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

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Tag Archive: anthrax

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

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    ANN ARBOR, Mich., (October 23, 2019) – BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company’s next-generation anthrax vaccine candidate. The Phase 1 clinical study is expected to begin enrollment this year and is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH).

    Development of an intranasal anthrax vaccine is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) under contract #HHSN272201600045C from NIAID for the development of a next-generation NanoVax® anthrax vaccine. The contract could be worth up to $24 million over its eight-year term if all options are exercised. The vaccine combines BlueWillow’s novel intranasal NanoVax system with recombinant protective antigen (rPA) for anthrax from PBL. The NanoVax platform employs a proprietary oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immunity, uniquely enabling protection against challenging respiratory infections such as anthrax.

    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.

    “The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine,” said BlueWillow CEO Dave Peralta. “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.”

    About BlueWillow

    BlueWillow Biologics® is a clinical-stage, privately-held biopharmaceutical company focused on developing and commercializing prophylactic and therapeutic vaccines using its patented NanoVax® platform. The NanoVax platform employs a novel oil-in-water nanoemulsion adjuvant that is effective when administered intranasally, intramuscularly and topically, and can elicit both mucosal and systemic immunity.

    BlueWillow is currently developing intranasal vaccines for several respiratory and sexually transmitted infections, including RSV, HSV2, pandemic influenza and anthrax, as well as vaccines for peanut allergy and other allergic conditions. Visit BlueWillow.com for details on the company’s vaccine pipeline and studies completed to date.

  2. BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

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    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.

    About BlueWillow

    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.