Initiation of Phase One Clinical Studies Expected This Year
ANN ARBOR, Mich., (May 29, 2019) – BlueWillow Biologics® today announced the issuance of U.S. patent number 10,138,279 covering an intranasal NanoVax® anthrax vaccine. The patent, issued to the University of Michigan 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.
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.
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. Advanced development of an intranasal NanoVax anthrax vaccine is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) of the United Kingdom. Phase one clinical studies are expected to begin in the second half of 2019.
PBL holds a contract (#HHSN272201600045C) from NIAID for the development of a next-generation NanoVax anthrax vaccine, which could be worth up to $24 million over its eight-year term, if all options are exercised. The vaccine combines BlueWillow’s novel intranasal adjuvant with PBL’s recombinant protective antigen (rPA) for anthrax. To date, the NanoVax anthrax vaccine has demonstrated safety, immunogenicity and protection in multiple animal studies. In contrast, animals exposed to anthrax without first receiving the NanoVax vaccine did not survive.
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. The technology employs a novel oil-in-water nanoemulsion adjuvant that is effective when administered via intranasal or intramuscular vaccination, and can elicit both mucosal and systemic immunity when applied intranasally.
BlueWillow is currently developing intranasal vaccines for several respiratory and sexually transmitted infections, including RSV, pertussis, influenza, anthrax, prophylactic and therapeutic HSV-2 and chlamydia. Visit BlueWillow.com for details on the company’s vaccine pipeline and studies completed to date.