Inovio Pharmaceuticals of Plymouth Meeting has started phase one of human clinical trials for a potential vaccine for COVID-19. The vaccine is called INO-4800.
The trial will involve up to 40 healthy adult volunteers, who will each receive two doses of INO-4800 four weeks apart. The goals of the phase 1 trial are to test the vaccine’s safety and its ability to trigger an immune response in the body. Inovio expects initial data from the phase one trial by late summer, and plans to move on to phase two clinical trials – which will test INO-4800’s efficacy – as soon as possible.
According to the Inovio website, the company specializes in “DNA-based immunotherapy in cancer and infectious diseases, pairing a revolutionary design process with a groundbreaking delivery system to help combat two of the most pressing needs in global health.”
Dr. Ami Shah Brown, Inovio’s senior vice president for regulatory affairs, told the Herald in early March that Inovio had already done research on the coronavirus – COVID-19 is just one of many viruses of the group, which includes MERS. Members of the family have similar qualities.
When Chinese researchers shared the DNA sequence of SARS-CoV-2, the virus that causes the illness, on Jan. 10, “we were able to utilize an algorithm to generate what we think might be effective treatment,” Dr. Brown said.
“Inovio was proactive. As soon as the sequence became known we had the power of our platform to begin designing of a vaccine.”
A timeline on the Inovio website shows that DNA vaccine INO-4800 was designed “in three hours after receiving the genetic sequence using its proprietary DNA medicines platform technology. INO-4800 was designed to precisely match the DNA sequence of the virus.”
Inovio scientists rushed to begin preclinical testing and on Jan. 23, with the epidemic growing, Inovio received a grant of up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI), which is based in Norway, to fund ongoing preclinical and initial clinical development of the vaccine. The vaccine is also backed by the Bill and Melinda Gates Foundation and other funds.
The U.S. Food and Drug Administration has accepted the New Drug application, clearing the way for phase one clinical testing in healthy volunteers. The company administered the first dose April 4.
According to Yahoo Finance online, the phase one study of INO-4800 is enrolling volunteers in Philadelphia and Kansas City, Mo.
Inovio Pharmaceuticals’ CEO, Dr. J. Joseph Kim said about the development in a statement for the online publication, “This is a significant step forward in the global fight against COVID-19. Without a new, safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods.”
Inovio expects to have a million doses of the vaccine available by year-end for trials and emergency use.