Vaccitech plc today announced topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 heterologous prime-boost immunotherapy in women with low-grade cervical human papillomavirus (HPV) lesions.
It is estimated that approximately 291 million women worldwide are carriers of HPV DNA.
Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2, and E6 antigens.
VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.
"These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024," said Bill Enright, CEO of Vaccitech, in a press release on March 20, 2023.
"Currently, people with persistent HPV infections have no treatment options until they develop high-grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking."
"VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions."
VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.
Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.
Over 95% of cervical cancers are caused by HPV infection.
The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the U.S., with over 4,280 women dying from the disease.
In the U.S., various HPV vaccines are authorized for women and men and available at most clinics and clinical pharmacies in March 2023.