Allergy is a major cause of illness and disability with an estimated 40-50 million people afflicted in the US alone. AIT provides long-term benefits for the patient and its need for optimization creates a compelling business opportunity. There is a very strong rationale to develop GLA for allergy based on its superior drug profile to MPL, a related TLR4 agonist that accelerates desensitization in people. Our preclinical development plan is easy to execute given the vaccines simple design, and it is very low risk given GLA's safety record in toxicology studies and current clinical programs. This Phase I SBIR will clarify the pharmacology and product profile for the IND. The goal is to confirm that GLA will augment the immunogenicity of multiple allergens and verify that it can accelerate desensitization in a compelling manner. The intention is to generate three potential vaccine candidates for evaluation by an external advisory board. In addition to new innovative allergy products, this work will help us understand the mechanisms of IgE-mediated disease and how to effectively "cure" allergy through tolerance induction. TRIA has the resources and experience to complete the task.
Public Health Relevance Statement: Public Health Relevance: Allergy is a major cause of illness and disability with an estimated 40-50 million people afflicted in the US alone. Allergy immunotherapy cures some patients although it is underutilized and suffers from poor compliance. Adjuvants can be mixed with allergy vaccines to accelerate tolerance with fewer injections and no adverse reactions.
NIH Spending Category: Allergic Rhinitis (Hay Fever); Clinical Research; Immunization; Prevention; Vaccine Related
Project Terms: Adjuvant; Admixture; Adverse reactions; Affect; Agonist; airway hyperresponsiveness; Allergens; Allergic; Anaphylaxis; Animal Model; base; Businesses; Chemicals; Child; Clinical; Clinical Research; crosslink; Cyclic GMP; Data; desensitization; design; Development; Development Plans; disability; Disease; Drug Formulations; Effectiveness; Evaluation; experience; FDA approved; Felis catus; Food; Funding; global health; Goals; Grant; Health Care Costs; Human; Hypersensitivity; IgE; Immune response; Immune Tolerance; Immunity; immunogenicity; Immunotherapy; Incidence; Injection of therapeutic agent; innovation; Insecta; Intention; interest; Lead; Link; Lipid A; Marketing; Mediating; Medical; Methods; Modeling; Monitor; Oryctolagus cuniculus; Outcome; Patients; Peanuts - dietary; Peripheral Blood Mononuclear Cell; Pharmaceutical Preparations; Pharmacology; Phase; Phleum; Physicians; Pollen; Population; pre-clinical; Prevalence; prevent; programs; public health relevance; Regulation; Relative (related person); Resources; Rhinitis; Risk; Route; Safety; Sales; Seasons; Series; Small Business Innovation Research Grant; subcutaneous; sublingual immunotherapy; success; Symptoms; T-Lymphocyte; Time; TLR4 gene; Toxicology; Vaccine Adjuvant; vaccine candidate; vaccine efficacy; vaccine safety; Vaccines; Work; World Health Organization
