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VGXI, Inc. Establishes Pilot mRNA Manufacturing Capabilities

Under a Technology License Agreement with the Houston Methodist Research Institute, Contract Developer and Manufacturer VGXI Achieves Key Milestones with Establishment of Pilot Production Capabilities for RNA-Based Medicines.


News provided by

VGXI, Inc.

Dec 06, 2019, 09:00 ET

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THE WOODLANDS, Texas, Dec. 6, 2019 /PRNewswire-PRWeb/ -- VGXI announces successful implementation of new RNA production services through completion of all Phase II initiatives as part of a license agreement with the Houston Methodist Research Institute. The company has established pilot mRNA manufacturing capabilities in a purpose built GMP production suite at its current facility in The Woodlands, Texas. A full range of capabilities have been developed to support client projects from initial plasmid DNA construction through linearization, in vitro translation, mRNA purification, and comprehensive quality control testing. VGXI will continue close collaborations with the Research Institute RNACore as it proceeds into the final phase of the agreement with process scale-up and optimization for large-scale GMP mRNA production services. Launch of clinical grade mRNA manufacturing is anticipated in 2020.

mRNA therapeutics are rapidly advancing in the clinic with a range of potential applications from gene therapies and gene editing to RNA-based vaccines. According to VGXI's CEO Young Park, "We are building on nearly 20 years of plasmid DNA manufacturing experience, making VGXI ideally poised to provide industry-leading solutions for high purity RNA production and testing." Contact VGXI today to learn more.

We are building on nearly 20 years of plasmid DNA manufacturing experience, making VGXI ideally poised to provide industry-leading solutions for high purity RNA production and testing.

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ABOUT VGXI, INC.

VGXI, Inc. 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 CDMO of GeneOne Life Science, Inc. To learn more or request a quote, visit http://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.

ABOUT HOUSTON METHODIST

Houston Methodist comprises a leading academic medical center and seven community hospitals serving the Greater Houston area. Houston Methodist's academic medical center 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. Houston Methodist Hospital is ranked as one of the nation's top 20 hospitals and the #1 hospital in Texas by U.S. News & World Report.

The RNAcore at the Houston Methodist Research Institute, directed by professor and chair, John Cooke, M.D., Ph.D. is a leader in RNA synthesis and generates 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 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://www.houstonmethodist.org/RNAcore.

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, Inc.

Related Links

http://www.vgxii.com

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