Plans have commenced to start the first Phase I study of BAT’s COVID-19 vaccine candidate.
This would be a first-time-in-human study and follows approval by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug application submitted by BAT.
This potential vaccine, developed by our U.S Bio-tech arm, Kentucky BioProcessing (KBP), has been created using innovative plant-based technology. It has been developed using a unique vaccine platform that may enable the development of vaccines that have advantages over traditional vaccines, including rapid reproduction of the antigen and potential stability at room temperature.
Our U.S biotech subsidiary, Kentucky BioProcessing (KBP), is a world leader in using plants to express, extract and purify proteins for use as vaccines and other pharmaceuticals. Watch the video on YouTube to find out more about their expertise and approach.
Enrollment into the study is expected to begin shortly. This move to human trials is the first phase of studies that could, if successful, form part of a full-scale development programme. Subject to regulatory approval, this could include phase 1-3 clinical trials that would aim to fully assess the safety and efficacy of the candidate vaccine.
Dr David O’Reilly, BAT’s Director of Scientific Research said: “Moving into human trials with both our COVID-19 and seasonal flu vaccine candidates is a significant milestone and reflects our significant efforts to accelerate the development of our emerging biologicals portfolio.
“This is part of our ongoing commitment to innovation and science, which are fundamental to our business. As a company committed to building A Better Tomorrow, we are proud to play our part in the global fight against this virus and – hopefully – we can contribute to the solution.”
BAT/KBP's COVID-19 candidate vaccine is not currently approved or licensed for use anywhere in the world.
Dr Hutan Ashrafian, BAT’s Chief Medical Officer, explains what a Phase I clinical study is and why it will be important milestone for KBP and BAT. Watch the video below to find out more.
This clinical study plans to enroll 180 healthy volunteers, divided into two age groups: 18-49 and age 50-70. They will be given either a high or low dose of the candidate vaccine, or a placebo and be assessed for up to 1 year, with the primary evaluation taken 44 days following treatment.
The candidate vaccine’s unique use of innovative fast-growing plant-based technology means rapid production of the vaccine’s active ingredients in around six weeks compared to several months using conventional methods. The vaccine also has the potential to be stable at room temperature, which could be a significant advantage for healthcare systems.
Read our press release in full here.