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news.Inovio has secured approval from the Brazilian health regulatory agency, ANVISA, to start the international Phase III part of Phase II/III INNOVATE clinical trial assessing its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800.
The Covid-19 DNA vaccine candidate is meant for intradermal administration. Credit: PixxlTeufel from Pixabay.
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Inovio has secured approval from the Brazilian health regulatory agency, ANVISA, to start the international Phase III part of Phase II/III INNOVATE clinical trial assessing its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800.
The vaccine candidate consists of a DNA plasmid. It is meant for intradermal administration with subsequent electroporation using a smart device to deliver the DNA plasmid directly into body cells.
Inovio, along with its partner Advaccine Biopharmaceuticals Suzhou, intends to perform the Phase III segment of INNOVATE in several countries apart from Brazil.
The Phase III part will assess the efficacy of a two-dose regimen of 2mg INO-4800 given one month apart in male and non-pregnant female participants aged 18 years and above.
To be carried out in Latin American, Asian and African countries, the trial’s primary endpoint is virologically confirmed Covid-19.
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 INNOVATE Phase III segment builds upon the data from the Phase II part performed in the US, where INO-4800 was observed to be well-tolerated and immunogenic in adults.
In a previous study with clinical samples, the vaccine was showed to offer wide cross-reactive immune responses, including neutralising antibodies and T cell responses, against SARS-CoV-2 variants of concern.
Earlier this month, Inovio received approval from the Center for Drug Evaluation of the National Medical Products Administration in China to carry out two trials of heterologous prime-boosting with INO-4800.