Immunofoco, a biotechnology company specializing in immunotherapy, has announced that its self-developed autologous CAR-T product, IMC002, targeting CLDN 18.2, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of patients with unresectable locally advanced, recurrent, or metastatic CLDN 18.2 positive gastric cancer.
High-Specificity VHH Nanobody Targeting CLDN18.2 IMC002 is an autologous CAR-T product based on a high-specificity VHH nanobody that selectively targets CLDN18.2. This high specificity is anticipated to enhance the tolerability of IMC002 and expand its clinical dosing range, potentially broadening its applications in frontline treatments and in combination or sequential therapies. CLDN18.2 is highly expressed in various tumors, including pancreatic and gastric cancers, making it an ideal target for CAR-T cell therapy.
Fast Track Designation Based on Safety and Efficacy The Fast Track Designation for IMC002 is based on its demonstrated safety and efficacy in registrational clinical studies. Since receiving clinical approval from the U.S. FDA in March 2023 and implicit permission from China’s CDE in April of the same year, IMC002 has completed registered clinical dose escalation. Preliminary data indicate that in patients with advanced gastric and pancreatic cancers who have failed all standard treatments, IMC002 has shown excellent safety and efficacy.-Fineline Info & Tech
