PathoVax's Licensed HPV Vaccine Receives FDA Clearance of HPV16 RG1-VLP Investigational New Drug Application

FDA approves RGVax's (HPV16 RG1-VLP) IND for Phase 1 clinical trials.

BALTIMORE, March 29, 2023 /PRNewswire/ -- 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."

About PathoVax LLC:

PathoVax LLC, is a start-up company that is based on foundational technology developed at Johns Hopkins University to advance RGVax^TM, the world's first comprehensive HPV vaccine that aims to target all clinically relevant HPV. It is expected that such additional protection will eventually establish new standards in the $2B HPV market. PathoVax's collaborative partnerships include well-known institutions such as the U.S. National Cancer Institute to push forward an academic phase 1 study.   For more information, visit: www.pathovax.com

Forward-Looking Statements
Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for PathoVax's product candidates; and the business strategies and development plans of PathoVax. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Pathovax's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Pathovax does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

CONTACT: [email protected]

SOURCE PathoVax