SHANGHAI, Jan. 13, 2026 /PRNewswire/ -- Immunofoco, a clinical-stage biotechnology company advancing innovative CAR-T cell therapies for solid tumors, recently announced clinical data from its Phase I/IIa study of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, in patients with advanced gastric cancer and gastroesophageal junction cancer (GC/GEJ). The data were presented as a poster (Abstract No. 398) at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2026).
The study is a multicenter, open-label, dose-escalation Phase I/IIa trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ who had failed at least two prior lines of systemic therapy. The results presented at ASCO GI 2026 focus on the GC/GEJ cohort.
As of the data cutoff on August 8, 2025, 16 patients had received a single infusion of IMC002 and were included in the safety analysis, with 15 patients evaluable for efficacy. IMC002 demonstrated a favorable and manageable safety profile, with no dose-limiting toxicities observed during the dose-escalation phase. Cytokine release syndrome (CRS) occurred in all patients but was limited to Grade 1 or 2, and no Grade ≥3 CRS, ICANS, or treatment-related deaths were reported.
In evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7% (10/15). Survival data were immature at the time of analysis, with a median progression-free survival (mPFS) of 7.0 months (95% CI: 3.9, NA) and a median overall survival (OS) of 10.3 months (95% CI: 6.1, NA).
Notably, one patient in the 2.5×10⁸ CAR-T cell dose cohort achieved a complete response (CR) and has remained tumor-free for 60 weeks, demonstrating antitumor activity following IMC002 treatment in a heavily pretreated setting.
Further analyses indicated that IMC002 provided clinically meaningful PFS benefits in third-line and later-line GC/GEJ patients, comparing favorably with historical outcomes reported for this population. Together with its well-tolerated safety profile, these findings support the continued clinical development of IMC002 and its potential evaluation in earlier-line treatment settings.
"IMC002 demonstrated a controllable safety profile and encouraging antitumor activity in patients with advanced gastric and gastroesophageal junction cancers, including those who had failed multiple prior lines of therapy," said Professor Jianming Xu, corresponding author of the study and Professor at the First Medical Center of the Chinese PLA General Hospital. "Of particular clinical significance, one patient achieved a complete response lasting for more than one year. These findings provide important clinical evidence supporting the application of CLDN18.2-targeted CAR-T therapy in solid tumors, and the favorable safety profile also opens the possibility for future exploration in earlier-line settings and strategies aimed at long-term clinical benefit."
IMC002 is a novel CLDN18.2-targeted CAR-T cell therapy incorporating a highly specific VHH domain, designed to enhance tumor targeting while maintaining a favorable safety profile in solid tumors. Based on the encouraging results from this Phase I/IIa study, a Phase III randomized controlled trial of IMC002 in late-line GC/GEJ patients has been initiated.
The presentation at ASCO GI 2026 highlights Immunofoco's continued progress in advancing CAR-T cell therapies for solid tumors and underscores the therapeutic potential of CLDN18.2-targeted approaches in addressing significant unmet medical needs in advanced gastrointestinal cancers.
About Immunofoco
Immunofoco is a clinical-stage biotech company, devoted to developing innovative immune cell therapies for patients with solid tumors worldwide. The company was established in September 2020 in Zhangjiang, Shanghai, by a team of renowned scientists and industry experts who achieved the approval of the first CAR-T product in China.
Immunofoco has developed several innovative platforms that overcome the treatment challenges of solid tumors. These platforms, such as Peri Cruiser, SNR, T-Booster, FOCO-CAR, Solid Guard are designed to improve the safety and efficacy of CAR-T products by 1) limiting CART entry to normal tissues, 2) counteracting tumor heterogeneity, 3) enhancing CART activation, proliferation and infiltration, We also developed iMagic platform that utilizes a noval fusogen and T-cell targeting modules to allow effecient T-cell transduction and CART generation in vivo.
Committed to addressing unmet clinical needs, our company has built a diverse and robust product pipeline. Notably, IMC002, a CLDN18.2-targeted CAR-T therapy, has progressed to a Phase III pivotal trial in China. This milestone follows the U.S. FDA and Chinese NMPA approvals of its Investigational New Drug (IND) applications in April 2023. IMC002 has also received significant regulatory recognitions from the U.S. FDA, including Fast Track Designation (FTD), Regenerative Medicine Advanced Therapy (RMAT) designation, and Orphan Drug Designation for both gastric cancer and pancreatic cancer. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, and its IND application has been approved in both the U.S. and China in February 2024, followed by the approval of a second IND in China in March 2025. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approvals from the U.S. FDA in August 2023. IMV101（in vivo CAR-T）has also rapidly moved to the IIT stage.
In August 2022, we successfully completed the construction validation of our nearly 2500m2 GMP plant in Suzhou and commenced operations. In December 2025, the company established its operational headquarters in the Shenzhen Qianhai Free Trade Zone to further promote the comprehensive development of the company's international business.
The company upholds the development concept of "collaboration, aspirations, striving for new heights," by assembling industry talents and expert support to jointly develop innovative cell therapies that provide long-term survival benefits to patients with solid tumors. For more information about Immunofoco, please visit the company's website at www.immunofoco.com.
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