LONDON — British American Tobacco’s (BAT) bio-tech arm, Kentucky BioProcessing (KBP) is starting a human study of its COVID-19 vaccine candidate following approval of its Investigational New Drug application by the U.S. Food and Drug Administration (FDA). The company said it expects to begin enrollment for the study shortly.
This vaccine candidate will become one of several potential vaccines that have progressed beyond pre-clinical testing. The study will involve 180 healthy volunteers who will be divided into age cohorts and low- and high-dose treatment groups. Results are expected to come mid-2021 and, if successful, could lead to continued progress into another study.
The possible vaccine was developed with Owensboro, Ky.-based KBP’s plant-based technology. The approach has possible advantages to other methods, including the rapid production of the vaccine’s active ingredients in about six weeks, compared to several months using conventional methods, according to the company. It also has the potential to be stable at room temperature.
The company also progressed with a seasonal flu vaccine, helping the science around tobacco plant-based vaccine development to gain momentum, according to David O’Reilly, London-based BAT’s director of scientific research.
“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,” O’Reilly said. “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.”