We are working on a potential vaccine for COVID-19.

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. In April, we announced that our proprietary, fast-growing plant-based technology was being used to develop a potential vaccine against COVID-19. BAT/KBP’s COVID-19 candidate vaccine is not currently approved or licensed for use anywhere in the world.

Discover more about our vaccine journey below.

Our expertise

Our technical team at KBP has worked on developing scalable processes for dozens of different proteins for a variety of commercial clients and governments. Watch the video below to find out more.

Our unique technology applied to COVID-19

Our plant-based candidate vaccine

Human trials

We will be progressing into human trials soon, following approval of our Investigational New Drug application by the U.S. Food and Drug Administration (FDA). Enrolment for the study is expected to begin shortly. This study will enroll 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 in mid-2021 and if positive would allow for continued progress into a Phase II study, subject to regulatory approval.

Our Chief Medical Officer, Dr Hutan Ashrafian, explains what a Phase I study is and why it will be an important milestone for KBP and BAT. Watch the video below.

The three phases of clinical trials

Find out more about the three phases of clinical trials below.

Our technical team at KBP has worked on developing scalable processes for dozens of different proteins for a variety of commercial clients and governments. In 2014, KBP was one of a few companies with an effective treatment for Ebola, having manufactured ZMapp™ with California-based company Mapp BioPharmaceuticals in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA).

KBP recently completed enrollment and is currently conducting a Phase I clinical study of a quadrivalent (four-strain) influenza vaccine candidate (KBP-V001; NCT04439695), which uses the same plant-based technology platform. If successful, the speed of production of the active ingredients has the potential to greatly reduce the time between identifying annual flu strains and vaccine development and deployment to those who need it.

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 significant 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 rapid progress in the development of potential vaccine candidates in response to the urgent global need for safe and effective treatments and vaccines.”

Sharing our story

We have been invited to discuss our vaccine development work at scientific conferences around the world. In early September, our Director of Scientific Research, Dr David O’Reilly, presented at EuroScience Open Forum (ESOF) , Europe’s leading scientific forum. As part of this, David was interviewed by The Financial Times’ Science Editor, Clive Cookson, at our global headquarters in London. Watch the video below.

David also took part in a COVID-19 panel at the virtual Global Tobacco and Nicotine Forum  (GTNF)  where he discussed the pandemic and its potential impact on the industry.

More about KBP

BAT’s U.S. subsidiary, Reynolds American Inc, acquired KBP  in 2014, with the aim of using some of its unique tobacco extraction technology to aid further development of its new category non-combustible products.

A key differentiator of KBP’s process is the use of plants instead of other traditional methods to create complex-protein products. Using plants allows for greater accuracy and speed in production. The tobacco plants we work with become manufacturing centres that produce the proteins we extract and purify to manufacture vaccines and other pharmaceuticals.

The processes we develop to purify plant-made proteins are conducted using principles of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) for pharmaceuticals, with a focus on developing protocols that can be consistently replicated on a large, commercial scale under those cGMP conditions.

Plants are seeded, germinate and grow before the genetic construct representing the protein of interest is inserted. With this transformation, plants incubate for several days during which they are reproducing the target protein. At this point, they are harvested and crushed to create a green-juice slurry. This liquid passes through filtration processes and sophisticated purification techniques to produce a final product. The entire process is enveloped in a rigorous quality-control framework, with analytical tests occurring at key points to verify process integrity.