Texas-based plasmid DNA Manufacturer VGXI, Inc. to Enable Accelerated Production of a Vaccine against the 2019 Novel Coronavirus in a CEPI Funded Collaboration
The Woodlands, TX – VGXI, a world leading contract manufacturer of clinical grade DNA plasmid, announced it will start production of a DNA vaccine against the novel coronavirus (2019-nCoV) that has recently emerged in Wuhan, China under an agreement executed with Inovio Pharmaceuticals . A grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI) will fund the vaccine development, manufacturing, and early stage clinical testing as part of the collaborative effort led by Inovio.
“The DNA vaccine manufacturing platform developed by VGXI is an ideal countermeasure against emerging diseases like the current coronavirus outbreak.” stated VGXI CEO Young Park. “These vaccines have an extensive safety profile and production can be rapidly scaled-up in response to an epidemic. Furthermore, the manufacturing process does not involve production of viral particles or viral proteins, unlike traditional vaccines.”
As of January 29, 2020, over 6,000 cases and 130 deaths from the 2019-nCoV virus have been confirmed across mainland China, with other cases identified in over a dozen countries worldwide including 5 in the US. Travel restrictions are currently in place for nearly 60 million people in China in an effort to control the disease spread. Similar to other viruses in the coronavirus family, 2019-nCoV causes flu-like symptoms with severe respiratory illness and viral pneumonia in some cases.
VGXI has demonstrated its ability to support urgent vaccine development timelines in response to recent outbreaks including Ebola, Zika, and a different coronavirus, Middle East Respiratory Syndrome (MERS) in collaboration with its partners including Inovio and GeneOne Life Science. Preparations are already underway at VGXI’s facility in The Woodlands, Texas to begin manufacturing of the DNA vaccine against the 2019-nCoV virus.
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, 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.
CEPI is an innovative partnership between public, private, philanthropic, and civil organizations launched in Davos in 2017 to develop vaccines to stop future epidemics. CEPI has received multi-year funding from Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and Wellcome. CEPI has also received single-year investments from the government of Belgium and the United Kingdom. The European Commission foresees substantial financial contributions to support relevant projects through EC mechanisms. CEPI has reached over US$ 750 million of its $1 billion funding target. Since its launch in January 2017, CEPI has announced three calls for proposals. The first call was for candidate vaccines against Lassa virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Nipah virus. The second call was for the development of platforms that can be used for rapid vaccine development against unknown pathogens. The third call is for candidate vaccines against Rift Valley fever and Chikungunya viruses. To date, CEPI has committed to investing over $310 million in 12 vaccine candidates (five against Lassa virus, four against MERS-CoV, three against Nipah virus) and two vaccine platforms to develop vaccines against Disease X.
ABOUT INOVIO PHARMACEUTICALS, INC.
Inovio (NASDAQ:INO) is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat, cure and/or protect people from diseases associated with HPV, cancer, and infectious diseases. Inovio is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to safely produce a robust immune response to destroy and clear high-risk HPV 16 and 18, which are responsible for 70% of cervical cancer, 90% of anal cancer and 69% of vulvar cancer. In addition to HPV, Inovio’s optimized plasmid design and delivery technology has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 development for the treatment of HPV-related cervical pre-cancer. Also in development are Phase 2 immuno-oncology programs targeting HPV-related cancers and GBM, as well as externally funded platform development programs in Zika, MERS, Lassa, and HIV. Partners and collaborators include ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Regeneron, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. For more information, visit www.inovio.com.
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
Sr. Manager, Business Development