Kentucky BioProcessing (KBP) plans to commence a Phase I first-time-in-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). Enrollment for the study is expected to begin shortly.
The Covid-19 vaccine candidate will become one of a number of potential vaccines to have progressed beyond pre-clinical testing. The study is designed to enroll a total of 180 healthy volunteers who will be divided into two age cohorts, 18 to 49 and 50 to 70. Each group will then be subdivided into low dose and high dose treatment groups and randomized 2:1 to receive either the low dose or placebo, or high dose or placebo. 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.
The candidate vaccine has been developed using KBP’s fast-growing plant-based technology. According to KBP parent company British American Tobacco (BAT), this 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, which could be a significant advantage for healthcare systems and public health networks worldwide. 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.
“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,” said David O’Reilly, BAT’s director of scientific research, in a statement. “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.”
Tobacco Reporter’s Stefanie Rossel highlighted KBP’s endeavor in a June 2020 feature story, titled “Shots on Goal.”
In July, Medicago, a Quebec-based biotechnology company backed by Philip Morris International and other investors, also started human trails for a tobacco-based Covid-19 vaccine.
Researchers in Thailand, too, are developing a tobacco-based Covid-19 vaccine.