Updated clinical results from I-Mab’s Phase 1 study of givastomig in the treatment of advanced solid tumors, including gastric cancer, will be reported in a poster presentation at the upcoming European Society for Medical Oncology (ESMO 2023) Congress, on Monday, October 23 at 12:00 p.m. CET.
Also known as TJ-CD4B or ABL111, Givastomig is a bispecific antibody designed to bind to Claudin 18.2 (CLDN 18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. The investigational agent binds to tumor cells expressing various levels of Claudin18.2 (CLDN18.2), i.e., gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T cells at the tumor site through the 4-1BB arm.
Claudin18.2 (CLDN18.2) is a tight junction protein that has been identified as a clinically proven target in gastric cancer. Stimulation of 4-1BB with agonistic antibodies is also a promising strategy for immunotherapy.
Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin18.2 (CLDN18.2) antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class.
The drug is being developed by I-Mab in collaboration with ABL Bio, a clinical-stage biotechnology company in South Korea.
Givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.
First-In-Human Phase I Study of Givastomig, A Novel Claudin 18.2/4-1BB Bispecific Antibody in Advanced Solid Tumors
Dr. Geoffrey Ku, Memorial Sloan Kettering Cancer Center
Poster Presentation: Investigational Immunotherapy
Hall 8, IFEMA Madrid, Spain
Monday, October 23, 2023, 12:00 p.m. – 1:00 p.m. CET
 Gao J, Wang Z, Jiang W, Zhang Y, Meng Z, Niu Y, Sheng Z, Chen C, Liu X, Chen X, Liu C, Jia K, Zhang C, Liao H, Jung J, Sung E, Chung H, Zhang JZ, Zhu AX, Shen L. CLDN18.2 and 4-1BB bispecific antibody givastomig exerts antitumor activity through CLDN18.2-expressing tumor-directed T-cell activation. J Immunother Cancer. 2023 Jun;11(6):e006704. doi: 10.1136/jitc-2023-006704. PMID: 37364935; PMCID: PMC10410885.
General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 – October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.