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June 9, 2021

Inovio to start Phase III efficacy trial of Covid-19 vaccine

The trial will be carried out in Latin American and Asian countries to assess the safety and efficacy of two doses of INO-4800.

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.

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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.

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