Phase I trial will evaluate ChronVac-C administered using Inovio electroporation followed by booster vaccination with Transgene’s TG4040.
Transgene is teaming up with ChronTech Pharma and Inovio Pharmaceuticals to carry out a Phase I study with a prime-boost therapeutic vaccination approach against HCV genotype 1. The combination treatment will comprise ChronTech’s ChronVac-C® plasmid DNA candidate as the priming vaccination followed by Transgene’s TG4040 therapeutic vaccine as the boost. ChronVac-C administration is aided by electroporation using Inovio’s Medpulser® DDS system. The firms expect to start the Phase I trial during 2011 in Germany. The study will include 12 treatment-naive patients with chronic hepatitis C infection.
ChronTech’s ChronVac-C DNA vaccine (delivered using Medpulser) and Transgene’s TG4040 are separately undergoing Phase II clinical trials. Trasngene’s TG4040 is an MVA vector-based vaccine designed to express three nonstructural HCV proteins: NS3, NS4, and NS5B. A Phase II study was initiated in 2010 to evaluate TG4040 in combination with standard of care and will include 140 treatment-naive patients chronically infected with genotype 1 HCV.
Transgene’s clinical pipeline is headed by the Novartis-partnered non-small-cell lung cancer vaccine, TG4010 (MVA-MUC1-IL2), which is projected to start in Phase IIb/III trials during 2011. Additional Phase II-stage candidates include TG6006, which is in development in partnership with Jennerex Pharmaceuticals for the treatment of hepatocellular carcinoma and other solid tumors. Phase IIb trials with TG6006 are expected to start during 2011. Trasngene is separately developing TG4001 (MVA-HPV-IL2) in house for treating cervical intraepithelial neoplasis. TG4001 is currently undergoing Phase IIb investigation.
ChronTec’s ChronVac-C vaccine is administered by intramuscular injection, followed by electroporation of the injection site using the Medpulser DDS system to facilitate uptake of the vaccine DNA by cells. ChronTech claims a Phase IIa study has confirmed that therapy using ChronVac-C administered by electroporation resulted in rapid antiviral responses in HCV patients who also received postvaccination treatment using interferon and ribavirin. Data from the study showed that five of six patients who completed treatment were free of the virus six months after vaccination. Last month the Swedish regulatory authorities cleared ChronTech to start a Phase IIb study evaluating ChronVac-C vaccination plus subsequent therapy using ribavirin and interferon in chronically infected HCV genotype 1 patients.
Inovio is developing a portfolio of electroporation-delivered SynCon™ DNA vaccines for the treatment and/or prevention of diseases including cancer, avian flu, and HIV. The firm claims its electroporation DNA delivery systems can increase vaccine uptake by 1,000 times or more and boost levels of plasmid transgene expression 100-fold.