“Inovio plans to inject its first voluntary test subject with the DNA candidate vaccine INO-4800 that it has developed, following promising results from preclinical studies in animals that have shown an increased immune response” Tech Crunch reported on Monday.
“This is an important step forward in the global fight against COVID-19,” said Dr. J. Joseph Kim, President and CEO of INOVIO, in a statement.
“Without a new, safe and effective vaccine, the COVID-19 pandemic should continue to threaten lives and livelihoods. It also demonstrates the power of our DNA-based drug platform to rapidly develop and advance a COVID-19 vaccine in phase 1 clinical trials. Our dedicated team of staff, partners and funders has been mobilized since the genetic sequence of the virus became available in early January and continues to work 24 hours a day to ensure that we are rapidly advancing INO-4800 through this phase 1 study towards planned efficacy trials. . ”
The INO-4800 phase 1 study will enroll up to 40 healthy adult volunteers in Philadelphia, Pennsylvania (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening for potential participants has already started. Study supplies for the INO-4800 arrived at the site last week. Each participant will receive two doses of INO-4800 four weeks apart, and initial immune responses and study safety data are expected by the end of the summer. Preclinical data, which has been shared with global regulatory authorities and submitted as part of the IND, has shown promising immune response results in several animal models. Other preclinical trials, including challenge studies, will continue in parallel with the phase 1 clinical trial.
Tech Crunch said Inovio was able to produce thousands of doses “in part thanks to support from the Bill and Melinda Gates Foundation, as well as funding from other nonprofits and organizations.”
The company says it should be able to produce up to a million doses of vaccine by the end of the year if the trials are successful. The doses would be ready for “potential emergency use pending approval,” reports Tech Crunch.
The first potential vaccine began human testing in mid-March. The National Institutes of Health is funding this trial, which is taking place in Seattle at the Kaiser Permanente Washington Health Research Institute. This test started with 45 young healthy volunteers who were injected with different doses of images co-developed by NIH and Moderna Inc.
Meanwhile, an initial series of tests in mice of a potential vaccine to prevent COVID-19 has shown that it can stimulate animals’ immune systems to produce antibodies against the coronavirus.
The vaccine is administered via a patch the size of a finger, similar to a bandage, made up of 400 small needles that line the skin. Researchers developing the vaccine say the immune system responds more easily to skin irritations, which means it could trigger it to target the coronavirus.
When tested in mice, they developed antibodies to fight the coronavirus in two weeks.