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Blue Water Vaccines, Developing Universal Flu Vaccine, to Partner With Ology Bioservices Inc.

Aug 7, 2019

CINCINNATI, Aug. 7, 2019 -- Blue Water Vaccines, a Cincinnati-based biotechnology startup, has signed an agreement with Ology Bioservices, Inc. to manufacture a novel universal influenza vaccine. The vaccine, based on technology licensed from the prestigious University of Oxford in the U.K., has shown promising results in a preclinical study done by Oxford researchers.

Vaccine based on pioneering mathematical models, research from University of Oxford
Product to be manufactured in Alachua, Florida, Blue Water headquartered in Cincinnati, Ohio
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.

Groundbreaking research by University of Oxford scientists Sunetra Gupta, Ph.D., and Craig Thompson, Ph.D., 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, Florida.

"The depth of knowledge and experience in vaccine manufacturing at Ology is incredible," said Joseph Hernandez, an experienced biotech entrepreneur and CEO of 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."

"We are proud to support the development of Blue Water Vaccines' influenza vaccine candidate," said Dr. Peter Khoury, CEO of Ology Bioservices. "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.

About Ology Bioservices, Inc.

Ology Bioservices is a privately held, full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing, from early-stage through commercial product.

Blue Water Vaccines, Inc.

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