Blue Water Vaccines, a Cincinnati, OH-based biotechnology startup, has signed an agreement with Ology Bioservices to manufacture a novel universal influenza vaccine. The vaccine, based on technology licensed from the University of Oxford in the UK, has shown promising results in a preclinical study done by Oxford researchers.
The vaccine is based on pioneering mathematical models and research from University of Oxford. The product will be manufactured in Alachua, FL.
Unlike many other viruses with preventative one-dose vaccines available, a universal influenza vaccine has eluded researchers. Current knowledge suggests the flu virus is unpredictable and ever-changing, leaving global health officials with the daunting task of predicting which strain will be most dominant during the upcoming flu season.
Historically, flu vaccines have only been 20-60% effective, and shortages have been commonplace. With nearly one billion cases and 500,000 deaths from influenza-related causes each year, there is a great need for an effective, manufacturable vaccine.
Research by University of Oxford scientists Sunetra Gupta and Craig Thompson suggests that the flu virus does not change as much as previously believed.
By studying components of historic flu viruses and applying mathematical models, researchers propose that the virus evolves in a predictable and cyclical way. Additional research identified certain regions of the virus, capable of eliciting an immune response, are limited in variability. In preclinical studies, vaccinating mice with four variants of these conserved regions resulted in immunity to all historical flu strains.
Partnering with Cincinnati-based investor CincyTech, Blue Water Vaccines has successfully raised $7 million to support an additional preclinical study, to be followed by a Phase 1 trial.
The agreement between Blue Water Vaccines and Ology Bioservices establishes that manufacturing of the vaccine, along with regulatory support during the clinical trial process, will occur at Ology headquarters in Gainesville, FL.
"The depth of knowledge and experience in vaccine manufacturing at Ology is incredible," said Joseph Hernandez, chief executive officer, Blue Water Vaccines. "While the company will be based in Cincinnati, Gainesville is the perfect place to manufacture this vaccine. Given the focus of biotechnology and health science innovation in Gainesville, we are thrilled to begin this partnership."
Peter Khoury, chief executive officer, Ology Bioservices, said, "We are proud to support the development of Blue Water Vaccines' influenza vaccine candidate. Influenza is one of the major threats to human health and innovative vaccine approaches are needed to increase the breadth of protection against new strains."
Following the successful fundraising led by CincyTech, Ology will begin another preclinical trial with the guidance of the Blue Water team and lab at the University of Oxford. Phase I trials are targeted for 2020.