AU2022260531B2 - Anti-ifnar1 dosing regime for subcutaneous injection - Google Patents

Anti-ifnar1 dosing regime for subcutaneous injection Download PDF

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Publication number
AU2022260531B2
AU2022260531B2 AU2022260531A AU2022260531A AU2022260531B2 AU 2022260531 B2 AU2022260531 B2 AU 2022260531B2 AU 2022260531 A AU2022260531 A AU 2022260531A AU 2022260531 A AU2022260531 A AU 2022260531A AU 2022260531 B2 AU2022260531 B2 AU 2022260531B2
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AU
Australia
Prior art keywords
anifrolumab
placebo
dose
week
ser
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Active
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AU2022260531A
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AU2022260531A9 (en
AU2022260531A1 (en
Inventor
Joachim ALMQUIST
Yen Lin Chia
Catharina LINDHOLM
Lorin Roskos
Tomas ROUSE
Rajendra TUMMALA
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AstraZeneca AB
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AstraZeneca AB
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Application filed by AstraZeneca AB filed Critical AstraZeneca AB
Publication of AU2022260531A1 publication Critical patent/AU2022260531A1/en
Publication of AU2022260531A9 publication Critical patent/AU2022260531A9/en
Application granted granted Critical
Publication of AU2022260531B2 publication Critical patent/AU2022260531B2/en
Priority to AU2024201743A priority Critical patent/AU2024201743A1/en
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    • 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
    • C07K16/2866—Immunoglobulins [IGs], 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Devices For Medical Bathing And Washing (AREA)
AU2022260531A 2021-04-23 2022-04-21 Anti-ifnar1 dosing regime for subcutaneous injection Active AU2022260531B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024201743A AU2024201743A1 (en) 2021-04-23 2024-03-18 Anti-ifnar1 dosing regime for subcutaneous injection

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US202163178739P 2021-04-23 2021-04-23
US63/178,739 2021-04-23
US202163245285P 2021-09-17 2021-09-17
US63/245,285 2021-09-17
US202163272851P 2021-10-28 2021-10-28
US63/272,851 2021-10-28
PCT/EP2022/060592 WO2022223714A1 (en) 2021-04-23 2022-04-21 Anti-ifnar1 dosing regime for subcutaneous injection

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024201743A Division AU2024201743A1 (en) 2021-04-23 2024-03-18 Anti-ifnar1 dosing regime for subcutaneous injection

Publications (3)

Publication Number Publication Date
AU2022260531A1 AU2022260531A1 (en) 2023-11-30
AU2022260531A9 AU2022260531A9 (en) 2023-12-07
AU2022260531B2 true AU2022260531B2 (en) 2024-03-07

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ID=81750490

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AU2022260531A Active AU2022260531B2 (en) 2021-04-23 2022-04-21 Anti-ifnar1 dosing regime for subcutaneous injection
AU2024201743A Pending AU2024201743A1 (en) 2021-04-23 2024-03-18 Anti-ifnar1 dosing regime for subcutaneous injection

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2024201743A Pending AU2024201743A1 (en) 2021-04-23 2024-03-18 Anti-ifnar1 dosing regime for subcutaneous injection

Country Status (25)

Country Link
US (4) US20220340669A1 (enExample)
EP (2) EP4114465B1 (enExample)
JP (2) JP7484027B2 (enExample)
KR (2) KR20230166134A (enExample)
CN (2) CN120514844A (enExample)
AU (2) AU2022260531B2 (enExample)
BR (1) BR112023021761A2 (enExample)
CA (1) CA3216387A1 (enExample)
CL (1) CL2023003114A1 (enExample)
CO (1) CO2023015498A2 (enExample)
DK (1) DK4114465T5 (enExample)
ES (1) ES2963757T3 (enExample)
FI (1) FI4114465T3 (enExample)
HR (1) HRP20231255T1 (enExample)
HU (1) HUE063562T2 (enExample)
IL (1) IL307748A (enExample)
LT (1) LT4114465T (enExample)
MX (1) MX2023012465A (enExample)
PL (1) PL4114465T3 (enExample)
PT (1) PT4114465T (enExample)
RS (1) RS64821B1 (enExample)
SI (1) SI4114465T1 (enExample)
SM (1) SMT202300382T1 (enExample)
TW (1) TW202317182A (enExample)
WO (1) WO2022223714A1 (enExample)

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JP5160887B2 (ja) * 2004-06-21 2013-03-13 メダレックス インコーポレイテッド インターフェロンアルファレセプター１抗体及びその使用法
CN116997359A (zh) * 2020-11-18 2023-11-03 阿斯利康(瑞典)有限公司 类固醇节制
PT4192882T (pt) * 2021-04-23 2025-05-02 Astrazeneca Ab Tratamento de nefrite lúpica com anticorpo anifrolumab de recetor inf anti-tipo i
MX2023012465A (es) 2021-04-23 2024-04-04 Astrazeneca Ab Regimen de dosificacion de anti-ifnar1 para inyeccion subcutanea.
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
WO2024241156A1 (en) 2023-05-19 2024-11-28 Astrazeneca Ab Treatment of lupus
WO2025022280A1 (en) 2023-07-21 2025-01-30 Astrazeneca Ab Treatment of neurodegenerative diseases
GB202315831D0 (en) 2023-10-16 2023-11-29 Astrazeneca Ab Treatment of skin disease
GB202402824D0 (en) 2024-02-28 2024-04-10 Astrazeneca Ab Treatment of chronic kidney disease

