Inovio has expanded its existing collaboration with Advaccine Biopharmaceuticals Suzhou to carry out a global Phase III segment of the ongoing Phase II/III INNOVATE trial of Covid-19 DNA vaccine candidate, INO-4800.
The companies will jointly analyse the safety and efficacy of a two-dose regimen of 2mg INO-4800 given at a gap of one month in healthy adults aged 18 and above.
The trial, to be mainly carried out in Latin American and Asian countries, will randomise the subjects in a 2:1 ratio to the vaccine candidate and placebo arms.
Incidence of virologically confirmed Covid-19 will be the Phase III segment’s primary goal.
The global Phase III trial comes after obtaining favourable results from the Phase II part which showed INO-4800 to be safe, well-tolerated and immunogenic in tested trial participants.
The 2mg dose of the vaccine candidate for the Phase III segment was selected based on the Phase II data.
Inovio president and CEO Dr Joseph Kim said: “Based on trial results to date, this vaccine has shown to be well-tolerated; produces balanced neutralising antibodies and favourable T cell response (CD8 and CD4) and is easy to administer.
“It is uniquely positioned to support vaccine rollout to underserved countries globally with a strong thermostability profile that is stable at room temperature for more than a year and does not require cold or ultra-cold-chain transport.”
As per the expanded partnership between Inovio and Advaccine, the companies plan to equally split the estimated total expenses of nearly $100m to conduct the Phase III trial.
The companies signed an agreement in January, which saw Advaccine gain exclusive rights to develop, produce and market INO-4800 in China, Hong Kong, Macao, and Taiwan.
As per the latest deal, Advaccine gained rights to more Asian countries.
In another development, Icosavax has dosed the first participants in a Phase I/II clinical trial of a virus-like particle exhibiting the SARS-CoV-2 receptor-binding domain, IVX-411.
Funded by the Bill & Melinda Gates Foundation, the randomised, observer-blinded, placebo-controlled trial will assess the safety and immunogenicity of adjuvanted and unadjuvanted IVX-411 in up to 168 healthy subjects in Australia.