BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today 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, with Porton Biopharma Limited’s (PBL) recombinant protective antigen (rPA) for anthrax. 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 NIAID 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 https://clinicaltrials.gov/ct2/show/NCT04148118.
PBL is a biopharmaceutical development and manufacturing company with approximately 400 staff. It was formed in April 2015 as a spin-out company of Public Health England, and has a sole shareholder in the Department of Health and Social Care. PBL is based at Porton Down, Wiltshire, which has a long history of pharmaceutical development and manufacturing.