VIRTICI LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant Our goal is to develop VTC as a novel tolerance inducing therapeutic to treat peanut allergy Peanut allergy is one of the most common and potentially fatal forms of food allergy affecting nearly three million Americans Unlike many food allergens approximately of individuals allergic to peanuts remain so throughout their lifetime Although several promising approaches to treat food allergies are in clinical development the current options for treatment of peanut allergy are limited and rely on strict avoidance For successful induction of tolerance mucosal tissues play a significant role The epithelial layer that covers Gut Associated Lymphoid Tissue GALT and Nasopharyngeal Associated Lymphoid Tissue NALT regions contains a subpopulation of microfold cells M cells specialized to sample environmental antigens and present them to the adjacent immune cells A number of studies now confirm that these cells play a crucial role in the generation of tolerance to a given antigen VTC is a recombinant protein composed of the reovirus head protein ps fused to the peanut allergen PNA ara h Ara h is a dominant peanut allergen that is recognized by human immunoglobulin E in more than of the patients who have peanut allergy Reoviruses are segmented double stranded RNA viruses that infect humans via mucosal surfaces Since reoviruses bind to the M cells surface via ps we have designed VTC to use ps to target ara h antigens specifically to M cells Importantly the ability of ps targeting to induce tolerance has been studied in both allergy and autoimmune models using oral and intranasal dosing routes and The results from these studies demonstrate that ps mediated tolerance in antigen sensitized mice by both oral and intranasal routes of administration is due to the induction of anti inflammatory cytokines and an increase in suppressive regulatory T Cells Tregs Our goal is to develop VTC as an orally administered tolerance inducing therapeutic for the rapid effective treatment of peanut allergy The proposed SBIR Phase studies have three key objectives produce sufficient quantities of the VTC ara h ps fusion protein determine the optimal oral dose of VTC to induce tolerance in peanut sensitized mice and validate that oral administration of VTC provides optimal efficacy over intranasal administration in mice PUBLIC HEALTH RELEVANCE Food allergies are a major health concern worldwide particularly in western countries Among food allergies reaction to peanuts is widespread and can be quite severe resulting in death in some cases This project aims to develop a novel peanut specific tolerance therapeutic VTC for the treatment of peanut allergy VTC is expected to rapidly induce long term tolerance to major peanut allergens in allergic patients following short term treatment Successful commercialization of VTC would ultimately provide a profound front line medical advancement in the treatment of peanut allergy