Texas based CMO VGXI Announces Completion of Initial Tech Transfer Milestones as part of its Partnership Agreement for Production of RNA Therapeutics with HMRI.
March 15, 2019, The Woodlands, TX – Under a license agreement with the Houston Methodist Research Institute (HMRI) for development of clinical grade RNA manufacturing services, VGXI announced it has completed all of the partnership’s Phase I initiatives and anticipates Phase II will conclude by 4Q 2019. The plan includes establishment and operation of a pilot RNA production plant at the VGXI facility in parallel with method optimization to prepare for scale-up and clinical grade service offerings.
VGXI’s experienced team is recognized among the DNA vaccine and gene therapy industries for its flexibility in meeting challenging client timelines and dedication to providing the highest quality DNA products and services. The addition of RNA production and testing in 2019 will provide an ideal complement to this service line by leveraging deep technical knowledge and proven processes for production of nucleic acid-based pharmaceuticals.
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.
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 GeneOne Life Science.
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.
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.
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Christy Franco, PhD
Manager, Business Development