Citations (4)

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US20150158949A1 (en) * 2012-06-13 2015-06-11 Medlmmune, Llc Fixed dosage regimens for anti-type i interferon receptor (ifnar) antibodies
US20170051066A1 (en) * 2015-08-19 2017-02-23 Medimmune, Llc Stable anti-ifnar1 formulation
WO2022074123A1 (en) * 2020-10-08 2022-04-14 Astrazeneca Ab Treatment of flares in lupus
WO2022106460A2 (en) * 2020-11-18 2022-05-27 Astrazeneca Ab Steroid sparing

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AU2002250236A1 (en) 2001-03-02 2002-09-19 Medimmune, Inc. Cd2 antagonists for treatment of autoimmune or inflammatory disease
US20040037809A1 (en) 2002-06-28 2004-02-26 Nastech Pharmaceutical Company Inc. Compositions and methods for enhanced mucosal delivery of interferon beta
KR101151477B1 (ko) 2003-12-10 2012-06-22 메다렉스, 인코포레이티드 인터페론 알파 항체 및 그의 용도
JP5160887B2 (ja) * 2004-06-21 2013-03-13 メダレックス インコーポレイテッド インターフェロンアルファレセプター１抗体及びその使用法
WO2006138275A2 (en) 2005-06-13 2006-12-28 The Regents Of The University Of Michigan Compositions and methods for treating and diagnosing cancer
CA2651866C (en) 2006-05-11 2014-10-28 Universiteit Gent Sialoadhesin-related compositions and methods
RU2527068C2 (ru) 2006-12-06 2014-08-27 Медиммун, Ллк Фармакодинамические маркеры, индуцированные интерфероном альфа
ES2542836T3 (es) 2007-07-12 2015-08-12 The Brigham And Women's Hospital, Inc. Composiciones y métodos para diagnosticar y evaluar miopatías inflamatorias
HUE025787T2 (en) 2007-11-05 2016-05-30 Medimmune Llc Method for treating scleroderma
PL2250279T3 (pl) 2008-02-08 2016-11-30 Przeciwciała anty-ifnar1 o zmniejszonym powinowactwie do liganda fc
US20110287022A1 (en) 2008-06-20 2011-11-24 Medlmmune, Llc Interferon alpha-induced pharmacodynamic markers
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IL298299A (en) 2020-05-29 2023-01-01 Astrazeneca Ab Treatment of cardiometabolic disease with inhibitors of type i interferon signalling
PT4192882T (pt) 2021-04-23 2025-05-02 Astrazeneca Ab Tratamento de nefrite lúpica com anticorpo anifrolumab de recetor inf anti-tipo i
MX2023012465A (es) 2021-04-23 2024-04-04 Astrazeneca Ab Regimen de dosificacion de anti-ifnar1 para inyeccion subcutanea.
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
CN113521276B (zh) * 2021-07-13 2022-04-12 江苏荃信生物医药股份有限公司 包含抗人干扰素α受体1(IFNAR1)单克隆抗体的液体制剂

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150158949A1 (en) * 2012-06-13 2015-06-11 Medlmmune, Llc Fixed dosage regimens for anti-type i interferon receptor (ifnar) antibodies
US20170051066A1 (en) * 2015-08-19 2017-02-23 Medimmune, Llc Stable anti-ifnar1 formulation
WO2022074123A1 (en) * 2020-10-08 2022-04-14 Astrazeneca Ab Treatment of flares in lupus
WO2022106460A2 (en) * 2020-11-18 2022-05-27 Astrazeneca Ab Steroid sparing

Also Published As

Publication number Publication date
HUE063562T2 (hu) 2024-01-28
DK4114465T5 (da) 2024-07-22
AU2022260531A9 (en) 2023-12-07
KR20250092298A (ko) 2025-06-23
DK4114465T3 (da) 2023-10-30
EP4306541A3 (en) 2024-03-27
KR20230166134A (ko) 2023-12-06
CA3216387A1 (en) 2022-10-27
WO2022223714A1 (en) 2022-10-27
EP4114465A1 (en) 2023-01-11
JP7484027B2 (ja) 2024-05-15
PT4114465T (pt) 2023-11-03
BR112023021761A2 (pt) 2023-12-26
MX2023012465A (es) 2024-04-04
SMT202300382T1 (it) 2024-01-10
JP2024102205A (ja) 2024-07-30
EP4306541A2 (en) 2024-01-17
US20240400699A1 (en) 2024-12-05
US20240360231A1 (en) 2024-10-31
CL2023003114A1 (es) 2024-04-19
CN120392997A (zh) 2025-08-01
LT4114465T (lt) 2023-11-10
US20230365698A1 (en) 2023-11-16
CO2023015498A2 (es) 2023-11-30
ES2963757T3 (es) 2024-04-01
IL307748A (en) 2023-12-01
HRP20231255T1 (hr) 2024-02-02
RS64821B1 (sr) 2023-12-29
SI4114465T1 (sl) 2023-11-30
CN120514844A (zh) 2025-08-22
EP4114465B1 (en) 2023-08-30
PL4114465T3 (pl) 2024-04-08
FI4114465T3 (fi) 2023-10-31
US12060429B2 (en) 2024-08-13
US20220340669A1 (en) 2022-10-27
JP2024511227A (ja) 2024-03-12
AU2022260531A1 (en) 2023-11-30
TW202317182A (zh) 2023-05-01
AU2024201743A1 (en) 2024-04-04

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