IMC001 has demonstrated good tolerability and preliminary efficacy in IIT clinical studies
The first EpCAM-targeted CAR-T product to receive IND approval
The high expression of EpCAM in various epithelial-derived tumors makes it a promising therapeutic target
Shanghai, Suzhou, Chengdu, China, December 20, 2024 — 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 acceptance 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. 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. Additionally, research has shown that EpCAM is expressed in 100% of patients with metastatic breast cancer. 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.
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 (1/3, 33.3%) and two in the middle-dose group (2/5, 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. Analysis of tumor immune microenvironment suggested that an inflamed tumor environment may favor the anti-tumor effects of IMC001.
Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, remarked, "IMC001, our pioneering CAR-T therapy for solid tumors, embodies our strategy of 'curing solid tumors as if they were hematologic malignancies.' EpCAM is a biomarker for circulating tumor cells (CTCs), which are the seeds of recurrence and metastasis. Targeting and eliminating CTCs can prevent recurrence and metastasis, potentially benefiting long-term survival for cancer patients. The IND application for a new indication is supported by IMC001's good safety and efficacy demonstrated in IIT studies on advanced gastrointestinal tumors and its potent anti-tumor effects across various models, including triple-negative breast cancer. With EpCAM's high expression in epithelial tumors, IMC001 is set to offer new hope to patients with advanced epithelial cancers, addressing the urgent clinical need for effective therapies.”
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. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval 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.
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