Junsai Bio's Global First-in-Class Non-Viral Vector-Engineered TIL Therapy GC203 Receives IND Acceptance from CDE for Advanced Solid Tumors
Juncell Therapeutics
Solid Tumor Cell Therapy Developer
Juncell Therapeutics' self-developedGenetically Modified TIL Cell DrugGC203IND Application Recently Accepted by CDE, intended for the treatment of advanced solid tumors. This is the second TIL cell drug applied for clinical registration by Juncell Therapeutics after the approval of its first natural TIL cell drug GC101 for clinical trials, and it is alsoThe world's first TIL new drug variety developed based on a non-viral vector。
GC203 Relies on Juncell TherapeuticsIndependently Developed, Globally LeadingOfDeepTIL®Cell Culture Technology Platform &NovaGMP®Developed from a gene modification technology platform,No need for lymphodepletion, no need for IL-2 injection combination, while maintaining the safety of natural TIL cells, enhance the therapeutic potential for complex solid tumors and significantly improve the accessibility of genetically modified TIL therapy.
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GC203 is based on natural TIL cells, throughNon-viral VectorMediated gene engineering technology, enabling TIL cellsStably Expressing Membrane-Bound, Spontaneously Aggregating Cytokines。Production ProcessNo need for trophoblasts,The process is simpler;Gene Modification Process, AdoptingNon-viral vector，Lower cost`, with higher safety and editing efficiency comparable to viral vectors.`. Like GC101, the cellsFinished ProductCryopreservation`, which can break through the limitations of distance and time`。
Preclinical studies have shown that GC203, in increasingProliferative activity, effector factor secretion, anti-exhaustion capability, bystanderStimulatory functions, etc.,Significantly Superior toNaturalTIL cells and TIL cells expressing conventional membrane-bound cytokines, canSignificantly IncreaseHighThe In Vivo Persistence and Tumor Microenvironment Remodeling Capability of TIL Cells.
IIT Clinical Research Phase，GC203Demonstrating Excellent Safety and Clinical Efficacy, which can rapidly and accurately home to tumor lesions, enhance local anti-tumor immune responses, and exertLong-lasting Anti-tumor Effect, andNot observedSevere adverse reaction events, as well as immune overreaction phenomena such as CRS and ICANS.
There have been multiple casesHigh malignancy, multiple treatment failuresPatients with gynecological tumors (mainly ovarian cancer) after GC203 infusion treatment,Tumor significantly reduced in size, with long-term relief, wherein2 casesPatientThe tumor was completely cleared., achieveCR Efficacy。
In addition, GC203 has also obtainedNational Ministry of Science and Technology"China Disruptive Technology Innovation Competition"Top Prize——Excellent Award, and selected into the Disruptive Technology Reserve.
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Juncell Therapeutics focuses on the field of solid tumor treatment and is committed to developingHigh Quality, High AccessibilityTIL Cells NewMedicine, AlreadyBuild aInternationalization,Specialization,High Cohesion and High ExecutionThe research team has built a facility that meets GMP requirements.High StandardsHardware Platform,Recognized as a National High-tech Enterprise and a Shanghai Specialized, Fine, New SME。
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