Inovio Pharmaceuticals Inc. (NASDAQ: INO) has announced that Mexican national health regulatory agency COFEPRIS has authorized the conduction of a clinical trial in the country, which is part of the company’s Phase 3 segment of the worldwide Phase2/3 study INNOVATE from the DNA vaccine candidate, INO-1800.
Innovio expanding INNOVATE study
The company is working on the INNOVATE Phase 3 section in numerous countries with its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd. INOVIO recently stated that it has acquired regulatory approval to begin Phase 3 clinical trials in the Philippines and Brazil and that it is seeking approval to perform trials in other countries.
The efficacy of INO-4800 in a two-dose regimen (2.0 mg per dosage), given a month apart, in 2-to-1 randomization in non-pregnant women and males above 18 years of age, will be evaluated globally in Phase 3 section of INNOVATE. This case-driven Phase 3 trial’s primary goal is virological confirmation of COVID-19.
CEO 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. With the virus threatening to become an endemic threat worldwide, while millions of people around the globe remain unvaccinated, we are committed to supporting the international public health response.”
Innovio to evaluate INO-4800 efficacy
Kim added, “I am extremely pleased that we are now positioned to evaluate the efficacy of INO-4800 which is an important developmental milestone. 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.”
The phase 3 segment develops in the Phase 2 segment conducted in the US, whose data was released May 2021 in MedRxiv.
