SBIR-STTR Award

Food allergy is an emerging health problem with increasing incidence and severity particularly in children and continuing throughout adulthood Since the incidence of self reported peanut allergy has risen significantly representing a mounting financial burden to the healthcare system With no approved therapeutics available various forms of immunotherapy have been evaluated but generally do not facilitate long term protection and can have adverse side effects BlueWillow will apply its novel oil in water NanoVax nanoemulsion mucosal adjuvant NE to formulate an intranasal vaccine against peanut allergy NE facilitates modulation of existing TH immune responses to promote THTH immunity In this Fasttrack proposal Phase I will establish compatibility short term vaccine stability and protection in a mouse model of peanut allergy In phase II we will establish and optimize processes for scale up clinical lot manufacturing and long term stability of both antigen and final vaccine formulation assess the long term protection in preclinical animal models hold a pre IND meeting with the FDA and conduct a GLP safety toxicity study Successful completion of this project will enable IND filing and initiation of clinical trials to assess the intranasal peanut NEvaccine This Peanut NE vaccine will be the first commercial vaccine available for the treatment of peanut allergies to address a significant unmet medical need