BlueWillow Biologics, an Ann Arbor-based pharma company developing a nasal mist vaccine for food allergies, reports it has demonstrated the safety and immunogenicity in humans of its intranasal technology. A vaccine is a preparation that is used to stimulate the body’s immune response against diseases.
The company, which received Fast-Track Small Business Research Innovation contract from the National Institute of Allergy and Infectious Diseases (NIAID), currently has vaccines in development for anthrax, pandemic flu, COVID-19, RSV, HSV (herpes) and peanut allergy. The anthrax vaccine is the furthest along, with positive interim data already announced from a Phase I trial showing safety and immunogenicity.
Said BlueWillow CEO Dr Chad Costley:
The Phase I trial was primarily focused on safety, and wasn’t powered to show superiority versus other vaccines, but we are seeing a very good indication of immunogenicity, and both systemic and mucosal immunity.
Theur NanoVax® platform is based on a water-in-oil emulsion containing droplets approximately 400 nm to 500 nm in diameter combined with specific antigens to induce immunity. “We have a very safe, very flexible platform. It can be combined with a single antigen or multiple antigens,” said Costley.
BlueWillow is currently developing vaccines to treat peanut allergies.
“We can develop vaccines for multiple food allergies (such as dairy, tree nuts or shellfish), as well as for environmental allergies,” said Costley. Once the vaccine is sprayed into the nose, the body’s response shifts from inflammatory (Th2) to protective (Th1).
We’re seeing long-lasting responses in sensitized animal models. How this translates to humans remains to be seen, but we envision this as an immunotherapy that would last longer than the daily oral immunotherapies that currently are available,” perhaps enabling monthly or yearly administration.
In addition to the induction of both mucosal and systemic immunity, advantages of an intranasal approach include the lack of needles, low cost and thermostability under normal refrigeration temperatures (2-8°C), which eases distribution.
The company is expected to commence multiple clinical trials in its lead commercial programs.