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BlueWillow Awarded NIH Contract to Advance Development of its Therapeutic Peanut Allergy Vaccine

Research Will Progress Treatment for Millions Suffering from Peanut Allergies

ANN ARBOR, Mich., (October 1, 2019) – BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced it has been awarded a Fast-Track Small Business Research Innovation (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of an intranasal therapeutic peanut allergy vaccine using the company’s NanoVax® platform. Pending approval of all phases, the contract will provide funding of up to $3.2 million which will enable BlueWillow to complete preclinical research and prepare to file an Investigational New Drug (IND) application for its candidate vaccine.

Peanut allergy is one of the most common food allergies, affecting over 7 million people worldwide and forcing families, schools and caregivers to manage the daily challenge and stress of keeping loved ones safe. Unfortunately, there are no approved treatments for peanut allergy. The current standard of care remains peanut avoidance which leaves many at risk of accidental exposure and potentially life-threatening allergic reactions. Oral and topical allergen-specific immunotherapies attempt to temporarily desensitize patients by regularly administering a progressively increasing amount of peanut allergen. However, these treatments can induce serious allergic reactions and their benefits are rapidly lost if therapy is ceased.

“Food allergy is a very significant healthcare concern today, and even more alarming is the fact that incidence is increasing,” said BlueWillow CEO Dave Peralta. “The immunotherapy regimens being studied provide some hope for families with loved ones suffering from food allergies, but these therapies come with risks and limitations. BlueWillow’s peanut allergy vaccine is a unique approach which combines miniscule amounts of purified peanut protein with our novel intranasal NanoVax system and is designed to reprogram the immune system to induce long-term suppression of allergic reactions. Our peanut allergy vaccine has demonstrated this profile in numerous animal studies, and we are thrilled to win this Fast-Track contract which will allow us to advance the program towards Phase I clinical studies.”

In animal studies conducted by researchers at the University of Michigan and published last year in The Journal of Allergy and Clinical Immunology, the NanoVax peanut vaccine was effective in treating established allergic disease by shifting the immune system towards a Th1/Th17 response and thereby suppressing inflammatory allergic responses. The first phase of the project will be completed in collaboration with Dr. Jessica J. O’Konek and other peanut allergy experts at the Mary H. Weiser Food Allergy Center at the University of Michigan. The associated work is being funded in whole with $300,000 of federal funds from NIAID, an institute within the National Institutes of Health (NIH) which is part of the Department of Health and Human Services, under Contract No. 75N93019C00035.

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.