JunCell Biosciences Launches Phase I Trial of GC203, the World’s First Non-Viral Vector-Modified TIL Therapy

May 30, 2024 08:37 CST Updated 08:37

Juncell Therapeutics

Solid Tumor Cell Therapy Developer

May 29, 2024, Juncell TherapeuticsWorld's First Non-Viral Vector Gene-Modified TIL Therapy GC203The Phase I Clinical Trial (KUNLUN-01) Kick-off Meeting Was Successfully Held at the Fudan University Affiliated Cancer Hospital,This is the first gene-modified TIL therapy in China to officially initiate a registration clinical trial.Director Wu Xiaohua of the Department of Gynecology and Director Wang Hongxia of the Department of Medical Oncology at Fudan University Shanghai Cancer Center, along with their clinical research team, Juncell Therapeutics Vice President Lin Shuwei, and the clinical medicine team attended the project kick-off meeting.

2024Year4Month28Day,GC203Awarded by the National Medical Products Administration(NMPA)Clinical Implied Consent,FromINDIt took only one month from approval to the start of clinical trials., which fully embodies the principal investigators, Director Wu Xiaohua and Director Wang Hongxia, as well as the relevant departments of the hospital.Recognition and support reflect the close cooperation and coordination of third-party partners, as well as the highly efficient execution of the Juncell Therapeutics team. This also demonstrates the patient-centered approach and the sense of urgency in addressing patients' needs embraced by the entire project team.

"There are not many drugs available for advanced gynecological tumors in clinical practice, representing a significant unmet clinical need. We are very pleased to collaborate with Juncell Therapeutics, contributing to the development of this highly promising innovative therapy. We look forward to GC203 delivering exciting results in subsequent clinical trials, providing us with another powerful weapon against advanced gynecological tumors."

“TIL cells have become a hot spot in clinical research in the field of solid tumor treatment. The approval for melanoma indication in the United States in the first half of this year has laid a good foundation for the treatment of malignant tumors, especially solid tumors, with TIL cells.We are very much looking forward to the clinical application of domestically produced TIL cell therapy drugs, which will benefit a large number of Chinese patients with solid tumors. We all hope to jointly explore through the implementation of this Phase I project, and we also hope that this project will be successful with everyone's joint efforts.

About GC203

GC203, developed by Juncell Therapeutics using its independently developed, globally leading DeepTIL® cell enrichment and expansion and NovaGMP® gene modification technology platforms, utilizes non-viral vector-mediated genetic engineering to enable natural TIL cells to stably express membrane-bound, self-aggregating cytokine IL-7. It has previously won the highest award in the "China Disruptive Technology Innovation Competition" organized by the Ministry of Science and Technology and has been included in the Disruptive Technology Reserve.

No need for conditioning, no need for IL-2 combination, in a general wardAfter receiving GC203 infusion therapy, tumor sizes significantly reduced and long-term relief was achieved in multiple gynecological cancer patients with high malignancy and multi-line treatment failures. Among them, all enrolled cervical cancer patients experienced varying degrees of significant tumor shrinkage; a high proportion of platinum-resistant ovarian cancer patients achieved objective remission.Tumors in 3 patients were completely cleared, achieving CR efficacy.。

About KUNLUN-01 Clinical Trial

GC203 TIL-ST-I (KUNLUN-001) is a Phase I, single-arm, open-label clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC203 TIL cell therapy in patients with advanced malignant solid tumors, while also exploring potential biomarkers associated with therapeutic effectiveness.

Main Inclusion Criteria:

1. Aged 18-75, regardless of gender;

2. Confirmed cases of cervical cancer, ovarian cancer, endometrial cancer, breast cancer, digestive system tumors, lung cancer, etc.;

3. Failure of standard treatment or lack of effective treatment methods;

4. At least 2 lesions, with the body able to support minimally invasive surgery for sampling.

Main Exclusion Criteria:

1. With severe underlying diseases;

2. Have major infectious diseases;

Contact Information:

Clinical email: clinicaltrials@juncell.com

Contact Number: 021-69990503

Teacher Zhang: 18019732895 (Same as WeChat)

Teacher Cheng: 18001759113 (Same as WeChat)

About Juncell Therapeutics

Juncell Therapeutics focuses on the development of TIL therapy, independently establishing the internationally leading DeepTIL® cell enrichment and expansion and NovaGMP® gene modification technology platforms. Based on these, it has developed a series of world-leading innovative TIL therapies, two of which have entered the clinical trial stage and are currently recruiting patients with advanced solid tumors.

GC101, the world's first natural TIL therapy that requires no lymphodepletion and no IL-2 injection, and GC203, the world’s first non-viral vector gene-modified TIL therapy, have both demonstrated excellent clinical efficacy in nine different types of advanced solid tumors (including pancreatic cancer and high-grade glioma that failed multiple lines of treatment). Among the patients, seven had their tumors completely eradicated, with the longest tumor-free survival time nearing three years.

Juncell Therapeutics will steadfastly uphold the noble mission of "Refining Cells, Guarding Life," embrace the inspiring vision of "Creating Miracles with Science, Making Miracles Commonplace," and adhere to the core values of "Focus, Innovation, Inclusiveness, and Sharing." The company is committed to developing more high-quality TIL innovative therapies to meet the diverse needs of cancer patients.

E.N.D

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