BlueWillow Biologics, a clinical-stage biopharmaceutical company in Ann Arbor, has been awarded a Fast-Track Small Business Research Innovation contract from the National Institute of Allergy and Infectious Diseases for the development of an intranasal therapeutic peanut allergy vaccine.
The vaccine will use the company’s NanoVax platform. Pending approval of all phases, the contract will provide funding of up to $3.2 million, which will allow the company to complete preclinical research and prepare to file an Investigational New Drug application for its candidate vaccine.
Peanut allergies are one of the most common food allergies, affecting more than 7 million people worldwide. There is no approved treatment, and the current standard of care is avoidance, leaving many at risk of exposure and 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 cause series allergic reactions, and their benefits are quickly lost if therapy ceases.
“Food allergy is a very significant health care concern today, and even more alarming is the fact that incidence is increasing,” says Dave Peralta, CEO of BlueWillow. “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 in Ann Arbor 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 toward a different response and suppressing inflammatory allergic responses.
The first phase of the project will be completed in collaboration with peanut allergy experts at the Mary H. Weiser Food Allergy Center at U-M. The associated work is being funded in whole with $300,000 of federal funds from the National Institute of Allergy and Infectious Diseases, an institute within the National Institutes of Health.
BlueWillow is a privately held company focused on creating vaccines using its patented NanoVax platform, which makes vaccines that are administered intranasally, intramuscularly, and topically. It is developing intranasal vaccines for allergies and respiratory and sexually transmitted infections.