Shanghai, Suzhou, Chengdu, China, August 13, 2025 — Immunofoco Biotech, a company dedicated to developing cell therapy products for solid tumors, announced that the latest research findings of its independently developed EpCAM-targeted CAR-T cell therapy IMC001 have been formally published in the journal Molecular Therapy. The study underscores IMC001’s remarkable antitumor efficacy and favorable safety profile, as demonstrated in preclinical models and clinical trials involving patients with advanced gastric cancer. Notably, IMC001 achieved an objective response rate (ORR) of 40% at the medium dose, with no dose-limiting toxicity observed, underscoring its therapeutic promise.
Epithelial cell adhesion molecule (EpCAM) is highly expressed on various epithelial-derived tumor tissues, including esophageal cancer, colorectal cancer, pancreatic cancer, ovarian cancer, lung cancer, gastric cancer, and breast cancer. In contrast, its expression is relatively low in normal tissues. In a study, EpCAM expression was not detected in 129 cases of normal gastric mucosa, but it was observed in 77% of gastric cancer cases, with 56% showing moderate to high expression. Due to the shift of EpCAM from the basal-lateral side to the cell membrane surface following malignant transformation, and its high expression in primary lesions, metastatic lesions, and circulating tumor cells, EpCAM has emerged as a potential target for CAR-T cell therapy, demonstrating its potential value in the treatment of various epithelial-derived tumors.
Despite the complex tumor microenvironment and target heterogeneity that have historically hindered CAR-T therapy’s progress in solid tumors, IMC001 has shown robust antitumor activity in preclinical studies, thanks to its unique target selection and innovative design. The therapy demonstrated efficient cytotoxicity against EpCAM-positive tumor cells in patient-derived organoid (PDO) models and mouse models, confirming its efficacy in preclinical research.
Addressing core unmet needs in solid tumors, Immunofoco has pioneered a strategy of curing the solid tumors by treating them as hematologic malignancies and has developed the EpCAM-targeted CAR-T cell candidate, IMC001. The company has collaborated with Changhai Hospital in Shanghai and the First Affiliated Hospital of Zhejiang University to conduct clinical studies on advanced digestive system tumors, including advanced gastric cancer.
Professor Luo Tianhang from Changhai Hospital, the study’s principal investigator, stated, "While surgery can remove visible solid tumors, residual CTCs often drive recurrence. IMC001’s precision targeting of EpCAM could eliminate these CTCs, reducing the risk of postoperative recurrence and bringing new hope to patients."
Dr. Ruidong Hao, partner and head of the R&D center at Immunofoco, added, "The early clinical research and trial data for IMC001 in patients with advanced gastric cancer not only validate EpCAM as a viable CAR-T treatment target but also highlight its broad potential in treating gastric cancer and other epithelial solid tumors. We are accelerating global collaborations to advance this innovative therapy."
IMC001 is the first EpCAM-targeted solid tumor CAR-T product to receive IND approval in both the United States and China. The product received IND approval for the treatment of advanced digestive system tumors with EpCAM expression in February 2024. An additional IND application for the treatment of advanced epithelial solid tumors was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China in March 2025. Immunofoco is advancing clinical registration trials to expedite patient access.
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, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) has been granted Fast Track designation and orphan drug designations (ODDs) for gastric and pancreatic cancers by the U.S. FDA, and its IND application received approval in both the United States and China in April 2023. 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.
