-Immunofoco’s proprietary SNR technology platform is dedicated to overcoming tumor heterogeneity and assisting solid tumor treatment.
-Obtaining orphan drug designation highlights the significant potential of IMC008 in the treatment of pancreatic cancer, offering new hope for patients.
August 16, 2023 - Immunofoco, a cell therapy product development company devoted to advancing treatments for solid tumors, announced that its independently developed next-generation autologous CAR-T product, IMC008, based on the company’s SNR technology platform, has recently obtained a second orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer patients, following its first designation for the treatment of gastric cancer patients in August 2023. Investigator-initiated trials (IIT) will be conducted at top-tier hospitals in Shanghai, Zhejiang, Nanchang, and other cities.
Mrs. Minmin Sun, Founder, Chairman, and CEO of Immunofoco said, “Pancreatic cancer, known as the ‘king of cancers,’ is characterized by challenges in early diagnosis, low surgical resection rate, and high postoperative recurrence and metastasis. By targeting pancreatic cancer as the second indication for IMC008, we hope to bring hope and treatment options to advanced pancreatic cancer patients who urgently need effective treatment choices. It also expresses our determination and confidence in using self-developed technology platform to achieve breakthroughs in the treatment of solid tumors.”
This ODD designation for IMC008 will further accelerate Immunofoco’s R&D process in the pancreatic cancer treatment, and this innovative immune cell therapy is expected to benefit more patients. Immunofoco pursues its efforts in breakthroughs in solid tumor treatments, providing long-term survival benefits to patients.
About Pancreatic Cancer
Pancreatic cancer is one of the common malignant tumors of the digestive system. In recent years, the incidence of pancreatic cancer has increased significantly in USA, China, and internationally. According to statistics in 2021, pancreatic cancer ranked 10th among all malignant tumors in men, and 9th among malignant tumors in women in the United States, and has a mortality rate of 4th among all malignant tumors. According to statistics from the Chinese National Cancer Center in 2021, the incidence of pancreatic cancer ranked 7th among malignant tumors in men and 11th among malignant tumors in women, with a mortality rate of 6th among all malignant tumors. According to The Lancet, the five-year survival rate for pancreatic cancer after diagnosis is about 10%, making it one of the worst-prognoses malignancies.
About IMC008
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. In August 2023, IMC008 received its first ODD designation from the U.S. FDA for the treatment of gastric 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.
