The Mexican government approved biotechnology company INOVIO to begin a Phase 3 efficacy trial of its COVID-19 DNA vaccine candidate, INO-4800, this week alongside its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd.
This Mexican trial is part of a larger, worldwide Phase 2/3 trial known as INNOVATE, and which is focused on regions underserved by other COVID-19 vaccines, such as Latin America, parts of Asia and Africa. In that same vein, the partners also recently received clearance to proceed with Phase 3 clinicals in Brazil and the Philippines.
“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,” Dr. J. Joseph Kim, president and CEO of INOVIO, said. “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. I am extremely pleased that we are now positioned to evaluate the efficacy of INO-4800 which is an important developmental milestone.”
Kim further touted INO-4800’s safety and thermostability results to date, along with its abilities to operate as both a primary vaccine and booster shot. Currently, the vaccine is being evaluated for use as a two-dose regimen administered one month apart. The trial’s primary endpoint will be virologically confirmed cases of COVID-19.
Phase 2 of the INNOVATE trials were conducted in the U.S., with funding and support from the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, U.S. Department of Health and Human Services and the Defense Health Agency. Pre-print data released in May indicated the vaccine to be well-tolerated and immunogenic among 401 patients at least 18 years old. Most adverse effects were low in severity and did not increase in frequency with a second dose.
Other studies have also lent hope to INO-4800’s capabilities against COVID-19 variants.