ABL Bio accelerates development of ABL111 as 1st-line therapy for gastric cancer

ABL Bio announced on Tuesday that it is accelerating the clinical development of ABL111 (givastomig), which it is jointly developing with the U.S. biotech company I-Mab.

The two companies plan to announce top-line data from the dose expansion part of the ongoing phase 1b clinical trial for the ABL111 combination therapy in the first quarter of 2026, followed by additional phase 1b trials and subsequent phase 2 trials.

ABL111 is a bispecific antibody that simultaneously targets Claudin18.2 and 4-1BB. It is undergoing a phase 1b trial in the U.S. in combination with nivolumab and chemotherapy.

The ABL111 phase 1b trial consists of a dose-escalation part and a dose-expansion part. Following the completion of the dose escalation phase, the dose expansion phase is underway with 40 patients. The dose expansion part evaluates two doses of ABL111 -- 8 mg/kg and 12 mg/kg.

Following the dose expansion phase, ABL Bio and I-Mab plan to conduct an additional phase 1b trial evaluating ABL111 in combination with chemotherapy in patients with Claudin 18.2 expression below 75 percent and PD-L1 CPS below 1.

This patient population cannot use existing Claudin 18.2-targeted therapies or immuno-oncology drugs, meaning the current standard of care remains chemotherapy alone, creating a significant unmet medical need.

Furthermore, the company plans to initiate a phase 1b clinical trial of ABL111 combined with chemotherapy for Claudin 18.2-positive pancreatic cancer patients, as well as a phase 1b trial of ABL111 combined with immunotherapy and chemotherapy for Claudin 18.2-positive biliary tract cancer patients.

In the phase 2 trial of ABL111, the combination therapy of ABL111, nivolumab, and chemotherapy will be evaluated as a first-line treatment for patients with metastatic gastric cancer, mirroring the ongoing phase 1b trial. Both companies aim to confirm progression-free survival (PFS) in the phase 2 clinical trial by 2027.

ABL Bio and I-Mab plan to develop ABL111 (givastomig) as a first-line treatment for gastric cancer patients while simultaneously expanding its indications to other Claudin 18.2-positive tumors,” ABL Bio CEO Lee Sang-hoon said. “In addition to the ongoing phase 1b trial, the subsequent phase 2 trial, and an additional phase 1b trial for indication expansion, investigator-initiated clinical trials are also planned in Japan and the United States.”