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- 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels
- Best-in-class potential as first-line standard-of-care treatment for HER2-negative, Claudin 18.2-positive, metastatic gastric cancers
Seoul (South Korea) – January 7, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that positive antitumor efficacy was confirmed in the Phase 1b dose expansion cohort of ABL111/Givastomig, which is being co-developed with U.S.-based biotech company, NovaBridge Biosciences. The newly released data are from patients with HER2-negative, Claudin 18.2-positive, metastatic gastric cancers receiving first-line standard of care (nivolumab and mFOLFOX6) plus ABL111/Givastomig.
ABL111/Givastomig is a bispecific antibody that simultaneously targets Claudin 18.2 and 4-1BB. It is currently being evaluated in a Phase 1b clinical trial in the United States in combination with the PD-1 inhibitor nivolumab and chemotherapy (mFOLFOX6). The Phase 1b study of the ABL111/Givastomig combination therapy is being conducted in patients with Claudin 18.2-positive gastric cancer and consists of both dose escalation and dose expansion cohorts.
The newly announced data represent an integrated analysis of patients who received ABL111/Givastomig at either 8 mg/kg or 12 mg/kg across both the dose escalation and dose expansion cohorts. The results showed an observed objective response rate (ORR) of 77% (20/26) in the 8 mg/kg cohort and 73% (19/26) in the 12 mg/kg cohort.
The ABL111/Givastomig combination therapy demonstrated consistent responses regardless of patients’ PD-L1 or Claudin 18.2 expression levels. In addition, the safety profile was comparable to that of current first-line standard therapies, showing overall favorable tolerability. The median progression-free survival (PFS) was 16.9 months at 8 mg/kg. PFS data for the 12 mg/kg cohort has not yet matured due to a relatively shorter follow-up period and are expected to be disclosed later in 2026.
ABL Bio CEO Sang Hoon Lee stated, “These data further confirm the potential of ABL111/Givastomig to become a best-in-class, first-line standard-of-care therapy. Given that gastric cancer represents a global market opportunity of approximately USD 12 billion, both companies will continue to accelerate the clinical development of ABL111/Givastomig. We also plan to expand combination therapy studies for other 4-1BB bispecific antibodies under development, including ABL503/Ragistomig.”
“The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression. The PFS data are very promising and continue to mature. Emerging efficacy data at 12 mg/kg are also strong and similar in terms of ORR. The 12 mg/kg cohort was enrolled after the 8 mg/kg cohort, so follow-up is shorter and PFS is less mature. We expect to report this data later in 2026. We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.
The full data set from the Phase 1b study of ABL111/Givastomig is scheduled to be presented at a global scientific conference in 2026. In addition, ABL Bio and NovaBridge plan to initiate a global randomized Phase 2 trial in the first quarter of 2026, comparing two doses of ABL111/Givastomig—8 mg/kg and 12 mg/kg—against existing standard-of-care treatments.
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 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), are underway for different indications in various countries, including the United States, China, Australia, and Korea. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
About NovaBridge
NovaBridge is a global biotechnology platform company committed to accelerating access to innovative medicines. We combine deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets. By bridging science, strategy, and execution, NovaBridge enables transformative therapies to progress rapidly from discovery toward patients in need.
The Company’s differentiated pipeline is led by givastomig, a potential best-in-class, Claudin 18.2 x 4-1BB bispecific antibody, and VIS-101, a second-in-class, potentially best-in-class bifunctional biologic, targeting VEGF-A and ANG2.
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 to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. The Company is also collaborating with its partner, ABL Bio, for the development of ragistomig, a bispecific antibody integrating PD-L1 as a tumor engager and 4-1BB as a conditional T cell activator, in solid tumors. Additionally, NovaBridge owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody that targets adenosine-driven immunosuppression in cancer.
VIS-101 targets VEGF-A and ANG-2 to provide more potent and durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). VIS-101 is currently completing a large, randomized, dose-ranging Phase 2 study for wet AMD. NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101, outside of Greater China and certain countries in Asia.
For more information, please visit www.novabridge.com and follow us on LinkedIn.