Inovio Biomedical Demonstrates Protective Immune Responses Against Novel H1N1 (2009) Influenza Virus in Ferret Model

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Mon Oct 5, 2009 5:30am EDT

Inovio Consensus H1N1 DNA Vaccines Show Protective Immune Responses after a
Single Shot in Pre-Clinical Animal Study
SAN DIEGO--(Business Wire)--
Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design,
development and delivery, announced today that a combination of its synthetic
consensus (SynConTM) H1N1 influenza vaccine candidates achieved protective
antibody responses against the novel pandemic influenza A/H1N1 (2009) in 100% of
tested ferrets. The ferret model is widely considered to be the most
representative of human influenza; achieving in ferrets a level of antibody
titers commonly associated with protection in humans is a critical milestone in
influenza vaccine development. Dr. Niranjan Y. Sardesai, Inovio`s Sr. VP,
Research and Development, presented this data at the Vaccine 3rd Global Congress
in Singapore in a presentation entitled, "Development of Universal SynCon DNA
Vaccines for Pandemic and Seasonal Flu." 

Following promising results in mice and pigs with SynCon H1N1 DNA vaccine
candidates, as referenced in previous news releases, in this study Inovio
scientists immunized ferrets with a formulation of H1N1 DNA vaccine candidates.
They then tested the ferrets` serum for hemagglutination inhibition (HI)
responses against one of the 2009 pandemic H1N1 strains,
A/H1N1/Mexico/InDRE4487/2009. 

HI measurements from the blood of vaccinated animals are used to assess the
generation of protective antibody responses. Generating an antibody titer of
1:20 is generally regarded as a positive vaccine response, with a titer of 1:40
or higher in the blood of vaccinated subjects generally associated with
protection against influenza in humans. 

In this experiment, a single vaccination showed induction of positive immune
responses in 78% (7 of 9) of ferrets, with a mean HI titer of 1:42. After two
booster shots, 100% of immunized ferrets had HI titers greater than 1:40, with
the mean titer rising to 1:390. 

Dr. Sardesai stated in his presentation, "Achieving positive data from the
important ferret model is a vital addition to the positive mice and swine data
we already reported for our H1N1 SynCon DNA vaccine candidates. Together with
our previously published H5N1 avian flu virus data, which highlighted the
vaccine`s cross-reactivity and broad immunogenicity across unmatched strains and
included protection data in mice, ferrets, and non-human primates, these new
H1N1 results further demonstrate the potential to protect against new strains of
influenza that do not specifically match the vaccine - unlike conventional
vaccines, which are strain-specific and usually provide limited protection
against emerging, divergent strains of influenza." 

Dr. J. Joseph Kim, Inovio`s CEO, said, "This is another important step on our
development path toward a universal influenza vaccine, which is intended to be a
proactive rather than reactive approach to addressing both seasonal and pandemic
strains. The beauty of our approach is that we can design universal DNA vaccines
with broad protective capabilities against known and unknown strains. Our H1N1
vaccine candidates have achieved the desired outcomes in several relevant animal
models against multiple unmatched virus strains. We are advancing our program
with H1N1 as well as for the H2, H3 and H5 sub-types that would also be
components of a universal vaccine. To this end, we have initiated cGMP clinical
product manufacturing of our H1N1 SynCon vaccine candidate." 

About Inovio`s SynConTM Universal Influenza Vaccines

Inovio is focused on developing DNA-based influenza vaccines able to provide
broad protection against known as well as newly emerging, unknown seasonal and
pandemic influenza strains. Using its SynCon process, Inovio`s scientists
designed DNA vaccines targeting an optimal consensus of HA, NA, and NP proteins
derived from multiple strains of the sub-types H1N1, H2N2, H3N2, and H5N1. These
influenza sub-types have been responsible for the majority of seasonal and
pandemic influenza outbreaks of the last century. 

Conventional vaccines are strain-specific and have limited ability to protect
against genetic shifts in the influenza strains they target. They are therefore
modified annually in anticipation of the next flu season`s new strain(s). If a
significantly different, unanticipated new strain emerges, such as the current
swine-origin pandemic strain, then the current vaccines provide little to no
protective capability. In contrast, Inovio believes that its design approach to
characterize a broad consensus of antigens across variant strains of each
influenza sub-type creates the ability to protect against new strains that have
common genetic roots, even though they are not perfectly matched. By formulating
a single vaccine with some or all of the key sub-types, protection may be
achieved against seasonal as well as pandemic strains such as swine flu or
pandemic-potential strains such as avian influenza. 

About Inovio Biomedical Corporation

Inovio Biomedical is focused on the design, development, and delivery of a new
generation of vaccines, called DNA vaccines, to prevent and treat cancers and
infectious diseases. The company`s SynCon technology enables the design of
DNA-based vaccines capable of protecting against both known and new, unknown
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. Inovio
is developing its universal and avian influenza vaccines in collaboration with
scientists from the University of Pennsylvania, the National Microbiology
Laboratory of the Public Health Agency of Canada, and the NIH`s Vaccine Research
Center. Other partners and collaborators include Merck, Tripep, University of
Southampton, National Cancer Institute, and HIV Vaccines Trial Network. 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, 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 ability to manufacture vaccine
candidates, the availability or potential availability of alternative therapies
or treatments for the conditions targeted by us or our collaborators, including
alternatives that may be more efficacious or cost-effective than any therapy or
treatment that we and our 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
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 June 30, 2009, 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.

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



Copyright Business Wire 2009

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