PathoVax LLC ("PathoVax"), a biotech company focused on developing a universally preventative Human Papillomavirus (HPV) vaccine - "RGVax", today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for its licensed monovalent component- HPV16 RG1-VLP and concluded that a Phase 1 clinical trial in the United States and Austria is now given the go-ahead to proceed.

This Phase 1, first-in-human, global multicenter clinical study seeks to demonstrate the safety and immunogenicity responses to HPV16 RG1-VLP in healthy volunteers. The underlying RGVax foundational technology was licensed from Johns Hopkins University and the subsequent GMP as well as Phase 1 development of this vaccine was supported by the NCI PREVENT cancer program.

"The world needs more, and particularly broad-based, HPV vaccines. We are excited that our collaborators have been able to move forward with the clinical development of HPV16 RG1-VLP. This clinical proof of concept will demonstrate the potential it holds for positively impacting the lives of many individuals at risk of HPV infection and diseases. We look forward to globally supporting these efforts in parallel and beyond this Phase 1 especially in Asia-Pacific and other developing countries too where there is a high burden of HPV diseases," said Dr Kevin Koh, Chairman of PathoVax.

PathoVax was co-founded to licensed and developed a game changing preventative universal HPV vaccine. The foundational technology (RGVax technology) is based off vaccine scientific research at the Johns Hopkins University and Medical University Vienna. Unlike existing HPV vaccines that do not target all HPV types, the RGVax technology and  formulation has been shown to provide comprehensive protection against at least 18 high risk HPV types with immunogenicity lasting over a year without additional boosts in head-to-head studies with existing approved HPV vaccines.  This leapfrogs current vaccines as multiple diseases are now linked to HPV infection. It is anticipated that such additional protection will eventually establish new standards of care for many patients.

Dr Joshua Wang, a co-founder of PathoVax LLC said the following "Securing FDA clearance to start clinical trials is a significant achievement. This could not have been possible without the ongoing academic-industry collaborations that have occurred since day one between PathoVax LLC, Johns Hopkins and the National Cancer Institute's PREVENT program."