JOP20190255A1 - صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها - Google Patents

صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها

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Publication number
JOP20190255A1
JOP20190255A1 JOP/2019/0255A JOP20190255A JOP20190255A1 JO P20190255 A1 JOP20190255 A1 JO P20190255A1 JO P20190255 A JOP20190255 A JO P20190255A JO P20190255 A1 JOP20190255 A1 JO P20190255A1
Authority
JO
Jordan
Prior art keywords
formulations
methods
human anti
same
rankl antibodies
Prior art date
Application number
JOP/2019/0255A
Other languages
English (en)
Inventor
Pavan K Ghattyvenkatakrishna
Jian Hua Gu
Lyanne M Wong
Monica Michelle Goss
Jaymille Fallon
Stephen Robert Brych
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of JOP20190255A1 publication Critical patent/JOP20190255A1/ar

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875Immunoglobulins [IGs], 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/12Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • 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
JOP/2019/0255A 2017-04-28 2017-06-16 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها JOP20190255A1 (ar)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201762492056P 2017-04-28 2017-04-28

Publications (1)

Publication Number Publication Date
JOP20190255A1 true JOP20190255A1 (ar) 2019-10-27

Family

ID=62165668

Family Applications (1)

Application Number Title Priority Date Filing Date
JOP/2019/0255A JOP20190255A1 (ar) 2017-04-28 2017-06-16 صيغ أجسام مضادة لـ rankl بشري، وطرق لاستخدامها

Country Status (31)

Country Link
US (2) US11192952B2 (ar)
EP (2) EP4190355A1 (ar)
JP (3) JP7190822B2 (ar)
KR (1) KR20190140464A (ar)
CN (1) CN110621342A (ar)
AR (1) AR111497A1 (ar)
AU (1) AU2018260750A1 (ar)
BR (1) BR112019022188A2 (ar)
CA (1) CA3054165A1 (ar)
CL (3) CL2019003032A1 (ar)
CO (1) CO2019011463A2 (ar)
CR (1) CR20190538A (ar)
DK (1) DK3615066T3 (ar)
EA (1) EA201992570A1 (ar)
FI (1) FI3615066T3 (ar)
HR (1) HRP20240167T1 (ar)
IL (2) IL293127B1 (ar)
JO (1) JOP20190255A1 (ar)
LT (1) LT3615066T (ar)
MA (1) MA48462A (ar)
MY (1) MY202479A (ar)
PE (1) PE20200343A1 (ar)
PH (1) PH12019502444A1 (ar)
PL (1) PL3615066T3 (ar)
PT (1) PT3615066T (ar)
RS (1) RS65299B1 (ar)
SG (1) SG11201909998TA (ar)
SI (1) SI3615066T1 (ar)
TN (2) TN2021000055A1 (ar)
UY (1) UY37707A (ar)
WO (1) WO2018200918A1 (ar)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113365658A (zh) * 2018-11-16 2021-09-07 三星Bioepis股份有限公司 包含蛋白质的稳定的液体组合物
CN109374779A (zh) * 2018-12-17 2019-02-22 杭州奕安济世生物药业有限公司 一种蔗糖含量的快速检测方法
CA3129901A1 (en) 2019-02-18 2020-08-27 Eli Lilly And Company Therapeutic antibody formulation
CN111704670B (zh) * 2020-08-18 2020-11-03 迈威(上海)生物科技股份有限公司 重组抗RANKL抗体IgG2型的二硫键异构体及其纯化方法
EP4339207A1 (en) * 2021-05-12 2024-03-20 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Antigen binding molecule specifically binding to rankl and ngf, and medical use thereof
AU2022325870A1 (en) 2021-08-12 2024-02-08 Amgen Inc. Antibody formulations
WO2023092177A1 (en) * 2021-11-23 2023-06-01 Adalta Limited Rank-l binding molecules
WO2023179791A1 (en) * 2022-03-24 2023-09-28 Angitia Biomedicines Limited Treatment of musculoskeletal disorders
WO2024064878A1 (en) 2022-09-23 2024-03-28 The University Of North Carolina At Chapel Hill Methods and compositions for the treatment of melanoma

