JP7746407B2 - 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療 - Google Patents

抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療

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Publication number
JP7746407B2
JP7746407B2 JP2023564485A JP2023564485A JP7746407B2 JP 7746407 B2 JP7746407 B2 JP 7746407B2 JP 2023564485 A JP2023564485 A JP 2023564485A JP 2023564485 A JP2023564485 A JP 2023564485A JP 7746407 B2 JP7746407 B2 JP 7746407B2
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Japan
Prior art keywords
anifrolumab
dose
patients
subject
upcr
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JP2023564485A
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English (en)
Japanese (ja)
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JP2024518735A5 (https=
JP2024518735A (ja
JPWO2022223771A5 (https=
Inventor
リンドホルム，カタリーナ
リン チア，イェン
トゥマラ，ラジェンドラ
ロスコス，ロリン
アルムクヴィスト，ヨアキム
ルーセ，トマス
トラシエヴァ，テオドラ
ホワイト，ウェンディ
シニバルディ，ドミニク
ラマスワミー，マドゥ
ニューコム，ポール
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AstraZeneca AB
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AstraZeneca AB
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Publication of JP2024518735A publication Critical patent/JP2024518735A/ja
Publication of JP2024518735A5 publication Critical patent/JP2024518735A5/ja
Publication of JPWO2022223771A5 publication Critical patent/JPWO2022223771A5/ja
Priority to JP2025153759A priority Critical patent/JP2026012677A/ja
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    • 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
    • C07K16/2866—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • 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
    • C07K2317/56—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/775—Apolipopeptides
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/79—Transferrins, e.g. lactoferrins, ovotransferrins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/10—Musculoskeletal or connective tissue disorders
    • G01N2800/101—Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
    • G01N2800/104—Lupus erythematosus [SLE]
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/34—Genitourinary disorders
    • G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Pathology (AREA)
  • Anesthesiology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Microbiology (AREA)
  • Vascular Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rehabilitation Therapy (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
JP2023564485A 2021-04-23 2022-04-22 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療 Active JP7746407B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025153759A JP2026012677A (ja) 2021-04-23 2025-09-17 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202163178745P 2021-04-23 2021-04-23
US63/178,745 2021-04-23
US202163221986P 2021-07-15 2021-07-15
US63/221,986 2021-07-15
US202163270091P 2021-10-21 2021-10-21
US63/270,091 2021-10-21
PCT/EP2022/060670 WO2022223771A1 (en) 2021-04-23 2022-04-22 Treatment of lupus nephritis with anti-type i inf receptor antibody anifrolumab

Related Child Applications (1)

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JP2025153759A Division JP2026012677A (ja) 2021-04-23 2025-09-17 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療

Publications (4)

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JP2024518735A JP2024518735A (ja) 2024-05-02
JP2024518735A5 JP2024518735A5 (https=) 2024-11-12
JPWO2022223771A5 JPWO2022223771A5 (https=) 2024-11-12
JP7746407B2 true JP7746407B2 (ja) 2025-09-30

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JP2023564485A Active JP7746407B2 (ja) 2021-04-23 2022-04-22 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療
JP2025153759A Pending JP2026012677A (ja) 2021-04-23 2025-09-17 抗ｉ型ｉｎｆ受容体抗体アニフロルマブによるループス腎炎の治療

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Country Link
US (2) US20220348669A1 (https=)
EP (2) EP4595996A3 (https=)
JP (2) JP7746407B2 (https=)
KR (1) KR20240001704A (https=)
AU (1) AU2022260544A1 (https=)
BR (1) BR112023021514A2 (https=)
CA (1) CA3216395A1 (https=)
DK (1) DK4192882T3 (https=)
ES (1) ES3021882T3 (https=)
FI (1) FI4192882T3 (https=)
HU (1) HUE070524T2 (https=)
IL (1) IL307751B2 (https=)
PL (1) PL4192882T3 (https=)
PT (1) PT4192882T (https=)
TW (1) TW202308691A (https=)
WO (1) WO2022223771A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20231255T1 (hr) 2021-04-23 2024-02-02 Astrazeneca Ab Režim doziranja anti-ifnar1 za potkožnu injekciju
CN113278071B (zh) * 2021-05-27 2021-12-21 江苏荃信生物医药股份有限公司 抗人干扰素α受体1单克隆抗体及其应用
GB202402824D0 (en) * 2024-02-28 2024-04-10 Astrazeneca Ab Treatment of chronic kidney disease

