Drug intelligence / Profile preview

Vvax001

Development stage
Phase 2
Lead developer
ViciniVax
Modality
Viral Vectors → Gene Addition/Replacement → Gene Therapies, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Vvax001 is a therapeutic cancer vaccine designed to treat high-grade cervical intraepithelial neoplasia (CIN3) associated with human papillomavirus type 16 (HPV16). It consists of replication-incompetent particles derived from the Semliki Forest virus that encode the HPV16 E6 and E7 oncoproteins. Upon intramuscular administration, these viral vectors express the antigens in host cells and stimulate robust CD4+ and CD8+ T cell responses against HPV16-infected cells. Clinical trials have demonstrated that Vvax001 is safe and well-tolerated, with most adverse events being mild injection site reactions or myalgia. In phase II studies involving patients with newly diagnosed HPV16-positive CIN3, three doses of Vvax001 led to significant regression of lesions in most patients—50% achieved complete histopathological response (regression to CIN1 or no dysplasia), 94% had lesion size reduction, and 63% cleared HPV16 infection. No recurrences were observed during follow-up periods up to 30 months. The vaccine offers a promising non-surgical alternative for treating precancerous cervical lesions[1][2][3][5][6][7][8][9].

Brand names
Vvax001Vvax-001Vvax 001
Other names
Semliki Forest Virus Based Cancer VaccineHPV E6/E7-encoding Semliki Forest virus vaccine
02

Targets

HPV16 E6 oncoprotein

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