BLUEWILLOW BIOLOGICS INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Food allergy is an emerging health problem with increasing incidence and severityparticularly in childrenand continuing throughout adulthoodSincethe incidence of self reported peanut allergy has risen significantly representing a mounting financial burden to the healthcare systemWith no approved therapeutics availablevarious forms of immunotherapy have been evaluated but generally do not facilitate long term protection and can have adverse side effectsBlueWillow will apply its novel oil in water NanoVax nanoemulsion mucosal adjuvantNEto formulate an intranasal vaccine against peanut allergyNEfacilitates modulation of existing THimmune responses to promote THTHimmunityIn this Fasttrack proposalPhase I will establish compatibilityshort term vaccine stability and protection in a mouse model of peanut allergyIn phase IIwe will establish and optimize processes for scale upclinical lot manufacturing and long term stability of both antigen and final vaccine formulationassess the longterm protection in preclinical animal modelshold a pre IND meeting with the FDAand conduct a GLP safety toxicity studySuccessful completion of this project will enable IND filing and initiation of clinical trials to assess the intranasal peanutNEvaccineThis Peanut NEvaccine will be the first commercial vaccine available for the treatment of peanut allergies to address a significant unmet medical need