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
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
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
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
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 www.inovio.com.
SOURCE Inovio Pharmaceuticals, Inc.