Kentucky BioProcessing will soon initiate clinical studies on humans for a seasonal influenza vaccine. According to officials with KBP, the biotech company’s potential vaccine — developed through the use of tobacco plants — and their platform to use it could enable scientists to make flu vaccines more efficient in the future.
Hugh Haydon, one of KBP’s founders and president, told Owensboro Times that KBP’s Quadrivalent Influenza Vaccine (QIV) platform included the ability to use tobacco plants as a host to manufacture large quantities of vaccine antigen much more rapidly than traditional egg-based vaccine production systems.
“We will be looking at using that as a template to create other vaccines, a whole series of vaccines,” Haydon said. “We’ve put a tremendous amount of energy and time into this. It’s very exciting.”
Efforts toward creating a new flu vaccine had been ongoing for years at KBP, Haydon said. He called the FDA’s supportive review of the Investigational New Drug package submitted by the company and the upcoming clinical study a milestone, both for KBP and Owensboro.
The first phase of human clinical studies will take place in Omaha, Neb., with the first of 120 healthy volunteers slated to be enrolled this week. Haydon said KBP should have the data and results from that study compiled by October.
After that, they will move forward to Phase 2, which will involve larger groups of people.
“Beyond that, it’s hard to predict,” Haydon said, adding that sometimes animal studies for vaccines go well, but that the effectiveness doesn’t always translate to humans.
This flu vaccine is designed to protect individuals from four different strains of influenza. Each year in late February, scientists in the northern hemisphere predict which four flu strains will be in circulation that year. Scientists then scramble from late February to flu season to develop an effective vaccine that protects individuals against those predicted strains.
Haydon said there’s great difficulty in predicting strains of influenza and creating a vaccine to match those predictions, in large part because the strains of flu are subject to change each year.
“We chose to have a seasonal influenza vaccine, and that’s the most challenging vaccine to create,” he said.
KBP’s flu vaccine is different in that tobacco will be used as a host to produce the antigen that forms the basis of the vaccine, Haydon said.
Pre-clinical studies revealed that the KBP QIV showed a strong safety profile while also producing rapid and long-lasting immune responses. Haydon said KBP’s platform for the vaccine combines the speed and robustness of transient genre expression in Nicotiana benthamiana host plants with a “novel delivery system to accelerate development of vaccines against both viral and bacterial pathogens.”
“In short, it’s just a different antigen, and it obeys [what we tell it to do],” he said.
