Tokyo-based biotech company VLP Therapeutics Japan, LLC (VLPT Japan) announced on September 29 that it has started a Phase 2 clinical trial of booster dose of VLPCOV-01, a COVID-19 vaccine candidate developed by the company using its proprietary self-amplifying “replicon” messenger RNA (saRNA) technology.
This is a randomized, multi-center, active-controlled (with Comirnaty), observer-blind study in healthy adults vaccinated with two or three doses of Comirnaty or Spikevax to evaluate the efficacy and safety and find appropriate dose of a single VLPCOV-01 booster shot. This trial will be conducted at three medical institutions in Japan with 300 participants who meet the inclusion/exclusion criteria. VLPCOV-01 is the first runner of saRNA vaccine that entered into a Phase 2 study in Japan.
With support from the Japan Agency for Medical Research and Development (AMED) and the Japanese Ministry of Health, Labour and Welfare, VLPT Japan has been collaborating with six institutions nationwide: the National Institutes of Biomedical Innovation, Health and Nutrition, Oita University, Osaka Metropolitan University, the National Center for Global Health and Medicine, the National Hospital Organization Nagoya Medical Center, and Hokkaido University in research and development as well as clinical studies of COVID-19 vaccine.
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About VLP Therapeutics Japan: VLP Therapeutics Japan, LLC (VLPT Japan), founded in 2020 by Dr. Wataru Akahata, is a wholly-owned subsidiary of US-based VLP Therapeutics, Inc. Currently VLPT Japan has operations at its Tokyo Office, Osaka Office, and Kyoto Lab for research and development of novel coronavirus disease (COVID-19) vaccine using self-amplifying “replicon” mRNA technology proprietary to VLPT, with support from the Japan Agency for Medical Research and Development (AMED) and the Japanese Ministry of Health, Labour and Welfare.
About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Gaithersburg, MD-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of vaccine treatment. Led by CEO Akahata VLPT is currently engaged in research and development of a cancer treatment vaccine as well as prophylactic vaccines against malaria, dengue, etc. using VLPT’s proprietary platform technologies.
About Dr. Wataru Akahata: Upon graduation from the University of Tokyo in 1997, Akahata studied at Kyoto University’s Graduate School of Human and Environmental Studies. In 2002 he earned a PhD for his HIV vaccine studies under supervision of professor Hayami Masanori at the Kyoto University Institute for Virus Research. He then started his career at the National Institutes of Health (NIH) Vaccine Research Center in the US through 2012. During that time he invented a virus-like particle (VLP) vaccine for chikungunya virus in 2009, on which he published an original article in Nature Medicine with the VLP image featured on the cover in 2010. He eventually won a NIH Director’s Award for his discovery of the vaccine and three other alphavirus vaccines in 2012. In addition to his role as the co-founder and CEO of VLP Therapeutics, Inc. in the US and CEO and chief R&D officer of VLP Therapeutics Japan, LLC, Akahata serves as a visiting professor at the Tokyo Institute of Technology and specially appointed associate professor at the Kyoto University Graduate School of Medicine in Japan, while also associated with Phoenixi Co Ltd as Special Fellow.
Contact: Yutaka Iijima, Director of Global Communications and IR