Inovio is set to commence the international Phase III segment of Phase II/III INNOVATE clinical trial assessing its deoxyribonucleic acid (DNA) vaccine candidate, INO-4800, for Covid-19.
The company obtained authorisation from Brazil’s health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA), to begin the trial.
INO-4800 contains an accurately designed DNA plasmid and is administered intradermally with subsequent electroporation using a smart device.
The device can carry the DNA plasmid directly into body cells, thereby potentially inducing a well-tolerated immune response.
Inovio, along with its partner Advaccine Biopharmaceuticals Suzhou , intends to carry out the Phase III segment of the INNOVATE trial in various countries, including Brazil.
In June this year, Inovio expanded its existing collaboration with Advaccine Biopharmaceuticals Suzhou to carry out the global Phase III segment.
The Phase III segment will assess the efficacy of a two-dose regimen of 2mg INO-4800 given at a gap of one month in healthy adults aged 18 years and above.
To be carried out in Latin American, Asian and African countries, the trial will randomise subjects in a 2:1 ratio.
Incidence of virologically confirmed Covid-19 is the Phase III trial’s primary goal.
Inovio president and CEO Dr J Joseph Kim said: “With many countries in the world experiencing low vaccination rates and seeing an increase in infections, we feel the urgency to advance INO-4800 globally.
“Inovio’s focus on supporting the global response to the pandemic is unwavering, and will bring forward the potential advantages of INO-4800, which in addition to being well-tolerated with balanced neutralising antibodies and T-cell responses (CD8 and CD4), has a strong thermostability profile, and potentially offers the ability to serve as both a primary as well as a booster vaccine.”
The Phase III segment builds upon the positive data from the Phase II part carried out in the US, where INO-4800 was demonstrated to be well-tolerated and immunogenic in adults.
Earlier this month, Inovio dosed the first participants in the Phase II clinical trial of its DNA vaccine candidate, INO-4700, to prevent Middle East Respiratory Syndrome (MERS).