British American Tobacco (BAT)’s US biotech arm, Kentucky BioProcessing (KBP), has announced plans to initiate a Phase I first-in-human study of its Covid-19 vaccine candidate.
The vaccine candidate (KBP-COVID-19) is created using KBP’s innovative plant-based technology.
This Phase I first-in-human study, which comes after the US Food and Drug Administration (FDA) approved its investigational new drug application, will start enrolment of participants soon.
The study will enrol 180 healthy adult volunteers and will be divided into two age groups of 18-49 years and 50-70 years.
Each cohort will again be subdivided into low and high dose treatment groups.
The subjects will be randomised in 2:1 ratio to receive either the low dose consisting of 15μg KBP-Covid-19 vaccine plus 0.5mg adjuvant or placebo, or a high dose consisting of 45μg vaccine + 0.5mg adjuvant or placebo.
BAT anticipates results from the study by next year mid. If positive results are obtained, it will advance into a Phase II study, subject to regulatory approval.
Claimed to be a unique approach, the plant-based technology will offer several benefits including the rapid production of the vaccine’s active ingredients in six weeks as compared to several months using conventional methods.
In addition, the candidate vaccine has the potential to be stable at room temperature.
BAT scientific research director Dr David O’Reilly said: “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.”
Recently, KBP completed enrolment for a Phase I clinical study of its quadrivalent (four-strain) influenza vaccine candidate, KBP-V001, which also uses the nicotiana benthamiana plant-based technology platform.