YiMoPharma's Nanobody-Based CLDN18.2 CAR-T Therapy IMC002 Granted FDA Fast Track Designation for Advanced Gastric Cancer

Recently, committed to breakthroughImmunofoco, a biotech company developing immunocyte therapy products for the treatment of solid tumors, announced that its self-developed autologous CAR-T product IMC002 targeting CLDN 18.2 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of unresectable locally advanced, recurrent, or metastatic CLDN 18.2-positive gastric cancer patients.

IMC002 is an autologous CAR-T product based on highly specific VHH nanobodies that selectively target CLDN18.2. This high-specificity VHH antibody is expected to enhance the tolerability of IMC002 and expand its clinical dosing range, while also facilitating broader applications in frontline therapy, combination/sequential treatments, ultimately addressing the challenges of solid tumor treatment.CLDN18.2 is highly expressed in various tumors, including pancreatic cancer and gastric cancer, making it an ideal target for CAR-T cell therapy.

The Fast Track Designation for IMC002 is based on its excellent safety and efficacy demonstrated in registrational clinical studies. Since receiving clinical approval from the U.S. FDA in March 2023 and implicit clinical approval from China's CDE in April of the same year, IMC002 has completed dose escalation in registrational clinical trials. Preliminary data indicates that IMC002 has shown promising safety and efficacy in patients with advanced gastric cancer and pancreatic cancer who have failed all standard treatments.

Dr. Sun Minmin, founder, chairman, and CEO of Immunofoco, stated: "IMC002 is the first solid tumor CAR-T product manufactured using a nanobody sequence to complete Phase I registrational clinical trials, and it has received FDA Fast Track designation. This not only highlights the urgent need for innovative and effective treatments among patients with advanced gastric cancer globally but also represents significant progress in our company's global clinical development of novel drugs. We will spare no effort to accelerate the pivotal clinical trial process for IMC002 and have strong confidence in its performance in the pivotal registrational clinical trial. Our goal is to bring the IMC002 CAR-T cell product to market as soon as possible, aiming to provide more effective treatment options for patients with advanced gastrointestinal tumors worldwide."