Plasmid CDMO VGXI, Inc. Completes Manufacturing and Release of a Vaccine against COVID-19 in Record-Setting Time
THE WOODLANDS, TEXAS (PRWEB) APRIL 06, 2020
VGXI, an industry leading provider of GMP grade plasmid DNA for vaccines and gene therapies, announced it has completed manufacturing and release of a DNA vaccine to combat the COVID-19 pandemic. VGXI was selected by Inovio Pharmaceuticals in late January to produce the vaccine under a $9 million grant to Inovio from the Coalition for Epidemic Preparedness Innovations (CEPI). Rapid mobilization of efforts across both companies enabled a record-setting timeline to release and initiation of clinical testing for the novel DNA vaccine within just 2 months from the start of production and only 3 months from public release of the virus genetic sequence. The large scale manufacturing campaign has supplied thousands of vaccine doses up to 4 times faster than traditional plasmid DNA production would support.
As of today, nearly 1,300,000 cases of COVID-19 have been identified worldwide, with about 70,000 deaths. In the US, there have been over 330,000 cases and nearly 10,000 deaths. Travel, commerce, and daily life is disrupted around the world as countries implement policies to slow the spread of the virus. In parallel with these efforts, the race to make a safe, effective vaccine widely available is essential to overcoming the current crisis.
“The dedicated team at VGXI has worked tirelessly to meet this challenge,” stated VGXI CEO Mr. Young Park. “Within a fraction of the typical manufacturing timeline, VGXI has manufactured and released a vaccine for human clinical testing. We are proud to be a part of the global effort to address the COVID-19 pandemic.”
With the Phase 1 trial beginning in the US, the vaccine developer and VGXI client for the last 13 years, Inovio Pharmaceuticals, is also coordinating simultaneous clinical trials in China and South Korea. Additional large scale manufacturing of the vaccine at the VGXI facility has already been scheduled in 2Q 2020. Mr. Rob Juba, VP of Biological Manufacturing and Clinical Supply Management at Inovio Pharmaceuticals said, “We are delighted to be working with our long term manufacturing partner VGXI to expedite manufacture of our COVID-19 vaccine candidate INO-4800 and enable rapid clinical testing.”
ABOUT VGXI, INC.
As a leading provider of plasmid DNA manufacturing and development services, VGXI, Inc. has proven its ability to support urgent vaccine development timelines in response to past outbreaks such as Ebola, Zika, and other coronaviruses including Middle East Respiratory Syndrome (MERS). 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 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 subsidiary located in Texas, is a leading cGMP DNA plasmid manufacturing facility. For more information, visit http://www.genels.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.
Within a fraction of the typical manufacturing timeline, VGXI has manufactured and released a vaccine for human clinical testing. We are proud to be a part of the global effort to address the COVID-19 pandemic.