ROCKVILLE, Md. - I-Mab (NASDAQ: IMAB), a biotech firm specializing in cancer immunotherapies, revealed encouraging preliminary results from its Phase 1 clinical trial of givastomig, a novel bispecific antibody immunostimulant, at the European Society for Medical Oncology (ESMO) Congress 2024. The study focuses on patients with advanced gastric cancers, including gastroesophageal carcinoma (GEC), expressing the protein Claudin 18.2.
The investigational drug givastomig targets Claudin 18.2-positive tumor cells and activates T cells via the 4-1BB pathway within the tumor microenvironment. The trial demonstrated efficacy in patients who have undergone extensive prior treatments, with a reported objective response rate (ORR) of 16.3% and a disease control rate (DCR) of 48.8% among the 43 participants. Notably, responses were observed across a spectrum of Claudin 18.2 expression levels, even in those who had previously received checkpoint inhibitors.
The recommended Phase 2 dose of givastomig was established between 8-12 mg/kg, with the treatment being well tolerated up to the highest doses tested. No dose-limiting toxicities were reported, and the most common treatment-related adverse events were of mild severity.
Currently, a Phase 1b study is underway to assess givastomig in combination with the standard-of-care treatments nivolumab and chemotherapy in first-line gastric cancer patients. Results from this combination study are anticipated in the second half of 2025.
The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to givastomig in March 2022 for the treatment of gastric cancer, including cancer of the gastroesophageal junction. I-Mab is developing the drug in partnership with ABL Bio, sharing worldwide rights outside of China and South Korea.
The optimistic view of givastomig’s potential as a differentiated therapy for gastric cancers was reinforced by Dr. Phillip Dennis, Chief Medical Officer of I-Mab. He expressed enthusiasm for the ongoing program and the forthcoming results from the combination therapy study.
This update on givastomig's clinical progress is based on a press release statement from I-Mab.
In other recent news, I-Mab has been making significant strides in its drug development programs. The company has unveiled Phase 1 data for uliledlimab, a potential treatment for metastatic non-small cell lung cancer, which has shown promise in treatment-naïve patients. The data will guide dose selection for upcoming studies, including a randomized Phase 2 trial with pembrolizumab and chemotherapy slated for the first half of 2025.
Furthermore, I-Mab presented updated data on its drug candidate, givastomig, at the European Society for Medical Oncology. The findings from the Phase I study in patients with CLDN18.2 positive gastric, esophageal, and gastroesophageal junction cancers indicate a favorable safety profile for the drug candidate, according to Piper Sandler. The firm maintains an Overweight rating on I-Mab, anticipating that givastomig will be well-positioned as it progresses into combination trials.
In terms of financials, I-Mab has reported a cash balance of $207.5 million as of mid-2024, with reserves expected to support operations until 2027. This follows a restructuring process that included the divestiture of its operations in China and the formation of a new U.S.-based leadership team. The company is focusing on three oncology programs, with uliledlimab as the leading candidate, and has received FDA clearance for a combination study of uliledlimab with pembrolizumab and chemotherapy. These recent developments reflect I-Mab's strategic focus on advancing cancer immunotherapy.
InvestingPro Insights
As I-Mab (NASDAQ: IMAB) continues to make strides in the development of givastomig for advanced gastric cancers, the company’s financial health and market performance provide additional context for investors. With a market capitalization of $85.51 million, I-Mab demonstrates a substantial commitment to its research and clinical programs, despite a challenging financial landscape for biotech firms.
One of the key InvestingPro Tips for IMAB is its strong cash position relative to its debt, which is a positive sign for stakeholders. This liquidity is crucial for sustaining operations and funding ongoing clinical trials like those for givastomig. Additionally, the company's liquid assets surpass its short-term obligations, further underlining its financial resilience in a competitive and capital-intensive industry.
InvestingPro Data reveals a noteworthy revenue growth of 101.38% in the last twelve months as of Q2 2024, signaling a significant increase in the company's financial intake, which may be attributed to strategic partnerships or advancements in its clinical pipeline. However, it's important to note that analysts do not anticipate the company will be profitable this year, and the stock is trading near its 52-week low. These factors suggest that while the company has potential, it also faces challenges and uncertainties that investors should consider.
For those interested in deeper analysis, InvestingPro offers additional InvestingPro Tips on IMAB, providing a comprehensive view of the company's financial metrics and market performance. Currently, there are 7 more tips available, which can be accessed for those looking to make an informed investment decision.
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