CO2019011463A2 - Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas - Google Patents

Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas

Info

Publication number
CO2019011463A2
CO2019011463A2 CO2019011463A CO2019011463A CO2019011463A2 CO 2019011463 A2 CO2019011463 A2 CO 2019011463A2 CO 2019011463 A CO2019011463 A CO 2019011463A CO 2019011463 A CO2019011463 A CO 2019011463A CO 2019011463 A2 CO2019011463 A2 CO 2019011463A2
Authority
CO
Colombia
Prior art keywords
methods
rankl antibody
human anti
antibody formulations
formulations
Prior art date
Application number
CO2019011463A
Other languages
English (en)
Inventor
Stephen Robert Brych
Lyanne M Wong
Jaymille Fallon
Monica Michelle Goss
Jian Hua Gu
Pavan K Ghattyvenkatakrishna
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 CO2019011463A2 publication Critical patent/CO2019011463A2/es

Links

Classifications

    • 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
    • A61K47/16—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
    • 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875—Immunoglobulins [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
    • 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
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/70—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

Landscapes

  • 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)

Abstract

En la presente se describen formulaciones farmacéuticas acuosas que comprenden denosumab u otro anticuerpo monoclonal anti-RANKL humano o parte de este, y características de pH, sistemas tampón e inhibidores de agregación de aminoácidos. También se describe una presentación de la formulación para su uso, por ejemplo, en un vial de único uso, una jeringa de único uso, o un recipiente de vidrio, métodos de uso de las formulaciones y artículos para prevenir o tratar enfermedades, y kits relacionados.
CO2019011463A 2017-04-28 2019-10-16 Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas CO2019011463A2 (es)

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
CO2019011463A2 true CO2019011463A2 (es) 2019-10-31

Family

ID=62165668

Family Applications (1)

Application Number Title Priority Date Filing Date
CO2019011463A CO2019011463A2 (es) 2017-04-28 2019-10-16 Formulaciones de anticuerpos humanos anti-rankl y métodos de uso de estas

Country Status (32)

Country Link
US (2) US11192952B2 (es)
EP (2) EP3615066B1 (es)
JP (3) JP7190822B2 (es)
KR (1) KR20190140464A (es)
CN (1) CN110621342A (es)
AR (1) AR111497A1 (es)
AU (1) AU2018260750A1 (es)
BR (1) BR112019022188A2 (es)
CA (1) CA3054165A1 (es)
CL (3) CL2019003032A1 (es)
CO (1) CO2019011463A2 (es)
CR (1) CR20190538A (es)
DK (1) DK3615066T3 (es)
EA (1) EA201992570A1 (es)
FI (1) FI3615066T3 (es)
HR (1) HRP20240167T1 (es)
HU (1) HUE065544T2 (es)
IL (2) IL293127B2 (es)
JO (1) JOP20190255A1 (es)
LT (1) LT3615066T (es)
MA (1) MA48462A (es)
MY (1) MY202479A (es)
PE (1) PE20200343A1 (es)
PH (1) PH12019502444A1 (es)
PL (1) PL3615066T3 (es)
PT (1) PT3615066T (es)
RS (1) RS65299B1 (es)
SG (1) SG11201909998TA (es)
SI (1) SI3615066T1 (es)
TN (2) TN2021000055A1 (es)
UY (1) UY37707A (es)
WO (1) WO2018200918A1 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3881865A4 (en) * 2018-11-16 2022-07-20 Samsung Bioepis Co., Ltd. STABLE LIQUID COMPOSITION WITH 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
US11634485B2 (en) 2019-02-18 2023-04-25 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
KR20240006586A (ko) * 2021-05-12 2024-01-15 지앙수 헨그루이 파마슈티컬스 컴퍼니 리미티드 Rankl 및 ngf에 특이적으로 결합하는 항원 결합 분자, 및 이의 의학적 용도
KR20240046881A (ko) 2021-08-12 2024-04-11 암젠 인크 항체 제형
WO2023092177A1 (en) * 2021-11-23 2023-06-01 Adalta Limited Rank-l binding molecules
CN118139882A (zh) * 2022-03-24 2024-06-04 安济盛生物医药有限公司 骨骼肌肉***疾病的治疗
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

