Date: 2015-04-21
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Inovio Pharmaceuticals (USA - PA) Roche (Switzerland)
Product: INO-1800, alone or in combination with INO-9112
Action
mechanism: plasmid/immunotherapy product. INO-1800 is a multi-antigen SynCon® DNA immunotherapy targeting hepatitis B virus clades A & C surface antigens & HBV core antigens. INO-9112 is an IL-12-based immune activator.
Disease: hepatitis B
Therapeutic area: Infectious diseases
Country:
Trial
details: This open-label study will evaluate the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding HBsAg and HBcAg) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 126 (one hundred twenty six) entecavir or tenofovir treated HBeAg positive patients. (NCT02431312)
Latest
news: * On April 21, 2015, Inovio Pharmaceuticals announced that it 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.
