I-Mab(US:IMAB)2025-07-08 19:00Summary of I-Mab Biopharma KOL Webinar (July 08, 2025) Company and Industry Overview - Company: I-Mab Biopharma (IMAB) - Industry: Biopharmaceuticals, specifically focusing on gastric cancer treatments Key Points and Arguments 1. Introduction of Gvastomik: Gvastomik (18.241 bb bispecific) is being developed as an addition to the current standard of care for frontline gastric cancer, which is immunotherapy (IO) combined with chemotherapy [6][8] 2. Market Opportunity: The addressable market for gastric cancer treatment is estimated to be $12 billion by February 2030, highlighting significant unmet medical needs in this area [8][11] 3. Clinical Study Results: Initial data from ESMO GI indicates that Gvastomik can be safely added to the standard of care, showing improved efficacy in patients with metastatic gastric cancer [8][9] 4. Patient Coverage: Gvastomik has a broader patient coverage requirement (1% of tumor cells expressing 1+ staining intensity) compared to zolbituximab, which requires 75% or more, potentially doubling the patient population eligible for treatment [9][15] 5. Financial Position: I-Mab has $168 million on its balance sheet, positioning the company well to support ongoing clinical trials and readouts [10] Clinical Data Highlights 1. Monotherapy Efficacy: Gvastomik demonstrated an 18% objective response rate (ORR) in heavily pretreated gastric cancer patients, with a favorable toxicity profile [22][26] 2. Comparison with Competitors: Gvastomik's ORR is higher than that of zolbituximab (9% ORR) and shows a lower incidence of grade 3 or above treatment-related adverse events [23][25] 3. Combination Study Design: The phase one study design includes dose escalation and expansion, focusing on safety and efficacy in a frontline setting [32][35] 4. Response Rates: In the combination study, a 71% response rate was observed, with an 83% response rate in the expanded dose cohorts [40][52] 5. Progression-Free Survival (PFS): The six-month PFS rate is reported at 82% for expanded cohorts, indicating promising durability of response [44] Safety and Toxicity Profile 1. Toxicity Management: Gvastomik has shown a low incidence of severe adverse events, with no grade 3 or 4 nausea or vomiting reported [48][52] 2. Infusion Reactions: While some infusion-related reactions were noted, they were manageable with premedication strategies, contrasting with the longer infusion times required for zolbituximab [81][83] Future Outlook 1. Upcoming Data Releases: I-Mab plans to present updated monotherapy data in Q4 2025 and dose expansion data in Q1 2026, which will provide further insights into the efficacy and safety of Gvastomik [55] 2. Potential in Other Cancers: There is potential for Gvastomik in other gastrointestinal malignancies with high claudin 18.2 expression, such as pancreatic and biliary tract cancers [54] Additional Insights 1. Biomarker Landscape: The discussion highlighted the importance of biomarkers like PD-L1 and claudin 18.2 in patient selection for therapies, with ongoing research to understand their interplay [68][87] 2. Commercial Considerations: The competitive landscape includes other therapies targeting claudin 18.2, but Gvastomik's favorable toxicity profile may provide a commercial advantage [76][87] This summary encapsulates the critical insights from the I-Mab Biopharma KOL webinar, focusing on the company's developments in gastric cancer treatment and the promising data surrounding Gvastomik.