- IMC002 is the first autologous CAR-T product targeting CLDN18.2 based on highly specific VHH nanoantibody that filed clinical trial application in China.

-Based on the highly specific anti-CLDN18.2 VHH nanoantibody, IMC002 has shown an excellent safety profiles in preclinical and IIT studies, as well as a potentially larger clinical dosage window and range of indications.

-As a proven anti-tumor target, there is a huge unmet clinical demand for CLDN18.2-positive tumors such as gastric, esophageal, and pancreatic cancers in China and the world.

Jan 16, 2023, Shanghai and Suzhou, China—Immunofoco, a leading company developing innovative cell therapy drugs, announced that the clinical trial application for IMC002, a self-developed autologous CAR-T product targeting CLDN18.2, has been officially accepted by the Center for Drug Evaluation (CDE), NMPA (Filing No. CXSL2300041). The indications of the applied clinical trial are advanced digestive system tumors with positive expression of CLDN18.2, including but not limited to advanced gastric cancer/ esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.

IMC002 is an autologous CAR-T product targeting CLDN18.2 based on a highly specific VHH nanoantibody. It has shown good safety and efficacy in preclinical and IIT studies. The highly specific VHH nanoantibody will give IMC002 a better safety profile and potentially larger clinical dosage window and range of indications. The applied clinical trial is a Phase I, open-label, multi-center, dose-escalation design to evaluate the safety and preliminary efficacy of IMC002. The IND in the United States will be submitted in the meantime, and orphan drug designation has been granted by FDA on July 18, 2022.

Gastric, esophageal, and pancreatic cancers affect the tissue or glandular lining of these organs and are usually not detected until the disease has progressed to an advanced stage. According to GLOBOCAN 2020 statistics, in China in 2020, the number of new cancer cases of gastric, esophageal and pancreatic cancers was 480,000, 320,000 and 120,000, respectively; and the number of deaths of gastric, esophageal and pancreatic cancers was 370,000, 300,000, 120,000, respectively. The effect of the current treatments for these cancers is not so good, with the five-year survival rates of gastric, esophageal and pancreatic cancers are only 32%, 20% and 11.5%, respectively, even if these diseases are clearly treated at an developing stage. Therefore, there are huge unmet clinical demands.

Crystal Sun, founder and CEO of Immunofoco, said: "CLND18.2 is a good target, but developing CAR-T is not easy because of the balance between safety and efficacy. IMC002 is the second CLDN18.2 targeted CAR-T product and the first CLDN18.2 targeted CAR-T product based on highly specific VHH nanoantibody with IND acceptance by CDE. IMC002 is undergoing investigator initiated trial (IIT), and has shown initial safety advantages and promising efficacy. The filing of IMC002 IND application is an important milestone of the company and also a verification of the team's industrialization capability. We look forward to advancing the registration of clinical trial as soon as possible after the IND approval, and then benefit the patients.