PL4190355T3 - Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania - Google Patents

Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania

Info

Publication number
PL4190355T3
PL4190355T3 PL22206709.2T PL22206709T PL4190355T3 PL 4190355 T3 PL4190355 T3 PL 4190355T3 PL 22206709 T PL22206709 T PL 22206709T PL 4190355 T3 PL4190355 T3 PL 4190355T3
Authority
PL
Poland
Prior art keywords
methods
human anti
antibody formulations
rankl antibody
rankl
Prior art date
Application number
PL22206709.2T
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=62165668&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL4190355(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc. filed Critical Amgen Inc.
Publication of PL4190355T3 publication Critical patent/PL4190355T3/pl

Links

Classifications

    • 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
    • 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
    • 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

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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (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)
  • 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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Pulmonology (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
PL22206709.2T 2017-04-28 2018-04-27 Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania PL4190355T3 (pl)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PL4190355T3 true PL4190355T3 (pl) 2025-02-10

Family

ID=62165668

Family Applications (2)

Application Number Title Priority Date Filing Date
PL18724690.5T PL3615066T3 (pl) 2017-04-28 2018-04-27 Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania
PL22206709.2T PL4190355T3 (pl) 2017-04-28 2018-04-27 Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PL18724690.5T PL3615066T3 (pl) 2017-04-28 2018-04-27 Formulacje ludzkich przeciwciał anty-RANKL i sposoby ich zastosowania

Country Status (37)

Country Link
US (3) US11192952B2 (pl)
EP (3) EP3615066B1 (pl)
JP (4) JP7190822B2 (pl)
KR (2) KR102681171B1 (pl)
CN (2) CN118987200A (pl)
AR (1) AR111497A1 (pl)
AU (2) AU2018260750B2 (pl)
BR (1) BR112019022188A2 (pl)
CA (1) CA3054165A1 (pl)
CL (3) CL2019003032A1 (pl)
CO (1) CO2019011463A2 (pl)
CR (2) CR20250034A (pl)
DK (2) DK4190355T3 (pl)
EA (1) EA201992570A1 (pl)
ES (2) ES2997833T3 (pl)
FI (2) FI3615066T3 (pl)
HR (2) HRP20240167T1 (pl)
HU (2) HUE065544T2 (pl)
IL (2) IL293127B2 (pl)
JO (2) JOP20190255B1 (pl)
LT (2) LT3615066T (pl)
MA (2) MA48462B1 (pl)
MX (1) MX2023013460A (pl)
MY (1) MY202479A (pl)
PE (2) PE20251534A1 (pl)
PH (1) PH12019502444A1 (pl)
PL (2) PL3615066T3 (pl)
PT (2) PT3615066T (pl)
RS (2) RS65299B1 (pl)
SG (1) SG11201909998TA (pl)
SI (2) SI4190355T1 (pl)
SM (2) SMT202400491T1 (pl)
TN (2) TN2019000297A1 (pl)
TW (2) TWI903512B (pl)
UY (2) UY40974A (pl)
WO (1) WO2018200918A1 (pl)
ZA (1) ZA202205141B (pl)

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SI4190355T1 (sl) 2017-04-28 2025-02-28 Amgen Inc. Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe
AU2019378544A1 (en) * 2018-11-16 2021-06-10 Samsung Bioepis Co., Ltd. Stable liquid composition comprising protein
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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
KR20230118573A (ko) * 2020-11-11 2023-08-11 에이치큐 한 액티빈/tgf-베타 및 rankl의 이작용성 길항제 및 이의 용도
CN117062837A (zh) * 2021-05-12 2023-11-14 江苏恒瑞医药股份有限公司 特异性结合rankl和ngf的抗原结合分子及其医药用途
JP2024518536A (ja) * 2021-05-12 2024-05-01 アナプティスバイオ インコーポレイティッド 抗体組成物
US20240343795A1 (en) 2021-08-12 2024-10-17 Amgen Inc. Antibody formulations
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WO2023179791A1 (en) * 2022-03-24 2023-09-28 Angitia Biomedicines Limited Treatment of musculoskeletal disorders
AU2023347288A1 (en) 2022-09-23 2025-03-13 The University Of North Carolina At Chapel Hill Methods and compositions for the treatment of melanoma
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WO2025116648A1 (ko) * 2023-12-01 2025-06-05 삼성바이오에피스 주식회사 항-IL-4Rα 항체의 안정한 완충제-프리 액상 제형

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SI4190355T1 (sl) 2017-04-28 2025-02-28 Amgen Inc. Formulacije humanih protiteles proti-RANKL in postopki njihove uporabe

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Publication number Publication date
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
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
LT3615066T (lt) 2024-02-26
ZA202205141B (en) 2025-04-30
SI4190355T1 (sl) 2025-02-28
US20220143181A1 (en) 2022-05-12
PE20251534A1 (es) 2025-06-05
SMT202400491T1 (it) 2025-01-14
UY40974A (es) 2024-12-13
JP2025093923A (ja) 2025-06-24
HUE069382T2 (hu) 2025-03-28
DK3615066T3 (da) 2024-03-11
CA3054165A1 (en) 2018-11-01
TW202435914A (zh) 2024-09-16
JP2023166396A (ja) 2023-11-21
CN110621342B (zh) 2024-08-02
ES2973572T3 (es) 2024-06-20
HRP20241604T1 (hr) 2025-01-31
TN2019000297A1 (en) 2021-05-07
MA62173B1 (fr) 2025-01-31
EP4477667A3 (en) 2025-05-07
CN118987200A (zh) 2024-11-22
PH12019502444A1 (en) 2020-07-20
DK4190355T3 (da) 2024-12-09
MA48462A (fr) 2020-03-04
PT4190355T (pt) 2024-12-05
HRP20240167T1 (hr) 2024-04-26
KR20190140464A (ko) 2019-12-19
UY37707A (es) 2018-10-31
TW201841654A (zh) 2018-12-01
JOP20190255B1 (ar) 2024-12-22
AR111497A1 (es) 2019-07-17
SI3615066T1 (sl) 2024-04-30
DK3615066T5 (da) 2024-09-02
AU2025205470A1 (en) 2025-08-14
LT4190355T (lt) 2024-12-27
IL293127A (en) 2022-07-01
AU2018260750A1 (en) 2019-08-29
PL3615066T3 (pl) 2024-04-29
WO2018200918A8 (en) 2019-10-17
HUE065544T2 (hu) 2024-05-28
JP2022062059A (ja) 2022-04-19
CL2019003032A1 (es) 2020-02-21
SMT202400095T1 (it) 2024-05-14
JP7190822B2 (ja) 2022-12-16
FI4190355T3 (fi) 2024-12-07
AU2018260750B2 (en) 2025-04-17
ES2997833T3 (en) 2025-02-18
RS66284B1 (sr) 2025-01-31
PT3615066T (pt) 2024-03-08
CR20190538A (es) 2020-02-26
IL268704B (en) 2022-06-01
US11873343B2 (en) 2024-01-16
TWI903512B (zh) 2025-11-01
FI3615066T3 (fi) 2024-02-29
RS65299B1 (sr) 2024-04-30
EP4477667A2 (en) 2024-12-18
JOP20240115B1 (ar) 2025-10-01
EP4190355A1 (en) 2023-06-07
CO2019011463A2 (es) 2019-10-31
EP3615066A1 (en) 2020-03-04
BR112019022188A2 (pt) 2020-05-12
US11192952B2 (en) 2021-12-07
MA48462B1 (fr) 2024-05-31
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CL2023002505A1 (es) 2024-03-08
JOP20190255A1 (ar) 2019-10-27

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