therapy.