Juncell Therapeutics' First Patient Successfully Discharged in Phase I Trial of GC203, a Novel Non-Viral Gene-Modified TIL Therapy

Oct 31, 2024 12:04 CST Updated 12:04

Juncell Therapeutics

Solid Tumor Cell Therapy Developer

Recently, Juncell TherapeuticsGene-Modified TIL Therapy GC203In the Phase I clinical trial (KUNLUN-001) research sub-centerChongqing University Cancer HospitalCompletion of the First Subject's Cell Infusion, Patient Discharged Smoothly on October 25. The Subject and Clinical Researchers Highly Evaluate the Clinical Safety and Operational Simplicity of GC203.。

GC203 isWorld's First Non-Viral Vector Gene-Modified TIL Therapy, which was approved by the NMPA on April 28, 2024, to enter clinical trials, is currently the only gene-modified TIL therapy in China to officially launch a registration clinical trial.

This product addresses the clinical pain points of conventional TIL therapy, which relies on high-dose chemotherapy for lymphodepletion and high-dose IL-2 injections. It adopts a unique cell culture process, gene modification technology, and gene structure design, demonstrating potential advantages in safety, efficacy, and accessibility, as evidenced by empirical data from clinical trial participants and researchers.

A year and a half ago, the subject was diagnosed with Stage IVB ovarian cancer. Despite undergoing two surgeries and multiple rounds of chemotherapy and targeted therapy, the tumor recurred and metastasized. Faced with disease progression, the subject has been suffering greatly.

After repeated setbacks with traditional treatments, the focus had to shift to innovative therapies in the clinical stage. However, faced with the unknown risks of clinical trials, especially upon learning about the cumbersome process of conventional TIL therapy and the adverse reactions associated with lymphodepletion chemotherapy and IL-2 injections, hesitation and confusion set in.

Ultimately, the clinical protocol for GC203, which requires no lymphodepletion pre-treatment and no IL-2 injections, partially alleviated her concerns. Moreover, learning that the treatment could be administered in a general ward, allowing her to be constantly accompanied and encouraged by family, further eased her anxiety and bolstered her confidence.

During the infusion process, there was only a fever lasting a few hours, which quickly resolved after symptomatic treatment; the adverse reactions were only transient decreases in blood counts as shown on the lab reports, which later recovered on their own. At discharge, the patient’s physical condition was excellent. Before leaving the hospital, the patient happily took a commemorative photo with the medical staff and expressed great anticipation for the treatment’s effectiveness.(Case from the clinical research of Chongqing Cancer Hospital, to read the original text, please click this link)

The principal investigator of the Phase I ward at the Cancer Hospital Affiliated to Chongqing University, Director Gong Yi, has personally managed conventional TIL projects and has firsthand experience with adverse reactions caused by lymphodepleting chemotherapy and IL-2 injections, leaving a deep impression of various emergency response scenarios.

Director Gong stated: "The new generation of gene-modified TIL GC203 has shown a significant improvement in safety compared to previous conventional TIL programs. Adverse reactions have remained within predictable and controllable ranges, greatly reducing the handling difficulty and psychological pressure on doctors and the nursing team. This is closely related to the fact that GC203 TIL requires only low-intensity preconditioning and no IL-2 injections. We look forward to demonstrating excellent therapeutic outcomes during the efficacy evaluation."

About GC203

GC203 relies on Juncell Therapeutics' independently developed, world-leading DeepTIL.®Cell Enrichment and Expansion with NovaGMP®Developed through a gene modification technology platform, using non-viral vector-mediated genetic engineering techniques to enable natural TIL cells to stably express membrane-bound, self-aggregating cytokine IL-7. It has previously won the highest award in the "National Disruptive Technology Innovation Competition" organized by the Chinese Ministry of Science and Technology and has been included in the disruptive technology reserve database.

Without IL-2 injection,Only requires low-intensity chemotherapy preconditioning,General WardAfter receiving GC203 infusion therapy, tumor size significantly decreased and long-term relief was achieved in multiple gynecological cancer patients with high malignancy and failure of multiple treatment lines. Among them, all enrolled cervical cancer patients experienced varying degrees of marked tumor shrinkage; a high proportion of platinum-resistant ovarian cancer patients achieved objective remission.Tumors in 3 patients were completely cleared, achieving CR efficacy.At the same time, patients who received TIL cell infusion and achieved disease control no longer underwent subsequent radiotherapy or chemotherapy, and their quality of life improved significantly.

Data from the early clinical trials of GC203 were disclosed at the 2024 American Society of Clinical Oncology (ASCO) conference (see detailsJuncell Therapeutics' GC203 Abstract Published on ASCO Website）。

Regarding KUNLUN-001 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 efficacy.

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. Failed after standard treatment or lack of effective treatment methods;

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

5. ECOG score 0-1;

6. Adequate hematological and end-organ function.

Main Exclusion Criteria:

1. With serious underlying diseases;

2. With major infectious diseases;

3. Brain metastasis leading to organic mental disorders;

4. Having received genetically engineered cell therapy within the past year.

Contact Information:

Clinical email: clinicaltrials@juncell.com

Contact Number: 021-69990503

Teacher Yang: 18019732895 (Same as WeChat)

Teacher Zhang: 18001759113 (Same as WeChat)

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