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detalimogene voraplasmid
- Development stage
- Phase 2
- Lead developer
- enGene
- Modality
- Lipid-mediated Delivery → Gene Addition/Replacement → Gene Therapies, Electrical: Electroporation → Physical Methods → Gene Addition/Replacement → Gene Therapies, Magnetic: Magnetofection → Physical Methods → Gene Addition/Replacement → Gene Therapies, Mechanical: Microinjection, microfluidics, gene gun → Physical Methods → Gene Addition/Replacement → Gene Therapies, Acoustic/Optical: Sonoporation, laser photoporation → Physical Methods → Gene Addition/Replacement → Gene Therapies, Pressure-driven: Hydrodynamic injection → Physical Methods → Gene Addition/Replacement → Gene Therapies
- Administration
- Intravesical
01
Overview
Detalimogene voraplasmid is a novel, investigational, non-viral gene therapy designed for intravesical administration in patients with high-risk non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It encodes RIG-I (retinoic acid-inducible gene I) activators and IL-12 to elicit local stimulation of anti-tumor immune responses in the bladder while mitigating the risk of systemic toxicities. Preclinically, it remodels the tumor microenvironment, activating both innate and adaptive anti-tumor immune responses. The therapy is administered intravesically in a four-instillation schedule and has received Fast Track designation from the FDA for BCG-unresponsive carcinoma in situ (CIS) NMIBC. It was developed using enGene's Dually Derivatized Oligochitosan (DDX) platform.
- Other names
- DetalimogeneDDX intravesicle gene therapy - enGeneBladder cancer gene therapy - enGene
02
Targets
IL-12R (Interleukin-12 receptor)
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