[Shanghai, Suzhou, Chengdu, China, December 7, 2024] Immunofoco Biotech, a company dedicated to developing cell therapy products for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to IMC002, a novel CAR-T therapy targeting CLDN 18.2, for the treatment of patients with unresectable locally advanced, recurrent, or metastatic CLDN 18.2-positive gastric cancer.

The Fast Track designation is a program established by the FDA to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill unmet medical needs. With this designation, Immunofoco is eligible for several benefits, including more frequent communication with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval and Priority Review if the relevant criteria are met, and Rolling Review, which allows a drug company to submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA as they are completed, rather than waiting until the entire application is finished.
IMC002, an autologous CAR-T product targeting CLDN18.2, utilizes a highly specific VHH nanobody, enhancing its safety and allowing for a broader clinical dose range, which may facilitate its use in earlier-line, combination, or sequential treatments. CLDN18.2 is highly expressed in a variety of tumors, including pancreatic and gastric cancer, making it an ideal target for CAR-T cell therapy.
IMC002 received clinical approval from the U.S. FDA in March 2023 and implicit approval from China's CDE in April 2023. Additionally, IMC002 has been granted orphan drug designation for gastric and pancreatic cancer by the FDA. Recently, IMC002 has completed the registered clinical dose-escalation phase in China, showing promising safety and efficacy in late-stage gastric and pancreatic cancer patients who have failed standard treatments.
Dr. Minmin Sun, Founder, Chairman, and CEO of Immunofoco, stated, "IMC002, marking a milestone as the first nanobody-derived CAR-T therapy for solid tumors to complete a registered Phase I clinical trial, has been granted FDA Fast Track designation. This recognition underscores the urgent global need for innovative and effective treatment options for advanced gastric cancer patients but also represents significant progress our company has made in the field of global new drug clinical development. We are fully committed to advancing IMC002 through its pivotal clinical trials and hold a strong conviction in its potential as demonstrated in the upcoming pivotal registrational trials. Our goal is to swiftly make the IMC002 CAR-T cell therapy available to the market, offering an effective alternative for patients battling advanced gastrointestinal tumors on a global scale.
About Immunofoco
Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) has been granted Fast Track designation and orphan drug designations (ODDs) for gastric and pancreatic cancers by the U.S. FDA, and its IND application received approval in both the United States and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, and its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at www.immunofoco.com.
Disclaimer: This news is intended to facilitate the communication and exchange of medical information and does not constitute a recommendation for any specific medication or treatment plan. Specific treatment plans should be carried out under the guidance of professional medical personnel.