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DK2270052T3 (en) 2001-06-26 2018-07-02 Amgen Inc Antibodies to OPGL
AR056806A1 (es) 2005-11-14 2007-10-24 Amgen Inc Moleculas quimericas de anticuerpo rankl- pth/ pthrp
CA2790018C (en) * 2006-12-21 2015-02-03 Amgen Inc. Formulations
WO2009002521A2 (en) 2007-06-25 2008-12-31 Amgen Inc. Compositions of specific binding agents to hepatocyte growth factor
SG10201402265YA (en) * 2008-02-07 2014-08-28 Amgen Inc Stabilized protein compositions
CL2009001735A1 (es) 2008-08-19 2010-02-19 Regeneron Pharma Anticuerpo humano o fragmento de union a antigeno del mismo que une e inhibe actividad de ligando del activador del receptor de nf-kb (rankl); adn codificante; vector de expresion; metodo para producir dicho anticuerpo; composicion farmaceutica que lo comprende; uso para atenuar o inhibir enfermedad o condicion mediada por rankl
US9265834B2 (en) 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
RU2600847C2 (ru) 2010-05-10 2016-10-27 Интас Биофармасьютикалс Лимитед Жидкий состав полипептидов, содержащих fc-домен иммуноглобулина
EP2433644A1 (en) 2010-09-22 2012-03-28 IMBA-Institut für Molekulare Biotechnologie GmbH Breast cancer therapeutics
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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
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Publication number Publication date
CL2019003032A1 (es) 2020-02-21
PE20200343A1 (es) 2020-02-14
IL293127B1 (en) 2024-02-01
TN2021000055A1 (en) 2022-10-03
CN110621342A (zh) 2019-12-27
US20220143181A1 (en) 2022-05-12
MY202479A (en) 2024-04-30
JP7356525B2 (ja) 2023-10-04
AU2018260750A1 (en) 2019-08-29
CA3054165A1 (en) 2018-11-01
WO2018200918A1 (en) 2018-11-01
PL3615066T3 (pl) 2024-04-29
JP2022062059A (ja) 2022-04-19
US20200354463A1 (en) 2020-11-12
UY37707A (es) 2018-10-31
HUE065544T2 (hu) 2024-05-28
DK3615066T3 (da) 2024-03-11
US11192952B2 (en) 2021-12-07
MA48462A (fr) 2020-03-04
JP2018188430A (ja) 2018-11-29
WO2018200918A8 (en) 2019-10-17
EA201992570A1 (ru) 2020-03-20
TN2019000297A1 (en) 2021-05-07
CL2023002505A1 (es) 2024-03-08
IL268704B (en) 2022-06-01
JP7190822B2 (ja) 2022-12-16
EP4190355A1 (en) 2023-06-07
AR111497A1 (es) 2019-07-17
IL293127B2 (en) 2024-06-01
BR112019022188A2 (pt) 2020-05-12
US11873343B2 (en) 2024-01-16
EP3615066A1 (en) 2020-03-04
LT3615066T (lt) 2024-02-26
PH12019502444A1 (en) 2020-07-20
HRP20240167T1 (hr) 2024-04-26
JOP20190255A1 (ar) 2019-10-27
KR20190140464A (ko) 2019-12-19
EP3615066B1 (en) 2023-12-27
TW201841654A (zh) 2018-12-01
IL268704A (en) 2019-10-31
PT3615066T (pt) 2024-03-08
CR20190538A (es) 2020-02-26
CL2020002012A1 (es) 2020-10-16
JP2023166396A (ja) 2023-11-21
RS65299B1 (sr) 2024-04-30
FI3615066T3 (fi) 2024-02-29
SG11201909998TA (en) 2019-11-28
SI3615066T1 (sl) 2024-04-30
IL293127A (en) 2022-07-01

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