Kentucky Bioprocessing (KBP) (owned by British American Tobacco) recently launched a clinical trial to test its seasonal flu vaccine candidate. Working with research site organization Meridian Clinical Research, the sponsor and principal investigator will be targeting 120 volunteers in Omaha, Nebraska. A world leader in using tobacco and other plants to produce pharmaceuticals and other high value products, the company is focused on developing standardized templates to produce highly effective vaccines that target a wide variety of diseases, while meeting stringent regulatory requirements for process and production control. After two years of preliminary work, the company has progressed to the Phase I clinical trial for the investigational influenza vaccine called KBP-V001.
The Investigational Vaccine Candidate
Back in April 2020, TrialSite News introduced Kentucky Bioprocessing (owned by British American Tobacco) and their effort to develop a COVID-19 vaccine. In May, Genetic Engineering & Biotechnology News updated the market that the COVID-19 vaccine was still in preclinical.
Now an investigational influenza vaccine known as KBP-V001 commenced in partnership with Meridian Clinical Research.
The Phase 1, observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-V001, the Kentucky Bioprocessing investigational Quadrivalent influenza in 120 healthy adults.
The sponsor will screen subjects up to 14 days prior to randomization. On the first planned vaccination day (Day 1), the volunteers are randomized in a 1:1:1:1 ration (N=30 subjects/group) to receive study vaccine or placebo by intramuscular (IM) injection. The sponsor targets approximately 5 participants per group (N=20) for enrollment in parallel initially, and safety data through Day 8 is collected. An Independent Data Monitoring Committee (IDMC) will convene to review Day 8 safety data before any additional subjects are enrolled. If no safety concerns are raised in the IDMC meeting then study enrollment commences. The study team will collect blood and serum samples for safety laboratory tests and HAI titers are obtained at baseline on Day 1 prior to administration of vaccine dose and post vaccination.
Hug Haydon, KBP President and one of the company’s founder, recently conveyed in a press release that the FDA clinical trials process is lengthy and arduous and that “The whole process takes a number of years.” Of course, if the product ultimately works and is approved by the U.S. FDA then this could absolutely transform KBP. Although the flu vaccine market is complicated and essentially dominated by a few big players penetrating this market with a superior product could open up many doors for tobacco-based vaccines and drugs.
Why is the Tobacco Plant a Differentiator?
That KBP is based on tobacco represents a valuable differentiator, reports Haydon. First and foremost, they believe they can produce vaccines much more efficiently and with more agility. As the strain of flu for any given season’s vaccine development cannot be predicted, e.g. its an “inexact science” as even within the two types of flu strains, there are hundreds of subtype combinations.
For egg-based vaccine manufacturing, the vaccine makers and epidemiologists must predict the right strain. There is at least a six-month run time to incubate and develop that egg -based vaccine. However, in that six month period any number of changes or modifications may be necessary. For example, the virus may in fact mutate or a producer might make a mistake as to specific subtype.
The Power of Tobacco
In the case of KBP’s tobacco-based process, the company can grow enough tobacco-based protein with a two week batch to host a flu antigen hence far less lag time in the vaccine development process. KBP’s (and British American Tobacco) bet: that this flexibility, agility and form of horsepower could change the flu vaccine landscape.
As mentioned previously, KBP is developing a clinical pipeline, including a COVID-19 candidate. Back in 2014, KBP was in the news for contributing to the development of a treatment for Ebola as the company partnered with California-based Mapp Biopharmaceuticals to produce ZMapp. The U.S. Biomedical Advanced Research and Development Authority (BARDA) helped fund the initiative.
The Research Site
Meridian Clinical Research was founded in 1999 and is headquartered in Omaha, Nebraska. A well known research site operation, Meridian Clinical Research conducts Phase I-IV studies at investigative sites across North America. They support research across numerous therapeutic areas and specialize in high volume vaccine trials. They are involved with COVID-19 vaccine trials.
Brandon Essink, MD, Meridian Clinical Research
Call to Action: The tobacco hypothesis for more rapid, flexible vaccine development is an intriguing one. TrialSite News will monitor for results.