SHANGHAI, China I May 24, 2024 I Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech developing innovative Tumor-Infiltrating Lymphocyte (TIL) therapies for cancers, announced latest clinical research results on GC203 (a novel non-viral vector gene-modified TIL therapy engineered with membrane-bound IL-7). These data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place on May 31 – June 4, 2024.

Researchers tested GC203 on patients diagnosed with recurrent ovarian cancer, without the combination of IL-2 administration or aggressive lymphodepletion. The objective of the study was to determine the safety and efficacy of this treatment. A total of 20 patients were enrolled between 09/2021 and 01/2024 in the open-label single-center trial, in which 18 patients were evaluable. The evaluable patients were with an ECOG PS of 1 (55.6%) or 2 (44.4%) and received a median of 5 previous systemic therapies (range: 2-11). 9 (50%) patients had 3 or more tumor lesions. The median target lesion size was 57 (range: 13-146) mm.

GC203 showed promising results in patients with recurrent or metastatic ovarian cancer. The safety profile was improved significantly compared with conventional TIL therapies, thanks to a low-intensity pretreatment and the elimination of IL-2 combination. Most of the Adverse Events (AEs) were grade 1 or grade 2 and could be alleviated or cured by symptomatic treatment. No grade 5 event occurred. By the cutoff date of 01/2024, the investigator-assessed Objective Response Rate (ORR) was 33.3% (95% CI: 16.3 – 56.3), including 11.1% Complete Response (CR). The Disease Control Rate (DCR) was 83.3% (95% CI, 60.8 – 94.2). And the 12-month Overall Survival (OS) rate was 68.8% (95% CI: 49.3 – 95.9). The median OS was not mature as data cut-off.

Presentation Details

Abstract Number: 5552

Abstract Title: A phase I single-arm, open-label trial of engineering tumor-infiltrating lymphocytes with membrane-bound lL-7 for recurrent ovarian cancer.

Session Type and Title: Poster Session – Gynecologic Oncology

Poster Presentation Time: 9:00 AM – 12:00 PM CDT, June 3, 2024

Presenter: Dr. Jing Guo, Shanghai Tenth People’s Hospital

The abstract is available on the ASCO website.

About Ovarian Cancer

Ovarian cancer has the highest mortality rate among gynecologic cancers. 70% of patients are diagnosed at an advanced stage. 70% of patients with advanced ovarian cancer have a survival time of less than five years. More than 200,000 people worldwide die from ovarian cancer each year, indicating a significant unmet clinical need. The primary treatment for advanced ovarian cancer is platinum-based chemotherapy. Ovarian cancer is insensitive to immunotherapy, with an ORR of less than 10%. Effective treatment options are limited.

About GC203

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.

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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SOURCE: Shanghai Juncell Therapeutics Co.