Shanghai, Suzhou & Chengdu, China — November 21, 2025 — Immunofoco Biotech announced that preclinical data for IMV103 (iMagic-18.2), its in vivo-generated CLDN18.2-targeted CAR-T therapy developed on the innovative iMagic platform, were presented at the American Society of Gene & Cell Therapy's (ASGCT) Breakthroughs in Targeted In Vivo Gene Editing symposium, held November 20-21, 2025, in San Diego, USA. The data were unveiled in a poster presentation.
The research focused on assessing the potential of IMV103 in treating gastric cancer. CLDN18.2, a tumor-associated antigen highly expressed in gastric, pancreatic and other solid tumors, represents a promising therapeutic target.
Efficient, Specific T-Cell Targeting and Transduction
IMV103 employs a T-cell–specific lentiviral vector engineered with a mutated MxV glycoprotein that ablates receptor binding yet preserves membrane fusion. Integrated with a next-generation T-cell targeting module, TCM3, the vector enables high-specificity binding to T-cell surface receptors, facilitating efficient transduction. In vitro studies confirmed that IMV103 robustly reprograms T cells into cytotoxic CAR-T cells whose potency rivals conventional ex vivo-manufactured CAR-T cells.
Low Exhaustion and Sustained Antitumor Activity
IMV103-generated CAR-T cells showed lower levels of exhaustion markers than conventionally prepared CAR-T cells, both at rest and upon activation, indicating superior persistence and sustained antitumor capacity. In an immunodeficient mouse model reconstituted with human peripheral blood mononuclear cells (PBMCs) and engrafted with the NUGC4-Luc gastric cancer cell line, a single dose of IMV103 successfully generated CAR-T cells in vivo, leading to potent and durable antitumor efficacy over an observation period exceeding 70 days.
Favorable Safety Profile and Application Potential
Pharmacokinetic analysis showed that a single intravenous administration of IMV103 induced the generation of CLDN18.2-specific CAR-T cells that persisted over time. Significant T-cell infiltration was observed in tumor tissue. The treatment was well tolerated throughout the study, with no notable adverse events or weight loss, supporting a favorable safety profile.
Dr. Ruidong Hao, Head of R&D at Immunofoco, stated, “These preclinical data confirm that IMV103 can safely and efficiently generate functional CAR-T cells in vivo, with low exhaustion characteristics and sustained antitumor activity. It holds particular promise for gastric cancer. More importantly, this platform technology could enable CAR-T therapy to be administered as conveniently as a conventional drug, significantly reducing costs and benefiting more patients with solid tumors.”
About IMV103
IMV103 (iMagic-18.2) is a novel in vivo CAR-T therapy targeting CLDN18.2, built on Immunofoco’s iMagic platform. The platform uses a T-cell–specific lentiviral vector coated with a mutated MxV glycoprotein that enables membrane fusion without receptor binding. Incorporated with the TCM3 targeting module, the vector achieves highly specific T-cell transduction. A single intravenous infusion of IMV103 delivers the CLDN18.2 CAR gene directly to T cells in vivo, generating functional CAR-T cells capable of killing tumor cells. IMV103 has demonstrated significant antitumor activity with a promising safety profile in mouse models of gastric cancer.
About Immunofoco
Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, T-Booster and In Vivo. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipelines. Notably, IMC002, a CLDN18.2-targeted CAR-T therapy, has progressed to a Phase III pivotal trial in China. This follows its IND approvals from both U.S. and Chinese authorities in April 2023, and it holds U.S. FDA Fast Track designation along with Orphan Drug Designations for both gastric 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, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.
