I-Mab Expands Investment In Lead Program Givastomig, A Claudin 18.2 x 4-1BB Bispecific Antibody, With Plans For Global Phase 2 Trial In 2026 & Phase 1b Data Readout In Early 2026, While Announcing Leadership Changes

I-Mab, a U.S.-based global biotech company specializing in precision immuno-oncology, has announced accelerated investment in its lead program, givastomig, an investigational Claudin 18.2 (CLDN18.2)-directed bispecific antibody targeting CLDN18.2 and 4-1BB. The company outlined plans to launch a global randomized Phase 2 study and additional Phase 1b cohorts, while also confirming its expectation to report Phase 1b dose expansion data in the first quarter of 2026. Alongside its clinical advancements, I-Mab also announced leadership changes, including the appointment of Mr. Wei Fu as Executive Chairman and Dr. Sean Cao as Chief Business Development Officer.

According to I-Mab’s CEO, Sean Fu, PhD, progress made in 2025, including strong Phase 1b combination data and positive investigator feedback, has strengthened confidence in givastomig’s potential to become a best-in-class Claudin 18.2 therapy for first-line metastatic gastric cancer. The company is now expanding its investment in the program with a global Phase 2 trial set to begin in early 2026. Executive Chairman Wei Fu emphasized that the company remains focused on clinical advancement and value creation, supported by a strong financial position.

The givastomig clinical program includes multiple studies targeting gastric cancer and other gastrointestinal malignancies. In first-line metastatic gastric cancer, Phase 1b dose expansion cohorts are testing givastomig in combination with nivolumab and chemotherapy at two dose levels, with data expected in early 2026. A global randomized Phase 2 trial will compare givastomig plus nivolumab and chemotherapy against nivolumab and chemotherapy alone, with progression-free survival data expected in 2027. Another Phase 1b cohort will evaluate givastomig with chemotherapy in “Double-Low” gastric cancer patients, who have low CLDN18.2 and PD-L1 expression and currently lack effective treatment options beyond chemotherapy.

Beyond gastric cancer, I-Mab plans to expand givastomig studies into other CLDN18.2-positive gastrointestinal cancers, including pancreatic ductal adenocarcinoma and biliary tract cancer, through additional Phase 1b cohorts. Investigator-initiated trials are also broadening evaluation of givastomig in neoadjuvant settings, including a study led by Dr. Kohei Shitara in Japan for locally advanced gastric cancers and a study led by Dr. Jeremy Kratz at the University of Wisconsin for resectable pancreatic cancer.

On the governance side, the Board has elevated Mr. Wei Fu to Executive Chairman, building on his existing role as Chairman, and appointed Dr. Sean Cao as Chief Business Development Officer. Dr. Cao, who will dedicate part of his time to I-Mab, brings experience from CBC Group and affiliates and will help drive future business development activities.