DK3615066T3 - Formuleringer af humane anti-rankl-antistoffer og fremgangsmåder til anvendelse deraf - Google Patents

Formuleringer af humane anti-rankl-antistoffer og fremgangsmåder til anvendelse deraf Download PDF

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Publication number
DK3615066T3
DK3615066T3 DK18724690.5T DK18724690T DK3615066T3 DK 3615066 T3 DK3615066 T3 DK 3615066T3 DK 18724690 T DK18724690 T DK 18724690T DK 3615066 T3 DK3615066 T3 DK 3615066T3
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Denmark
Prior art keywords
formulations
methods
human anti
rankl antibodies
rankl
Prior art date
Application number
DK18724690.5T
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English (en)
Inventor
Stephen Robert Brych
Lyanne M Wong
Jaymille Fallon
Monica Michelle Goss
Jian Hua Gu
Pavan K Ghattyvenkatakrishna
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Amgen Inc
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Publication of DK3615066T3 publication Critical patent/DK3615066T3/da

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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Oncology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
DK18724690.5T 2017-04-28 2018-04-27 Formuleringer af humane anti-rankl-antistoffer og fremgangsmåder til anvendelse deraf DK3615066T3 (da)

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 (1)

Publication Number Publication Date
DK3615066T3 true DK3615066T3 (da) 2024-03-11

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ID=62165668

Family Applications (1)

Application Number Title Priority Date Filing Date
DK18724690.5T DK3615066T3 (da) 2017-04-28 2018-04-27 Formuleringer af humane anti-rankl-antistoffer og fremgangsmåder til anvendelse deraf

Country Status (33)

Country Link
US (2) US11192952B2 (da)
EP (2) EP4190355A1 (da)
JP (3) JP7190822B2 (da)
CN (1) CN110621342A (da)
AR (1) AR111497A1 (da)
AU (1) AU2018260750A1 (da)
BR (1) BR112019022188A2 (da)
CA (1) CA3054165A1 (da)
CL (3) CL2019003032A1 (da)
CO (1) CO2019011463A2 (da)
CR (1) CR20190538A (da)
DK (1) DK3615066T3 (da)
EA (1) EA201992570A1 (da)
ES (1) ES2973572T3 (da)
FI (1) FI3615066T3 (da)
HR (1) HRP20240167T1 (da)
HU (1) HUE065544T2 (da)
IL (2) IL293127B2 (da)
JO (1) JOP20190255A1 (da)
LT (1) LT3615066T (da)
MA (1) MA48462B1 (da)
MX (1) MX2023013460A (da)
MY (1) MY202479A (da)
PE (1) PE20200343A1 (da)
PH (1) PH12019502444A1 (da)
PL (1) PL3615066T3 (da)
PT (1) PT3615066T (da)
RS (1) RS65299B1 (da)
SG (1) SG11201909998TA (da)
SI (1) SI3615066T1 (da)
TN (2) TN2019000297A1 (da)
UY (1) UY37707A (da)
WO (1) WO2018200918A1 (da)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3120190A1 (en) * 2018-11-16 2020-05-22 Samsung Bioepis Co., Ltd. Stable liquid composition comprising protein
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
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
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
JP2024518081A (ja) * 2021-05-12 2024-04-24 江▲蘇▼恒瑞医▲薬▼股▲フン▼有限公司 Ranklとngfに特異的に結合する抗原結合分子およびその医薬用途
TW202319398A (zh) 2021-08-12 2023-05-16 美商安進公司 抗體配製物
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
WO2024104409A1 (zh) * 2022-11-16 2024-05-23 苏州盛迪亚生物医药有限公司 一种含抗rankl-ngf双特异性抗体的药物组合物

