Inovio Pharmaceuticals, Inc., a leader in the development of synthetic vaccines against cancers and infectious diseases, announced that it has entered into a product development collaboration agreement with its affiliate, VGX International Inc. (KSE:011000), to co-develop Inovio's SynCon 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 non-structural proteins 3 (NS3) and 4A (NS4A), as well as NS4B and NS5A proteins. The vaccine will be delivered with Inovio's Cellectra 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 SynCon vaccine targeting NS3/4A, which were published in the journal Molecular Therapy in the paper, “HCV 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-? (IFN-?) 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 Joseph 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-C) encoding for NS3/4A protein (genotype 1a) administered by Inovio's MedPulser 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 per cent) 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 per cent 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 SA 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 SynCon therapeutic vaccine for Hepatitis B Virus (HBV).

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 HBV and HCV. It is estimated that as many as 5.3 million people—or about 2 per cent 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 US 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 ageing 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.

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.