Inovio Pharmaceuticals, Inc., a biotechnology company revolutionizing the fight against cancer and infectious diseases,  has initiated a phase I trial to evaluate Inovio's DNA immunotherapy in patients who are chronically infected with hepatitis B.

In 2013, Roche and Inovio entered into a partnership to co-develop and commercialize Inovio's hepatitis B immunotherapy. This trial initiation triggers a $3 million milestone payment from Roche to Inovio.

This phase I, randomized, open-label, active-controlled, dose escalation study will evaluate the safety, tolerability, and immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator.

This international study will enroll patients in the United States and Asia Pacific region with a primary endpoint of safety and tolerability of the therapy. The secondary endpoints will evaluate the cellular and humoral immune response to INO-1800 and investigate the therapy's effect on several viral and antiviral parameters. All trial subjects are also medicated with standard-of-care antiviral therapies.

Dr. J. Joseph Kim, president and CEO, said "We are pleased our partnership has achieved this initial clinical advance emanating from the collaborative efforts at Roche and Inovio. While this is primarily a safety study, we will also investigate our therapy's impact on antibody and T-cell responses, which will help advance the product into further trials. Recent developments have seen several successful drugs built on hepatitis C treatments. Hepatitis B has a prevalence nearly double that of hepatitis C and antiviral treatment can control but usually does not eliminate the virus. A successful immunotherapy for hepatitis B holds significant potential."  

Inovio has reported preclinical data showing its hepatitis B immunotherapy (INO-1800) generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice. These results indicate that the immunotherapy may have potential in the treatment of hepatitis B infection. In a preclinical study, researchers found hepatitis B-specific T-cells exhibited a killing function, and could migrate to and stay in the liver and cause clearance of target cells without evidence of liver injury.

This was the first study to provide evidence that intramuscular immunization can induce killer T-cells that can migrate to the liver and eliminate target cells.

One of the major causes and risk factors for liver cancer is infection by hepatitis B. The virus is extremely infectious – 100 times more so than HIV – and 240 million people are chronically infected worldwide.

Hepatitis B contributes to an estimated one million deaths worldwide each year. Liver cancer is the third most common cancer and the most deadly, killing most patients within five years of diagnosis. About 600,000 new cases arise each year.