February 7, 2024 - Immunofoco, a cell therapy product development company dedicated to advancing treatments for solid tumors, announced that its independently developed, EpCAM-targeting autologous CAR-T cell product for infusion, (IMC001), has officially received approval from the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China for its Investigational New Drug (IND) application, the acceptance Number is CXSL2300792.This approval is granted for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).
Epithelial cell adhesion molecule (EpCAM) is highly expressed on various epithelial-derived tumor tissues, including digestive tract tumors, with expression rates exceeding 90% in colorectal cancer and gastric cancer. 1Additionally, EpCAM can serve as a therapeutic target for circulating tumor cells (CTCs), and the expression of EpCAM in metastatic lesions is often higher than that in primary lesions, without antigen loss due to metastasis. Therefore, EpCAM CAR-T can target primary lesions, CTCs, and metastatic lesions simultaneously. By genetically engineering chimeric antigen receptors (CARs) into a patient’s autologous T cells, CAR-T cells can recognize and kill tumor cells expressing EpCAM, achieving anti-tumor effects. The development of IMC001 aims to target EpCAM to address the challenges of metastasis and recurrence, providing a new treatment option for advanced digestive system tumors.
In the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose was determined, and 2 out of 5 patients in this dose group were confirmed to have achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient successfully underwent a gastric cancer radical surgery after a single infusion of IMC001 for 27 weeks and survived for over 81 weeks. Another PR patient experienced a 48% reduction in tumor size at week 16. In addition, the overall survival (OS) of the 2 stable disease (SD) patients was 55 weeks and 43 weeks, respectively. The patients’ survival time was significantly prolonged compared to historical data.
Dr. Crystal Sun, Founder, Chairman and CEO of Immunofoco, said, “With determination and perseverance, we embark on a new chapter. Immunofoco has achieved its first milestone of 2024, with the IND application of IMC001 receiving implied approval from CDE. In China, there is a large number of new patients with gastrointestinal malignant tumors each year, including 358,700 new gastric cancer patients and 517,100 new colorectal cancer patients. 2Immunofoco will actively push forward the registration clinical trial of IMC001 in China, aiming to provide more effective treatment options for these patients.”
About Advanced Gastric Cancer (GC)/ Gastroesophageal Junction Adenocarcinoma (GEJ)
Gastric cancer (GC) refers to a malignant tumor originating from the epithelium of the stomach. According to GLOBOCAN 2022 data, the incidence and mortality rates of gastric cancer rank sixth and third, respectively, among all malignant tumors. In 2022, there were about 970,000 new cases of gastric cancer worldwide, and China accounted for about 37% of them, 358,700 cases. In China, early-stage gastric cancer accounts for a low proportion, and most cases are diagnosed at an advanced stage, with an overall 5-year survival rate of approximately 26.4%.2 Gastroesophageal junction adenocarcinoma (GEJ) shares similar underlying pathogenic mechanisms and genomic changes with gastric cancer, and is typically discussed as a cancer type along with 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, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) obtained orphan drug designation from the US FDA in July 2022, and its IND application has been approved in both the US and China in April 2023. IMC001 (EpCAM CAR-T) has undergone two investigator-initiated trials (IITs), demonstrating good tolerability, safety, and preliminary efficacy. It obtained US FDA orphan drug designation in August 2023, and its IND application was approved by the CDE in February 2024. IMC008 (SNR CAR-T) has rapidly advanced to the IIT stage and received two US FDA orphan drug designations in August 2023 for the treatment of gastric cancer and pancreatic cancer, respectively. The company upholds the development concept of “collaboration, aspiration, and dedication for the best clinical results,” by assembling industry talents and experts together, to 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.
Reference
1. P Went ,et al. Frequent high-level expression of the immunotherapeutic target Ep-CAM in colon, stomach, prostate and lung cancers.Br J Cancer. 2006 Jan 16; 94(1): 128–135.doi: 10.1038/sj.bjc.6602924.PMID: 16404366
2. GLOBOCAN 2022 database version 22.0 released in February 2024
