GENERAL NUTRACEUTICAL TECHNOLOGY, LLC

http://www.gnt-us.com

914-434-8140

contact@gnt-us.com

LUN XUE

Asian Pacific American, Other Minority Owned, Women-Owned Small Business, Woman Owned

P2785388

TWSCJ6T3LNW7

86M80

2025-07-17

http://www.gnt-us.com

2024-07-19

2018-08-31

471831237

2020

2

9144348140

View File

2023-07-12

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Department of Health and Human Services

IGE-SUPPRESSING SMALL MOLECULE COMPOUND XANTHOPURPURIN ANALOG FOR MULTIPLE FOOD ALLERGIES - FOOD ALLERGY (FA), A POTENTIALLY LIFE-THREATENING CONDITION, HAS RAPIDLY INCREASED FOR 2 DECADES, AFFECTING 32 MILLION AMERICANS WITH ANNUAL COSTS OF $25 BILLION. TREATMENT OPTIONS ARE EXTREMELY LIMITED. FOOD AVOIDANCE AND RESCUE MEDICATION AFTER ACCIDENTAL EXPOSURE ARE PRIMARY TO FA MANAGEMENT. PEANUT ALLERGY (PNA) CAUSES SEVERE REACTIONS, OFTEN CO-EXISTING WITH TREE NUT ALLERGIES (TNA). SHELLFISH ALLERGY (SHA) IS THE MAIN CAUSE OF ADULT ANAPHYLAXIS. MULTIPLE FOOD ALLERGIES AND CROSS-REACTIVITY AMONG GROUPS OF FOODS SUCH AS TREE NUTS AND SHELLFISH FURTHER COMPLICATE FOOD AVOIDANCE. FA IS PRIMARILY MEDIATED BY ABNORMALLY ELEVATED FOOD PROTEIN- SPECIFIC IMMUNOGLOBULIN E (SIGE). THE INABILITY TO CURB PERSISTENT FOOD SIGE IS A SIGNIFICANT BARRIER TO FA THERAPEUTICS. THUS, A NON-FOOD RESTRICTED TREATMENT WORKING FOR “ALL” FA INCLUDING MULTIPLE AND SEVERE FAS, WITH THE ABILITY TO REVERSE ELEVATED SIGE, WILL NARROW TREATMENT GAPS AND HAVE SIGNIFICANT MARKET VALUE. GENERAL NUTRACEUTICAL TECHNOLOGY LLC (GNT), A NY-BASED BIOTECHNOLOGY STARTUP, IS BUILDING ON GROUNDBREAKING FA RESEARCH STARTED AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI. WE FOR THE FIRST TIME ISOLATED AND IDENTIFIED IGE INHIBITORY COMPOUND XANTHOPURPURIN (XPP, A SMALL MOLECULE ANTHRAQUINONE) FROM RUBIA CORDIFOLIA. OUR PRELIMINARY DATA SHOW THAT XPP EXHIBITS FAVORABLE BIOAVAILABILITY AND IS STABLE WITH A HIGH PRECLINICAL SAFETY PROFILE (NO AES AT 10X DAILY DOSE). STRIKINGLY, A 4-WEEK ONCE-A-DAY ORAL LOW DOSE OF XPP (0.4MG /MOUSE, EQUIVALENT TO A HUMAN ADULT DOSE OF 0.1G/DAY BASED ON BODY SURFACE AREA44) INDUCED 100% SUPPRESSION OF ANAPHYLAXIS, 80-100% OF REDUCTION OF SERUM PEANUT (PN)-SIGE AND PLASMA HISTAMINE LEVELS IN A MURINE MODEL OF PNA, WITH NO OVERALL IMMUNE SUPPRESSION OF IGG OR IGA. THE PRELIMINARY MECHANISMS OF ACTION (MOA) INCLUDE XPP SUPPRESSING IGE+ B CELLS, REDUCING IL-4 BY INCREASED DNA METHYLATION AT IL-4 PROMOTER, WITHOUT AFFECTING IL-10 OR IFN-, AND INDUCING A DISTINCT B CELL TRANSCRIPTOMIC PROFILE. TO ENSURE MEDICINAL SOURCING SUSTAINABILITY AND ENVIRONMENTAL CONSERVATION, WE ADVANCED XPP PRODUCTION BY GENERATING SYNTHETIC XPP (SXPP) AND ITS ANALOGS. WE FOUND THAT ONE OF THE ANALOGS (NAMED XPP1A) IS A SUPERIOR IGE INHIBITOR AND SHOWED EXCELLENT IN VITRO SAFETY. THEREFORE, DEVELOPING AN XPP1A PRODUCT FOR FA WILL BE THE FOCUS OF THIS STTR PHASE I GRANT APPLICATION. WE HYPOTHESIZE XPPIA WILL BE EFFECTIVE FOR PNA AND FOR OTHER FAS SUCH AS TNA AND SHA, AND FOR SEVERE FAS. THUS, THE GOAL OF THIS 1-YEAR PHASE I STTR APPLICATION IS TO GENERATE THE FEASIBILITY OF XPP1A EFFICACY, SAFETY, AND PK PROFILE AND EXPLORE/VALIDATE THE MOA IN CONVENTIONAL AND HUMANIZED FA MODELS. WE WILL PURSUE 2 SPECIFIC AIMS: AIM # 1: DETERMINE XPP1A PROTECTION AGAINST IGE- MEDIATED ANAPHYLAXIS IN CONVENTIONAL AND HUMANIZED MURINE MODELS OF FA; AIM #2. DETERMINE XPPIA SAFETY AND PK PROFILES. COMPLETION OF THIS PROJECT WILL LEAD TO THE NEXT PHASE STUDY (PHASE II STTR) FOR IND FILING TOWARDS COMMERCIALIZATION OF XPP1A TO TREAT MULTIPLE AND SEVERE FA.

