I-Mab’s givastomig shows promising results in gastric cancer study

ROCKVILLE, MD - I-Mab (NASDAQ:IMAB), a clinical-stage biotech company whose stock has surged over 200% in the past six months, announced Monday that data from its first-in-human study of givastomig, a bispecific antibody targeting Claudin 18.2 and 4-1BB, has been published in Clinical Cancer Research. According to InvestingPro data, the company maintains a strong liquidity position with cash reserves exceeding its debt obligations.

The Phase 1 monotherapy study showed givastomig achieved a 16% objective response rate in heavily pretreated Claudin 18.2-positive gastric cancer patients. After the data cutoff, an additional confirmed partial response increased the rate to 18% across 45 patients. While the company is currently unprofitable as typical for clinical-stage biotechs, InvestingPro analysis suggests I-Mab is undervalued relative to its potential, with analyst price targets ranging from $5 to $7.

The study evaluated 75 patients with gastric cancers or other solid tumors, including 43 efficacy-evaluable patients with Claudin 18.2-positive advanced or metastatic gastroesophageal carcinoma. Patients had received a median of three prior lines of therapy.

The drug demonstrated activity across tumors with Claudin 18.2 expression ranging from 11% to 100%, suggesting effectiveness even in cases with low expression levels. Five of the seven patients who achieved partial responses had previously received checkpoint inhibitor therapy.

No dose-limiting toxicity was reported up to 15 mg/kg dosed every two weeks, and 18 mg/kg dosed every three weeks. The most common treatment-related adverse events were mainly Grade 1 or 2.

"Givastomig monotherapy demonstrated an ORR of ~18% in heavily pre-treated gastric cancer patients, across a wide range of Claudin 18.2 expression levels, with a 9.4-month median duration of response," said Phillip Dennis, Chief Medical Officer of I-Mab.

The company is currently evaluating givastomig in combination with nivolumab plus chemotherapy as a first-line treatment for gastric cancers. Initial data from this ongoing Phase 1b combination study will be presented at the ESMO Gastrointestinal Cancers Congress on July 2 in Barcelona. For investors interested in deeper analysis, InvestingPro offers comprehensive research reports covering I-Mab’s financial health, market position, and growth prospects, along with 8 additional ProTips that could inform investment decisions.

The findings were based on a press release statement from I-Mab.

In other recent news, I-Mab has reported promising results from a Phase 1b study of its bispecific antibody, givastomig, in combination with other treatments for metastatic gastric cancers. The study highlighted a 71% overall response rate, with an 83% response rate at selected doses, and a favorable safety profile. Meanwhile, H.C. Wainwright reiterated its buy rating on I-Mab, citing strong cancer data and a price target of $7.00, emphasizing the potential of givastomig as a key value driver. Additionally, Lucid Capital Markets initiated coverage with a buy rating and a $5.00 price target, reflecting confidence in the drug’s market potential. I-Mab has also regained compliance with Nasdaq’s minimum bid price requirement, ensuring continued trading on the exchange. The company holds cash and equivalents of approximately $168.6 million, providing a financial runway through several key data readouts into 2027. These developments come as I-Mab prepares to present further results at the ESMO GI conference, with expectations for givastomig’s impact on the gastric cancer market. Investors are closely watching the company’s strategic direction and the potential of its therapeutic pipeline.

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