Promising data on preventive vaccine appears in the peer-reviewed journal Science Translational Medicine
PLYMOUTH MEETING, Pa. – August 19, 2015 – Inovio Pharmaceuticals (NASDAQ: INO) today announced its DNA vaccine targeting the virulent Middle East Respiratory Syndrome (MERS) induced 100% protection from a live virus challenge in a preclinical study. This medical advancement is notable because there is no vaccine or effective treatment for the MERS virus, which is clearly able to transmit from human to human. Since 2012, MERS has infected 1,400 people and killed over 500. Recently, the largest outbreak outside of Saudi Arabia of this emergent global health concern infected 186 people with 36 fatalities in South Korea.
In preclinical studies, Inovio and its collaborators evaluated its synthetic DNA-based MERS vaccine in mice, camels and monkeys, or non-human primates. In all three species, the vaccine induced robust immune responses capable of preventing the virus from infecting cells. The data from camels is an important finding because camels represent not only a host reservoir of the disease but act as a mode of transmission to humans. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS disease when challenged with a live MERS virus. Inovio has reported on the preventive power of its synthetic DNA-based vaccines in a variety of infectious diseases including HIV, influenza, hepatitis B, Ebola and dengue.
Results from Inovio's MERS vaccine development efforts appear in the peer-reviewed journal Science Translational Medicine in an article entitled, "A synthetic consensus anti-spike protein DNA vaccine induces protective immunity against Middle East Respiratory Syndrome Coronavirus in non-human primates." Inovio's collaborators for this study include researchers from the University of Pennsylvania, Public Health Agency of Canada, NIH, University of Washington, and University of South Florida.
Dr. J. Joseph Kim, President and CEO, Inovio, said: "Once again, our data demonstrates we can rapidly turn our SynCon® DNA-based immunotherapy platform to create innovative products with the potential to prevent and treat multiple infectious diseases and cancers. In this preclinical study, our synthetic vaccine shows its capability to combat a disease for which there is no vaccine. We look forward to clinically testing this product as an effective shield against the deadly MERS virus."
Under a previously announced collaboration agreement with GeneOne Life Science Inc. (KSE: 011000), Inovio's MERS vaccine product will advance into a clinical trial in healthy volunteers in the fourth quarter of this year. GeneOne will fund and conduct a phase I trial to evaluate the safety, tolerability and immunogenicity of the vaccine.
About Inovio's SynCon® Immunotherapy and Vaccine Design
Inovio's antigen-targeting DNA immunotherapies are designed to activate robust, durable and functional immune responses against cancers or infectious diseases. Our proprietary SynCon process also has a greater purpose: to break the immune system's tolerance to cancer or provide universal protection against unmatched mutating viruses. We identify immunologically important characteristics from multiple variants or strains of the disease, then synthetically create a novel, patentable genetic sequence for each target antigen. Our immunotherapies and vaccines enable the production of these consensus antigens in the body, activating a broader immune response "footprint" than is possible naturally or by other technologies.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy 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.
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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, 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 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 June 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.