Inovio has dosed the first participants in Phase II clinical trial of its deoxyribonucleic acid (DNA) vaccine candidate, INO-4700, to prevent Middle East Respiratory Syndrome (MERS).
The company noted that MERS is an infectious disease caused by a type of coronavirus that is 100 times fatal compared with Covid-19 and lethal to 34% of the infected patients.
The multi-centre, randomised, double-blinded, placebo-controlled Phase II trial will assess the safety, tolerability and immunogenicity of INO-4700 given using Inovio’s Cellectra 2000 device.
Cellectra is a handheld smart device designed to intramuscularly or intradermally deliver plasmids directly into cells.
The Phase II trial, which will involve nearly 500 healthy adults, is being performed at centres in Jordan and Lebanon where the incidence of MERS is identified.
It is sponsored by the company and funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
The latest trial comes after positive data were obtained in the first-in-human open-label, single-arm, dose-escalation Phase I trial.
Results showed high binding antibody levels in 92% of participants assessed. Additionally, substantial antigen-specific cytotoxic T-lymphocyte responses were reported.
Notably, 98% of participants inoculated with INO-4700 produced an antibody and/or T cell response against the vaccine, Inovio said.
Inovio president and CEO Dr Joseph Kim said: “This advancement not only complements our late-stage efforts with Covid-19, but it also represents an important milestone for Inovio’s infectious disease platform.
“We look forward to continuing our collaboration with CEPI and moving another step closer to providing patients with a safe and effective preventive vaccine against MERS.”
First detected in Saudi Arabia in 2012, the MERS virus later spread to a total of 27 countries but currently lacks approved vaccines and therapies.
Inovio’s MERS vaccine research is financed by a previous $56m CEPI grant. The company is using these funds to conduct Phase II field trials of two vaccine candidates against MERS and Lassa fever, respectively.
The company and CEPI intend to generate a stockpile of these vaccine candidates for emergency use soon after Phase II evaluation.
In June 2021, Inovio started a global Phase III segment of the ongoing Phase II/III INNOVATE trial of its Covid-19 DNA vaccine candidate, INO-4800.