Drug intelligence / Profile preview

PVX-4

Development stage
Phase 1
Lead developer
PapiVax Biotech
Modality
Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intramuscular
01

Overview

PVX-4 is a DNA-based therapeutic vaccine under development by PapiVax Biotech for the treatment of high-grade intraepithelial neoplasias associated with human papillomavirus type 16 (HPV16), including cervical, vaginal, vulvar, and anal intraepithelial neoplasia (CIN2/3, VaIN2/3, VIN2/3, AIN2/3). The vaccine encodes the E6, E7, and L2 genes of HPV16 fused to calreticulin (CRT) as a molecular adjuvant. It is administered intramuscularly using the TriGrid Delivery System. The mechanism of action involves inducing an immune response against HPV16-infected cells to eliminate existing lesions and prevent new infections. Early clinical data suggest high efficacy in viral clearance and resolution of abnormal pathology in patients with HPV16+ lesions. As of early 2025, PVX-4 is in Phase I clinical trials with plans for late-stage testing[1][2][3].

Other names
CRTE6E7L2 DNA vaccineCRTE-6E7L2 DNA vaccineCRTE 6E7L2 DNA vaccine
02

Targets

HPV16 E6 oncoproteinHPV16 E7 (Human papillomavirus 16 E7 protein)HPV16 L2

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