Junshi Bio's First-in-Class Non-Viral Vector-Engineered TIL Therapy GC203 Receives IND Approval in China
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
April 29, 2024
eMedClub News
April 28,NMPA Center for Drug Evaluation (CDE) official website shows, Juncell TherapeuticsJuncell Therapeutics' GC203 TIL Cell Injection Receives Clinical Trial Implied Permission, Intended for TreatmentAdvanced solid tumors with clear diagnosis by cytology or histopathology。Juncell Therapeutics once stated,This is the second TIL cell new drug applied for clinical registration by Juncell Therapeutics after the company's first natural TIL cell new drug, GC101, was approved for clinical trials.The world's first TIL new drug variety developed based on a non-viral vector。
GC203 Relying onJuncell TherapeuticsIndependently Developed, Globally Leading DeepTIL®Cell Culture Technology Platform and NovaGMP®Developed through a gene modification technology platform using non-viral vector-mediated genetic engineering techniques,Enable natural TIL cells to stably express membrane-bound, spontaneously aggregating cytokine IL-7.。GC203No need for lymphodepletion, no need for IL-2 injection in combination, enhance the therapeutic potential for complex solid tumors while maintaining the safety of natural TIL cells, and significantly improve the accessibility of genetically modified TIL therapy.
GC203 is based on natural TIL cells and uses non-viral vector-mediated gene engineering technology to enable TIL cells to stably express membrane-bound, self-aggregating cytokines. The production process does not require feeder cells, making it simpler; the gene modification process uses non-viral vectors, which are lower in cost, higher in safety, and have modification efficiency comparable to viral vectors. Similar to GC101, the final cell product is cryopreserved, overcoming limitations of distance and time.
Preclinical studies have shown that,GC203In terms of proliferation activity, effector factor secretion, anti-exhaustion capability, and bystander stimulation function,Significantly superior to natural TIL cells and TIL cells expressing conventional membrane-bound cytokines, which can greatly enhance the in vivo persistence and remodeling of the tumor microenvironment.。
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During the IIT clinical research phase, GC203 demonstrated excellent safety and clinical efficacy, rapidly and precisely homing to tumor lesions, enhancing localized anti-tumor immune responses, exerting long-lasting anti-tumor effects, with no severe adverse events observed, nor CRS, ICANS, or other immune overactivation phenomena.
There have been multiple cases with high malignancy,Gynecological cancer patients (mainly ovarian cancer) who have failed multiple lines of treatmentAfter treatment with GC203 infusion, the tumors significantly shrank and achieved long-term remission. Among them, the tumors of 3 patients were completely eliminated, reaching CR efficacy. Ovarian cancer patients resistant to platinum-based therapies also showed a high proportion of objective response efficacy, and the tumors of all enrolled cervical cancer patients shrank to varying degrees.
A Single-Arm, Multi-Center, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of GC203 in Advanced Solid Tumors, Led by Fudan University Shanghai Cancer Center with Professor Wu Xiaohua and Professor Wang Hongxia as Principal Investigators, is Now Recruiting Participants.
In addition, GC203 also won the highest award — the Excellence Award — in the "National Disruptive Technology Innovation Competition" organized by the Ministry of Science and Technology of China, and was selected into the Disruptive Technology Reserve. Recently,Juncell TherapeuticsAnnounced that it will present the latest clinical research data of its world-first non-viral vector gene-modified TIL GC203 at the American Society of Clinical Oncology Annual Meeting (2024 ASCO) to be held in Chicago, USA, from May 31 to June 4, 2024.
GC203 Advantages
01: No trophoblast cells, no IL-2 dependency
02: High Load, High Efficiency, Low Cost, Low Risk
03: Maintain cellular memory without activating Treg
04: Anti-exhaustion, stronger bystander stimulation ability
05: Enhance local immunity and avoid systemic toxicity
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