Citations (1)

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JP2015526391A (ja) 2012-06-13 2015-09-10 メディミューン，エルエルシー 抗ｉ型インターフェロン受容体（ｉｆｎａｒ）抗体のための固定用量レジメン

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HUE035082T2 (en) 2004-06-21 2018-05-02 Squibb & Sons Llc Interferon alpha receptor 1 antibodies and their use
HRP20160855T1 (hr) 2008-02-08 2016-09-23 Medimmune, Llc Anti-ifnar1 protutijela sa smanjenim afinitetom fc liganda
US20120251546A1 (en) 2009-09-03 2012-10-04 Medimmune Llc Type 1 inteferon diagnostic
PH12016502073B1 (en) * 2010-11-17 2024-04-05 Chugai Pharmaceutical Co Ltd Multi-specific antigen-binding molecule having alternative function to function of blood coagulation factor viii
US8790651B2 (en) * 2011-07-21 2014-07-29 Zoetis Llc Interleukin-31 monoclonal antibody
CA2995222C (en) 2015-08-19 2021-07-13 Medimmune, Llc Stable anti-ifnar1 formulation
WO2017186928A1 (en) * 2016-04-29 2017-11-02 Curevac Ag Rna encoding an antibody
CN106243226B (zh) 2016-08-05 2019-02-12 北京智仁美博生物科技有限公司 抗人ifnar1的抗体及其用途
HRP20231255T1 (hr) * 2021-04-23 2024-02-02 Astrazeneca Ab Režim doziranja anti-ifnar1 za potkožnu injekciju
CN113278070B (zh) 2021-04-25 2022-06-14 福州迈新生物技术开发有限公司 抗ck17蛋白单克隆抗体及其细胞株、制备方法和应用
CN113527490B (zh) * 2021-07-13 2022-03-01 江苏荃信生物医药股份有限公司 一种抗人ifnar1单克隆抗体浓缩溶液的制备方法
CN113621063A (zh) * 2021-08-02 2021-11-09 江苏荃信生物医药有限公司 降低单克隆抗体生产中宿主细胞蛋白含量的亲和纯化方法

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
JP2015526391A (ja) 2012-06-13 2015-09-10 メディミューン，エルエルシー 抗ｉ型インターフェロン受容体（ｉｆｎａｒ）抗体のための固定用量レジメン

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Proliferative Lupus Nephritis，Clinical Study Protocol, Drug Substance Anifrolumab, Study Code D3461C00007，Ver.4, 193 pages，2017年11月13日，<https://cdn.clinicaltrials.gov/large-docs/22/NCT02547922/Prot_000.pdf>
Lancet Rheumatol，2021年02月，Vol.3, e101-110，<https://doi.org/10.1016/ S2665-9913(20)30342-8>

Also Published As

Publication number Publication date
EP4192882B1 (en) 2025-02-19
EP4595996A2 (en) 2025-08-06
EP4192882A1 (en) 2023-06-14
IL307751B2 (en) 2025-12-01
HUE070524T2 (hu) 2025-06-28
ES3021882T3 (en) 2025-05-27
WO2022223771A1 (en) 2022-10-27
EP4595996A3 (en) 2025-12-03
DK4192882T3 (da) 2025-03-10
IL307751A (en) 2023-12-01
KR20240001704A (ko) 2024-01-03
JP2024518735A (ja) 2024-05-02
US20220348669A1 (en) 2022-11-03
BR112023021514A2 (pt) 2023-12-19
CA3216395A1 (en) 2022-10-27
US20250002590A1 (en) 2025-01-02
AU2022260544A9 (en) 2023-12-07
IL307751B1 (en) 2025-08-01
PT4192882T (pt) 2025-05-02
JP2026012677A (ja) 2026-01-27
FI4192882T3 (fi) 2025-03-26
PL4192882T3 (pl) 2025-04-28
AU2022260544A1 (en) 2023-11-30
TW202308691A (zh) 2023-03-01

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