HRP20231076T1 - Postupci detektiranja neutralizirajućih protutijela protiv leptina - Google Patents

Postupci detektiranja neutralizirajućih protutijela protiv leptina Download PDF

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Publication number
HRP20231076T1
HRP20231076T1 HRP20231076TT HRP20231076T HRP20231076T1 HR P20231076 T1 HRP20231076 T1 HR P20231076T1 HR P20231076T T HRP20231076T T HR P20231076TT HR P20231076 T HRP20231076 T HR P20231076T HR P20231076 T1 HRP20231076 T1 HR P20231076T1
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leptin
labeled
signal
sample
coated matrix
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HRP20231076TT
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Jeffrey SAILSTAD
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Amryt Pharmaceuticals Inc.
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854Immunoglobulins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (12)

1. Postupak detektiranja neutralizirajućih protutijela protiv leptina u uzorku, naznačen time što se sastoji u koracima: (a) inaktiviranja leptina prisutnog u uzorku; (b) dodavanja poznate količine obilježenog leptina u uzorak; (c) stavljanja u kontakt uzorka koji sadrži obilježeni leptin iz (b) sa supstratom koji se može vezati na obilježeni leptin, gdje navedeni supstrat koji se može vezati na obilježeni leptin sadrži obloženu matricu i obilježeni leptinski receptor vezan na obloženu matricu; (d) ispiranja supstrata kako bi se uklonilo nevezani obilježeni leptin; i (e) mjerenja signala iz biljega kojeg proizvodi obilježeni leptin vezan na supstrat.
2. Postupak identificiranja subjekata koji imaju neutralizirajuća protutijela protiv leptina u krvi, serumu ili plazmi iz subjekta, naznačen time što se sastoji u koracima: (a) inaktiviranja leptina i leptina prisutnog u uzorku subjektove krvi, seruma ili plazme; (b) dodavanja poznate količine obilježenog leptina u uzorak; (c) stavljanja u kontakt uzorka koji sadrži obilježeni leptin iz (b) sa supstratom koji se može vezati na obilježeni leptin, gdje navedeni supstrat koji se može vezati na obilježeni leptin sadrži obloženu matricu i obilježeni leptinski receptor vezan na obloženu matricu; (d) ispiranja supstrata kako bi se uklonilo nevezani obilježeni leptin; (e) mjerenja signala iz biljega kojeg proizvodi vezani obilježeni leptin; (f) mjerenja pozitivnog kontrolnog signala, gdje se navedeni pozitivni kontrolni signal proizvodi provođenjem koraka (a)-(e), te dodatno uključuje dodavanje poznate količine protutijela protiv leptina u koraku (b); i (g) uspoređivanja signala iz (e) sa signalom iz (f), gdje ako je razina signala izmjerenog u koraku (e) jednaka ili niža od razine signala izmjerenog u koraku (f), subjekt daje pozitivan test na neutralizirajuća protutijela protiv leptina.
3. Postupak identificiranja subjekata koji imaju neutralizirajuća protutijela protiv leptina u krvi, serumu ili plazmi iz subjekta, naznačen time što se sastoji u koracima: (a) inaktiviranja leptina prisutnog u uzorku krvi, seruma ili plazme; (b) dodavanja poznate količine obilježenog leptina u uzorak; (c) stavljanja u kontakt uzorka koji sadrži obilježeni leptin iz (b) sa supstratom koji se može vezati na obilježeni leptin, gdje navedeni supstrat koji se može vezati na obilježeni leptin sadrži obloženu matricu i obilježeni leptinski receptor vezan na obloženu matricu; (d) ispiranja supstrata kako bi se uklonilo nevezani obilježeni leptin; (e) mjerenja signala iz biljega kojeg proizvodi vezani obilježeni leptin; (f) mjerenja negativnog kontrolnog signala, gdje se navedeni negativni kontrolni signal proizvodi provođenjem koraka (a)-(e), gdje uzorak krvi, seruma ili plazme ne sadrži neutralizirajuća protutijela protiv leptina; i (g) uspoređivanja postotne razlike u signalu iz (e) i signalu iz (f) s rubnom točkom, gdje ako je postotna razlika u signalu iz (e) i signalu iz (f) veća od rubne točke, subjekt daje pozitivan test na neutralizirajuća protutijela protiv leptina.
4. Postupak u skladu s patentnim zahtjevom 3, naznačen time što je rubna točka između otprilike 5% i otprilike 40%.
5. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je leptin obilježen peroksidazom iz hrena ili tris(bipiridin)rutenijem.
6. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se korak inaktiviranja (a) provodi grijanjem uzorka.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što je obložena matrica matrica obložena streptavidinom.
8. Postupak u skladu s patentnim zahtjevom 7, naznačen time što je leptinski receptor obilježen biotinom.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što navedeni supstrat koji se može vezati na obilježeni leptin sadrži: (i) obloženu matricu; (ii) protutijelo vezano na matricu iz (i); i (iii) obilježeni leptinski receptor, vezan na protutijelo iz (ii).
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time što je leptinski receptor obilježen heksahistidinskim biljegom, a protutijelo je protutijelo protiv heksahistidina.
11. Postupak u skladu s bilo kojim od patentnih zahtjeva 9 i 10, naznačen time što je protutijelo obilježeno biljegom pogodnim za vezanje na obloženu matricu.
12. Postupak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je obilježeni leptin dodan u koraku (b) obilježeni metreleptin.
HRP20231076TT 2016-09-12 2017-09-12 Postupci detektiranja neutralizirajućih protutijela protiv leptina HRP20231076T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662393632P 2016-09-12 2016-09-12
PCT/US2017/051232 WO2018049424A1 (en) 2016-09-12 2017-09-12 Methods of detecting anti-leptin neutralizing antibodies
EP17849795.4A EP3509624B1 (en) 2016-09-12 2017-09-12 Methods of detecting anti-leptin neutralizing antibodies

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CA (1) CA3036551A1 (hr)
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HU (1) HUE063647T2 (hr)
MX (1) MX2019002818A (hr)
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RS64850B1 (sr) 2023-12-29
EP3509624A1 (en) 2019-07-17
BR112019004715A2 (pt) 2019-07-16
HUE063647T2 (hu) 2024-01-28
PL3509624T3 (pl) 2024-03-25
EP4283304A3 (en) 2024-02-28
JP2019529904A (ja) 2019-10-17
EP3509624B1 (en) 2023-08-09
ES2959990T3 (es) 2024-02-29
EP4283304A2 (en) 2023-11-29
PT3509624T (pt) 2023-08-28
EA201990720A1 (ru) 2019-08-30
JP2022176209A (ja) 2022-11-25
FI3509624T3 (fi) 2023-10-18
WO2018049424A1 (en) 2018-03-15
CN110139663B (zh) 2024-05-07
US20200378988A1 (en) 2020-12-03
CN110139663A (zh) 2019-08-16
MX2019002818A (es) 2019-08-29
JP7139317B2 (ja) 2022-09-20
US10775386B2 (en) 2020-09-15
US20180074073A1 (en) 2018-03-15
US11709166B2 (en) 2023-07-25
DK3509624T3 (da) 2023-11-13
EP3509624A4 (en) 2020-02-19
SI3509624T1 (sl) 2023-12-29
CA3036551A1 (en) 2018-03-15
US20230314447A1 (en) 2023-10-05

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