Inovio Pharmaceuticals to Initiate Clinical Trial for its Hepatitis C Therapeutic Vaccine (INO-8000) Later this Year

    Inovio Pharmaceuticals to Initiate Clinical Trial for its Hepatitis C
                Therapeutic Vaccine (INO-8000) Later this Year

Phase I/IIa Trial Follows Preclinical Study Demonstrating for First Time that
a Multi-Antigen HCV Vaccine Can Generate Potent T-Cell Response in Liver

PR Newswire

BLUE BELL, Pa., Jan. 9, 2013

BLUE BELL, Pa., Jan. 9, 2013 /PRNewswire/ -- Inovio Pharmaceuticals, Inc.
(NYSE MKT: INO) and its development partner VGX International, Inc. (KSE:
011000) will move Inovio's hepatitis C (HCV) DNA vaccine into a phase I/IIa
clinical trial by the end of 2013. This advancement is based on outstanding
results of a preclinical study which demonstrated for the first time that a
multi-antigen SynCon® HCV vaccine can generate robust T-cell responses not
only in the blood but, more importantly, in the liver, an organ known to
supress T-cell activity. VGX International is funding all preclinical and
clinical development.

In preparation for entering clinical trials with its HCV vaccine (INO-8000),
Inovio has completed manufacturing of its multi-antigen HCV vaccine and is
performing IND (Investigational New Drug application)-enabling toxicity
testing in animals. INO-8000 is a SynCon HCV therapeutic vaccine targeting
NS3/4A, NS4B, and NS5A proteins of HCV. INO-8000 was designed with Inovio's
SynCon process to broadly cover HCV genotypes 1a and 1b, the types that have
been most difficult to treat with drug therapies.

It is estimated that more than 5 million people in the United States are
infected with hepatitis C, and perhaps as many as 200 million around the
world. This makes HCV one of the greatest public health threats of this

HCV vaccine research to date has mostly focused on one area of the virus (the
NS3/4A proteins) to induce T-cell responses; however, there has been little
research aimed at elucidating whether vaccines targeting proteins other than
NS3/4A can induce potent T-cell responses within the liver. In this study,
Inovio and its collaborators developed SynCon antigen constructs that targeted
three other areas of the HCV virus (NS4B, NS5A and NS5B) and then demonstrated
that each vaccine construct expressed its respective protein and that all
three constructs induced potent HCV-specific T-cells in mice.

Prior research has also identified that a successful HCV vaccine must be able
to induce not only strong HCV-specific T-cell responses that target several
components of the virus but that these cells must migrate to the liver and
remain activated. In this study, Inovio researchers observed in the liver not
only NS4B-, NS5A- and NS5B-specific CD4+ and CD8+ (or killer T-cell)
responses, but also a large pool of vaccine-specific T-cells. This pool of
vaccine-specific T-cells was shown to be fully functional in an environment in
which T-cell activity is usually suppressed. In fact, using a transient HCV
infection model in mice, therapeutic immunization with INO-8000 was able to
clear HCV antigens from the liver, demonstrating the therapeutic potential of
this vaccine. 

The pioneering preclinical research appears in the peer-reviewed journal Plos
One in an article entitled: "Induction of Intrahepatic HCV NS4B, NS5A and NS5B
Specific Cellular Immune Responses following Peripheral Immunization."

In addition to moving forward with INO-8000, Inovio has a long-standing
partnership with ChronTech Pharma, which is developing its NS3/4A-based HCV
DNA vaccine using Inovio's proprietary delivery technology. Interim results of
ChronTech's open-label, randomized phase II trial are expected later in the
first quarter of this year. 

Dr. J. Joseph Kim, Inovio's President and CEO, said, "Inovio is a leader in
developing therapeutic vaccines for HCV and HBV. The major hurdle to
developing therapeutic vaccines for these ailments has been the inability to
generate a functional T-cell response in the liver. The fact that our
preclinical model demonstrated functional T-cells in the liver in this
published study suggests that INO-8000 has the capacity to clear that hurdle.
There have been important recent drug therapy advances for HCV; however, a
safe and effective therapeutic vaccine could play a vital role in enhancing
the potency of HCV treatments, especially for genotype 1, while achieving the
desired goal of eliminating the use of interferon/ribavirin and their
undesirable side effects."

About Hepatitis C and Inovio's SynCon® Vaccines

Hepatitis C is an infectious disease affecting primarily the liver, caused by
the hepatitis C virus (HCV). The infection is often asymptomatic, but chronic
infection can lead to liver failure or liver cancer. Approximately 80% of
people who become infected with hepatitis C virus develop chronic infection.

The major obstacle to HCV vaccine development has been the extensive genetic
variation between different strains and genotypes, and even the significant
antigenic variation among virus within individual patients. In addition, the
absence of a clearly defined protective immune response after natural
infection has historically complicated the prospects of developing a vaccine
against HCV infection.

However, unlike traditional vaccines constrained by the paradigm of matching a
preventive or therapeutic vaccine to a single pathogen strain or strains,
Inovio's SynCon vaccines are based on genetic code for a specific antigen from
multiple strains of the target pathogen. Thus, while the SynCon antigens may
not be perfectly (100%) matched to the pathogenic strains, they are designed
to protect against multiple existing strains as well as changing strains of a
virus. Extensive preclinical data has validated their ability to protect
against many strains of a disease; initial human data for our influenza
vaccine has also provided evidence of this capability.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and
challenging infectious diseases. Its SynCon vaccines are designed to provide
universal cross-strain protection against known as well as newly emergent
unmatched strains of pathogens such as influenza. These synthetic vaccines, in
combination with Inovio's proprietary electroporation delivery, have been
shown in humans to generate best-in-class immune responses with a favorable
safety profile. Inovio's clinical programs include phase II studies for
cervical dysplasia, leukemia and hepatitis C virus and phase I studies for
influenza and HIV. Partners and collaborators include the University of
Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV
Research Program, NIH, HIV Vaccines Trial Network, University of Southampton,
US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine
Initiative. More information is available at

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 pre-clinical studies and
clinical trials may not commence or be completed in the time periods
anticipated, 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, our ability to secure new partnerships and
collaborations, capital market conditions, 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, 2011, our Form 10-Q for the quarter ended
September 30, 2012, 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

Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101,
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211,


SOURCE Inovio Pharmaceuticals, Inc.

Press spacebar to pause and continue. Press esc to stop.