Tokyo-based biotech company VLP Therapeutics Japan, Inc. (VLPT Japan) announced on December 20 the initiation of a Phase 3 clinical trial of booster dose of VLPCOV-04, a monovalent self-amplifying “replicon” RNA COVID-19 vaccine targeting Omicron XBB.1.5 developed by the company.
The objective of this trial is to evaluate the immunogenicity of one booster dose of VLPCOV-04 against Omicron subvariant XBB.1.5 in 2,000 healthy Japanese adults who have completed initial and booster COVID-19 mRNA vaccines in Japan and verify non-inferiority to the control drug (Comirnaty: a monovalent COVID-19 vaccine targeting Omicron XBB.1.5).
VLPT Japan has been conducting research and development of COVID-19 vaccine using its proprietary replicon RNA technology in cooperation with several institutions across Japan. Based on the outcomes to date this multi-center, randomized, active-controlled, observer-blinded study (jRCT2051230141) will be conducted at medical institutions in Japan with the support of the Japan Agency for Medical Research and Development (AMED) and the Ministry of Health, Labour and Welfare (MHLW).
After demonstrating the efficacy and safety of VLPCOV-04 in this study, VLPT Japan plans to seek approval to manufacture and market the vaccine in Japan at the earliest date possible.
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About VLP Therapeutics Japan: VLP Therapeutics Japan, Inc. (VLPT Japan), founded in 2020 by Dr. Wataru Akahata originally as a wholly owned subsidiary of US-based VLP Therapeutics, Inc., is a Tokyo-based biotech company. VLPT Japan is currently engaged in research and development of prophylactic vaccines against infectious diseases, including COVID-19, influenza, and dengue. The COVID-19 project is funded by the Japan Agency for Medical Research and Development (AMED) and the Japanese Ministry of Health, Labour and Welfare (MHLW).
About VLP Therapeutics: VLP Therapeutics, Inc. (VLPT), co-founded in 2013 by Drs. Wataru Akahata, Ryuji Ueno, and Sachiko Kuno, is a Maryland, US-based biotech company with a mission to address unmet medical needs worldwide and expand the frontiers of vaccine treatment. VLPT is currently engaged in research and development of a cancer treatment vaccine as well as prophylactic vaccines against infectious diseases including malaria and dengue.