#China #Shanghai #CAR-T therapy #Immunofoco #IMC002

Immunofoco Reports Phase I/IIa Clinical Data of IMC002 at ASCO GI 2026

In January 2026, Immunofoco, a burgeoning biotechnology company focused on CAR-T cell therapies, presented pivotal Phase I/IIa data on its innovative therapy, IMC002, at the ASCO Gastrointestinal Cancers Symposium. This presentation, specifically highlighting outcomes in patients with advanced gastric cancer and gastroesophageal junction cancer, garnered significant attention from the oncology community.

Trial Design and Objectives
The trial is a multicenter, open-label, dose-escalation study aimed to assess the safety, tolerability, and preliminary efficacy of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy. This treatment was specifically designed for patients with CLDN18.2-positive, locally advanced or metastatic gastric cancer who had not responded to at least two prior lines of systemic therapy. As of the data cutoff on August 8, 2025, the study included 16 patients for safety analysis and 15 for efficacy assessment.

Safety Profile and Efficacy Results
Patients receiving IMC002 demonstrated a favorable safety profile, with no dose-limiting toxicities observed throughout the dose-escalation phase. Although all patients experienced cytokine release syndrome (CRS), it remained manageable, limited to Grades 1 or 2, and no serious adverse events were recorded. The encouraging efficacy results saw an overall response rate (ORR) of 66.7%, indicating that 10 out of 15 evaluable patients responded positively to the treatment.

Additionally, survival metrics showed a median progression-free survival (mPFS) of 7.0 months and a median overall survival (OS) of 10.3 months at the time of analysis, highlighting the potential of IMC002 in this heavily pretreated patient population. Impressively, one patient in the cohort treated with a higher CAR-T cell dose managed to achieve a complete response, remaining tumor-free for over 60 weeks.

Significance of the Findings
Professor Jianming Xu, the study’s corresponding author, emphasized the clinical relevance of these results, stating that IMC002 exhibited remarkable antitumor activity, especially in patients who had exhausted multiple treatment options. The trial not only demonstrated safety but also highlighted the potential for IMC002 to address significant unmet medical needs in advanced gastrointestinal cancers, particularly in patients with limited therapeutic alternatives.

The study outcomes support continued clinical development efforts for IMC002, with potential evaluations in earlier treatment lines. The promising ORR and manageable safety profile underscore the importance of targeting CLDN18.2 in CAR-T therapy, offering hope for patients suffering from aggressive forms of cancer.

Next Steps for IMC002
Following these notable findings, Immunofoco has initiated a Phase III randomized controlled trial of IMC002 for late-line gastric cancer patients. This advancement signals the company's commitment to further exploring the therapeutic capabilities of CLDN18.2-targeted CAR-T therapies in solid tumors. The positive results from this Phase I/IIa study bolster Immunofoco's reputation as a leader in immunotherapy solutions designed to enhance patient outcomes.

About Immunofoco
Founded in 2020 and located in Shanghai, Immunofoco is dedicated to pioneering innovative immune cell therapies targeted at solid tumors worldwide. The company has rapidly developed a varied pipeline of products designed to address significant clinical challenges in oncology. Their focus on enhancing the safety and efficacy of CAR-T therapies aims to provide enduring solutions for patients battling complex cancers. The advancements and findings showcased at ASCO GI 2026 mark a significant milestone in their journey to revolutionize cancer treatment.

For more information about Immunofoco and its developments, visit their official website at www.immunofoco.com.