YiMuFeng's CLDN18.2-Targeted CAR-T Therapy IMC002 Becomes China's Second Candidate to Enter Clinical Trial Application

On January 17, the CDE website showed that Immunofoco's self-developed CLDN18.2-targeted autologousCAR-TThe clinical trial application for product IMC002 has been officially accepted, intended for the treatment of advanced CLDN18.2-positive expression.DigestionSystemic tumors, including but not limited to advanced stagesGastric Cancer/Adenocarcinoma of the Esophagogastric Junction, Advanced StagePancreatic CancerThis is also the second CLDN18.2-targeted CAR-T product to declare clinical trials in China, following CT041 from Immunofoco.

Stomach cancer, esophageal cancer, and pancreatic cancer affect the lining of tissues or glands within these organs and are often discovered only when the disease has progressed to an advanced stage. According to GLOBOCAN 2020StatisticsIn 2020, among the new cancer cases in China, there were 480,000 cases of gastric cancer, 320,000 cases of esophageal cancer, and 120,000 cases of pancreatic cancer. Among the death cases, there were 370,000 cases of gastric cancer, 300,000 cases of esophageal cancer, and 120,000 cases of pancreatic cancer. The current treatment methods for these cancers have shown limited effectiveness. Even when treated at an early stage of disease progression, the five-year survival rates for gastric cancer, esophageal cancer, and pancreatic cancer are only 32%, 20%, and 11.5%, respectively. Therefore, there is a significant unmet clinical need.

IMC002 is an autologous CAR-T cell therapy drug targeting CLDN18.2 based on highly specific VHH antibodies, demonstrating good safety and efficacy in preclinical studies and IIT research. The highly specific VHH antibody will provide IMC002 with better tolerability and a potentially wider clinical dosage window and range of indications.

Immunofoco, founded in 2020, is a company focused on developing cell therapies. Based on the clinical strategy of "transforming solid tumors into hematological tumors," the company has developed the Peri Cruiser® technology platform targeting tumor metastasis. This technology platform controls the tissue distribution of CAR-T cells in the body, avoiding damage to normal tissues while preserving the ability to kill primary tumors and effectively controlling tumor metastasis.

Peri Cruiser® Technology Platform (Source: Immunofoco Official Website)

Currently, Immunofoco has a total of 9 products in its pipeline, among which IMC002 is the second product to enter clinical trials.

IMC001 is an autologous CAR-T product targeting EpCAM, which has now entered Phase I clinical trials. EpCAM is highly expressed in various epithelial cell-derived tumors, especially inDigestionHighly expressed in systemic malignant tumors with uniform expression (expression rate 90%), it is an effective target for this type of advanced cancer. Meanwhile, EpCAM is also expressed on circulating tumor cells (CTC), which are the seeds of tumor metastasis, and clearing CTC helps block distant tumor metastasis.