Inovia to begin hepatitis C clinical trial

Inovia Pharmaceuticals will move its hepatitis C DNA vaccine into a phase 1/11a clinical trial by the end of 2013.

The advancement of this work is based on exceptional results of a preclinical study, which showed for the first time that a multi-antigen SynCon HC vaccine can deliver robust T-cell responses in the blood and liver.

All preclinical and clinical development is to be funded by VGX International, while Inovio has carried out the manufacturing of its multi-antigen HCV vaccine (INO-8000) and is performing 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 and was designed with Inovio's SynCon process, covering HCV genotypes 1a and 1b.

These have been generally proven to be the most difficult to treat with drug therapies.

Estimates suggest that over five million people in the US are infected with hepatitis C, with this figure potentially rising to 200 million worldwide.

Research into the HCV vaccine has mainly focused on the NS3/4A proteins of the virus to induce T-cell responses, though there has been minimal research targeted at understanding whether vaccines targeted at other proteins can lead to potent T-cell responses in the liver.

However, this latest study saw Inovio and its collaborators develop SynCon antigen constructs to focus on three other areas of the HCV virus (NS4B, NS5A and NS5B).

The work also shwoed that each vaccine construct expressed its respective protein, with all three constructs inducing potent HCV-specific T-cells in mice.

Dr Joseph Kim, Inovio's president and chief executive, 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."

Dr Kim suggested that a safe and effective therapeutic vaccine could play a "vital role" in boosting the potency of HCV treatments.

Posted by Fiona Griffiths