[Shanghai, Suzhou, Chengdu, China, March 21, 2025] — Immunofoco, a company dedicated to developing cell therapy products for solid tumors, today announced that its independently developed EpCAM-targeting autologous CAR-T cell therapy, IMC001, has been granted clearance by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its second Investigational New Drug (IND) application, with the acceptance number CXSL2400901. This IND application is aimed at treating EpCAM-positive epithelial advanced solid tumors. Previously, IMC001 had obtained IND approvals in both China and the United States in February 2024 for the treatment of EpCAM-positive advanced gastrointestinal tumors.
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. Despite challenges such as the complexity of the solid tumor microenvironment and target heterogeneity, IMC001 has demonstrated favorable safety and preliminary efficacy in earlier clinical trials for gastrointestinal tumors, owing to its unique target selection and innovative design. This additional indication aims to further explore its clinical potential.
In the poster presentations at the 2024 ASCO and CSCO conferences, the IIT clinical study data of IMC001 demonstrated that among 10 evaluable patients with advanced gastric cancer, the disease control rate was 90%, with one patient in the low-dose group 33.3% and two in the middle-dose group 40% achieved a partial response (PR). The median overall survival (OS) in the medium-dose group exceeded 55 weeks. One patient in the middle-dose group achieved a confirmed PR by Week 24, leading to a radical gastrectomy at Week 27, and the patient had survived for more than 22 months by the cutoff date.
The clearance of this additional IND represents a pivotal milestone in expanding IMC001’s clinical exploration scope from gastrointestinal tumors to a broader spectrum of epithelial solid tumors, including small-cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and other malignancies.
Dr. Minmin Sun, Founder, Chairman, and CEO of Immunofoco Biotech, stated, “The indication aligns with our clinical strategy of ‘curing solid tumors as if they were hematologic malignancies’ to unlock IMC001’s therapeutic potential. Leveraging EpCAM’s target mechanism and existing data, IMC001 may pioneer novel approaches for treating epithelial solid tumors, preventing post-operative recurrence, enabling synergistic combination therapies, and facilitating conversion surgery. We will steadily advance its registrational clinical studies.”
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.
Reference
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