CA3216387A1 - Anti-ifnar1 dosing regime for subcutaneous injection - Google Patents

Anti-ifnar1 dosing regime for subcutaneous injection Download PDF

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Publication number
CA3216387A1
CA3216387A1 CA3216387A CA3216387A CA3216387A1 CA 3216387 A1 CA3216387 A1 CA 3216387A1 CA 3216387 A CA3216387 A CA 3216387A CA 3216387 A CA3216387 A CA 3216387A CA 3216387 A1 CA3216387 A1 CA 3216387A1
Authority
CA
Canada
Prior art keywords
dose
anifrolumab
ifnar1
unit dose
inhibitor
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CA3216387A
Other languages
English (en)
French (fr)
Inventor
Catharina LINDHOLM
Yen Lin Chia
Rajendra TUMMALA
Lorin Roskos
Joachim ALMQUIST
Tomas ROUSE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AstraZeneca AB
Original Assignee
AstraZeneca AB
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=81750490&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3216387(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by AstraZeneca AB filed Critical AstraZeneca AB
Publication of CA3216387A1 publication Critical patent/CA3216387A1/en
Pending legal-status Critical Current

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
    • C07K16/2866—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
    • 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

Landscapes

  • 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)
CA3216387A 2021-04-23 2022-04-21 Anti-ifnar1 dosing regime for subcutaneous injection Pending CA3216387A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3216387A1 true CA3216387A1 (en) 2022-10-27

Family

ID=81750490

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3216387A Pending CA3216387A1 (en) 2021-04-23 2022-04-21 Anti-ifnar1 dosing regime for subcutaneous injection

Country Status (25)

Country Link
US (4) US20220340669A1 (https=)
EP (2) EP4114465B1 (https=)
JP (2) JP7484027B2 (https=)
KR (2) KR20230166134A (https=)
CN (2) CN120392997A (https=)
AU (2) AU2022260531B2 (https=)
BR (1) BR112023021761A2 (https=)
CA (1) CA3216387A1 (https=)
CL (1) CL2023003114A1 (https=)
CO (1) CO2023015498A2 (https=)
DK (1) DK4114465T5 (https=)
ES (1) ES2963757T3 (https=)
FI (1) FI4114465T3 (https=)
HR (1) HRP20231255T1 (https=)
HU (1) HUE063562T2 (https=)
IL (1) IL307748A (https=)
LT (1) LT4114465T (https=)
MX (1) MX2023012465A (https=)
PL (1) PL4114465T3 (https=)
PT (1) PT4114465T (https=)
RS (1) RS64821B1 (https=)
SI (1) SI4114465T1 (https=)
SM (1) SMT202300382T1 (https=)
TW (1) TW202317182A (https=)
WO (1) WO2022223714A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE035082T2 (en) * 2004-06-21 2018-05-02 Squibb & Sons Llc Interferon alpha receptor 1 antibodies and their use
JP2023549872A (ja) * 2020-11-18 2023-11-29 アストラゼネカ・アクチエボラーグ ステロイド節約
HRP20231255T1 (hr) 2021-04-23 2024-02-02 Astrazeneca Ab Režim doziranja anti-ifnar1 za potkožnu injekciju
PT4192882T (pt) * 2021-04-23 2025-05-02 Astrazeneca Ab Tratamento de nefrite lúpica com anticorpo anifrolumab de recetor inf anti-tipo i
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
CN121127499A (zh) 2023-05-19 2025-12-12 阿斯利康(瑞典)有限公司 狼疮的治疗
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