289622.00

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0.00

2023-05-11

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Department of Health and Human Services

IGE SUPPRESSING BERBERINE NANOMEDICINE FOR TREATMENT OF FOOD ALLERGIES - 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-, 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.

1814418.00

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2023-04-03

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Department of Health and Human Services

IGE SUPPRESSING BERBERINE NANOMEDICINE FOR TREATMENT OF PEANUT AND TREE NUT ALLERGIES - ABSTRACT (30 LINES) FOOD ALLERGY (FA) IS A SUBSTANTIAL US PUBLIC HEALTH PROBLEM, AFFECTING OVER 30 MILLION PEOPLE, 1-3 CAUSING 81% OF PEDIATRIC ANAPHYLAXIS. 4 OUTSIDE OF RESCUE MEDICATION AND AVOIDANCE, CURRENT FA TREATMENT IS LIMITED WITH NO LONG-LASTING THERAPEUTICS. NORMALLY, IGE PRODUCING B CELLS AND PLASMA CELLS ARE MINOR POPULATION WITH MINIMAL IGE PRODUCTION. DYSREGULATION OF THESE CELLS CAUSES EXCESSIVE IGE PRODUCTION, A KEY PATHOLOGICAL MECHANISM OF FA ANAPHYLACTIC SHOCK. FA IS HIGHLY DIVERSE. PEANUT AND TREE NUT ALLERGIES (PNA AND TNA) ARE MOST SEVERE, RARELY OUTGROWN, AND OFTEN CO-EXIST.5,6 CROSS REACTIVITY AMONG TREE NUT (TN) FURTHER INCREASE THE RISK OF REACTIONS COMPLICATE CURRENT PRACTICE. DESPITE DECADES OF AWARENESS ABOUT THE CENTRALITY OF ALLERGEN-SPECIFIC IGE IN FOOD ANAPHYLAXIS7, INHIBITING IGE PRODUCTION BY B CELLS/PLASMA REMAINS A MAJOR CHALLENGE. OMALIZUMAB, THE ANTI- IGE ANTIBODY, “TRAPS” IGE BUT DOES NOT TARGET PRODUCTION. ORAL IMMUNOTHERAPY (OIT), INCLUDING PALFORZIA® FOR PEANUT (PN) OIT, MAY PARADOXICALLY INCREASE IGE.8-13 THEREFORE, NOVEL THERAPEUTICS SHOULD ADDRESS BROAD FA AND BE ORALLY ADMINISTERED WITH SUSTAINABLE SUPPRESSION OF FOOD SPECIFIC IGE AND ANAPHYLAXIS AFTER STOPPING TREATMENT. WE, FOR THE FIRST TIME, DEMONSTRATED THAT A SMALL MOLECULE COMPOUND BERBERINE (BBR), ISOLATED FROM PHILODENDRON CORTEX, INHIBITED IGE PRODUCTION BY PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) FROM FA PATIENTS AT VERY LOW DOSES.14 REAL CLINICAL BARRIER TO USE OF BBR USE IS POOR ORAL BIOAVAILABILITY.15-17 WE FURTHER DEVELOPED AN INNOVATIVE NANOPARTICLE-BASED