Inovio Pharmaceuticals and VGX International to Advance Therapeutic Hepatitis C and Hepatitis B Synthetic Vaccines into Clinical Studies

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Inovio Pharmaceuticals and VGX International to Advance Therapeutic Hepatitis C

and Hepatitis B Synthetic Vaccines into Clinical Studies

From the PharmaLive.com News Archive - Oct. 13, 2011

Data published in Molecular Therapy indicates strong vaccine-generated T cell

immune responses in monkeys to consensus multi-antigen HCV vaccine

BLUE BELL, PA - October 10, 2011 -- Inovio Pharmaceuticals, Inc. (NYSE Amex:

INO), a leader in the development of synthetic vaccines against cancers and

infectious diseases, announced today that it has entered into a product

development collaboration agreement with its affiliate, VGX International Inc.

(KSE:011000), to co-develop Inovio's SynConR therapeutic vaccines for hepatitis

B and C infections.

Under the terms of the agreement, VGX International will receive marketing

rights for these vaccines in Asia, excluding Japan, and in return will fully

fund IND-enabling and initial phase I and II clinical studies. Inovio will

receive payments based on the achievement of clinical milestones and royalties

based on sales in the licensed territories and retains all commercial rights in

all other territories.

The first product to enter clinical testing will be a synthetic multi-antigen

hepatitis C virus (HCV) vaccine covering genotypes 1a and 1b and targeting the

antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A

(NS4A), as well as NS4B and NS5A proteins. The vaccine will be delivered with

Inovio's CELLECTRAR delivery device. IND-enabling toxicology tests will be

conducted in 1H 2012, with the intent being to initiate a phase I clinical study

in late 2012. The target population for the vaccine clinical trials will be HCV

infected individuals.

Supporting this product development advancement are positive preclinical results

from Inovio's novel SynConR vaccine targeting NS3/4A, which were published in

the journal Molecular Therapy in the paper, " Hepatitis C Virus NS3/NS4A DNA

Vaccine Induces Multi-epitope T Cell Responses in Rhesus Macaques Mimicking

Human Immune Responses. " Following immunization, rhesus macaques mounted strong

HCV-specific T cell immune responses strikingly similar to those reported in

patients who have cleared the virus on their own. The responses included strong

NS3-specific interferon-ã (IFN-ã) induction, robust CD4 and CD8 T cell

proliferation, and induction of polyfunctional T cells. The study was funded in

part by a $2.8 million PA CURE grant received by Inovio and its collaborators in

2010 to develop this multi-antigen synthetic HCV vaccine.

" Hepatitis B and C are a major global health problem, with about 470 million

people infected worldwide. As a development leader of synthetic vaccines, we are

pleased to collaborate with our affiliate VGX International to advance our

global, multi-antigen HCV vaccine into the clinic. This latest development is an

integral part of Inovio's multi-pronged approach to develop our therapeutic

hepatitis vaccine pipeline, " stated Dr. J. ph Kim, President and CEO.

Inovio has an ongoing open label Phase II clinical study with ChronTech Pharma

AB to test the effect of a DNA vaccine (ChronVac-CR) encoding for NS3/4A protein

(genotype 1a) administered by Inovio's MedPulserR electroporation delivery

device followed by the standard of care (SOC) drug treatment using interferon

and ribavirin. In an earlier phase I study, 5 of 6 participants (83%) who

received the vaccine along with SOC cleared the virus. SOC drug treatment alone

in patients infected with HCV genotype 1 results in clearance of the virus in

40-50% of patients. Interim results from this phase II study are expected in

2012.

Inovio previously announced a research collaboration with ChronTech Pharma AB

and Transgene S.A. to test the immunogenicity of a DNA/electroporation prime -

MVA boost approach against HCV by combining two promising, previously studied

clinical candidates. A Phase I clinical study is anticipated to start in Q4

2011.

