I-Mab completes enrollment for givastomig trial ahead of schedule

Published 11/08/2025, 12:18
I-Mab completes enrollment for givastomig trial ahead of schedule

ROCKVILLE, Md. - I-Mab (NASDAQ:IMAB), a clinical-stage biopharmaceutical company with a market capitalization of $392 million, announced Monday that enrollment in the Phase 1b dose expansion cohorts for its bispecific antibody givastomig has been completed ahead of schedule. The trial is evaluating the drug in combination with nivolumab and mFOLFOX6 as a first-line therapy for patients with Claudin 18.2-positive gastric cancers. The company’s stock has shown remarkable momentum, with InvestingPro data showing a 252% return over the past six months.

The study enrolled 40 patients across two dosage levels (8 mg/kg and 12 mg/kg) at U.S. clinical sites. Topline results from the trial are expected in the first quarter of 2026, according to the company’s press release.

Earlier data from the dose escalation portion of the trial, presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress on July 2, showed an 83% objective response rate among 12 patients at the selected doses. The company reported that responses were rapid, durable and deepened over time. According to InvestingPro, I-Mab maintains a strong financial position with more cash than debt on its balance sheet, providing runway for continued clinical development. Subscribers can access 8 additional ProTips and comprehensive financial analysis through the Pro Research Report.

Givastomig targets Claudin 18.2-positive tumor cells and conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment. The primary endpoint of the current Phase 1b study is safety.

"I am encouraged by the Phase 1b dose escalation data, and hopeful that givastomig can become a new treatment option for patients with Claudin 18.2-positive gastric cancers," said Phillip Dennis, Chief Medical Officer of I-Mab. With analyst price targets ranging from $5 to $7 per share and the next earnings report due on September 2, investors seeking detailed analysis can access comprehensive metrics and valuation models through InvestingPro’s exclusive research platform.

The drug is being jointly developed through a partnership with ABL Bio, with I-Mab leading development and sharing worldwide rights outside of Greater China and South Korea.

In other recent news, I-Mab has reported significant developments regarding its cancer therapy, givastomig. The company announced positive Phase 1b data for givastomig in combination with nivolumab and mFOLFOX6, achieving an impressive 83% objective response rate at selected doses in a gastric cancer study. This data was presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025. Additionally, I-Mab published results from its first-in-human study of givastomig, showing an 18% objective response rate in heavily pretreated Claudin 18.2-positive gastric cancer patients. 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, which will eliminate future royalty obligations and reduce milestone payments. H.C. Wainwright has maintained its buy rating for I-Mab, noting the strong performance of givastomig in recent trials. The firm’s analysis highlighted a 71% overall response rate across all dose levels in the Phase 1b study. These developments underscore I-Mab’s ongoing efforts to advance its cancer treatment portfolio.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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