Inovio Pharmaceuticals, Inc, an immunotherapy company, announced the company will continue to develop its hepatitis B DNA immunotherapy (INO-1800) independently following Roche’s notice that it will discontinue its collaboration with Inovio and its development of INO-1800. INO-1800 was licensed to Roche from Inovio in 2013. All of Roche's rights to INO-1800, including the right to license the product to other parties, will be returned.
Inovio will continue to advance its current phase I study of INO-1800, which is enrolling as planned in 30 clinical sites in the U.S. and Asia-Pacific regions. Inovio anticipates completing enrollment in the first half of 2017 and expects results in the second half of 2017.
This randomized, open-label, active-controlled, dose escalation study is evaluating the safety, tolerability, and immunogenicity of INO-1800, alone or in combination with INO-9112, Inovio's IL-12-based immune activator in adults with chronic hepatitis B infection. The primary endpoints are safety and tolerability. 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 oral antiviral therapies. The study has completed interim safety reviews with a favourable safety profile to date. Immunology analyses are planned after completion of enrollment.
Dr J Joseph Kim, Inovio’s president & CEO, said, “While we acknowledge Roche’s strategic decision in the area of hepatitis B, we are optimistic that our potent immunotherapy platform will make a difference in this globally important chronic viral infection, similar to what we have demonstrated in HPV-related disease. Inovio was already managing the phase 1 clinical trial so the study will continue on track without disruption.”
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. Notably, researchers found that hepatitis B-specific T cells exhibited a killing function and could migrate to and stay in the liver and cause clearance of chronically infected cells without evidence of liver injury. These results indicate that INO-1800 may have potential to treat chronic hepatitis B infection.
Chronic infection with hepatitis B virus is one of the major causes and risk factors for liver cirrhosis and liver cancer. The virus is very infectious, with over 240 million people chronically infected worldwide. More than 60 million of these people are at risk of the major complications of liver cirrhosis and liver cancer, which cause over 700,000 deaths globally each year.