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Drug intelligence / Profile preview
tirvalimogene teraplasmid
- Development stage
- Phase 2
- Lead developer
- Genexine
- Modality
- Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
- Administration
- Intramuscular
01
Overview
GX-188E (tirvalimogene teraplasmid) is a first-in-class therapeutic DNA vaccine developed to treat cancers associated with human papillomavirus (HPV) types 16 and 18, which are responsible for the majority of cervical cancer cases and a significant proportion of head and neck squamous cell carcinomas. The vaccine encodes the E6 and E7 antigens from HPV16/18, fused to immune-enhancing elements such as Flt3L and tissue plasminogen activator signal sequence, to promote antigen presentation by dendritic cells. Delivered intramuscularly via electroporation, GX-188E is designed to induce strong antigen-specific CD8+ T cell responses with a Th1-polarized immune profile. Clinical trials have shown that it can lead to regression of high-grade cervical lesions (CIN3), clearance of persistent HPV infection, and improved response rates when combined with pembrolizumab in advanced cervical cancer patients[1][2][3][5][6][8].
- Other names
- HPV E6/E7 DNA vaccine GX-188E
02
Targets
HPV16 E6 oncoproteinHPV16 E7 (Human papillomavirus 16 E7 protein)Human papillomavirus type 18 protein E7 (HPV18 E7)HPV18 E7
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