(By Balaseshan) Inovio Pharmaceuticals Inc. (NYSEAMEX: INO) and its development partner VGX International Inc. will initiate a phase 1/2a clinical trial for Inovio's hepatitis C (HCV) DNA vaccine by the end of 2013.
This advancement is based on outstanding results of a preclinical study which demonstrated that a multi-antigen SynCon HCV vaccine can generate robust T-cell responses not only in the blood but, more importantly, in the liver, an organ known to supress T-cell activity. VGX International is funding all preclinical and clinical development.
In preparation for entering clinical trials with its HCV vaccine (INO-8000), Inovio has completed manufacturing of its multi-antigen HCV vaccine and is performing IND (Investigational New Drug application)-enabling toxicity testing in animals.
INO-8000 is a SynCon HCV therapeutic vaccine targeting NS3/4A, NS4B, and NS5A proteins of HCV. INO-8000 was designed with Inovio's SynCon process to broadly cover HCV genotypes 1a and 1b, the types that have been most difficult to treat with drug therapies.
In this study, Inovio and its collaborators developed SynCon antigen constructs that targeted three other areas of the HCV virus (NS4B, NS5A and NS5B) and then demonstrated that each vaccine construct expressed its respective protein and that all three constructs induced potent HCV-specific T-cells in mice.
In the preclinical study, Inovio researchers observed in the liver not only NS4B-, NS5A- and NS5B-specific CD4+ and CD8+ (or killer T-cell) responses, but also a large pool of vaccine-specific T-cells. This pool of vaccine-specific T-cells was shown to be fully functional in an environment in which T-cell activity is usually suppressed.
In fact, using a transient HCV infection model in mice, therapeutic immunization with INO-8000 was able to clear HCV antigens from the liver, demonstrating the therapeutic potential of this vaccine.
In addition to moving forward with INO-8000, Inovio has a long-standing partnership with ChronTech Pharma, which is developing its NS3/4A-based HCV DNA vaccine using Inovio's proprietary delivery technology. Interim results of ChronTech's open-label, randomized phase 2 trial are expected later in the first quarter of this year.
INO closed Tuesday's regular session at $0.620. The stock has been trading between $0.38 and $0.90 for the past 52 weeks.