Kentucky Bioprocessing, an Owensboro-based biotech company, is beginning human clinical studies for its Quadrivalent Influenza Vaccine (QIV) to prevent seasonal flu.
The clinical study comes following U.S. Food and Drug Administration review of the Investigational New Drug package submitted by KBP in support of this vaccine candidate.
The initial clinical study will assess the safety and immunogenicity of the KBP QIV in approximately 120 healthy volunteers in Omaha, Nebraska. The study will begin with the first subject to be enrolled this week.
In pre-clinical studies, the vaccine has shown a strong safety profile while also producing rapid and long -lasting immune responses. A key feature of the KBP Platform is 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.
“Our platform combines the well-established speed and robustness of transient gene expression in Nicotiana benthamiana host plants with a novel delivery system to accelerate development of vaccines against both viral and bacterial pathogens,” Hugh Haydon, one of KBP’s founders and its President, said in a release Thursday.
In 2014, KBP made headlines for its role in developing a treatment for Ebola, having manufactured ZMapp alongside California-based Mapp Biopharmaceuticals and in partnership with the U.S. Biomedical Advanced Research and Development Authority.
