Ann Arbor’s BlueWillow Biologics Receives Patent for Intranasal Anthrax Vaccine

BlueWillow Biologics in Ann Arbor today announced the issuance of a U.S. patent for its intranasal NanoVax anthrax vaccine, which offers long-term protection against lethal anthrax challenge in animals.
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anthrax diagram
BlueWillow Biologics has received a patent for its intranasal NanoVax anthrax vaccine for animals. // Image courtesy of the Centers for Disease Control and Prevention

BlueWillow Biologics in Ann Arbor today announced the issuance of a U.S. patent for its intranasal NanoVax anthrax vaccine, which offers long-term protection against lethal anthrax challenge in animals.

The patent was issued to the University of Michigan in Ann Arbor under exclusive license to BlueWillow and is based on research conducted by the university demonstrating the vaccine’s effectiveness.

The National Institute of Allergy and Infection Diseases lists Bacillus anthracis, or anthrax, as a Category A pathogen, or a biological agent that poses the highest possible risk to national security and public health. Anthrax exposure can cause severe illness and death when spores enter the body through inhalation, ingestion, or cuts. The disease poses a threat in situations such as bioterrorism.

BlueWillow’s intranasal NanoVax platform employs an oil-in-water emulsion adjuvant that elicits systemic and mucosal immunity, protecting against respiratory infections. Advanced development of an intranasal NanoVax anthrax vaccine is ongoing through BlueWillow’s partnership with Portion Biopharma Ltd. of the United Kingdom. Phase one clinical studies are expected to begin the second half of 2019.

“Our intranasal NanoVax platform has successfully demonstrated safety and efficacy in the primary animal models for several respiratory and sexually transmitted diseases,” says Dave Peralta, CEO of BlueWillow. “We have plans to begin P1 human testing of our intranasal anthrax vaccine later this year, and we are looking to begin human testing of intranasal vaccines for pandemic influenza and RSV during 2020 and 2021. The issuance of this anthrax patent expands our existing patent portfolio, and further demonstrates the unique and novel approach we are taking to develop safe vaccines for some of the world’s most concerning diseases.”

Portion Biopharma Ltd.  holds a contract from the institute for the development of a next-generation NanoVax anthrax vaccine that could be worth up to $24 million over its eight-year term. The vaccine combines BlueWillow’s intranasal adjuvant with Portion Biopharma’s recombinant protective antigen for anthrax. To date, the vaccine has demonstrated safety, immunogenicity, and protection in animal studies. Animals who were exposed to anthrax without first receiving the NanoVax vaccine did not survive.

BlueWillow is a privately held biopharmaceutical company focused on developing and commercializing vaccines that can be administered via intranasal or intramuscular vaccination and can elicit both mucosal and systemic immunity when applied intranasally.

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