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JP4212470B2 (ja) 2001-06-26 2009-01-21 アムジェン フレモント インク. Opglへの抗体
PE20070684A1 (es) 2005-11-14 2007-08-06 Amgen Inc MOLECULAS QUIMERICAS DE ANTICUERPO RANKL-PTH/PTHrP
MX2009006594A (es) * 2006-12-21 2009-08-12 Amgen Inc Formulaciones de ph regulado y estables que contienen polipeptidos.
US7951368B2 (en) * 2007-06-25 2011-05-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
BRPI0908361A2 (pt) 2008-02-07 2015-04-07 Amgen Inc Seringas previamente cheias contendo composição e métodos de preparação das mesmas e de estabilização de agente de ligação específico em composição.
AR073072A1 (es) 2008-08-19 2010-10-13 Regeneron Pharma Anticuerpos humanos para el ligando del activador del receptor de nf-kb (rankl) humano
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
CN102946858B (zh) 2010-05-10 2015-09-30 英塔斯制药有限公司 含有免疫球蛋白Fc的多肽的液体制剂
EP2433644A1 (en) 2010-09-22 2012-03-28 IMBA-Institut für Molekulare Biotechnologie GmbH Breast cancer therapeutics
JP2014510152A (ja) * 2011-04-07 2014-04-24 グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー 粘度が低減された処方物
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EP3139960B1 (en) 2014-05-07 2024-01-17 Takeda Pharmaceutical Company Limited Liquid formulation comprising gm-csf neutralizing compound

Also Published As

Publication number Publication date
JP7190822B2 (ja) 2022-12-16
PH12019502444A1 (en) 2020-07-20
LT3615066T (lt) 2024-02-26
KR20190140464A (ko) 2019-12-19
CL2023002505A1 (es) 2024-03-08
IL268704B (en) 2022-06-01
TN2019000297A1 (en) 2021-05-07
CL2019003032A1 (es) 2020-02-21
PL3615066T3 (pl) 2024-04-29
WO2018200918A8 (en) 2019-10-17
UY37707A (es) 2018-10-31
EP4190355A1 (en) 2023-06-07
EP3615066B1 (en) 2023-12-27
RS65299B1 (sr) 2024-04-30
TN2021000055A1 (en) 2022-10-03
IL293127A (en) 2022-07-01
AR111497A1 (es) 2019-07-17
JP2018188430A (ja) 2018-11-29
EP3615066A1 (en) 2020-03-04
CL2020002012A1 (es) 2020-10-16
SI3615066T1 (sl) 2024-04-30
BR112019022188A2 (pt) 2020-05-12
AU2018260750A1 (en) 2019-08-29
CO2019011463A2 (es) 2019-10-31
IL268704A (en) 2019-10-31
JP2023166396A (ja) 2023-11-21
US11192952B2 (en) 2021-12-07
US20200354463A1 (en) 2020-11-12
PT3615066T (pt) 2024-03-08
CR20190538A (es) 2020-02-26
HRP20240167T1 (hr) 2024-04-26
PE20200343A1 (es) 2020-02-14
MY202479A (en) 2024-04-30
CA3054165A1 (en) 2018-11-01
MA48462A (fr) 2020-03-04
WO2018200918A1 (en) 2018-11-01
JP7356525B2 (ja) 2023-10-04
US11873343B2 (en) 2024-01-16
DK3615066T3 (da) 2024-03-11
SG11201909998TA (en) 2019-11-28
FI3615066T3 (fi) 2024-02-29
JP2022062059A (ja) 2022-04-19
TW201841654A (zh) 2018-12-01
EA201992570A1 (ru) 2020-03-20
IL293127B1 (en) 2024-02-01
CN110621342A (zh) 2019-12-27
US20220143181A1 (en) 2022-05-12

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