-IMC002 is Immunofoco’s first CAR-T product approved for clinical research, which reflects the company team’s execution and industrialization ability.

-The highly specific anti-CLDN18.2 VHH nanoantibody may give IMC002 a better safety profile and potentially larger clinical dosage window and range of indications.

March 14, 2023, Shanghai and Suzhou, China—Immunofoco, a leading biotech company focused on developing revolutionary immune cell drugs for solid tumors, announced today that the FDA has approved its Investigational New Drug (IND) application for IMC002, a self-developed autologous CAR-T product targeting CLDN18.2. The indications 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 Immunofoco's first CAR-T product approved for clinical research, and it is based on a highly specific VHH nanoantibody that may give IMC002 a better safety profile and potentially larger clinical dosage window and range of indications. It has shown good safety and efficacy in preclinical and IIT studies. Furthermore, the IND application of IMC002 has been accepted by the Center for Drug Evaluation (CDE), NMPA, and granted orphan drug designation (ODD) by the FDA.

Crystal Sun, founder and CEO of Immunofoco, said: “Since founded in 2020, Immunofoco has always been guided by clinical value and rapidly developed multiple pipelines. The FDA approval of IMC002 IND application is an important milestone for Immunofoco, and it also validates our team’s execution and industrialization ability again.”