BlueWillow Biologics sees positive results from Phase 1 trial of anthrax vaccine

ANN ARBOR—BlueWillow Biologics Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, announced positive interim results from the Phase 1 clinical trial of BW-1010, its next-generation intranasal anthrax vaccine candidate.

BW-1010 combines BlueWillow’s patented technology, a novel oil-in-water emulsion platform that efficiently presents antigens to the immune system via the nasal mucosa, using recombinant protective antigen for anthrax developed by Porton Biopharma Limited, a spinout of the British national health system. The interim data showed that vaccine administered intranasally as two doses 4 weeks apart was safe and well tolerated. In addition, BW-1010 induced systemic and mucosal immunity as evidenced by levels of neutralizing systemic antibodies, nasal IgA/IgG and Th17 response in peripheral blood cells. The trial was funded under contract HHSN272201600045C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Anthrax is included in the list of the National Institute of Allergy and Infectious Diseases Category A priority pathogens that pose the highest risk to national security and public health. Pathogens in this category can be easily disseminated, may result in high mortality rates, and have the potential for major public health impact.

“Given the numerous advantages of intranasal over intramuscular vaccination and the growing recognition of the critical importance of mucosal immunity, we’re confident that BlueWillow’s platform is game-changing vaccine technology,” said Chad Costley, MD, CEO of BlueWillow. “We’re thankful for the commitment of our colleagues at PBL and NIAID’s support for the Phase 1 trial. We look forward to reporting complete results when the trial concludes this fall and advancing the anthrax vaccine through further clinical trials. The human proof of concept demonstrated through this program will prove invaluable to our robust pipeline of vaccine candidates.”

More information on the Phase 1 clinical trial for BW-1010 can be found at

BlueWillow Biologics is developing a new generation of safe and effective nasal vaccines to help protect people from respiratory infections, sexually transmitted diseases and food allergies. It is studying using the treatment method on several diseases, including COVID-19, pandemic flu, RSV, HSV, anthrax and peanut allergy.

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