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ROCKVILLE - I-Mab (NASDAQ:IMAB), a clinical-stage biotech company currently valued at $188 million, announced positive Phase 1b data for its bispecific antibody givastomig in combination with nivolumab and mFOLFOX6 for gastric cancer treatment, according to a company press release. According to InvestingPro analysis, the company maintains a strong financial health score of 2.51/5, with more cash than debt on its balance sheet.
The data, presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress 2025 in Barcelona, showed a confirmed objective response rate of 83% at the doses selected for the ongoing expansion study (8 mg/kg and 12 mg/kg). The positive clinical results have contributed to the stock’s impressive 158% surge over the past six months, though InvestingPro data suggests the company remains undervalued based on its Fair Value analysis.
The study enrolled 17 treatment-naïve patients with metastatic gastric, esophageal or gastroesophageal adenocarcinomas who were HER2-negative and Claudin 18.2-positive. Responses were observed in patients with both low and high PD-L1 and Claudin 18.2 expression levels.
At a median follow-up of 9.0 months, 8 of 17 patients remained on treatment, with the longest duration reaching 13.3 months. The disease control rate was 100% across all dose levels.
The treatment demonstrated a favorable safety profile with primarily Grade 1 or 2 adverse events. No dose-limiting toxicities were observed, and only one Grade 3 treatment-related adverse event for increased liver enzymes was reported.
"Givastomig has been well tolerated when combined with immuno-oncology and chemotherapy, has shown a high objective response rate, with rapid onset and durable responses that have deepened over time," said Phillip Dennis, Chief Medical Officer of I-Mab.
Givastomig is designed to conditionally activate T cells through the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed. The company is currently conducting a Phase 1b dose expansion study following these results.
The bispecific antibody is being jointly developed through a global partnership with ABL Bio, with I-Mab as the lead party sharing worldwide rights, excluding Greater China and South Korea.
In other recent news, I-Mab has reported promising results from its Phase 1b study of givastomig, a bispecific antibody, in combination with nivolumab and chemotherapy for treating metastatic gastric cancers. The study revealed a 71% overall response rate, with an 83% response rate at specific doses, indicating potential effectiveness even in patients with low PD-L1 and Claudin 18.2 expression levels. Additionally, I-Mab announced that it has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the exchange. Analysts from H.C. Wainwright have maintained a buy rating on I-Mab with a price target of $7.00, citing the strong performance of givastomig as a key factor. Lucid Capital Markets also initiated a buy rating with a $5.00 price target, highlighting the potential market for givastomig in gastric cancer. The company’s ongoing development of givastomig, including its application in first-line metastatic gastric cancers, has drawn significant attention from investors. I-Mab is preparing to present further data at the ESMO Gastrointestinal Cancers Congress. These developments underscore I-Mab’s strategic focus on advancing its cancer therapeutics pipeline.
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