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Inovio Pharmaceuticals (INO) DNA Vaccine Against Ebola and Marburg Filoviruses Provides Complete Protection in Preclinical Challenge Study


5/14/2013 9:52:20 AM

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BLUE BELL, Pa., May 14, 2013 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that in a preclinical study of Inovio's SynCon® DNA vaccine against Ebola and Marburg filoviruses, labeled "Category A" bioterrorism agents by the U.S. government, the vaccine induced strong and broad immune responses and demonstrated 100% protection against death following a challenge with multiple variants of the pathogen in two animal models.

There is no approved vaccine or therapy available against these highly virulent pathogens that have killed up to 90% of the people they infected. Because these viruses could potentially be easily transmitted, result in high mortality rates and cause a major public health impact, various agencies are seeking solutions for public health preparedness. A DNA vaccine could offer faster design and manufacturing timelines than traditional vaccine approaches, but particularly important, Inovio's SynCon® products offer the potentially preemptive advantage of enabling a design to provide broad protection encompassing multiple families of these so-called filoviruses.

Preclinical data was published in the peer-reviewed journal Molecular Therapy in a paper, "Induction of Broad Cytotoxic T Cells by Protective DNA Vaccination Against Marburg and Ebola," authored by Inovio researchers and collaborators.

Using Inovio's proprietary SynCon® design approach, Inovio researchers developed a polyvalent DNA vaccine consisting of three consensus plasmids to broadly target variant virus strains within three distinct families of Ebola and Marburg viruses. In the first part of this study, following two vaccinations using Inovio's proprietary CELLECTRA® electroporation device, 100% of vaccinated guinea pigs were protected from death following a virus challenge. The researchers observed significant increases in neutralizing antibody titers and strong and broad levels of vaccine-induced T-cells, including "killer" T-cells, and subsequently conducted a test in mice using only one vaccination this single dose also fully protected the animals from death following a virus challenge. In addition, unlike the non-vaccinated animals, vaccinated animals were protected from weight loss.

Dr. Joseph Kim, Inovio's President and CEO said, "This study again demonstrates the preventive potency and broad immune response that we consistently see in studies of our DNA portfolio of vaccines. These immune response characteristics are the type considered necessary to achieve protection in humans. These outstanding results support Inovio's active biodefense program, which has garnered multiple grants from the Department of Defense, Defense Threat Reduction Agency (DTRA), National Institute of Allergy and Infectious Diseases (NIAID), and other government agencies focused on public health which value our DNA vaccine approach to treating and preventing disease."

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal protection against known as well as new unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary electroporation delivery, have been shown in humans to generate best-in-class immune responses with a favorable safety profile. Inovio's clinical programs include phase II studies for cervical dysplasia, leukemia and hepatitis C virus and phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.

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 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, 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, 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, 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, 2012, our Form 10-Q for the quarter ended March 31, 2013, 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.

CONTACTS:

Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com

(Logo: http://photos.prnewswire.com/prnh/20120131/LA44118LOGO)

SOURCE Inovio Pharmaceuticals, Inc.



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