Oxford, UK – Vaccitech Ltd, 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, today announced the dosing of the first patient as part of the HPV001 clinical study. HPV001 is a randomized, placebo-controlled Phase 1/2 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 utilizes 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 enrollment 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
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Ryo Imai / Robert Flamm, Ph.D. (US), Burns McClellan, Inc.
212-213-0006 ext. 315 / 364
Henry Hodge, Vaccitech
Direct: +44 (0) 7533 421 442