A new COVID-19 vaccine candidate is entering clinical phase 1 human clinical trials today after the U.S. Food and Drug Administration (FDA) submitted an application from Inovio Pharmaceuticals as part of the Investigational New Drug program Supervisory authority has adopted. Inovio plans to inject its first volunteer volunteer with the INO-4800 DNA vaccine candidate it has developed after promising results from preclinical studies in animals suggesting an increased immune response.
The Inovio DNA vaccine candidate injects a specific manipulated plasmid (a small, independent genetic structure) into a patient so that his cells can produce a desired, targeted antibody to ward off a particular infection. Although DNA vaccines are available and approved for a wide variety of animal infections in veterinary medicine, they have not yet been approved for human use.
However, Inovio's work does not start from scratch: The company has previously completed a phase 1
Inovio was able to rapidly scale, develop, and manufacture "thousands of cans" of INO-4800 in just a few weeks to support the Phase 1 and Phase 2 studies. The company has done this in part thanks to the support of the Bill and Melinda Gates Foundation and funding from other nonprofits and organizations. If clinical trials are successful, Inovio can have up to a million doses of the vaccine available by the end of the year to use for both additional trials and a potential emergency, pending approval.
This is the second vaccine for phase 1 clinical trials in humans: Moderna started its study in mid-March. Inovio's study will consist of 40 volunteers, all of whom are healthy adults, selected through screening conducted at either the Perelman School of Medicine in Philadelphia at the University of Pennsylvania or the Center for Pharmaceutical Research in Kansas City. It will extend over the next few weeks and the company expects data on test subjects' immune responses and information on the safety of treatment for humans will be available by the end of this summer.
Any broad approval or approval for use is likely to be at least a year to 18 months away, but the pace of human experimentation is still exceptional, so hopefully we won't have to wait too long.