FORMULATION, NAMED NIT-X. PRELIMINARY DATA SHOWED ORAL NIT-X IS SIGNIFICANTLY MORE BIOAVAILABLE THAN PARENT COMPOUND WITH AN EXCELLENT PRECLINICAL SAFETY PROFILE (NO ADVERSE EFFECTS FOUND AFTER FEEDING 14X EFFECTIVE DAILY DOSE), AND THAT IN PN-SENSITIZED MICE 4-WEEKS OF ONCE-A-DAY ORAL NIT-X AT 2MG BBR WITHIN THE NANO PARTICLE (EQUIVALENT TO A HUMAN DOSE OF 0.3G/DAY, BASED ON BODY SURFACE AREA18) REDUCED 95-100% PN-SPECIFIC IGE AND 100% PN ANAPHYLAXIS WITH EFFECTS LASTING AT LEAST 28 WEEKS POST TREATMENT, WITHOUT AFFECTING IGG AND IGA LEVELS. IGE+ B CELLS AND IGE+ PLASMA CELLS WERE REDUCED NEARLY TO NORMAL. AN ONGOING EXPERIMENT SHOWED NIT-X ALSO WORKED IN CASHEW (CSH) AND WALNUT (WN) ALLERGY IN ADDITION TO PN ALLERGY IN MURINE MODEL. WE THEREFORE HYPOTHESIZE THAT NIT-X, AS NON-FOOD RESTRICTED THERAPEUTIC INTERVENTION, WILL BE EFFECTIVE, THEORETICALLY, FOR ALL FA BY RESTORING NORMAL IGE REGULATION. THE GOAL OF THIS 2-YEAR R21 GRANT IS TO EXPLORE NIT-X AS A NOVEL THERAPEUTIC TO RESOLVE MULTIPLE FA FOCUSING ON AND NEARLY ALL TN ALLERGY AND EXPLORE ITS MECHANISMS POSSIBLY NORMALIZE IGE REGULATION. AIM # 1: DETERMINE LONG- TERM PROTECTION AGAINST IGE-MEDIATED ANAPHYLAXIS IN PN AND MULTI-TN ALLERGIES BY NIT-X, AND AIM #2: IDENTIFY THE MECHANISMS CONTRIBUTING TO SUSTAINED SUPPRESSION OF IGE PRODUCTION BY NIT-X. SUCCESSFUL COMPLETION OF THIS PROPOSAL WOULD PROVIDE A STRONG RATIONALE TO FURTHER INVESTIGATE NIT-X AS A SAFE AND EFFECTIVE TREATMENT EVEN FOR THOSE WITH MULTI-FOOD ALLERGIES OR HIGH REACTION RISK. NON-FOOD-RESTRICTED NIT-X THERAPY MAY CHANGE THE COURSE OF FA BY RESTORATION OF IGE REGULATION, AND ADVANCE CLINICAL PRACTICE.

490531.00

0.00

0.00

2021-02-26

View on USAspending

Small Business Administration

TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.

0.00

44687.00

44687.00

2020-06-18

View on USAspending

Small Business Administration

TO AID SMALL BUSINESSES IN MAINTAINING WORK FORCE DURING COVID-19 PANDEMIC.

0.00

41665.00

41665.00

2021-02-26

Paid in Full

100

44687

44687

Asian

Not Hispanic or Latino

Female Owned

Non-Veteran

45139.53

2020-06-17

Paid in Full

100

41665

41665

Asian

Not Hispanic or Latino

Female Owned

Non-Veteran

42035.89