JOP20190255B1 - صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها - Google Patents

صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها

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Publication number
JOP20190255B1
JOP20190255B1 JOJO/P/2019/0255A JOP20190255A JOP20190255B1 JO P20190255 B1 JOP20190255 B1 JO P20190255B1 JO P20190255 A JOP20190255 A JO P20190255A JO P20190255 B1 JOP20190255 B1 JO P20190255B1
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Jordan
Prior art keywords
methods
human rankl
antibody formulations
rankl antibody
identification
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JOJO/P/2019/0255A
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English (en)
Inventor
Stephen Robert Brych
Pavan K Ghattyvenkatakrishna
Jian Hua Gu
Monica Michelle Goss
Jaymille Fallon
Lyanne M Wong
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Amgen Inc
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Application filed by Amgen Inc filed Critical Amgen Inc
Publication of JOP20190255A1 publication Critical patent/JOP20190255A1/ar
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Epidemiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Pregnancy & Childbirth (AREA)
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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

يتعلق الاختراع الحالي بالكشف عن صيغ صيدلية مائية تشتمل على دينوسوماب أو جسم مضاد أحادي النسيلة مضاد لـ RANKL بشري آخر أو جزء منه، ولها خصائص رقم هيدروجيني (pH)، أنظمة محاليل منظِّمة، ومثبطات تراكم أحماض أمينية. ويتعلق الاختراع أيضًا بالكشف عن شكل الصيغة لاستخدامها، على سبيل المثال في قنينة تُستخدم مرةً واحدة، أو محقنة تُستخدم مرةً واحدة، أو حاوية زجاجية، كما يتعلق بطرق لاستخدام الصيغ والمنتجات للوقاية من أو علاج أمراض، وبأطقم ذات صلة. الشكل 1
JOJO/P/2019/0255A 2017-04-28 2018-04-27 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها JOP20190255B1 (ar)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762492056P 2017-04-28 2017-04-28
PCT/US2018/029728 WO2018200918A1 (en) 2017-04-28 2018-04-27 Formulations of human anti-rankl antibodies, and methods of using the same

Publications (2)

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JOP20190255A1 JOP20190255A1 (ar) 2019-10-27
JOP20190255B1 true JOP20190255B1 (ar) 2024-12-22

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JOJO/P/2019/0255A JOP20190255B1 (ar) 2017-04-28 2018-04-27 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها
JOJO/P/2024/0115A JOP20240115B1 (ar) 2017-04-28 2024-05-21 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها

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JOJO/P/2024/0115A JOP20240115B1 (ar) 2017-04-28 2024-05-21 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها

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US (3) US11192952B2 (ar)
EP (3) EP3615066B1 (ar)
JP (4) JP7190822B2 (ar)
KR (2) KR102681171B1 (ar)
CN (2) CN118987200A (ar)
AR (1) AR111497A1 (ar)
AU (2) AU2018260750B2 (ar)
BR (1) BR112019022188A2 (ar)
CA (1) CA3054165A1 (ar)
CL (3) CL2019003032A1 (ar)
CO (1) CO2019011463A2 (ar)
CR (2) CR20250034A (ar)
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EA (1) EA201992570A1 (ar)
ES (2) ES2997833T3 (ar)
FI (2) FI3615066T3 (ar)
HR (2) HRP20240167T1 (ar)
HU (2) HUE065544T2 (ar)
IL (2) IL293127B2 (ar)
JO (2) JOP20190255B1 (ar)
LT (2) LT3615066T (ar)
MA (2) MA48462B1 (ar)
MX (1) MX2023013460A (ar)
MY (1) MY202479A (ar)
PE (2) PE20251534A1 (ar)
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PL (2) PL3615066T3 (ar)
PT (2) PT3615066T (ar)
RS (2) RS65299B1 (ar)
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SM (2) SMT202400491T1 (ar)
TN (2) TN2019000297A1 (ar)
TW (2) TWI903512B (ar)
UY (2) UY40974A (ar)
WO (1) WO2018200918A1 (ar)
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KR102681171B1 (ko) 2024-07-05
PE20200343A1 (es) 2020-02-14
EP3615066B1 (en) 2023-12-27
JP7356525B2 (ja) 2023-10-04
IL293127B2 (en) 2024-06-01
EP4190355B1 (en) 2024-09-25
CR20250034A (es) 2025-03-06
KR20240110083A (ko) 2024-07-12
SG11201909998TA (en) 2019-11-28
CN110621342A (zh) 2019-12-27
PL4190355T3 (pl) 2025-02-10
JP7851438B2 (ja) 2026-04-24
TN2021000055A1 (en) 2022-10-03
JP2018188430A (ja) 2018-11-29
US20250326853A1 (en) 2025-10-23
MX2023013460A (es) 2023-12-15
TWI839331B (zh) 2024-04-21
WO2018200918A1 (en) 2018-11-01
IL268704A (en) 2019-10-31
CL2020002012A1 (es) 2020-10-16
EA201992570A1 (ru) 2020-03-20
US20200354463A1 (en) 2020-11-12
IL293127B1 (en) 2024-02-01
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