SAN DIEGO--(BUSINESS WIRE)--Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine
design, development and delivery, announced today that the company's
SynCon™ H1N1 influenza DNA vaccines achieved protection against current
circulating swine origin influenza A/H1N1 viruses in animal studies.
The company had previously reported interim data from an ongoing study
in a pig model in which the SynCon™ based H1N1 vaccines achieved
hemagglutination inhibition (HI) titers above the protection threshold
in 100% of the vaccinated animals against the swine influenza virus
(A/Iowa/35233/1999). In a continuation of this study, Inovio
investigators tested the immune sera for responses against a virus
isolated from the current circulating strain of swine origin influenza
A/H1N1 (Swine A/Mexico/InDRE4487/2009). All the animals immunized with
the SynCon™ H1N1 vaccine developed HI titers exceeding the 1:40 level
commonly associated with protective immunity.
In a second study, the investigators immunized mice with the NP and m2E
components of the vaccine and challenged these animals with a second
related strain also isolated from the current circulating influenza
A/H1N1 (A/Canada/AB/RV1532/2009). While all mice showed effects of virus
challenge as judged by significant weight loss, the vaccinated mice
recovered from virus infection-induced morbidity significantly faster
compared to the non-immunized control animals.
In a previous study, the Inovio team demonstrated that mice immunized
with Inovio’s SynCon™ 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.
The challenge of current seasonal influenza vaccines is they are not
effective against new strains that emerge, like the present swine origin
influenza A/H1N1. The CDC reported low human prevaccination response
rates and cross-reactivity to swine origin influenza
(A/California/04/2009), suggesting that current H1N1 seasonal flu
vaccines were likely to be ineffective against the new 2009 A/H1N1
strains. Similarly, the USDA recently reported there was limited
cross-reactivity against the new 2009 A/H1N1 virus in pig herds
vaccinated with existing swine influenza vaccines.
Dr. J. Joseph Kim, Inovio’s CEO, said, “The latest data further
underscores the potential of the SynCon™ technology to create vaccines
capable of protecting against emerging pandemic influenza viruses. Our
SynCon™ influenza vaccines were developed prior to the emergence of the
current swine flu strains and have yielded strong protective responses
in animal models against a variety of unmatched influenza strains. This
is an advantage for our universal flu program over conventional
influenza vaccines, which are strain-specific. Inovio, along with its
collaborators, is amongst the first groups to report on the successful
protection of vaccinated animals against a virus challenge with the 2009
influenza A/H1N1 virus. We are also one of the first groups to report on
preclinical results regarding this virus using a large-animal model like
pigs, a more natural host for the current influenza pandemic.”
Inovio’s novel SynCon™ technology enables the company to design
DNA-based vaccines with the potential to protect against unmatched
sub-types and strains of pathogens and provides the opportunity to have
vaccines on hand against new strains that perpetually emerge, as in the
case of influenza. Inovio has created SynCon™ DNA vaccines based on
influenza HA, NA, and NP proteins from strains H1N1, H2N2, H3N2, and
H5N1, which make up the majority of seasonal and pandemic influenza.
Resulting vaccines could target seasonal as well as pandemic-potential
influenza strains such as avian influenza and swine-origin 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, a
universal vaccine would have the potential to provide greater protection
against new, 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 SynCon™ 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. Inovio is developing its universal
and avian influenza vaccines in collaboration with scientists from the
University of Pennsylvania and the National Microbiology Laboratory of
the Public Health Agency of Canada. Other 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, 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 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 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 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:
Inovio Biomedical
Bernie Hertel, 858-410-3101
or
Media:
Richardson
& Associates
Jeff Richardson, 805-491-8313