US-based immunotherapy firm Inovio Pharmaceuticals has launched a Phase I/IIa clinical trial of its vaccine candidate GLS-5300 to treat Middle East Respiratory Syndrome (MERS) infection in South Korea.
The initiation follows approval from the Korean Ministry of Food and Drug Safety, while Inovio’s MERS development partner GeneOne Life Science will carry out the trial.
GLS-5300 is a DNA immunotherapy being developed to offer broad protective antibody and therapeutic T-cell responses against various MERS virus strains.
The Phase I/IIa trial is designed to evaluate the responses of intradermal GLS-5300, and is being fully funded by the International Vaccine Institute (IVI) through a $34m grant obtained from Samsung Foundation in 2015 for the development of a MERS vaccine.
Inovio Pharmaceuticals president and CEO Dr Joseph Kim said: “Korea was devastated by a MERS outbreak two years ago and now looks to Inovio to produce an approved product for emergency use in Korea.
“Our Korean study is also notable because it will utilise our intradermal vaccine delivery device, which has demonstrated in other infectious disease trials (HIV, Ebola & Zika) to elicit very high immune responses at a much lower dose.”
GLS-5300 is also being studied in a Phase I trial for MERS infection at the Walter Reed Army Institute of Research in Maryland, US.
During this trial, high-binding antibody levels were observed in 92% of the subjects after administration of three dose vaccine regimen of intramuscular GLS-5300.
Additionally, the trial demonstrated significant antigen-specific cytotoxic T-lymphocyte (CTL) responses and antibody and / or T-cell response against the vaccine with a favourable tolerability and safety profile.