Date: 2011-04-18
Type of information:
phase: 1
Announcement: preparation
Company: Inovio Pharmaceuticals (USA) Transgene (France) ChronTech Pharma (Sweden)
Product: novel therapeutic vaccination strategy against genotype 1 hepatitis C virus (HCV)
Action mechanism: In this collaboration, ChronTech’s ChronVac-C® DNA vaccine consists of a codon-optimized NS3/4A gene. It is delivered using Inovio’s MedPulser® electroporation DNA Delivery System. Inovio's electroporation-based DNA delivery systems dramatically increase cellular uptake of a DNA vaccine and resulting gene expression (i.e. production of the coded protein) and increase immune responses by 100 times or more compared to plasmid DNA delivered without other delivery enhancements. Transgene’s TG4040 product candidate is based on an MVA virus carrying and expressing non-structural proteins NS3, NS4 and NS5B of hepatitis C virus. The ChronVac-C DNA vaccine was recently reported to be safe and generate antigen specific immune responses and antiviral effects in a phase I/IIa clinical trial. Rapid virologic responses were seen in 5 out of 7 of the patients receiving a post-vaccination standard of care interferon-ribavirin therapy. TG4040 was itself shown to be safe and immunogenic in a phase I program. Phase II studies in combination with the standard of care are ongoing for both products. In preclinical studies, the novel combination of these DNA and MVA vaccine approaches demonstrated greater immune responses than those observed with the vaccines injected separately.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: Germany
Trial details: * On April 18, 2011, Inovio Pharmaceuticals, Transgene and ChronTech Pharma have announced that they will contribute their respective products and equally share study related costs. The planned phase I clinical study will enroll 12 treatment-naive patients with chronic hepatitis C at a site in Germany.
Latest
news: * On April 2, 2013, ChronTech has announced that the company now has made the first analysis of 12 weeks treatment with interferon and ribavirin in patients with (n=17) or without (n=12) two monthly previous vaccinations with 500 µg ChronVac-C® administered with Inovio's Medpulser. No serious adverse events were noted and the number of moderate adverse events were lower in the vaccinated group than in the non-vaccinated group. At treatment week 12, 71 % of the vaccinated group had less than 15 international units of HCV RNA as compared to 58 % in the non-vaccinated group. As regards to number of patients who were virus negative at treatment week 12 in the vaccinated group 65 % were HCV RNA negative as compared to 58 % in the non-vaccinated group. All in all the study shows that ChronVac-C® is very safe but the differences in treatment outcome so far were too low to be statistically significant.
