ABL Bio’s partner to unveil ABL111 combo therapy’s phase 1 results in Europe

ABL Bio said Tuesday that its partner I-Mab will present data from the phase 1b study of ABL111 (trademark name: Givastomig) combination therapy in a mini oral presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI). ESMO GI will be held next month from July 2 to 5 in Barcelona, Spain.

The oral presentation on ABL111 at ESMO GI 2025 is entitled "Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18. 2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC))," which will feature the Dose Escalation Part of the phase 1b study.

Dr. Samuel J. Klempner, Associate Professor of Medicine at Massachusetts General Hospital, will give the presentation on July 2, local time.

The phase 1b study evaluates ABL111 as a first-line treatment for gastric cancer. It evaluates ABL111 in combination with the anti-PD-1 immune checkpoint inhibitor nivolumab and chemotherapy through a Dose Escalation and Expansion Part.

The Dose Escalation Part is now closed, enrollment in the first Dose Expansion Part is complete, and patient enrollment in the second Dose Expansion Part is ongoing. Data from the Dose Expansion Part will be available in the first half of next year.

ABL111 is a pipeline co-developed by ABL Bio and I-Mab, and is one of the first bispecific antibodies to be developed with ABL Bio's 4-1BB-based bispecific antibody platform, Grabody-T. It has a mechanism that activates immune T cells only in the tumor microenvironment where one of the cancer antigens, Claudin18.2, is expressed, and the activated T cells selectively attack Claudin18.2-positive cancer cells while sparing normal cells, minimizing the risk of toxicity in non-tumor tissue.

“These phase 1b results for ABL111 represent the first clinical data for a combination therapy from our Grabody-T-based pipeline, our 4-1BB bispecific antibody platform,” ABL Bio CEO Lee Sang-hoon said. “We will continue to work closely with I-Mab to successfully advance ABL111 into global clinical trials while further accelerating the development of other Grabody-T-based bispecific antibodies to enhance its value as a next-generation immuno-oncology drug.”