A second potential COVID-19 vaccine has entered Phase 1 clinical human testing after the U.S. Food and Drug Administration (FDA) accepted an application from Inovio Pharmaceuticals.
“Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, following promising results from preclinical studies performed on animals that did indicate increased immune response,” Tech Crunch reported Monday.
“This is a significant step forward in the global fight against COVID-19,” Dr. J. Joseph Kim, INOVIO’s president and CEO, said in a statement.
“Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing. Our dedicated team of staff, partners and funders have been mobilized since the genetic sequence of the virus became available in early January and continues to work around the clock to ensure that we are rapidly advancing INO-4800 through this Phase 1 study towards planned efficacy trials.”
The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. Study supplies of INO-4800 arrived at the sites last week. Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer. Preclinical data, which have been shared with global regulatory authorities and submitted as part of the IND, have shown promising immune response results across multiple animal models. Additional 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 backing 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 as much as one million doses of the vaccine by the end of the year if the trials are successful. The doses would be ready for “potential emergency use pending authorization,” Tech Crunch reports.
The first potential vaccine began human testing in mid-March. The National Institutes of Health is funding that trial, which is taking place in Seattle at the Kaiser Permanente Washington Health Research Institute. That testing began with 45 young, healthy volunteers who have been injected with different doses of shots co-developed by NIH and Moderna Inc.
Meanwhile, a first set of tests in mice of a potential vaccine to prevent COVID-19 has shown it can spur the animals’ immune systems to produce antibodies against the coronavirus.
The vaccine is delivered via a fingertip-sized, Band-Aid-like patch made of 400 tiny needles that scratch the skin. The researchers who are developing the vaccine say the immune system reacts more readily to irritations of the skin, which means doing so could trigger it to target the coronavirus.
When tested on mice, they developed antibodies to fight the coronavirus within two weeks.