Inovio Pharmaceuticals said today it will go it alone in continuing to develop its hepatitis B DNA immunotherapy vaccine candidate INO-1800, after Roche pulled out of a nearly 3-year collaboration with the biotech.
Inovio said it received notice from Roche that it was ending the companies’ collaboration on INO-1800, which is the subject of a Phase I study and returning to Inovio its rights to the immunotherapy—including rights to license the product to other companies.
The companies launched their up-to-$422.5 million partnership in 2013 to develop and commercialize INO-1800 as well INO-5150, an Inovio vaccine candidate targeting prostate cancer.
Despite the pullout, infectious diseases is one of Roche’s six areas of therapeutic focus. The other five are oncology, neuroscience, immunology, cardiovascular and metabolism, and ophthalmology.
In a presentation to investors accompanying its first-half results released July 21, Roche said its pipeline for hepatitis B consisted of INO-1800 alone and in combination with INO-9112, as well as two other candidates: the Phase I small molecule RG7834 and RG7795, a Phase II TLR7 agonist slated for a regulatory filing in “2019 and beyond.”
Roche acquired RG7795 (formerly ANA 773) when it bought Anandys Pharmaceuticals in 2011.
“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 [human papillomavirus]-related disease,” Inovio’s President & CEO J. Joseph Kim, Ph.D., said in a statement.
The Phase I trial, Inovio said, will continue as planned. The trial has been enrolling patients at 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 that year.
The Phase I trial is a randomized, open-label, active-controlled, dose-escalation study designed to assess the safety, tolerability, and immunogenicity of INO-1800, alone or in combination with INO-9112, Inovio's interleukin-12 (IL-12)-based immune activator in adults with chronic hepatitis B infection.
Primary endpoints for the trial are safety and tolerability, whereas the secondary endpoints will assess the cellular and humoral immune response to INO-1800, as well as the effect of the therapy on several viral and antiviral parameters, Inovio said.
Inovio has reported positive preclinical data for INO-1800, showing the hepatitis B immunotherapy generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice.
Researchers also found that hepatitis B-specific T cells not only exhibited a killing function but could also migrate to the liver and stay there, causing clearance of chronically infected cells without evidence of liver injury, the company said.