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GTL001
- Development stage
- Phase 2
- Lead developer
- Calliditas Therapeutics
- Modality
- Vaccines & Immunotherapeutics, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
- Administration
- Intramuscular
01
Overview
GTL001 (ProCervix) is a bivalent therapeutic vaccine developed by Genticel for the treatment of women infected with high-risk human papillomavirus (HPV) types 16 and 18 who have not yet developed high-grade cervical lesions. The vaccine consists of two recombinant fusion proteins: HPV16 E7 and HPV18 E7, each fused to a detoxified adenylate cyclase (CyaA) vector derived from *Bordetella pertussis*. This vector specifically targets CD11b+ antigen-presenting cells (APCs), such as dendritic cells, to deliver the viral antigens directly into the cytosol for processing and presentation on MHC class I molecules. This process is designed to elicit a robust antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) response to clear HPV-infected cells. GTL001 is typically administered intradermally and adjuvanted with topical 5% imiquimod cream. Despite promising Phase I results, the program was discontinued following a Phase II trial failure.
- Brand names
- ProCervix
- Other names
- HPV16 E7-CyaA and HPV18 E7-CyaA therapeutic vaccineHPV-16 E7-CyaA and HPV18 E7-CyaA therapeutic vaccineHPV 16 E7-CyaA and HPV18 E7-CyaA therapeutic vaccine
02
Targets
αMβ2 (Integrin αMβ2)HPV16 E7 (Human papillomavirus 16 E7 protein)HPV18 E7
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