On May 24, 2024 Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotech developing innovative Tumor-Infiltrating Lymphocyte (TIL) therapies for cancers, reported latest clinical research results on GC203 (a novel non-viral vector gene-modified TIL therapy engineered with membrane-bound IL-7) (Press release, Juncell Therapeutics, MAY 24, 2024, View Source [SID1234643696]). These data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place on May 31 – June 4, 2024.
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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 (Free ASCO Whitepaper) 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.