VGXI Announces Exclusive License to Establish GMP-Grade RNA Manufacturing Services

Monday, September 17, 2018 Medico Legal News
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Texas based CMO VGXI Announces Licensing Agreement with the Houston Methodist Research Institute for Production of RNA Therapeutics.

THE WOODLANDS, Texas, Sept. 17, 2018 /PRNewswire-PRWeb/ --VGXI, an industry leading plasmid DNA contract manufacturer,

announced today that they have entered into an exclusive license with the Houston Methodist Research Institute to produce clinical grade RNA at the VGXI facility in The Woodlands, Texas. VGXI has established a track record of success supplying preclinical through cGMP grade DNA plasmids for vaccines, gene therapies and viral vector production. The addition of RNA manufacturing services will provide the world's first dedicated CMO encompassing both DNA and RNA biopharmaceuticals.

The agreement will additionally enable VGXI's parent company, GeneOne Life Science, to leverage the design capabilities provided by Houston Methodist and the research team led by John Cooke, MD, PhD for development of new RNA vaccines and therapies.

Driven by successes in preclinical and early clinical studies, RNA based therapeutics and vaccines are developing rapidly, with an estimated market value of $1.2B by 2020. In particular, groundbreaking new therapies such as genome editing often require both RNA and DNA components, highlighting the necessity of a one-stop solution for supply of these products. This licensing agreement will support the growing industry by complementing VGXI's existing DNA services and increasing access to the acclaimed expertise and clinical RNA production methods developed by the team at the Research Institute RNAcore.

Anticipating the agreement, VGXI is already nearing completion of a facility expansion that includes purpose-built GMP production areas for RNA synthesis. Technology transfer in support of these new services is expected to commence immediately. "RNA vaccines and therapeutics are the future of nucleic acid based technologies," stated Young K. Park, President and CEO of VGXI. "With this license VGXI looks forward to being able to offer both RNA and DNA contract manufacturing for our clients."

ABOUT HOUSTON METHODIST Houston Methodist Hospital is ranked as one of the nation's best hospitals and the #1 hospital in Texas by US News & World Report. The Houston Methodist central campus includes the flagship hospital and the Houston Methodist Research Institute, located in the heart of the Texas Medical Center, the largest medical center in the world. The RNAcore at the Research Institute, directed by professor and chair, John Cooke, MD, PhD is a leader in RNA synthesis and generate both research and clinical grade RNA constructs including mRNA, modified mRNA (mmRNA), microRNA cassettes, and noncoding RNA. In addition to manufacturing methods, the RNAcore has also developed exceptional technologies for improved stability of RNA products and enhanced delivery of nucleic acid based therapies. Beginning as a core group for the Progenitor Cell Biology Consortium of the National Heart, Lung, and Blood Institute, the RNAcore is now also supported by the Cancer Prevention Research Institute of Texas, to further the development of cutting-edge RNA technologies. For more information, visit http://houstonmethodist.org/RNAcore

ABOUT VGXI, INC. VGXI, Inc. has over 15 years of experience and is a leading provider of manufacturing and development services for DNA vaccines and gene therapies. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, 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 or request a quote, visit https://www.vgxii.com

ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) is an international DNA vaccine and product developer and leading contract manufacturer of DNA plasmid-based agents for pre-clinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines and products 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. For more information, visit http://www.genels.com/en

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS Materials in this press release contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements relate to expectations or forecasts of future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. They include words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Any or all of our forward-looking statements here or in other publications may turn out to be incorrect. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed, and forward-looking statements may be adversely affected by factors, including general market conditions, competitive product development, product availability, current and future branded and generic competition, federal and state regulations and legislation, manufacturing issues, timing of the elimination of trade buying, patent positions, litigations and investigations. Our actual results may vary materially, and there are no guarantees about the performance or valuation of GeneOne stock. It is also important to read the disclosure notice contained in many of the individual GeneOne documents available on the website, as many contain important information on such cautionary factors as of the date of the individual document. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our reports.

SOURCE VGXI



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