Inovio Pharmaceuticals and GeneOne Life Science have dosed the first patient in a Phase l trial of GLS-6150 for the treatment of hepatitis C.
Developed jointly by both companies, the open-label trial is designed to investigate the ability of GLS-6150 to enhance immunity in people who have been treated and cleared of hepatitis C virus.
The trial is expected to examine 24 people with a sustained virologic response (SVR) following treatment for Hepatitis C and an additional eight healthy controls to compare immune responses.
During the trial, the participants will receive one of two doses (1mg or 2mg) of the GLS-6150 vaccine, which will be given intra-dermally and followed by electroporation with Cellectra-3P device.
Vaccinations will be given as a three-dose priming series at 0, 4, and 12 weeks, or as a two dose priming series at 0 and 8 weeks. They will be followed by a booster dose at six months.
The final study visit is four weeks after the six-month booster vaccination.
The trial has already started patient enrolment in South Korea, where GeneOne is responsible for performing and funding the trial.
Inovio Pharmaceuticals president and CEO Dr J Joseph Kim said: “Developing the first successful vaccine against hepatitis C virus is a highly ambitious endeavour but a truly impactful effort for global health as well as being transformative for us commercially.
“The key to a successful hepatitis C vaccine will be its ability to activate the body’s immune system to prevent or treat infection by a virus with multiple or ever-changing strains.
“Inovio’s innovative DNA-based technology platform is uniquely positioned to address this challenge and it has been optimising over the last several years in demonstrating strong in vivo immune responses against very tough-to-treat viruses like HIV, Zika and flu.”
Data from the Phase l trial is expected to be available next year.