-The first CAR-T product targeting EpCAM with its clinical trial data.
-Obtaining orphan drug designation highlights the significant potential of IMC001 in the treatment of gastric cancer, offering new hope for patients.
September 17, 2023 - Immunofoco, a cell therapy product development company devoted to advancing treatments for solid tumors, announced that its independently developed autologous CAR-T cell therapy product (IMC001) targeting EpCAM has recently received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer patients.
IMC001 is an independently developed autologous CAR-T cell therapy product targeting EpCAM. EpCAM is a biomarker for circulating tumor cells (CTCs), and it is highly expressed in metastatic and in situ lesions of digestive system tumors, while its expression is relatively low in normal tissues. EpCAM is expressed on the basolateral side of the normal tissues and has very limited access by immune cells. However, during the malignant transformation of tumors, the expression pattern of EpCAM changes to a uniform distribution on the cell membrane. Based on the different expression and patterns of EpCAM in the normal and tumor tissues, IMC001 can distinguish tumor tissues from normal tissues. It also has a good therapeutic window, and has shown promising anti-tumor activity in the preclinical studies.
To evaluate the safety and preliminary efficacy of IMC001 in advanced EpCAM+ digestive system tumors, Immunofoco has conducted two investigator-initiated trials (IITs). In a clinical trial for advanced gastric cancer, two out of six patients in the low-to-moderate-dose group were assessed as having partial responses (PR), and three patients in the moderate-dose group survived for more than 10 months. Among them, one PR patient successfully completed a gastric cancer radical surgery after a single infusion of IMC001 for 28 weeks, indicating that IMC001 has a good drug safety profile.
The orphan drug designation for IMC001 in the treatment of gastric cancer recognizes its significant value. Orphan drug designation is a special drug approval system for diseases that are rare or have a total patient population of less than 200,000. This designation will bring many advantages to the further development and commercialization of IMC001, as well as a series of preferential policies and support provided by the U.S. FDA. It provides a strong guarantee for the implementation of IMC001.
Mrs. Sun Minmin, the founder, chairman, and CEO of Immunofoco, said: “We are very pleased with the significant progress made on our strategically important product pipeline IMC001, which has enabled the company to obtain its third orphan drug designation this year. IMC001 is a product developed under the strategy of curing the solid tumors by treating them as hematological malignancies, and its feasibility has been preliminarily verified in early IITs. Patients treated with IMC001 can have a better control of relapse and metastasis, and have the possibility of long-term survival benefits. There is a patient who has successfully transformed from a state with no chance to surgery to complete response after the surgery, because with the help of IMC001, the tumor size had decreased and was operable. There are about 400,000 new gastric cancer patients in China each year, with a huge unmet clinical need. The second-line treatment options for gastric cancer are inherently limited, and there is a lack of good treatment options after relapse. Moving forward, we will continue to explore the IND application and clinical research of IMC001, to provide innovative CAR-T cell immunotherapy solutions and more treatment choices for patients, aiming to improve the quality of life of patients with advanced gastric cancer and prolong their survival.”
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.
