HPV001 is a randomized, placebo-controlled Phase 1/2a clinical trial designed to evaluate the safety and preliminary efficacy of VTP-200, Vaccitech’s immunotherapy for high-risk HPV infection and associated low-grade cervical intraepithelial neoplasia.
The study plans to enroll 105 women with high-risk HPV infection and will take place at clinical sites across the UK and EU to assess the safety and efficacy of VTP-200 in clearing high-risk HPV infection and associated lesions 12 months after patients receive treatment
VTP-200 utilises Vaccitech’s ChAdOx (prime) and MVA (boost) platform to elicit an immune response against HPV. The platform has a differentiated ability to induce CD8+ T cells, cells of the immune system which naturally clear HPV infected cells in cervical tissue. VTP-200 targets six early proteins from five different high-risk HPV groups and therefore covers more types of HPV than any other immunotherapy previously tested.
“Nearly all global cases of cervical cancer are caused by HPV,” said Bill Enright, Chief Executive Officer of Vaccitech. “A non-invasive solution to clear HPV infection and the spectrum of diseases it causes is urgently needed. VTP-200 is designed for unprecedentedly broad coverage of HPV infected patients. The HPV001 study will evaluate the therapeutic efficacy of VTP-200 and allow rapid progression into late-stage development if successful.”
High-risk HPV infection is one of the major causes of infection-related cancer worldwide. It is estimated over 500,000 new cases of cervical cancer and 300,000 deaths are attributable to HPV infection each year. There is no curative treatment for HPV infection. Patients diagnosed with HPV currently wait for additional testing to confirm their infection has not led to cancer or undergo invasive surgery to remove any pre-cancerous cells. VTP-200 could offer a non-invasive solution to resolve HPV infection and pre-cancerous changes immediately after detection.
“The enrolment of the first patient marks a huge milestone and is a crucial step in the fight against cervical cancer,” added Karin Hellner, M.D., Ph.D., Senior Fellow in Women’s Health, Oxford University Hospitals NHS Foundation Trust and principal investigator of the study. “Vaccitech’s broad spectrum HPV immunotherapy VTP-200 has the potential to change the lives of millions of women suffering from HPV associated disease worldwide.”
More information on the HPV001 study can be found at ClinicalTrials.gov
About Vaccitech Ltd.
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company’s proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable safety profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.