Inovio Pharmaceuticals’ Minimally Invasive Intradermal Electroporation Technology Showcased at Vaccine Forum
26 Januar 2011 - 10:00AM
Business Wire
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the
development of novel therapeutic and preventive vaccines against
cancers and infectious diseases, announced today the presentation
of recent preclinical data using its next generation of minimally
invasive intradermal (skin) electroporation delivery devices at the
Phacilitate Vaccine Forum 2011 in Washington, DC. The presentation,
titled “Potent cellular responses to SynCon™ DNA vaccines targeting
traditional prophylactic vaccine targets,” was made by Dr. Niranjan
Y. Sardesai, Inovio’s Sr. VP of Research and Development, and
highlighted recent developments made by Inovio to improve the
immune potency, usability, and tolerability of DNA vaccines
delivered by electroporation.
The use of in vivo electroporation has focused on intramuscular
(IM) delivery due to the durability of gene expression achievable
from this tissue. Skin is an attractive target tissue for
delivering DNA vaccines for multiple reasons: skin is the largest
organ of the human body and readily accessible; it is highly
immunocompetent, meaning it is the tissue most capable of
developing a broad immune response to antigens; it offers the
possibility of reducing invasiveness by requiring little or no
penetration of the skin and avoiding stimulation of muscle
tissue.
While Inovio’s current IM delivery technologies are well
tolerated, the company is also advancing device development to
achieve various desirable attributes. Its intradermal (ID)
electroporation (EP) device penetrates to no more than 3 mm,
compared to intramuscular devices that go deeper. Furthermore, its
minimally invasive surface electroporation (SEP) device sits on the
surface of the skin and uses a virtually undetectable scratch to
facilitate delivery of the vaccine. With the advancement of these
devices, Inovio’s aim is to make electroporation delivery amenable
to mass prophylactic vaccination by decreasing dose levels,
increasing tolerability of the vaccination, and increasing the
breadth of viable vaccine targets.
The data highlighted by Dr. Sardesai, which relates to
influenza, HIV, malaria, and smallpox antigens, demonstrates that
DNA delivery with this newer generation of ID and surface
electroporation devices yields levels of immunogenicity in terms of
both antibody and T-cell responses and/or efficacy against a virus
challenge that is comparable to intramuscular electroporation
devices currently in the clinic. In particular, immune responses
achieved with influenza antigens targeting H1, H3, and H5
immunogens yielded hemagglutination titers of greater than 1:40 (a
level considered protective in humans) in 100% of vaccinated
animals after two immunizations, with magnitudes comparable to or
better than those reported from animal studies of the IM-delivered
flu vaccine (VGX-3400) currently in the clinic.
Similarly, data presented from a head-to-head comparison of an
ID and IM-delivered 8-component smallpox vaccine in a non-human
primate challenge model showed that the monkeys vaccinated with ID
EP mounted stronger antibody responses and protection against a
virus challenge compared to those vaccinated via IM EP. Even more
significant, the antibody titers produced by ID EP vaccination in
the monkey model were comparable to those produced by the currently
stock-piled but no longer manufactured Dryvax™ smallpox vaccine in
the same monkey model.
The first vaccine utilizing Inovio’s ID EP delivery to be tested
in a human study is INO-3510, a universal H1N1 and H5N1 SynCon™ DNA
vaccine. Inovio expects to initiate a Phase I clinical study of
this vaccine in 2Q 2011.
Dr. Sardesai noted, “Our R&D and engineering teams are
extending the boundaries of not only DNA vaccine design but also of
the electroporation delivery devices that are facilitating the
best-in-class immune responses we recently reported from human
studies, as well as encouraging animal efficacy results. The unique
design of these minimally invasive devices demonstrates our
commitment to develop increasingly optimized products to better
facilitate vaccine delivery and bodes well for our vaccine
development activities focused on preventive targets.”
Dr. J. Joseph Kim, president and CEO of Inovio Pharmaceuticals,
said, “We are pleased that the excellent results obtained with our
current-generation IM delivery devices continue to hold up in
clinical studies as we make improvements to better serve the
end-user. The preference for less invasive vaccine delivery and our
demonstration of relevant vaccine responses using less-invasive
Inovio devices highlights the broader potential of our vaccine
platform for both therapeutic and prophylactic vaccine
targets.”
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA
vaccines, to treat and prevent cancers and infectious diseases.
These SynCon™ vaccines are designed to provide broad cross-strain
protection against known as well as newly emergent strains of
pathogens such as influenza. These vaccines, in combination with
Inovio’s proprietary electroporation delivery devices, have been
shown to be safe and generate significant immune responses.
Inovio’s clinical programs include HPV-caused cervical dysplasia
and cancer (therapeutic), avian flu (preventive), and HIV vaccines
(both preventive and therapeutic). Inovio is developing DNA
vaccines in collaboration with scientists from the University of
Pennsylvania. Other partners and collaborators include Merck,
National Cancer Institute, U.S. Military HIV Research Program, NIH,
HIV Vaccines Trial Network, University of Southampton and PATH
Malaria Vaccine Initiative. More information is available at
www.inovio.com.
This press release contains certain forward-looking statements
relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines and our capital resources. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in pre-clinical
studies, 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 the studies or trials may not be successful or achieve the
results desired, 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 adequacy of our
capital resources, 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 product liability,
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 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 company’s 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, 2009, our Form 10-Q for the
nine months ended September 30, 2010, 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.
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