I-Mab to initiate phase 2 study for gastric cancer drug in Q1 2026

ROCKVILLE, Md. - I-Mab (NASDAQ:IMAB), a $503 million market cap biotech company whose stock has surged over 400% in the past six months, plans to accelerate investment in its lead cancer drug givastomig with a global randomized Phase 2 study for metastatic gastric cancer set to begin in Q1 2026, the company announced Monday. According to InvestingPro data, the company maintains a strong financial position with liquid assets exceeding short-term obligations.

The biopharmaceutical firm reiterated expectations to report topline data from its ongoing Phase 1b dose expansion study in the first quarter of next year. The company also intends to expand the drug’s development into locally advanced gastric cancer and other tumor types including biliary tract cancer and pancreatic ductal adenocarcinoma. With analyst price targets ranging from $5 to $8 per share, Wall Street appears optimistic about the company’s pipeline potential.

Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells that conditionally activates T cells through the 4-1BB signaling pathway. The drug is being developed as a first-line treatment for metastatic gastric cancers.

The company also announced leadership changes, with Board Chairman Wei Fu appointed as Executive Chairman and Sean Cao joining as Chief Business Development Officer.

"Based on these accomplishments, we are expanding our investment in givastomig, with plans to initiate a randomized Phase 2 study in Q1 2026," said Sean Fu, Chief Executive Officer of I-Mab, in the press release.

The Phase 2 study will evaluate givastomig in combination with nivolumab and chemotherapy versus nivolumab and chemotherapy alone, with progression-free survival data expected in 2027.

I-Mab is also planning additional Phase 1b cohorts, including one for gastric cancer patients whose tumors express low levels of Claudin 18.2 and have low PD-L1 expression, a group not eligible for existing approved therapies.

The company is jointly developing givastomig through a global partnership with ABL Bio, sharing worldwide rights equally except for Greater China and South Korea.

In other recent news, I-Mab has reported its Q2 2025 financial results, which were followed by Brookline Capital Markets raising its price target for the company from $6 to $8, while maintaining a Buy rating. This decision was influenced by promising Phase 1b dose escalation data for I-Mab’s cancer treatment, givastomig, in combination with nivolumab and chemotherapy. H.C. Wainwright also reiterated its Buy rating with a $7 price target, citing strong trial data showing an 83 percent objective response rate for givastomig in first-line metastatic gastric cancers.

Additionally, I-Mab completed enrollment ahead of schedule for its Phase 1b dose expansion cohorts in the givastomig trial, with results expected in the first quarter of 2026. In a strategic move, I-Mab has acquired Bridge Health Biotech Co., Ltd., securing upstream rights to the CLDN18.2 parental antibody used in givastomig. This acquisition eliminates future royalty obligations and reduces milestone payments previously owed to Bridge Health. The company presented positive data at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025, confirming an 83% response rate for givastomig in gastric cancer treatment.

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