Inovio Pharmaceuticals, Inc. 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 favorable 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.”