Grant: Proof of Principle Program - Phase I

Cervical cancer is caused by infection with high risk strains of human papilloma virus (HPV) and is the second most common cancer among women with 500,000 new cases every year worldwide. HPV is highly prevalent in the general population, and the lifetime incidence is estimated to as high as 80%. Although many HPV infections are thought to be self self-limiting, persistent infection can lead to cervical dysplasia and ultimately to cancer. Over the last several years, prophylactic HPV vaccines have been developed that target the two most common high risk HPVs (HPV16 and HPV18) and have begun to enter the marketplace. These vaccines are reported to provide excellent protection against new HPV infections and are thus being administered to pre-adolescent girls prior to the onset of sexual activity. However, prophylactic vaccines have been shown to be ineffective against pre-existing infection. We have developed a novel therapeutic vaccine for treatment of cancers and pre-cancerous lesions caused by the five most common high-risk strains of HPV. This new vaccine (Pentarix) targets five HPV strains which together account for more than 90% of all HPV-associated cancers. Pentarix elicits strong immune responses that are capable of fully regressing tumors in pre-clinical models of HPV-induced cancer. Pentarix is currently poised to enter process development/scale up and to enter IND-enabling pre-clinical toxicology studies.