Owensboro’s Kentucky BioProcessing announced plans Wednesday to begin a Phase I clinical trial in adult volunteers for their COVID-19 candidate vaccine created using innovative plant-based technology.
The study follows the approval of KBP’s Investigational New Drug application by the U.S. Food and Drug Administration. KBP is the US Bio-tech arm of British American Tabacco.
Enrollment for the study is expected to begin shortly. The study is designed to enroll a total of 180 healthy volunteers who will be divided into two age cohorts — age 18-49 and age 50-70.
Each group will then be subdivided into low- and high-dose treatment groups. Results from the study are expected mid-2021 and, if positive, would allow for continued progress into a Phase 2 study, subject to regulatory approval.
KBP announced the candidate vaccine has been developed using their innovative fast-growing plant-based technology.
“Moving into human trials with both our COVID-19 and seasonal flu vaccine candidates is a significant milestone and reflects our considerable efforts to accelerate the development of our emerging biologicals portfolio,” BAT’s Director of Scientific Research David O’Reilly said in the release. “It is our unique plant-based vaccine technology, which acts as a fast, efficient host for the production of antigens for a variety of diseases, that has enabled us to make this progress and respond to the urgent global need for safe and effective treatments and vaccines.”
According to a release, this unique approach has a number of possible advantages, including the rapid production of the vaccine’s active ingredients in around six weeks, compared to several months using conventional methods. The candidate vaccine also has the potential to be stable at room temperature.
If successful, the speed of production of the active ingredients has the potential to reduce the time between identifying new viruses and strains, and vaccine development and deployment to those who need it.