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ530765A (en) 2001-06-26 2006-11-30 Amgen Fremont Inc Antibodies that bind OPGL and compositions and methods for the treatment of bone diseases
PE20070684A1 (es) 2005-11-14 2007-08-06 Amgen Inc MOLECULAS QUIMERICAS DE ANTICUERPO RANKL-PTH/PTHrP
ES2748526T3 (es) 2006-12-21 2020-03-17 Amgen Inc Formulaciones tamponadas estables que contienen polipéptidos
EP2170268A2 (en) 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
SG10201402265YA (en) * 2008-02-07 2014-08-28 Amgen Inc Stabilized protein compositions
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
WO2011141926A2 (en) 2010-05-10 2011-11-17 Intas Biopharmaceuticals Limited Liquid formulation of polypeptides containing an fc domain of an immunoglobulin
EP2433644A1 (en) 2010-09-22 2012-03-28 IMBA-Institut für Molekulare Biotechnologie GmbH Breast cancer therapeutics
AU2012243126A1 (en) 2011-04-07 2013-10-17 Glaxosmithkline Llc Formulations with reduced viscosity
KR101759694B1 (ko) 2011-10-28 2017-07-19 인테그리티 바이오, 아이엔씨. 아미노산을 함유하는 단백질 제제
TWI679019B (zh) 2013-04-29 2019-12-11 法商賽諾菲公司 抗il-4/抗il-13之雙特異性抗體調配物
CN103965357B (zh) 2013-12-31 2016-08-17 嘉和生物药业有限公司 一种抗人rankl抗体
WO2015134406A1 (en) * 2014-03-03 2015-09-11 La Jolla Biologics, Inc. Stable aqueous recombinant protein formulations
US11173208B2 (en) 2014-05-07 2021-11-16 Takeda Gmbh Liquid formulation comprising GM-CSF neutralizing compound

Also Published As

Publication number Publication date
AR111497A1 (es) 2019-07-17
CR20190538A (es) 2020-02-26
PT3615066T (pt) 2024-03-08
IL293127B1 (en) 2024-02-01
ES2973572T3 (es) 2024-06-20
JP2023166396A (ja) 2023-11-21
MY202479A (en) 2024-04-30
UY37707A (es) 2018-10-31
CA3054165A1 (en) 2018-11-01
PL3615066T3 (pl) 2024-04-29
US11192952B2 (en) 2021-12-07
HRP20240167T1 (hr) 2024-04-26
SG11201909998TA (en) 2019-11-28
CL2023002505A1 (es) 2024-03-08
JP2022062059A (ja) 2022-04-19
TN2021000055A1 (en) 2022-10-03
IL293127B2 (en) 2024-06-01
TW201841654A (zh) 2018-12-01
CL2019003032A1 (es) 2020-02-21
JP7356525B2 (ja) 2023-10-04
IL293127A (en) 2022-07-01
TN2019000297A1 (en) 2021-05-07
IL268704A (en) 2019-10-31
AU2018260750A1 (en) 2019-08-29
EA201992570A1 (ru) 2020-03-20
US11873343B2 (en) 2024-01-16
LT3615066T (lt) 2024-02-26
RS65299B1 (sr) 2024-04-30
US20200354463A1 (en) 2020-11-12
IL268704B (en) 2022-06-01
PH12019502444A1 (en) 2020-07-20
JOP20190255A1 (ar) 2019-10-27
MA48462A (fr) 2020-03-04
KR20190140464A (ko) 2019-12-19
WO2018200918A8 (en) 2019-10-17
US20220143181A1 (en) 2022-05-12
MX2023013460A (es) 2023-12-15
PE20200343A1 (es) 2020-02-14
HUE065544T2 (hu) 2024-05-28
WO2018200918A1 (en) 2018-11-01
CN110621342A (zh) 2019-12-27
BR112019022188A2 (pt) 2020-05-12
MA48462B1 (fr) 2024-05-31
JP2018188430A (ja) 2018-11-29
EP3615066A1 (en) 2020-03-04
EP3615066B1 (en) 2023-12-27
CO2019011463A2 (es) 2019-10-31
EP4190355A1 (en) 2023-06-07
JP7190822B2 (ja) 2022-12-16
CL2020002012A1 (es) 2020-10-16
FI3615066T3 (fi) 2024-02-29
SI3615066T1 (sl) 2024-04-30

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