VTP-200 is an investigational heterologous prime boost immunotherapy consisting of an initial dose using the ChAdOx vector and a second dose using MVA, both encoding the same HPV antigens, to elicit an immune response to HPV. It is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.
“These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024. Currently people with persistent HPV infections have no treatment options until they develop high grade lesion. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking,” said Bill Enright, CEO of Vaccitech. “VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions.”
Vaccitech, a spin out company from the University of Oxford’s Jenner Institute, is developing products to treat and prevent infectious disease and cancer. It co-invented a COVID-19 vaccine with the University of Oxford, which is now approved and exclusively licensed worldwide to AstraZeneca.
Along with VTP-200, the company’s lead product candidates include VTP-300, an immunotherapy candidate designed as a component of a potential component of a functional cure for chronic hepatitis B viral (HBV) infection; VTP-850, a novel T cell investigational therapy for prostate cancer; and VTP-1000, a preclinical T cell therapeutic product candidate for immune tolerance in celiac disease.
The ongoing Phase 1b/2 clinical trial of VTP-200, called HPV001, is designed to assess the safety and efficacy of VTP-200 and determine the optimal immunotherapeutic dose regimen in women with HPV-related low grade cervical lesions.
Data from the first 58 women enrolled who reached their six-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint, said the UK firm.
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, it continued.
VTP-200 was well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs, as per the interim data readout.
Vaccitech confirmed that these latest results will be presented orally at next month’s International Papillomavirus Conference in Washington DC.
Cervical pre-cancerous lesions
It is estimated that about 291 million women worldwide are carriers of human papillomavirus (HPV) DNA. Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma, according to WHO data. That same data showed cervical cancer was the fourth most common cancer in women in 2020, with approximately 604,000 cases and 342,000 deaths from the disease worldwide.