Under the same agreement, Inovio and VGX International will also co-develop

Inovio's SynConR therapeutic vaccine for hepatitis B virus.

About Hepatitis B and Hepatitis C Virus Infections

HBV and HCV infections pose a major global public-health problem and are major

causes of chronic liver disease. Three to five times more people are living with

chronic viral hepatitis infections than with HIV infection. In the next 10

years, about 150,000 people in the United States are expected to die from liver

cancer and end-stage liver disease associated with chronic hepatitis B virus

(HBV) and hepatitis C virus (HCV). It is estimated that as many as 5.3 million

people-or about 2% of the US population-are living with chronic HBV or HCV

infections. Of those, 800,000 to 1.4 million have HBV and 2.7-3.9 million have

HCV. Worldwide there are about 300 million people infected with chronic HBV and

170 million people with chronic HCV.

The direct medical costs associated with HBV and HCV infections in the U.S. are

estimated to reach nearly $8 billion annually. Almost half the liver

transplantations in the United States are necessitated by end-stage liver

disease associated with HBV or HCV infection. Because of the aging of people now

infected (including some people with asymptomatic infections who will become

symptomatic), HBV- and HCV-related illnesses, deaths, and costs are all expected

to rise substantially during the next two decades.

About Inovio Pharmaceuticals, Inc.

Inovio is developing its revolutionary synthetic consensus immunogen

technologies to extend the profound medical benefits of the 20th century's

immune-system-stimulating vaccines by preventing and treating today's cancers

and challenging infectious diseases. Its SynConR 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

method, have been shown in humans to be safe and generate best-in-class immune

responses. Inovio's clinical programs include Phase II studies for cervical

dysplasia/cancer, 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 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 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, 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, 2010, our Form 10-Q for the quarter ended June 30, 2011, 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.

CONTACTS:

Investors: Bernie Hertel, Inovio Pharmaceuticals 858-410-3101 bhertel@...

Media: Jeff , & Associates 805-491-8313

jeff@...

[Guest guest]

http://www.therapeuticsdaily.com/news/article.cfm?contentValue=807737 & contentTyp\

e=newsarchive & channelID=26

Inovio Pharmaceuticals and VGX International to Advance Therapeutic Hepatitis C

and Hepatitis B Synthetic Vaccines into Clinical Studies

From the PharmaLive.com News Archive - Oct. 13, 2011

Data published in Molecular Therapy indicates strong vaccine-generated T cell

immune responses in monkeys to consensus multi-antigen HCV vaccine

BLUE BELL, PA - October 10, 2011 -- Inovio Pharmaceuticals, Inc. (NYSE Amex:

INO), a leader in the development of synthetic vaccines against cancers and

infectious diseases, announced today that it has entered into a product

development collaboration agreement with its affiliate, VGX International Inc.

(KSE:011000), to co-develop Inovio's SynConR therapeutic vaccines for hepatitis

B and C infections.

Under the terms of the agreement, VGX International will receive marketing

rights for these vaccines in Asia, excluding Japan, and in return will fully

fund IND-enabling and initial phase I and II clinical studies. Inovio will

receive payments based on the achievement of clinical milestones and royalties

based on sales in the licensed territories and retains all commercial rights in

all other territories.

The first product to enter clinical testing will be a synthetic multi-antigen

hepatitis C virus (HCV) vaccine covering genotypes 1a and 1b and targeting the

antigens NS3/4A, which includes HCV nonstructural proteins 3 (NS3) and 4A

(NS4A), as well as NS4B and NS5A proteins. The vaccine will be delivered with

Inovio's CELLECTRAR delivery device. IND-enabling toxicology tests will be

conducted in 1H 2012, with the intent being to initiate a phase I clinical study

in late 2012. The target population for the vaccine clinical trials will be HCV

infected individuals.

