GeneOne Life Science, Inc. (“GeneOne” KOSPI: 011000) today announced the dosing of the first subjects in its multi-center Phase I trial to evaluate the Zika DNA vaccine (GLS-5700). Refer to ClinicalTrials.Gov, study number NCT02809443. GeneOne has received approval from both the US FDA and Health Canada’s Health Products and Food Branch to conduct the clinical trial for GLS-5700. The study will be conducted at clinical sites in Miami, University of Pennsylvania Hospital, and Quebec City, Canada.
This Phase I, open-label, dose-ranging study of 40 healthy adult volunteers is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with the CELLECTRA®-3P intradermal electroporation device. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses − the immune responses necessary to fight viral infections − in small and large animal models.
Young K. Park, GeneOne’s CEO, said, “Development of this Zika vaccine has been the fastest in history in terms of receiving FDA approval for a clinical trial from the initial concept. I would like to thank everyone involved in the development. This could not have been possible without the hard work of our collaborators and employees around the globe. We look forward to the approval and availability of an effective vaccine to counter the Zika virus epidemic.”
This vaccine is manufactured by VGXI, Inc., GeneOne’s wholly owned subsidiary, located in the Woodlands, Texas. VGXI is the only facility in the world to have manufactured DNA vaccines for Ebola, MERS, and Zika.
GeneOne is developing the Zika DNA vaccine, GLS-5700, with Inovio Pharmaceuticals, Inc. and academic collaborators from the Wistar Institute, Philadelphia PA, US and at Université Laval in Quebec City, Canada. No vaccine or therapy currently exists for the prevention or treatment of infection with the Zika virus.Details of the study are at https://clinicaltrials.gov/ct2/show/NCT02809443?term=zika&rank=7.
ABOUT GENEONE LIFE SCIENCE, INC. GeneOne Life Science Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid-based agents for preclinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world. To learn more about GeneOne Life Science, visit http://www.genels.com/en.
ABOUT VGXI, INC. With over 15 years of experience, VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for clinical trials in the US, EU, Asia and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI’s ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and experienced development team. VGXI, Inc. is a wholly-owned subsidiary CMO of GeneOne Life Science, Inc. To learn more about VGXI, visit https://vgxii.com/about-us.
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