Yimufeng Bio's EpCAM-Targeted CAR-T Therapy IMC001 Granted New IND Approval for Advanced Epithelial Solid Tumors Amid Hong Kong IPO Filing

Mar 22, 2025 08:48 CST Updated 08:48

Immunofoco

Developer of Novel Therapeutics for Solid Tumors

▎WuXi AppTec Content Team Report

On March 21, Immunofoco announced that its self-developedEpCAM-Targeted Autologous CAR-T Cell InjectionThe clinical trial application for the new indication of product (IMC001) has received tacit approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment ofEpithelial advanced solid tumors, including but not limited to advanced gastric cancer/esophagogastric junction adenocarcinoma, triple-negative breast cancer, and other solid tumorsPreviously, IMC001 received IND approval for dual filing in China and the U.S. in February 2024 for the treatment of advanced digestive system tumors positive for EpCAM expression. The press release stated that the approval of this additional indication's IND application marks a significant milestone for the product.Clinical Exploration from Digestive System Tumors to Pan-Epithelial Solid TumorsAn important step forward.

Screenshot source:CDE Official Website

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 long been restricted.

Immunofoco's press release stated that IMC001, with its unique target selection and innovative technical design,Has previously demonstrated good safety and preliminary efficacy in clinical trials for digestive system tumors., the newly added indications aim to further explore its clinical application value.

According to the public information from the 2024 ASCO conference, in an investigator-initiatedFor Advanced Gastric CancerIn the exploratory clinical study (IIT): As of March 31, 2024, among 10 patients who had undergone at least one efficacy evaluation, the infusion of IMC001 demonstrated good safety and90% Disease Control Rate (DCR)An objective response rate (ORR) of 33.3% in the low-dose group and 40% in the medium-dose group. In the medium-dose group, three patients survived for more than 10 months at the data cutoff point. Among them, one patient confirmed to have achieved partial response (PR) at week 24 and underwent radical gastrectomy at week 27. This patient has survived for over 22 months as of the cutoff date.

ImmunofocoDr. Sun Minmin, Founder, Chairman & CEO, stated: "The expansion of IMC001's indications is based on Immunofoco's clinical strategy of 'transforming solid tumors into hematological tumors,' further developing the potential therapeutic value of this product. Based on the mechanism of action of the EpCAM target and existing clinical research data,IMC001 has the potential to provide new treatment directions for the treatment of various epithelial solid tumors, postoperative prevention of recurrence and metastasis, combination with surgery, and conversion surgery.", we will steadily advance the registration clinical research."

References:

[1] Immunofoco's EpCAM CAR-T Cell Therapy Product Receives CDE Approval for New Indication in IND Application. Retrieved Mar 21，2025, from https://mp.weixin.qq.com/s/p_U2V0PRdNuv2BRd4x1eBg

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