Supporting this product development advancement are positive preclinical results

from Inovio's novel SynConR vaccine targeting NS3/4A, which were published in

the journal Molecular Therapy in the paper, " Hepatitis C Virus NS3/NS4A DNA

Vaccine Induces Multi-epitope T Cell Responses in Rhesus Macaques Mimicking

Human Immune Responses. " Following immunization, rhesus macaques mounted strong

HCV-specific T cell immune responses strikingly similar to those reported in

patients who have cleared the virus on their own. The responses included strong

NS3-specific interferon-ã (IFN-ã) induction, robust CD4 and CD8 T cell

proliferation, and induction of polyfunctional T cells. The study was funded in

part by a $2.8 million PA CURE grant received by Inovio and its collaborators in

2010 to develop this multi-antigen synthetic HCV vaccine.

" Hepatitis B and C are a major global health problem, with about 470 million

people infected worldwide. As a development leader of synthetic vaccines, we are

pleased to collaborate with our affiliate VGX International to advance our

global, multi-antigen HCV vaccine into the clinic. This latest development is an

integral part of Inovio's multi-pronged approach to develop our therapeutic

hepatitis vaccine pipeline, " stated Dr. J. ph Kim, President and CEO.

Inovio has an ongoing open label Phase II clinical study with ChronTech Pharma

AB to test the effect of a DNA vaccine (ChronVac-CR) encoding for NS3/4A protein

(genotype 1a) administered by Inovio's MedPulserR electroporation delivery

device followed by the standard of care (SOC) drug treatment using interferon

and ribavirin. In an earlier phase I study, 5 of 6 participants (83%) who

received the vaccine along with SOC cleared the virus. SOC drug treatment alone

in patients infected with HCV genotype 1 results in clearance of the virus in

40-50% of patients. Interim results from this phase II study are expected in

2012.

Inovio previously announced a research collaboration with ChronTech Pharma AB

and Transgene S.A. to test the immunogenicity of a DNA/electroporation prime -

MVA boost approach against HCV by combining two promising, previously studied

clinical candidates. A Phase I clinical study is anticipated to start in Q4

2011.

Under the same agreement, Inovio and VGX International will also co-develop

Inovio's SynConR therapeutic vaccine for hepatitis B virus.

About Hepatitis B and Hepatitis C Virus Infections

HBV and HCV infections pose a major global public-health problem and are major

causes of chronic liver disease. Three to five times more people are living with

chronic viral hepatitis infections than with HIV infection. In the next 10

years, about 150,000 people in the United States are expected to die from liver

cancer and end-stage liver disease associated with chronic hepatitis B virus

(HBV) and hepatitis C virus (HCV). It is estimated that as many as 5.3 million

people-or about 2% of the US population-are living with chronic HBV or HCV

infections. Of those, 800,000 to 1.4 million have HBV and 2.7-3.9 million have

HCV. Worldwide there are about 300 million people infected with chronic HBV and

170 million people with chronic HCV.

The direct medical costs associated with HBV and HCV infections in the U.S. are

estimated to reach nearly $8 billion annually. Almost half the liver

transplantations in the United States are necessitated by end-stage liver

disease associated with HBV or HCV infection. Because of the aging of people now

infected (including some people with asymptomatic infections who will become

symptomatic), HBV- and HCV-related illnesses, deaths, and costs are all expected

to rise substantially during the next two decades.

About Inovio Pharmaceuticals, Inc.

Inovio is developing its revolutionary synthetic consensus immunogen

technologies to extend the profound medical benefits of the 20th century's

immune-system-stimulating vaccines by preventing and treating today's cancers

and challenging infectious diseases. Its SynConR 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

method, have been shown in humans to be safe and generate best-in-class immune

responses. Inovio's clinical programs include Phase II studies for cervical

dysplasia/cancer, 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 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 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, 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, 2010, our Form 10-Q for the quarter ended June 30, 2011, 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.

CONTACTS:

Investors: Bernie Hertel, Inovio Pharmaceuticals 858-410-3101 bhertel@...

Media: Jeff , & Associates 805-491-8313

jeff@...