Kentucky BioProcessing (KBP), the U.S. bio-tech arm of big tobacco company British American Tobacco (BAT), has announced it will be entering into Phase 1 of its first-time-in-human study of its COVID-19 vaccine candidate. This will commence following the approval of its investigational new drug application by the U.S. Food and Drug Administration (FDA). Enrollment for the study will also begin soon.
Kentucky BioProcessing’s potential COVID-19 vaccine made news due to the company’s use of tobacco plant-based vaccine development science which gave their research momentum early on. One advantage of using this plant-based technology to develop a COVID-19 vaccine is the rapid production of the vaccine’s active ingredients, which will come in at around 6-weeks time, compared to several months that would come from more conventional methods. Kentucky BioProcessing’s vaccine candidate could also be stable at room temperature, another advantage to healthcare systems that are having to use freezers to store the current vaccines that have been released for use. Also, tobacco plants cannot host pathogens that can cause human disease, another advantage of Kentucky BioProcessing’s potential COVID-19 vaccine.
The potential vaccine, known as KBP-COVID-19; NCT04473690, will become one of several potential COVID-19 vaccines that have progressed beyond pre-clinical testing. For the study, Kentucky BioProcessing will enroll 180 healthy volunteers that will be divided into two age groups–one that is 18-49, another that is 50-70. Each group will be divided again into low and high dose treatment groups and randomized 2:1 to receive either a low dose, a high dose, or a placebo. Results from this study are expected mid 2021 and should the results be positive, Kentucky BioProcessing will then proceed to Phase 2 of the study, pending regulatory approval.