I-Mab advances gastric cancer treatment with swift trial enrollment

ROCKVILLE, Md. - I-Mab (NASDAQ: IMAB), a global biotech company specializing in precision immuno-oncology treatments with a market capitalization of $71 million, has announced the completion of enrollment for the first dose expansion cohort of its Phase 1b givastomig combination study ahead of schedule. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, positioning it well for continued clinical development. The study is focused on evaluating givastomig, a potential leading bispecific antibody, for the treatment of gastric cancer.

The Phase 1b clinical program, which includes both a dose escalation study with 17 participants and a 40-patient dose expansion study, is investigating givastomig’s safety, preliminary efficacy, and pharmacokinetics as a potential first-line treatment for gastric cancer. The drug is being evaluated in combination with standard care, including nivolumab (an anti-PD-1 checkpoint inhibitor) and chemotherapy. With the company’s next earnings report due on March 26, investors following this development can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US-listed companies.

Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab, expressed optimism regarding the program’s progress and recruitment momentum. He anticipates that the data from these studies will help establish an optimal dosing regimen and demonstrate givastomig’s potential to improve efficacy in the first-line treatment of gastric cancers.

Sam Klempner, MD, from Massachusetts General Hospital, highlighted the encouraging activity of givastomig across various CLDN18.2 expression levels and its tolerability in combination with standard treatments. The medical community is hopeful that the results will validate the activity of the CLDN18.2 x 4-1BB bispecific strategy in treating gastroesophageal cancers.

Givastomig (TJ033721 / ABL111) is designed to target CLDN18.2-positive tumor cells and activate T cells through the 4-1BB signaling pathway within the tumor microenvironment. The drug has shown promise in a Phase 1 monotherapy study, maintaining strong tumor-binding properties and anti-tumor activity while minimizing common toxicities associated with other 4-1BB agents.

The program is a joint effort with ABL Bio, where I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

Topline results from the 40-patient dose expansion study are expected in the first half of 2026, while data from the dose escalation study are anticipated in the second half of 2025. Currently trading at $0.87 per share, InvestingPro analysis suggests the stock is undervalued, despite showing a -50% return over the past year. The company’s Financial Health score stands at "Fair," with particularly strong metrics in cash flow management. This announcement is based on a press release statement from I-Mab.

In other recent news, I-Mab announced that its Chairman, Wei Fu, plans to purchase up to $2 million of the company’s American Depository Shares (ADSs). This move is seen as a demonstration of confidence in I-Mab’s strategic direction and its focus on increasing shareholder value. The company has prioritized its product portfolio around givastomig, a cancer treatment antibody, which is currently in clinical trials. Early results from these studies are anticipated in the latter half of 2025, with additional data expected in early 2026. I-Mab projects its financial resources to last until 2027, providing a runway for ongoing and future developments. The announcement, which was part of a press release, included forward-looking statements about the company’s pipeline and the timing of studies. These statements are subject to risks and uncertainties that could impact actual outcomes. The press release emphasized that such forward-looking statements fall under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995.

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