GeneOne Life Science Announces Full Enrollment of First-In-Human Study of MERS Vaccine

SEOUL, South Korea, Aug. 08, 2016 (GLOBE NEWSWIRE) — GeneOne Life Science Inc. (KSE:011000) today announced that enrollment has been completed of the first-in-human clinical trial of the GLS-5300 vaccine for MERS (Middle East Respiratory Syndrome) with a total of 75 subjects. GeneOne Life Science and U.S.-based Inovio Pharmaceuticals (NASDAQ:INO) are co-developing the vaccine.  This phase I clinical trial is funded by the Walter Reed Army Institute of Research (WRAIR) and is being conducted at its Clinical Trials Center in Silver Spring, Md.

The MERS vaccine (GLS-5300) was designed as a SynCon® vaccine by Inovio and was manufactured by VGXI, Inc., which is GeneOne’s wholly owned subsidiary and located in the Woodlands, Texas.

Middle East Respiratory Syndrome is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS) virus that over 10 years ago infected more than 8,000 people, with a 10% death rate. There is no vaccine or effective treatment against MERS, which spreads from human to human. Since 2012, MERS has infected almost 1,500 people and killed about 600 (40%). In the summer of 2015, South Korea was the site for the largest outbreak outside of Saudi Arabia of this emergent global health concern with 186 people infected with 36 (20%) fatalities.

Mr. Young K. Park, CEO, GeneOne Life Science, said, “MERS cases are continuing in the Middle East and we are moving rapidly with our partners to test a MERS vaccine in the clinic because there is no vaccine or treatment for this virulent virus. The completion of enrollment is a major step forward in combatting a highly lethal infection that has triggered widespread outbreaks in the Middle East and Korea.

About Inovio Pharmaceuticals, Inc.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

About the Walter Reed Army Institute of Research

Headquartered in Silver Spring, Maryland, the Walter Reed Army Institute of Research (WRAIR) is the oldest and most diverse biomedical research laboratory in the Department of Defense. WRAIR provides unique research capabilities and innovative solutions to a range of force health and readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations. Emerging infectious diseases such as MERS pose an ongoing threat to military operations and readiness. WRAIR develops vaccines, drugs and diagnostics for these diseases of importance to military and public health.  For more information on WRAIR, visit http://wrair-www.army.mil/

About VGXI, Inc.

With over 15 years of experience, VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services for DNA vaccine and gene therapy research. The company has an outstanding track record of success in manufacturing plasmid products under cGMP conditions for clinical trials in the US, EU, Asia 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 about VGXI’s services, visit http://www.vgxii.com/about.

About GeneOne Life Science

GeneOne Life Science Inc. is an international DNA vaccine 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 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 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 GeneOne Web site 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.

Media inquiries:
J.C. Richardson
267-440-4211
jeff@richardsonglobalpr.com