Inovio assesses vaccine against swine flu

Inovio Biomedical, National Microbiology Laboratory, and University of Pennsylvania to Evaluate Candidate DNA Vaccines Against “Swine” Influenza A (H1N1)

Collaboration of vaccine experts to assess DNA vaccines designed to provide broad protective immunity against new influenza strains such as the H1N1 swine flu

SAN DIEGO, June 30, 2009 -- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today it has established a new collaboration with the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania to further evaluate Inovio DNA vaccine candidates against swine influenza A (H1N1) virus. As a part of its universal influenza vaccine program, Inovio has designed and manufactured consensus DNA vaccines for H1N1 influenza strains. These consensus vaccines, delivered using Inovio’s proprietary electroporation technology, have the potential to provide protection against a broad scope of existing as well as currently unknown, unmatched influenza strains that could emerge--one of the perpetual challenges in trying to protect against influenza. The purpose of this collaboration is to test these vaccine candidates against pandemic and seasonal influenza strains in animal models and will include testing against a recently identified swine H1N1 strain.

The World Health Organization’s (WHO) upgrade on June 11, 2009, of the “swine flu” to a full pandemic status acknowledged the detection of the virus in 74 countries. This first declaration of a global pandemic since 1968 reflected more the rate and ease of spread rather than virulence of the virus. Significantly, by early June scientists had characterized over 60 different gene sequences of the swine influenza A (H1N1) virus amongst the first 259 samples isolated from humans. The rapid spread and evolution of this virus highlights the great potential risk should a more virulent strain of the virus emerge.

While strain-specific vaccines may provide some protective immunity against a known influenza strain, they do not resolve the fundamental challenge to protecting against influenza, which is the virus’ constant evolution beyond the protective capabilities of strain-specific vaccines. Unfortunately, even the relatively short period of six to nine months to launch a new strain-specific vaccine could allow a more virulent influenza strain to rapidly spread and potentially wreak significant havoc.

“We believe a consensus vaccine approach is imperative and look forward to continuing our collaborative evaluation of Inovio’s novel DNA vaccines with their ability to provide protection against evolving, unmatched influenza strains,” said Dr. David B. Weiner, Professor, Dept. of Pathology & Laboratory Medicine, University of Pennsylvania and Chairman of Inovio’s Scientific Advisory Board.

Dr. J. Joseph Kim, Inovio’s CEO, stated, “The current swine flu outbreak highlights the fact that the world cannot rely solely on the “catch-up” strategy of influenza vaccine design. We need vaccines that provide at least some broad protective capability against evolving seasonal influenza strains and those with pandemic potential. We have already achieved significant validating data in large animal models regarding the ability of Inovio’s consensus vaccines to protect against unmatched strains of different influenza sub-types and look forward to the data resulting from this collaboration of vaccine experts.”

Work completed by Dr. Gary Kobinger, Head, Vector Design and Immunotherapy, Special Pathogens, National Microbiology Laboratory, Public Health Agency of Canada, and his colleagues recently resulted in the characterization of several currently-circulating clinical isolates of the swine-like H1N1 virus.

Inovio, the National Microbiology Laboratory of the Public Health Agency of Canada, and the University of Pennsylvania have previously collaborated and published on studies involving Inovio’s consensus DNA vaccines. In a study of Inovio’s VGX-3400, ferrets vaccinated with this H5N1 avian flu vaccine candidate, when challenged with the unmatched “bird flu” A/Vietnam/1203/04 strain, showed 100% protection.

In another study, mice immunized with an Inovio H1N1 consensus DNA vaccine were then challenged with a lethal dose of the unmatched H1N1 virus that caused the 1918 Spanish flu, which killed over 40 million people. All the immunized mice survived the challenge (100% protection) to the end of the experiment and displayed significant protection from infection-associated morbidity. All the control mice died by day 8 after being challenged with the virus.

Inovio’s influenza vaccine constructs were designed using the company’s novel SynCon<http://www.SwiftPage3.com/SpeClicks.aspx?X=2V0QC8JDHQUH7B0Y02YVWW>™ technology, which facilitates the design of DNA-based vaccines capable of protecting against unmatched sub-types and strains of pathogens. Inovio scientists have created DNA vaccine candidates broadly targeting the H1N1, H2N2, H3N2, and H5N1 influenza sub-types, which make up the majority of seasonal and pandemic influenza. By formulating combinations of these individual component vaccines, Inovio can employ this designer approach to rapidly develop universal influenza vaccines potentially capable of targeting multiple influenza sub-types and able to protect against evolving strains of the virus.

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 SynCon™ technology enables the design of DNA-based vaccines capable of providing cross-protection against evolving, unmatched strains of pathogens such as influenza. Inovio’s proprietary electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Initial human data has shown this method can 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<http://www.SwiftPage3.com/SpeClicks.aspx?X=2V0QC8JDHQUH7B0Y03YVWW>.

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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.

 

 

 

 

CONTACTS: Investors: Bernie Hertel, Inovio Biomedical, 858-410-3101 Media: Jeff Richardson, Richardson & Associates, 805-491-8313

 

Posted: June 2009

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