Yimufeng Announces CDE Approval of New IND Application for EpCAM-Targeted CAR-T Therapy IMC001 in Advanced Epithelial Solid Tumors

On March 21, Immunofoco, located in Zhangjiang Science City, announced that the Investigational New Drug (IND) application for a new indication of its self-developed EpCAM-targeted autologous CAR-T cell injection product (IMC001), has received tacit approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for the treatment of advanced epithelial solid tumors. Previously, IMC001 had already received IND approval in both China and the United States in February 2024 for the treatment of advanced digestive system tumors with positive EpCAM expression.

EpCAM is a type I transmembrane glycoprotein that is uniformly and highly expressed on the membrane of various human epithelial-derived tumors such as esophageal cancer, colorectal cancer, pancreatic cancer, ovarian cancer, lung cancer, gastric cancer, and breast cancer, while its expression in normal tissues is relatively low.

However, due to challenges such as the complex microenvironment of solid tumors and high target heterogeneity, the progress of CAR-T therapy in the field of solid tumors has been limited for a long time.IMC001, with its unique target selection and innovative technical design, has demonstrated good safety and preliminary efficacy in previous clinical trials for digestive system tumors. This newly added indication aims to further explore its clinical application value.

According to the public information from the 2024 ASCO conference, in an investigator-initiated exploratory clinical study (IIT) for advanced gastric cancer: As of March 31, 2024, among 10 patients who had undergone at least one efficacy evaluation, IMC001 infusion demonstrated good safety and a 90% disease control rate (DCR). The low-dose group showed an objective response rate (ORR) of 33.3%, while the medium-dose group achieved an ORR of 40%. In the medium-dose group, three patients survived for over 10 months as of the study cutoff date, with one patient confirmed to have reached PR at week 24 and underwent radical gastrectomy at week 27, surviving for more than 22 months as of the cutoff date.

The approval of this new IND application marks an important step for the product in its clinical exploration, expanding from gastrointestinal tumors to pan-epithelial-derived solid tumors (including but not limited to small cell lung cancer, triple-negative breast cancer, etc.).