Inovio Pharmaceuticals and GeneOne Life Science Initiate Patient Recruitment for MERS Vaccine Trial
PLYMOUTH MEETING, Pa., Jan. 28, 2016 (GLOBE NEWSWIRE) -- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the beginning of recruitment for its collaborative vaccine study for MERS (Middle East Respiratory Syndrome). Inovio and GeneOne Life Science Inc. (KSE:011000) are co-developing Inovio’s MERS vaccine (GLS-5300) in partnership with the Walter Reed Army Institute of Research (WRAIR) in Maryland, where the trial is being conducted.
The primary and secondary goals of this first-in-man phase I trial are to obtain safety and immunogenicity data. This trial represents the first MERS vaccine to be tested in humans for this disease that has no approved vaccines or treatments.
Dr. J. Joseph Kim, Inovio President and CEO, said, “After partnering with WRAIR and receiving an IND approval from the FDA late last year, we are pleased to now open this trial with our collaborators. The MERS virus has triggered widespread outbreaks and deaths in the Middle East and Korea and the healthcare community is urgently exploring possible preventive and therapeutic solutions.
“Our broad experience with DNA-based immunotherapies and with MERS specifically suggests we can potentially make an important contribution to developing such a solution. As demonstrated by our recent vaccine development efforts for Ebola, we can readily apply Inovio’s technology to target other threatening infectious threats like MERS and Zika virus as well as other emergent infectious diseases.”
Last year, GLS-5300 induced 100% protection from a live virus challenge in a rhesus macaque non-human primate study. Inovio and its collaborators evaluated its MERS vaccine in mice, camels as well as non-human primates. As published in Science Translational Medicine, the vaccine induced robust immune responses capable of preventing the virus from infecting cells in all three species. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS when challenged with a live MERS virus.
Middle East Respiratory Syndrome is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS). While SARS infected more than 8,000 people, the disease was short-lived between 2002 and 2004 and had a mortality rate of about 10%. Since 2012, MERS has infected over 1,600 people, with almost 600 deaths, a mortality rate of about 40%, and is still ongoing. Highlighting the global concern for MERS, in the summer of 2015 a single business person returned to South Korea from Saudi Arabia and was the index case for a country-wide epidemic involving 186 persons with a 20% mortality rate.
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 is 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, Roche, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
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.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100 and INO-3112, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, our Form 10-Q for the quarter ended September 30, 2015, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
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