Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine
design, development and delivery, announced today that its affiliate VGX
International Inc. (Korean Stock Exchange: 011000) has received approval
in Korea to begin a Phase I clinical trial in healthy volunteers for
Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian
influenza. Inovio is co-developing VGX-3400 with Korea-based VGX
International. The 30-patient three-dose Phase I study will be conducted
in multiple clinical research sites in Korea. A parallel study in the
U.S. is also planned for this year.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “Initiation of our
H5N1 vaccine clinical trial marks an important milestone for our
universal flu program. Inovio has been one of the first organizations to
demonstrate a vaccine capable of providing protection against a broad
set of unmatched influenza sub-types and strains, both seasonal and
pandemic, in multiple animal models.”
“If we achieve similar results in human studies, this universal vaccine
concept has the potential to shift the current reactive paradigm of
influenza vaccine design, manufacturing, and delivery. Such a shift
would provide tremendous health and economic benefits worldwide,” Dr.
Kim added.
In pre-clinical studies, vaccination with VGX-3400 generated broadly
protective levels of hemagglutination inhibition (HAI) titers in 100% of
the immunized animals in five separate animal models - mice, ferrets,
rabbits, pigs, and rhesus monkeys. Vaccination with VGX-3400 also
protected animals from an unmatched, lethal H5N1 virus challenge in
mouse, ferret, and monkey models. According to the World Health
Organization, the H5N1 bird flu has infected 478 people in 15 countries
since 2003 with 286 deaths (60% death rate). While H5N1 has never spread
widely, one concern is the potential for the lethal H5N1 to “reassort”
with another of the influenza sub-types that have been prone to spread
more rapidly, possibly creating a more dangerous influenza strain.
About Inovio's SynCon™ 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 in humans.
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 2009 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 “universal” vaccines capable of protecting against
multiple – including newly emergent, 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, in addition to historical information,
forward-looking statements. Such statements are based on management’s
current estimates and expectations and are subject to a number of
uncertainties and risks that could cause actual results to differ
materially from those described in the forward-looking
statements. Inovio is providing this information as of the date of this
press release, and expressly disclaims any duty to update information
contained in this press release.
Forward-looking statements in this press release include, without
limitation, express and implied statements relating to Inovio’s
business, plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines and pre-clinical and clinical studies.
Actual events or results may differ from the expectations set forth
herein as a result of a number of risks, uncertainties and other
factors, including but not limited to: Inovio has a history of losses;
all of Inovio’s potential human products are in research and development
phases; no revenues have been generated from the sale of any such
products, nor are any such revenues expected for at least the next
several years; Inovio’s product candidates will require significant
additional research and development efforts, including extensive
preclinical and clinical testing; uncertainties inherent in clinical
trials and product development programs, including but not limited to
the fact that pre-clinical and clinical results 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, that results from an animal study
may not be indicative of results achievable in human studies, that
clinical testing is expensive and can take many years to complete, that
the outcome of any clinical trial is uncertain and failure can occur at
any time during the clinical trial process, and that Inovio’s
electroporation technology and DNA vaccines may fail to show the desired
safety and efficacy traits in clinical trials; all product candidates
that Inovio advances to clinical testing will require regulatory
approval prior to commercial use, and will require significant costs for
commercialization; the availability of funding; the ability to
manufacture vaccine candidates; the availability or potential
availability of alternative therapies or treatments for the conditions
targeted by Inovio or its collaborators, including alternatives that may
be more efficacious or cost-effective than any therapy or treatment that
Inovio and its collaborators hope to develop; whether Inovio’s
proprietary rights are enforceable or defensible or infringe or
allegedly infringe on rights of others or can withstand claims of
invalidity; and the impact of government healthcare proposals. Readers
are also referred to Inovio’s Annual Report on Form 10-K for the year
ended December 31, 2008 and its Quarterly Report on Form 10-Q for the
quarter ended September 30, 2009 filed with the Securities and Exchange
Commission which identify important risk factors that could cause actual
results to differ from those contained in the forward-looking statements.
