I-Mab announces accelerated investment in givastomig program

I-Mab (IMAB) announced accelerated investment in its lead program, givastomig, an investigational Claudin 18.2-directed bispecific antibody, including plans to initiate a global randomized Phase 2 study and additional Phase 1b cohorts. The Company also reiterated its expectations to report Phase 1b dose expansion data in Q1 2026. In addition, I-Mab announced leadership additions, including the appointment of Mr. Wei Fu as Executive Chairman, and the appointment of Dr. Sean Cao as Chief Business Development Officer. 1L Gastric Cancer Studies: Phase 1b dose expansion data expected in Q1 2026: Phase 1b dose expansion cohorts evaluating givastomig at two dose levels in combination with nivolumab and chemotherapy as a first-line treatment for patients with metastatic gastric cancers. Initiation of a global randomized Phase 2 study in 1L metastatic gastric cancers: The Company intends to initiate a randomized Phase 2 study in 1L metastatic gastric cancers evaluating givastomig in combination with nivolumab and chemotherapy versus nivolumab and chemotherapy alone. Progression free survival data are expected in 2027. Initiation of a 1L metastatic GC cohort for patients who do not qualify for checkpoint inhibitors or the existing approved CLDN18.2 1L GC therapy: The Company intends to initiate an additional Phase 1b cohort evaluating givastomig in combination with chemotherapy as a 1L treatment for patients with metastatic gastric cancers whose tumors express Claudin 18.2 in less than75% of cells and CPS scores less than1, known as patients. This population represents a significant unmet medical need since these patients are not eligible to receive the existing approved CLDN18.2-directed therapy or immunotherapies. The current standard of care is chemotherapy alone in this patient population. Expansion of Givastomig into Gastrointestinal Malignancies Characterized by CLDN18.2 Expression: 1L Pancreatic Ductal Adenocarcinoma: The Company intends to initiate an additional Phase 1b cohort in 1L, CLDN18.2-positive PDAC evaluating givastomig in combination with chemotherapy. 1L Biliary Tract Cancer: The Company intends to initiate an additional Phase 1b cohort in 1L, CLDN18.2-positive BTC evaluating givastomig in combination with a checkpoint inhibitor and chemotherapy. Investigator Initiated Trials Broaden Evaluation into Other Tumor Types in a Neoadjuvant Setting: Dr. Kohei Shitara, National Cancer Center Hospital East, Japan: A single arm study evaluating givastomig in combination with a checkpoint inhibitor and chemotherapy as a 1L neoadjuvant therapy for locally advanced, CLDN18.2-positive, resectable gastric cancers. Dr. Jeremy Kratz, University of Wisconsin, sponsored by the Department of Veterans Affairs: A single arm study evaluating givastomig in combination with chemotherapy as a 1L neoadjuvant therapy for CLDN18.2-positive, resectable pancreatic cancer. Governance and Leadership Updates: Mr. Wei Fu, the current Chairman of the Board of Directors has been appointed to the role of Executive Chairman by the Board. Additionally, the Board has appointed Dr. Sean Cao to the newly created role of Chief Business Development Officer (CBO). Dr. Cao will devote approximately half of his professional time to I-Mab to further support I-Mab’s growth. Dr. Cao joins I-Mab from CBC Group and affiliates, bringing expertise in business development.