The first EpCAM-targeting CAR-T product to apply for IND approval.
Immunofoco has conducted two IIT clinical studies with IMC001, and it has demonstrated good tolerability and preliminary efficacy.
November 20, 2023 - 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 formal acceptance from the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) in China for its clinical trial 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).
In China, the incidence of new cases of malignant digestive system tumors, such as esophageal cancer, gastric cancer, and colorectal cancer, reaches 1.058 million per year, resulting in 819,000 annual deaths. Patients diagnosed with malignant digestive system tumors face a five-year survival rate of less than 30%1, posing a severe threat to people’s lives. IMC001 is an EpCAM-targeting autologous CAR-T product. EpCAM is a membrane surface glycoprotein closely associated with cancer, and it plays a crucial role in tumor development and metastasis. EpCAM is expressed on the basolateral side of normal tissues, with very limited access by immune cells. However, during the malignant transformation of tumors, the expression pattern of EpCAM changes to a uniform distribution on the cell membrane. Based on the distinct expression and patterns of EpCAM in normal and tumor tissues, IMC001 can distinguish tumor tissues from normal tissues. It also shows a favorable therapeutic window and has demonstrated promising anti-tumor activity in the preclinical studies.
To evaluate the safety and preliminary efficacy of IMC001 in advanced EpCAM+ digestive system tumors, Immunofoco has conducted two investigator-initiated trials (IITs). In a clinical trial for advanced gastric cancer, two out of six patients in the low-to-moderate-dose group were evaluated to have partial responses (PR), and three patients in the moderate-dose group survived for more than 10 months. Notably, one PR patient successfully underwent a gastric cancer radical surgery after a single infusion of IMC001 for 28 weeks, indicating a favorable drug safety profile for IMC001. In August 2023, IMC001 obtained orphan drug qualification designation (ODD) from the US FDA.
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 2020 data in China, the incidence and mortality rates of gastric cancer are both ranked third among all malignant tumors. Globally, there are approximately 1.2 million new cases of gastric cancer per year, with China accounting for approximately 40%. Early gastric cancer accounts for a low proportion, only about 20%, with most cases already in the advanced stages at the time of discovery. The overall 5-year survival rate is less than 50%.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 accepted by the CDE in November 2023. 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.
