August 16, 2023 - Immunofoco, a cell therapy product development company devoted to advancing treatments for solid tumors, announced today that its independently developed next-generation autologous CAR-T product, IMC008, based on the company’s SNR technology platform, has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer patients.
IMC008 is a next-generation autologous CAR-T product developed using the Synthetic Natural killer Receptor (SNR) technology platform. Tumor antigen heterogeneity has been a critical factor limiting the efficacy of CAR-T in solid tumors. The SNR platform not only targets those specific antigens through double recognition and functional enhancement mechanisms, but also expands the antigen recognition range of CAR-T cells through SNR receptors, so as to effectively solves the challenges brought by tumor antigen heterogeneity. Moreover, the synergistic effect of SNR signal and CAR signal further increases the proportion of memory T cells in CAR-T cells, improves the expansion and tumor infiltration of CAR-T cells in animal models, and enhances their ability to eliminate antigenically heterogeneous tumor tissues.
The acquisition of the ODD for IMC008 marks an important milestone for Immunofoco’s innovative research and development, making a breakthrough in solid tumor treatment. This designation will provide IMC008 with priority review and other incentive policies during its development and approval process, including tax reduction during the research process, financial support for the research expenses, and potential extension of market exclusivity rights after product launch. These policies will, to some extent, reduce Immunofoco’s development costs and commercialization risks, and accelerate the process of providing innovative treatment options to more patients.
Mrs. Minmin Sun, Founder, Chairman, and CEO of Immunofoco said, “The company will continue to advance the clinical research and further development of IMC008, aiming to provide the patients with safer and more effective treatment options. Additionally, Immunofoco will strengthen its collaboration with global partners to drive scientific breakthroughs in the field of cell therapy and bring new opportunities for cancer patients.”
About Immunofoco
Immunofoco is a clinical-stage biotech company, devoted to bringing revolutionary immune cell drugs to patients with solid tumors. The company was established in September 2020 in Zhangjiang, Shanghai, by a team of renowned scientists and industry experts, among whom succeeded in introducing the first CAR-T product to the Chinese market.
Immunofoco has pioneered a clinical strategy that “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 outcome, our company maintains an extensive spectrum of product pipeline. Notably, our CLDN18.2-CAR-T (IMC002) received orphan drug designation from the U.S. FDA in July 2022, and its dual IND approval from the U.S. FDA and China CDE in March and April 2023, respectively. The company upholds the development concept of “collaboration, aspiration, and dedication for the best clinical results,” by assembling industry talents and experts together, to develop innovative cell therapies that provide long-term survival benefits to patients with solid tumors. For more information about Immunofoco, please visit the company’s website at www.immunofoco.com.
