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Principal Investigator: Xiu-Min Li
Organization: GENERAL NUTRACEUTICAL TECHNOLOGY, LLC
Fiscal Year: 2024
Award: $894,193
Funding agency: National Institute of Allergy and Infectious Diseases
ABSTRACT
Food allergy (FA) has rapidly increased over 2 decades affecting 32 million Americans, with annual costs
of $25 billion. FA anaphylaxis, a potentially life-threatening condition, increased 200-400% in children from
toddlers to teens.10 Peanut/ tree nut and sesame allergy often co-exist, last a lifetime, cause severe reactions,
and there is currently no cure. Common treatments, either prophylactic i.e., food avoidance, or therapeutic i.e.,
food allergen oral immunotherapy are limited and impractical. Safe, effective, and non-food restricted
therapeutics are needed. FA is primarily mediated by food protein specific immunoglobulin E. Persistent IgE
caused by long-lived plasma cells (IgE+LPC) is a significant barrier to FA mitigation. General Nutraceutical
Technology LLC (GNT), a NY-based biotechnology startup, is building on groundbreaking research for FA
started at Icahn School of Medicine at Mount Sinai. Our oral product “NIT-X” contains the small molecule
compound berberine captured by nanoparticles. It significantly increased bioavailability, showed excellent
preclinical safety and nearly 100% reduction of PN-IgE and protection against anaphylaxis in animal model of
peanut and tree nut allergies, associated with suppressing IgE+ plasma cells/B cells, reducing IL-4, increasing
IFN-γ, inducing a distinct B cell transcriptomic profile. We hypothesize that by restoring balanced immunity.
NIT-X will be a potentially novel non-food restricted therapeutic for severe and multiple FAs. The goals of this
SBIR Phase II are generating robust NIT-X Chemistry, Manufacturing and Control (CMC), along further
preclinical pharmacokinetic (PK), toxicology and pharmacology data, and file the phase Ia clinical study. We
will conduct 4 Specific Aims: #1 Generating NIT-X CMC data, characterization of product and preclinical PK
profile; #2. Further generation of data on NIT-X preclinical toxicology; #3. Investigate dose efficacy of NIT-X in
murine models. #4. File phase Ia clinical trial as a sub-program to an ongoing parent botanical IND. Solid SBIR
phase I feasibility data and strong team and design for phase II study enable GNT to generate rigorous date for
CMC, preclinical PK, safety, and efficacy for obtaining approval of IND for a subproject to the current IND for
clinical trials with NIT-X, towards commercialization for treating FA.
Terms: <0-11 years old><21+ years old><7S Gamma Globulin><Accidents><Acute><Adult><Adult Human><Affect><Age><Allergic to food><Allergy><Allergy to food><Amendment><American><Anaphylactic Reaction><Anaphylactic Shock><Anaphylaxis><Animal Model><Animal Models and Related Studies><Annual Reports><Antibodies><Area Under Curve><B blood cells><B cell><B cell growth factor><B cells><B-Cell Differentiation Factor-1><B-Cell Growth Factor-1><B-Cell Growth Factor-I><B-Cell Proliferating Factor><B-Cell Stimulating Factor><B-Cell Stimulating Factor-1><B-Cell Stimulation Factor-1><B-Cell Stimulatory Factor-1><B-Cells><B-Lymphocytes><B-cell><BCDF-1><BCGF><BCGF-1><BCSF 1><BSF-1><BSF1><Berberine><Binetrakin><Bioavailability><Biochemistry><Biological Availability><Biological Chemistry><Biotech><Biotechnology><Blood Plasma><Blood Plasma Cell><Body Surface><Botanicals><CSIF><CSIF-10><Categories><Chemistry><Child><Child Youth><Children (0-21)><Chronic><Clinical><Clinical Research><Clinical Study><Clinical Trials><Cytokine Synthesis Inhibitory Factor><Data><Dose><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Drug Kinetics><Drugs><Encapsulated><Epithelial Cells><FDA approved><Food><Food Allergy><Food Hypersensitivity><Generations><Goals><Heavy Metals><Hematology><Histamine><Histology><Hypersensitivity><IFN-Gamma><IFN-g><IFN-γ><IFNG><IFNγ><IL-10><IL-4><IL10><IL10A><IL4 Protein><IgA><IgE><IgG><Immune Interferon><Immune reaction><Immunity><Immunoglobulin A><Immunoglobulin E><Immunoglobulin G><Immunosuppression><Immunosuppression Effect><Immunosuppressive Effect><Individual><Industry><Inflammation><Interferon Gamma><Interferon Type II><Interleukin 10 Precursor><Interleukin-10><Interleukin-4><Interleukin-4 Precursor><Investigational Drugs><Investigational New Drugs><Laboratories><Life><Lymphocyte Stimulatory Factor 1><MCGF-2><Marketing><Marrow Mast Cell><Mast Cell Growth Factor-2><Mediating><Medication><Mice><Mice Mammals><Morbidity><Morbidity - disease rate><Murine><Mus><Nut Allergy><Nut Hypersensitivity><Nutraceutical><Nuts><Oral><Outcome><Parents><Persons><Pesticides><Pharmaceutical Preparations><Pharmacokinetics><Pharmacology><Pharmacology and Toxicology><Phase><Phase 1a Clinical Trial><Phase Ia Clinical Trial><Physiologic Availability><Placebo Control><Placebos><Plasma><Plasma Cells><Plasma Serum><Plasmacytes><Preparation><Production><Proteins><Reaction><Research><Residual><Residual state><Reticuloendothelial System, Serum, Plasma><Risk><SBIR><Safety><Sesame><Sesame - dietary><Sham Treatment><Small Business Innovation Research><Small Business Innovation Research Grant><Solid><T-Cell Growth Factor 2><Technology><Teen><Teenagers><Testing><Therapeutic><Time><Tissue Basophils><Toddler><Toxicology><Tree Nut Allergy><Tree Nut Hypersensitivity><Trees><Umbellatine><Work><absorption><adulthood><ages><allergic to nuts><allergy to nuts><anti-IgE><anti-IgEid><commercialization><common treatment><cost><drug development><drug/agent><food allergen><food avoidance><high risk><immune suppression><immune suppressive activity><immune suppressive function><immunoreaction><immunosuppressive activity><immunosuppressive function><immunosuppressive response><innovate><innovation><innovative><intestinal epithelium><kids><lFN-Gamma><manufacture><mast cell><mastocyte><medical college><medical schools><meeting><meetings><microbial><model of animal><mortality><mouse model><murine model><nano><nano medicinal><nano medicine><nano particle><nano-sized particle><nanomedicinal><nanomedicine><nanoparticle><nanosized particle><new drug treatments><new drugs><new pharmacological therapeutic><new therapeutics><new therapy><next generation therapeutics><novel><novel drug treatments><novel drugs><novel pharmaco-therapeutic><novel pharmacological therapeutic><novel therapeutics><novel therapy><omalizumab><oral immunotherapy><parent><phase 1 designs><phase 1 trial><phase 2 designs><phase 2 study><phase I designs><phase I trial><phase II designs><phase II study><placebo controlled><plasmocyte><pre-clinical><pre-clinical safety><preclinical><preclinical safety><preparations><programs><prophylactic><protective effect><school of medicine><sham therapy><small molecule><teen years><teenage><transcriptomics><youngster>