Immunofoco, a pioneering company in cell therapy for solid tumors, has achieved a milestone with the approval of its clinical trial application for IMC001 by the China Drug Evaluation (CDE) and the Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA). 

IMC001 is an autologous CAR-T cell product targeting EpCAM for infusion, designed to treat EpCAM-positive advanced gastrointestinal tumors, including advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

EpCAM, a biomarker for circulating tumor cells (CTCs), is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, making it a promising therapeutic target. IMC001 is the first CAR-T product to adopt the strategy of treating solid tumors as hematologic malignancies, aiming to provide a breakthrough in the treatment of GI tumors.

The clinical results of IMC001 were presented at medical conferences, including the annual meetings of the European Society of Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO). In a clinical trial for advanced gastric cancer, IMC001 demonstrated a safe and effective recommended dose, with a notable overall response rate (ORR) of 40 percent.

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her appreciation to the team for achieving dual IND approvals for IMC001 in the U.S. and China. She emphasized the significance of targeting EpCAM, which shows great potential for CAR-T therapy in solid tumors. 

With about 90 percent of patients with gastrointestinal tumors exhibiting EpCAM expression, IMC001 addresses a critical clinical need.