Junshi Bio's GC101 TIL Therapy Enters Pivotal Phase II Trial for Advanced Melanoma, Marking a Major Breakthrough in Solid Tumor Cell Therapy

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GC101 is the world's first natural TIL cell therapy that does not require lymphodepletion or IL-2 injection. Its first indication has been approved to enter the pivotal Phase II clinical trial, marking a significant breakthrough in the field of solid tumor cell therapy.

In China, the mortality rate of melanoma is relatively high, and its incidence shows an increasing trend year by year. Compared with Caucasians in Europe and America, there are significant differences in the characteristics of melanoma in China: among Caucasians, about 90% of melanomas originate in the skin; whereas among Asians and other people of color, approximately 50% of melanomas originate in acral sites, and 20-30% originate in mucosal tissues. In contrast, the prognosis for acral and mucosal melanomas is worse.

In February 2024, the U.S. FDA granted accelerated approval to the first TIL therapy, Lifileucel, for the treatment of advanced melanoma patients who have progressed on or after second-line therapy. Its objective response rate (ORR) reached 31.5%, with a median progression-free survival (mPFS) of 4.1 months. However, due to the need for high-intensity lymphodepleting chemotherapy and repeated injections of high-dose IL-2 during treatment, which triggered numerous adverse reactions, the FDA issued a black box warning.

GC101 is a TIL therapy developed by Juncell Therapeutics based on its independently developed DeepTIL® cell expansion platform. It can culture a sufficient number of highly active TIL cells without high concentrations of IL-2 or feeder cells and does not rely on IL-2. In clinical applications, GC101 demonstrates excellent efficacy without the need for lymphodepletion or any dose of IL-2 injection. Although the majority of GC101 subjects are patients with more difficult-to-treat acral and mucosal melanoma, its ORR is similar to that of Lifileucel, with mPFS extended by more than a month. In terms of safety, GC101 subjects are treated in general wards, with no treatment-related deaths or ICU admissions, no patients requiring blood cell transfusions, and hospital stays reduced by approximately 80%.

Jin Hua Jun, Ph.D., Founder, CEO & CTO of Juncell Therapeutics"The entry of GC101 into the pivotal Phase II clinical trial marks an important milestone for Juncell Therapeutics in the development of innovative TIL therapies. We sincerely thank the participants and their families for their trust and cooperation, as well as the efforts and dedication of the clinical research team! We look forward to further clinical studies confirming the strong clinical efficacy of GC101, bringing benefits to more melanoma patients in the near future."

About GC101

GC101, developed based on Juncell Therapeutics' independently developed and globally leading DeepTIL® cell enrichment and expansion platform, is the fastest progressing TIL therapy pipeline in Juncell Therapeutics’ portfolio. It is also the world's first natural TIL therapy that does not require lymphodepletion or IL-2 injections. Existing clinical data shows that GC101 achieves an objective response rate (ORR) of over 35% in various types of advanced solid tumors. Complete tumor clearance has been observed in four patients who achieved complete response (CR), with the longest disease-free survival time exceeding three years.

If you would like to learn more about this clinical trial, please contact us for further information through the following contact details.

Clinical Email:clinicaltrials@juncell.com

Contact Number: 021-69990503

Teacher Yang: 18019732895 (Same as WeChat)

Teacher Zhang: 18001759113 (Same as WeChat)

Juncell Therapeutics focuses on the development of innovative drugs and therapies based on Tumor-infiltrating Lymphocytes (TIL). It has independently established internationally leading DeepTIL® cell enrichment and expansion and NovaGMP® gene modification technology platforms. Based on these, it has developed a series of globally first-in-class or best-in-class natural TIL and genetically modified TIL pipelines. Two of them have entered the clinical trial stage and are currently recruiting patients with advanced solid tumors. GC101, the world's first natural TIL therapy that does not require lymphodepletion or IL-2 injection, and GC203, the world’s first non-viral vector genetically modified TIL therapy, have demonstrated excellent clinical efficacy in 10 different types of advanced solid tumors (including pancreatic cancer and high-grade glioma that failed to respond to multiple lines of treatment). Among the treated patients, tumors were completely eliminated in seven cases, with the longest tumor-free survival time exceeding three years.

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