Inovio is set to commence the Phase III segment of its international Phase II/III INNOVATE clinical trial of its Covid-19 deoxyribonucleic acid (DNA) vaccine candidate, INO-4800, in Mexico.
The move comes after receiving authorisation from the Mexican health regulatory agency, Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), to carry out the trial.
INO-4800 contains a well-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.
The Phase III part will assess the efficacy of a two-dose regimen of 2mg INO-4800 given at a one-month gap in men and non-pregnant women aged 18 years and above.
Virologically confirmed Covid-19 is the primary goal of the Phase III trial.
Inovio and its partner Advaccine Biopharmaceuticals Suzhou are working on the Phase III trial in various other countries.
The company had earlier obtained regulatory authorisation to conduct Phase III trials in Brazil and the Philippines and is now pursuing approval to progress the trials to more regions.
The Phase III part builds upon the Phase II segment carried out in the US, in which INO-4800 demonstrated to be well-tolerated and immunogenic in adults aged 18 and above.
Inovio president and CEO Dr J Joseph Kim said: “Inovio looks forward to working with the health authorities and investigators in Mexico, as well as in Brazil and the Philippines, to advance the evaluation of INO-4800 as a solution in the fight against the Covid-19 pandemic.
“We feel that INOVIO’s Covid-19 vaccine is uniquely suited to contribute to the global response given its strong safety and thermostability profile, ability to generate cross-reactive immune responses, and its potential to function in a primary series, as well as a booster vaccine.”
Last month, Inovio obtained regulatory approval from China’s Center for Drug Evaluation of the National Medical Products Administration to conduct two trials of heterologous prime-boosting with its Covid-19 vaccine candidate, INO-4800.
In a separate development, Cytodyn has obtained approval from Brazil’s regulatory authority, Agência Nacional de Vigilância Sanitária (ANVISA), to initiate another Phase III CD16 trial of its CCR5 antagonist, leronlimab.