BAT’s US Bio-tech arm, Kentucky BioProcessing (KBP) on Tuesday announced 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).
Enrolment for the study is expected to begin shortly.
The COVID-19 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 then be subdivided 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.
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 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.
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.
KBP is conducting and recently completed enrolment for a Phase I clinical study of its quadrivalent (four-strain) influenza vaccine candidate (KBP-V001; NCT04439695), which uses the same nicotiana benthamiana plant-based technology platform.
In a statement issued Tuesday, BAT’s Director of Scientific Research Dr. David O’Reilly said that this reflects a significant milestone and espouses the company’s efforts to accelerate the development of the company’s emerging biologicals portfolio
“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. 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.
With both vaccines reaching these important milestones, the science around tobacco plant-based vaccine development and the unique platform continue to gain momentum.
On her part, BAT Kenya’s Managing Director Beverley Spencer-Obatoyinbo said this is part of the company’s ongoing commitment to innovation and science which are fundamental to the company’s 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.” said Ms. Spencer-Obatoyinbo.