Eureka Biologics Announces Promising Phase 1/2a Clinical Data of CLDN18.2-Targeted CAR-T Therapy IMC002 in Advanced Gastric and Gastroesophageal Junction Cancer
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
On January 10, Immunofoco announced the publication of its independently developedCLDN18.2-Targeted Nanobody (VHH) CAR-T Cell Therapy ProductIMC002 in ChinaAdvanced Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJ)Latest Data from Phase 1/2a Clinical Study in Patients.
IMC002 is a novel CAR-T cell therapy product targeting CLDN18.2.Designed with highly specific nanobody (VHH) domains to enhance safety and efficacy in solid tumor treatment.. This study is a multicenter, open-label, dose-escalation Phase 1/2a clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in CLDN18.2-positive advanced GC/GEJ patients who have failed multiple lines of treatment.
As of the data cutoff date (August 8, 2025), a total of 16 patients had received a single infusion of IMC002 and were all included in the safety analysis. Among them, 15 patients were evaluable for efficacy. The study results showed that IMC002 demonstrated excellent safety profiles and encouraging anti-tumor activity in this population.
In terms of safety, no dose-limiting toxicity (DLT) was observed during the study period. All patients experienced treatment-related adverse events (TRAEs), with cytokine release syndrome (CRS) being grade 1–2 only; no grade 3 or higher CRS was reported, nor were any instances of ICANS or treatment-related deaths observed, demonstrating an overall excellent safety profile.
In terms of efficacy, among 15 evaluable patients,Objective Response Rate (ORR) Reached 66.7%. As of now,The median progression-free survival (mPFS) was 7 months, and the median overall survival (OS) was 10.3 months.。
Notably, one patient treated with the 2.5×10^8 dose group experienced complete disappearance of the tumor lesion, achieving complete remission (CR), which has been sustained for 60 weeks in a state of continued complete remission.
In patients who failed third-line or higher treatments, IMC002 still demonstrated clinically meaningful relief and PFS benefits, showing its potential in the treatment of advanced gastric/GEJ cancer.
Based on the results of this study,Immunofoco has initiated a Phase 3 randomized controlled clinical trial of IMC002 in patients with advanced GC/GEJ.，To further verify efficacy and safety. This data release marks Immunofoco's continued progress in the field of CAR-T for solid tumors, particularly in indications with high unmet clinical needs such as gastric cancer, offering new hope for patients with advanced gastric/GEJ cancer.
References:
[1]Objective Response Rate 66.7%, Sustained Complete Response Over One Year! Immunofoco's IMC002 Phase I/IIa Clinical Data for Advanced Gastric/Gastroesophageal Junction Cancer Released. From https://mp.weixin.qq.com/s/3nPO1Nud6VnkItI6uPpTmw
Disclaimer: This article is for information exchange purposes only. The views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes the views mentioned. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.