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002098370A2 (en) 2001-03-02 2002-12-12 Medimmune, Inc. Methods of administering/dosing cd2 antagonists for the prevention and treatment of autoimmune disorders or inflammatory disorders
US20040037809A1 (en) 2002-06-28 2004-02-26 Nastech Pharmaceutical Company Inc. Compositions and methods for enhanced mucosal delivery of interferon beta
NZ547157A (en) 2003-12-10 2009-07-31 Medarex Inc Interferon Alpha Antibodies and their uses
HUE035082T2 (en) * 2004-06-21 2018-05-02 Squibb & Sons Llc Interferon alpha receptor 1 antibodies and their use
EP1907858A4 (en) 2005-06-13 2009-04-08 Univ Michigan COMPOSITIONS AND METHODS OF TREATMENT AND DIAGNOSIS OF CANCER
CA2651866C (en) 2006-05-11 2014-10-28 Universiteit Gent Sialoadhesin-related compositions and methods
EP2077858A4 (en) 2006-12-06 2011-07-20 Medimmune Llc INTERFERON ALPHA-INDUCED PHARMACODYNAMIC MARKERS
ES2542836T3 (es) 2007-07-12 2015-08-12 The Brigham And Women's Hospital, Inc. Composiciones y métodos para diagnosticar y evaluar miopatías inflamatorias
PT2219452E (pt) 2007-11-05 2016-01-26 Medimmune Llc Métodos de tratamento de esclerodermia
HRP20160855T1 (hr) 2008-02-08 2016-09-23 Medimmune, Llc Anti-ifnar1 protutijela sa smanjenim afinitetom fc liganda
US20110287022A1 (en) 2008-06-20 2011-11-24 Medlmmune, Llc Interferon alpha-induced pharmacodynamic markers
UA104868C2 (uk) 2008-08-15 2014-03-25 Меррімак Фармасьютікалз, Інк. Спосіб лікування пацієнта, що має неопластичну пухлину, відповідно до спрогнозованої реакції
US20120251546A1 (en) 2009-09-03 2012-10-04 Medimmune Llc Type 1 inteferon diagnostic
AU2013274389A1 (en) * 2012-06-13 2015-01-22 Astrazeneca Ab Fixed dosage regimens for anti-type I interferon receptor (IFNAR) antibodies
CA2995222C (en) * 2015-08-19 2021-07-13 Medimmune, Llc Stable anti-ifnar1 formulation
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
EP3713955A4 (en) * 2018-09-18 2022-03-09 I-Mab Biopharma (Hangzhou) Co., Ltd. ANTI-IFNAR1 ANTIBODIES FOR THE TREATMENT OF AUTOIMMUNE DISEASES
EP3924383A1 (en) * 2019-02-15 2021-12-22 Astrazeneca AB Type i interferon-mediated disorders
KR102766960B1 (ko) 2019-11-11 2025-02-11 아스트라제네카 아베 전신성 홍반성 루푸스에서 i형 인터페론 억제
CN115667309A (zh) 2020-05-29 2023-01-31 阿斯利康(瑞典)有限公司 使用i型干扰素信号传导的抑制剂治疗心血管代谢疾病
TW202237647A (zh) 2020-10-08 2022-10-01 瑞典商阿斯特捷利康公司 狼瘡發作之治療
JP2023549872A (ja) 2020-11-18 2023-11-29 アストラゼネカ・アクチエボラーグ ステロイド節約
HRP20231255T1 (hr) 2021-04-23 2024-02-02 Astrazeneca Ab Režim doziranja anti-ifnar1 za potkožnu injekciju
PT4192882T (pt) 2021-04-23 2025-05-02 Astrazeneca Ab Tratamento de nefrite lúpica com anticorpo anifrolumab de recetor inf anti-tipo i
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

Also Published As

Publication number Publication date
FI4114465T3 (fi) 2023-10-31
JP7484027B2 (ja) 2024-05-15
MX2023012465A (es) 2024-04-04
EP4114465A1 (en) 2023-01-11
AU2022260531B2 (en) 2024-03-07
PT4114465T (pt) 2023-11-03
IL307748A (en) 2023-12-01
CL2023003114A1 (es) 2024-04-19
KR20230166134A (ko) 2023-12-06
LT4114465T (lt) 2023-11-10
AU2022260531A1 (en) 2023-11-30
JP7805393B2 (ja) 2026-01-23
JP2024102205A (ja) 2024-07-30
DK4114465T3 (da) 2023-10-30
TW202317182A (zh) 2023-05-01
EP4114465B1 (en) 2023-08-30
ES2963757T3 (es) 2024-04-01
EP4306541A3 (en) 2024-03-27
KR20250092298A (ko) 2025-06-23
SMT202300382T1 (it) 2024-01-10
SI4114465T1 (sl) 2023-11-30
EP4306541A2 (en) 2024-01-17
BR112023021761A2 (pt) 2023-12-26
CN120392997A (zh) 2025-08-01
US12060429B2 (en) 2024-08-13
HUE063562T2 (hu) 2024-01-28
WO2022223714A1 (en) 2022-10-27
DK4114465T5 (da) 2024-07-22
AU2024201743A1 (en) 2024-04-04
CN120514844A (zh) 2025-08-22
US20240360231A1 (en) 2024-10-31
HRP20231255T1 (hr) 2024-02-02
JP2024511227A (ja) 2024-03-12
AU2022260531A9 (en) 2023-12-07
US20220340669A1 (en) 2022-10-27
PL4114465T3 (pl) 2024-04-08
US20230365698A1 (en) 2023-11-16
US20240400699A1 (en) 2024-12-05
CO2023015498A2 (es) 2023-11-30
RS64821B1 (sr) 2023-12-29

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