Anthrax Vaccine Candidate NanoVax Awarded Patent

A privately-held biopharmaceutical company headquartered in Michigan announced the issuance of U.S. patent number 10,138,279, covering an intranasal NanoVax® anthrax vaccine. 

BlueWillow’s intranasal NanoVax platform employs a novel oil-in-water emulsion adjuvant that elicits both systemic and mucosal immunity, thereby uniquely protecting against challenging respiratory infections.   

‘The NanoVax nanoemulsion platform is unique because when administered intranasally, the vaccine can elicit both a systemic and mucosal response. Most vaccines are injected (intramuscular) and fail to provide mucosal immunity.’ 

‘By being able to generate an immune response that can respond to mucosal pathogens like anthrax, the platform may be able to provide more effective protection against the deadly disease,’ said BlueWillow in a press release. 

This patent issued to the University of Michigan on May 29, 2019, under exclusive license to BlueWillow, is based on research conducted by the University demonstrating the vaccine’s ability to elicit long-term protection against lethal anthrax challenge in animals. 

To date, the NanoVax anthrax vaccine has demonstrated safety, immunogenicity, and protection in multiple, non-human, animal studies. In contrast, animals exposed to anthrax without first receiving the NanoVax vaccine did not survive the study. 

Vaccine development is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) of the United Kingdom. The vaccine combines BlueWillow’s novel intranasal adjuvant with PBL’s recombinant protective antigen (rPA) for anthrax. 

The currently available vaccination schedule for anthrax consists of 5 intramuscular injections at months 0, 1, 6, 12 and 18, followed by annual booster injections thereafter. Evidence indicates that the current vaccine can cause acute side effects and may provide only partial protection against some strains of B. anthracis. 

BlueWillow is supplying its NE adjuvant for use with Public Health England (PHE)’s rPA antigen to enable the development of an intranasal vaccine that requires fewer doses than current treatments. 

The National Institute of Allergy and Infectious Diseases (NIAID) lists Bacillus anthracis (anthrax) as a Category A pathogen, indicating the biological agent 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 in the skin. The disease poses an immense threat in situations such as bioterrorism, says the NIAID. 

PBL holds a contract (#HHSN272201600045C) from NIAID for the development of a next-generation NanoVax anthrax vaccine. Phase one clinical studies are expected to begin in the second half of 2019. 

BlueWillow Biologics is a privately-held biopharmaceutical company headquartered in Ann Arbor, Michigan, focused on developing and commercializing vaccines using its patented NanoVax® technology platform.

In 2012, BlueWillow Biologics partnered with Public Health England (PHE) to develop an intranasal anthrax vaccine.