Inovio Biomedical H1N1 Influenza DNA Vaccines Demonstrate 100% Responses Against Swine Flu in Vaccinated Pigs
Preclinical Data Validates Capability of Inovio SynConTM DNA Vaccines to Provide Universal Protection Against Unmatched Flu Virus Strains
SAN DIEGO -- Jul. 13, 2009-- Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that the company's SynConTM H1N1 influenza DNA vaccines achieved protective antibody responses against H1N1 swine influenza virus (A/Swine/Iowa/35233/1999) in 100% of pigs immunized with a two-dose vaccine regimen.
Dr. Niranjan Sardesai, Senior VP, Research & Development, presented the data at the Annual Conference of DNA Vaccines in Asia 2009 held in Beijing, China, July 9-10, 2009, in a presentation entitled, "Pandemic and Seasonal Influenza DNA Vaccines Delivered Via Electroporation."
In this study, scientists immunized pigs with consensus H1N1 influenza DNA vaccine candidates on day 0, day 14, and day 28. Sera collected on day 28 and day 42, after two or three doses of vaccine, respectively, showed hemagglutination inhibition (HI) titers above the protection threshold in 100% of the vaccinated animals against a swine H1N1 virus previously isolated from pigs. On-going additional animal studies are testing the ability of Inovio's SynConTM human H1N1 and swine H1N1 based vaccines to cross-protect from currently circulating human and swine H1N1 viruses as well as the new influenza A/H1N1 of swine origin.
In a similar collaborative study with scientists from the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania, Inovio previously demonstrated that mice immunized with Inovio's SynConTM H1N1 DNA vaccine provided 100% protection in a lethal challenge study against an unmatched H1N1 virus that caused the 1918 Spanish flu, which killed over 40 million people worldwide.
Dr. J. Joseph Kim, Inovio's CEO, said, "Our innovative SynConTM technology has the potential to protect people from influenza strains not exactly like the ones that make up the existing vaccines. This is a clear advantage for our universal flu program over conventional influenza vaccines. We are pleased to report our H1N1 preclinical results using pigs, a more natural model for the current influenza pandemic. We look forward to advancing our SynConTM universal flu vaccine program toward clinical investigation."
Inovio's novel SynConTM technology enables the company to design DNA-based vaccines with the potential to protect against unmatched sub-types and strains of pathogens. Inovio has created SynConTM DNA vaccines based on influenza HA, NA, and NP proteins that are common to strains H1N1, H2N2, H3N2, and H5N1, which make up the majority of seasonal and pandemic influenza. Using a designer approach, Inovio can formulate these DNA plasmids together to rapidly develop a universal influenza vaccine potentially targeting all these strains. The resulting vaccine could target seasonal as well as pandemic-potential influenza strains such as avian influenza and swine flu, which has already been designated pandemic status. Significantly, being based on a common set of antigens derived from a broad range of flu strains, such a universal vaccine would have the potential to provide greater protection against evolving, unmatched flu strains.
About Inovio Biomedical Corporation
Inovio Biomedical is engaged in the design, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. The company's SynConTM technology enables the design of DNA-based vaccines capable of providing cross-protection against new, unmatched strains of pathogens such as influenza. Inovio's proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio's clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Partners and collaborators include Merck, Tripep, University of Southampton, University of Pennsylvania, and HIV Vaccines Trial Network. Inovio's product candidates and technologies are protected by an extensive global intellectual property portfolio. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in 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 and that results from one study may not necessarily be reflected or supported by the results of other similar 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 availability or potential availability of alternative therapies or treatments for the conditions targeted by the parties or their collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the parties and their collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide the parties 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 combined 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 companies' combined technology by potential corporate or other partners or collaborators, capital market conditions, our ability to successfully integrate Inovio and VGX Pharmaceuticals, the impact of government healthcare proposals, our ability to maintain listing of our common stock under the rules and regulations of the NYSE Amex and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2008, our Form 10-Q for the three months ended March 31, 2009, and other regulatory filings from time to time, including our current report on Form 8-K reporting the closing of the merger transaction with VGX Pharmaceuticals, Inc. 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.