Inovio Pharmaceuticals, Inc. announced that the safety, tolerability and immunogenicity of its therapeutic vaccine for hepatitis C (INO-8000/VGX-6150) will be studied in a phase I clinical trial in chronically HCV infected patients. Under a 2011 collaborative development agreement, Inovio's affiliate, VGX International Inc., is fully funding and conducting the study at multiple sites in Korea. Inovio is also planning to evaluate this hepatitis C (HCV) vaccine in additional clinical studies in the US beginning in 2014.

Dr J Joseph Kim, Inovio's president and CEO, said, "More effective antiviral drugs have changed the prognosis for patients with hepatitis C; however, treatment failures remain and combination with an immunotherapeutic approach could make the difference for many patients. In preclinical studies, Inovio's HCV immunotherapy has shown to generate powerful T cell responses in the liver, which could be important in clearing HCV-infected liver cells. We have already shown in published clinical studies that our vaccines generate best-in-class T-cell responses. In this study, the effects of Inovio's HCV immunotherapy will be directly tested in patients who have previously failed standard drug therapies. We look forward to entering the hepatitis C treatment arena, which is one of the fastest-developing markets in healthcare, with a projected value of $20 billion by the end of the decade."

This study is a multi-centre, open-label, dose-escalating phase I trial in which 18 subjects will be divided into three groups and given four monthly vaccinations of one mg, three mg and six mg doses of VGX-6150, respectively. Individuals with chronic HCV who failed previous standard of care therapy with pegylated interferon and ribavirin or triple therapy with standard of care and direct-acting antiviral agents such as boceprevir or telaprevir will be enrolled. Both immunogenicity and virologic response will be evaluated in addition to the safety and tolerability of VGX-6150.

VGX-6150 is a SynCon multi-antigen DNA vaccine covering hepatitis C virus (HCV) genotypes 1a and 1b and targeting HCV nonstructural proteins 3 (NS3) and 4A (NS4A) as well as NS4B and NS5A proteins. VGX-6150 also includes DNA encoding IL-28B to adjuvant the immune response. VGX-6150 will be administered with Inovio's proprietary CELLECTRA delivery device.

Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. Hepatitis C can be either "acute" or "chronic."

Currently there is no vaccine available for the prevention of hepatitis C infection. HCV mutation contributes to the difficulty in development of a prophylactic vaccine. The World Health Organization estimates that nearly 200 million people around the world are infected with hepatitis C, a prevalence of around 3.3 per cent of the world's population. As many people are infected with HCV as are with HIV, the virus that causes AIDS. Without large scale efforts to contain the spread of HCV and treat infected populations, the death rate from hepatitis C will surpass that of AIDS in this century.

Inovio's SynCon DNA vaccine, INO-8000, is coded to produce the antigens NS3/4A, NS4B, and NS5A of HCV genotypes 1a and 1b, the most difficult-to-treat genotypes. This broad spectrum of antigens targets HCV to create a higher probability to induce the desired therapeutic immune response. Our proprietary DNA vaccines are uniquely designed to enhance gene expression and antigen secretion, processing, and presentation through a proprietary combination of DNA, RNA, and codon optimization techniques as well as the use of patent protected IgE leader sequences. Our novel SynCon design is intended to provide broader protection against new mutations of a virus. Our CELLECTRA electroporation device co-localizes vaccine delivery with the applied electric field and operates under more effective constant-current EP parameters. Together these next-generation technologies have generated levels of T-cells that are often orders of magnitude greater than competing technologies, including those using viral vectors and other facilitated delivery systems.

Under a co-development agreement signed between Inovio and VGX International in 2011, VGX International is funding the studies in Asia and has the commercialization right for the product (also known as VGX-6150) in Asia (excluding Japan).

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