SHANGHAI, Dec.05, 2024-- Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech focused on innovative IL-2-independent Tumor-Infiltrating Lymphocyte (TIL) therapies, announced that the first pivotal Phase II registration clinical trial of GC101 TIL injection has been approved by the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA), for the treatment of advanced melanoma (NCT06703398).
The trial will be led by Professor Guo Jun, a world-renowned expert in the field of melanoma and a professor at Peking University Cancer Hospital, who will conduct a multicenter clinical study across the country.
Professor Guo Jun of Beijing Cancer Hospital, a leading global expert in the field of melanoma treatment is the principal investigator.
Dr. Jin Huajun, Founder, CEO & CTO of Juncell，stated，“The advancement of GC101 into a pivotal Phase II clinical trial marks a significant milestone in the development of Juncell‘s innovative TIL therapies. We sincerely appreciate the trust and cooperation of the trial participants and their families, and we are grateful for the efforts and dedication of the clinical researchers! We look forward to further clinical studies of GC101, with the hope of benefiting more melanoma patients in the future.”
About Melanoma
In China, the mortality rate of melanoma is higher and the incidence rate is increasing year by year. Compared with European or American, there are significant differences in the characteristics of melanoma in Chinese: about 90% of melanoma originates in the skin among European and American. In Asian, about 50% of melanoma originates at the extremity and 20-30% in the mucous membrane. In contrast, melanoma of the extremity and mucosal type has a worse prognosis.
About GC101
GC101 is an autologous natural TIL TIL therapy developed leveraging Juncell Therapeutics' proprietary DeepTIL® cell expansion 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.
As the first TIL therapy which only needs low-intensity pre-treatment and no IL-2 injection in the world, GC101 has been validated for its clinical efficacy and safety which greatly improves the safety and accessibility of TIL therapy.
About MIZAR-003
MIZAR-003 is to investigate the efficacy and safety of autologous tumor infiltrating lymphocyte (GC101 TIL) therapy versus investigator's choice of chemotherapy in patients with advanced melanoma.
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 ten 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 over 3 years.
