BAT has announced plans to commence a Phase I first-time-in-human study of its Covid-19 vaccine candidate.
The announcement by BAT’s US Bio-tech arm, Kentucky BioProcessing (KBP) was made after approval of its Investigational New Drug application by the U.S. Food and Drug Administration (FDA). Enrolment for the study is expected to begin soon.
According to Dr David O’Reilly, 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.”
He added that it is their 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.
The vaccine candidate (KBP-COVID-19; NCT04473690) 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, age 18-49 and age 50-70.
Each group will be divided into low and high dose treatment groups (N~45) and randomised 2:1 to receive either the low dose (15 μg KBP-COVID-19 vaccine + 0.5 mg adjuvant) or placebo, or high dose (45 μg KBP-COVID-19 vaccine + 0.5 mg adjuvant) or placebo.
It is expected that results from the study would arrive 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 innovative fast-growing plant-based technology.
This unique approach has a number of possible advantages, including the rapid production of the vaccine’s active ingredients in around 6-weeks, compared to several months using conventional methods.
(With inputs from The OnLook News Research Bureau)