Immunomic Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: R

Description

DESCRIPTION provided by applicant Extreme reactions to food results in over incidents of anaphylaxis and between deaths in the US each year Allergies to tree nuts TN such as almond cashew hazelnut and walnut are collectively the second most common triggers of anaphylaxis behind peanut An estimated million Americans are allergic to TNs with many impacted by exposure to trace amounts and no recourse but to stringently avoid ingestion or risk a potentially fatal anaphylactic episode In response to NIAIDandapos s commitment to address the health challenge posed by food allergies Immunomic Therapeutics Inc andquot ITIandquot proposes innovative SBIR Phase I research to design a novel multivalent TN immunotherapy that utilizes a lysosomal associated membrane protein andquot LAMPandquot chimeric construct to direct the major TN allergens of almond hazelnut cashew and walnut into the MHC II endosomal pathway ITI envisions a novel therapeutic product consisting of plasmids each encoding the major TN allergens as a LAMP chimera When administered this product TN LAMP vax is expected to rapidly desensitize subjects to the encoded allergens and cross reactive allergens by inducing a helper T cell type Th response The proposed therapeutic product is anticipated to be a safe hypoallergenic and cost effective immunotherapy that significantly reduces or eliminates sensitivity to TN allergens ITI has successfully designed tested and validated multiple antigen LAMP vax DNA formulations including multivalent peanut and cedar allergy vaccines Recently ITI completed a Phase I clinical study of JRC LAMP vax an immunotherapeutic for treating Japanese red cedar allergy through administration of the major cedar allergen Cry j When administered intramuscularly as naked DNA in saline four times biweekly no severe adverse events were reported and skin test conversion from Japanese red cedar positive to negative was observed in out of patients at the end of the trial at day The putative mechanism of action behind this result is suggested by previous work with LAMP that shows immunization initiates a Th response high titers of immunoglobulin Ig G and immunological memory The Th and IgG immune response provides a compelling argument in support of LAMP vaccines to treat IgE mediated allergic diseases The LAMP vaccine immune response follows the accepted medical paradigm for allergy de sensitization and establishes a new level of safety by eliminating exposure to free allergen as required in traditional immunotherapy This Phase I research draws on ITIandapos s experience in commercializing LAMP based allergy vaccines and completion of the Aims will clearly provide a rationale for commercializing the therapeutic TN vaccine for allergic patients Phase I Aims are to design and synthesize TN allergen encoding plasmids evaluate and optimize immunogenicity of TN LAMP vax and evaluate TN LAMP vax in single TN and multi nut anaphylaxis animal model and optimize dosing and delivery During Phase II ITI will prepare TN LAMP vax under current Good Manufacturing Practices cGMP and conduct biodistribution andamp toxicology studies in support of an IND filing The goal of this project is to commercialize TN LAMP vax ITI strongly believes that this proposal supports NIAIDandapos s commitment to address the health challenge posed by food allergy and TN induced anaphylaxis for which there is no treatment PUBLIC HEALTH RELEVANCE TNs are a common cause of food allergies in the US TN allergies have become more prevalent over the last decade and now affect of Americans TN allergies are rarely overgrown An immunotherapy that desensitizes TN allergies would greatly impact patients with food allergy by helping to prevent potentially fatal anaphylactic reactions and providing a significant improvement in quality of life