Juncell Therapeutics’Investigational New Drug Application (IND) Allowed to Proceed for genetic modified Tumor Infiltrating Lymphocyte (GC203) in advanced malignant solid tumors
SHANGHAI, April 28, 2024 -- Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech developing innovative Tumor-Infiltrating Lymphocyte (TIL) therapies for cancers, today announced that National Medical Products Administration (NMPA) has allowed an Investigational New Drug Application (IND) to proceed for its first genetically modified TIL therapy, GC203 , for the treatment of advanced malignant solid tumors.
GC203 is a novel non-viral vector gene-modified TIL therapy developed leveraging Juncell Therapeutics' proprietary DeepTIL® cell expansion platform and NovaGMP® gene modification platform. DeepTIL® enables TILs to be potent enough that no IL-2 combination will be required after infusion, and the intensity of pretreatment could be lower. NovaGMP® modifies T cells with a high efficiency comparable with the Lentiviral vector in an economic way. GC203 is engineered with self-associating membrane-bound interleukin-7, which can maintain the stemness of memory T cells, activate internal immune cells and avoid systemic toxicities.
A poster highlighting preclinical activity and characterization of GC203 will be presented at the upcoming American Association for Cancer Research (AACR) 2024 Annual Meeting.
About Juncell Therapeutics
Juncell Therapeutics is a biotech dedicated to developing high-quality, accessible TIL cell therapies for the treatment of solid tumors. Juncell Therapeutics has established its proprietary DeepTIL® cell expansion and NovaGMP® gene modification technology platforms, which are designed to address the key challenges of conventional TIL therapies, making TILs "robust, competent, affordable, and accessible." Two clinical-stage TIL therapies have demonstrated promising safety and efficacy in the treatment of nine types of heavily pretreated advanced solid tumors, including lung cancer, triple-negative breast cancer, pancreatic cancer, high-grade glioma, ovarian cancer, endometrial cancer, cervical cancer, bile duct cancer and melanoma. 7 of these late-stage tumor patients have achieved CR, and the longest tumor-free survival time is approaching 3 years.
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