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

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Tue Jun 30, 2009 3:00am EDT

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--(Business Wire)--
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 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. 

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.



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

Copyright Business Wire 2009

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