BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

Ann Arbor-based BlueWillow Biologics, a clinical-stage biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) clearance to begin the Phase 1 clinical study of its intranasal anthrax vaccine, NanoVax.
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BlueWillow Biologics will begin Phase 1 clinical testing of its intranasal anthrax vaccine this year. // File photo

Ann Arbor-based BlueWillow Biologics, a clinical-stage biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) clearance to begin the Phase 1 clinical study of its intranasal anthrax vaccine, NanoVax.

The study, which is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), is expected to begin this year. The active ingredient in the vaccine is a compound called BW-1010.

Development of an intranasal anthrax vaccine is ongoing through BlueWillow’s NIAID contract with Porton Biopharma Limited (PBL), which could be worth up to $24 million over its eight-year term if all options are exercised.

“The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine,” says Dave Peralta, CEO of BlueWillow. “Animal studies have demonstrated BW-1010 is safe and elicits protection against anthrax after just one or two vaccinations.

“In addition, informal stability studies have shown that our vaccine has a shelf life of over five years, compared to three years for the current injectable vaccine. The improved stability of BW-1010 would allow for longer-term storage, potentially saving the U.S. government over $100 million annually.”

Anthrax is listed as a Category A priority pathogen by NIAID, indicating the biological agent poses the highest possible risk to national security and public health. When introduced to the body through inhalation, ingestion or cuts in the skin, anthrax-causing bacteria can cause severe illness and death.

The disease poses a massive threat in situations such as bioterrorism. To protect the nation against the potential risk of an anthrax attack, the U.S. Department of Health and Human Services (HHS) currently stores tens of millions of doses of injectable anthrax vaccine in the U.S. Strategic National Stockpile, the nation’s largest supply of potentially life-saving medical products for emergency use.

The currently licensed injectable vaccine requires three immunizations in addition to antimicrobial therapy as a medical countermeasure following potential anthrax exposure. Evidence indicates the current vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women.

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