Juncell Therapeutics Reveals GC203 TIL Therapy Data in Ovarian Cancer at ASCO 2024

Shanghai Juncell Therapeutics Co., Ltd. (Juncell Therapeutics), a clinical-stage biotechnology company focusing on innovative Tumor-Infiltrating Lymphocyte (TIL) therapies for cancer treatment, has unveiled promising clinical outcomes for their latest therapy, GC203. This non-viral vector gene-modified TIL therapy, enhanced with membrane-bound IL-7, is set to be highlighted at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4, 2024.

GC203 was assessed in a study involving patients with recurrent ovarian cancer. Unlike traditional methods, this trial did not use IL-2 administration or severe lymphodepletion. The primary aim was to evaluate the safety and effectiveness of GC203. The open-label, single-center trial enrolled 20 participants between September 2021 and January 2024, with 18 patients being eligible for evaluation. These patients had an ECOG Performance Status (PS) of 1 (55.6%) or 2 (44.4%) and had undergone a median of five systemic therapies prior to the study. Half of the evaluable patients presented with three or more tumor lesions, and the median target lesion size was 57 mm (ranging from 13 to 146 mm).

The study's findings indicated that GC203 could be a viable option for treating recurrent or metastatic ovarian cancer, demonstrating a significantly improved safety profile compared to conventional TIL therapies. This improvement is attributed to the less intense pretreatment regimen and the absence of IL-2. Most adverse events reported were of grade 1 or grade 2 severity and could be managed with symptomatic treatment. No grade 5 adverse events were observed.

As of January 2024, the investigator-assessed Objective Response Rate (ORR) for GC203 was 33.3% (95% CI: 16.3 - 56.3), including an 11.1% Complete Response (CR). The Disease Control Rate (DCR) stood at 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 had not been determined by the data cutoff date.

The presentation of these findings is scheduled for a poster session on Gynecologic Oncology at the ASCO Annual Meeting. Dr. Jing Guo from Shanghai Tenth People's Hospital will present the data on June 3, 2024.

Ovarian cancer, which holds the highest mortality rate among gynecologic cancers, often goes undiagnosed until it reaches an advanced stage. This late diagnosis contributes to a survival rate of less than five years for 70% of patients with advanced ovarian cancer. Annually, over 200,000 deaths worldwide are attributed to ovarian cancer, highlighting the urgent need for effective treatments. Current standard treatments primarily involve platinum-based chemotherapy, with immunotherapy showing an Objective Response Rate (ORR) of less than 10%.

GC203 represents a significant advancement, developed using Juncell Therapeutics' DeepTIL® cell expansion and NovaGMP® gene modification platforms. DeepTIL® ensures the TILs' potency, eliminating the need for IL-2 post-infusion and allowing for lower intensity pretreatment. NovaGMP® efficiently modifies T cells economically, comparable with lentiviral vectors. GC203's incorporation of self-associating membrane-bound interleukin-7 helps maintain the stemness of memory T cells, activate internal immune responses, and avoid systemic toxicities.

Juncell Therapeutics aims to provide high-quality, accessible TIL therapies for solid tumors. Their two clinical-stage TIL therapies have shown promising results across nine types of advanced solid tumors, including lung, triple-negative breast, pancreatic, high-grade glioma, ovarian, endometrial, cervical, bile duct cancers, and melanoma. Notably, seven late-stage tumor patients have achieved Complete Response (CR), with the longest tumor-free survival period nearing three years.