The US Food and Drug Administration approved the investigational new drug application, so the cigarette maker’s subsidiary can now start the first phase of clinical trials.
The study will enrol 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, while half of the participants in each segment will receive a 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 jab has been developed using KBP’s plant-based technology, which allows producing the active ingredients in around six weeks, compared to several months using conventional methods, which the company said can speed up development after identifying new viruses and strains.
It also remains stable at room temperature.
KBP, which was acquired by BAT in 2014, develops and executes processes to transform tobacco plants into ‘biomanufacturing factories’ that produce complex proteins they would not otherwise produce.
The company uses licensed and proprietary technologies to temporarily encode tobacco plants with genetic instructions to produce specific target proteins.
The plants are grown in an automated, climate-controlled environment that can be adjusted to optimise their production of a protein of interest.
Shares in BAT dipped 1% to 2,788p on Thursday late morning.