TWI847979B - 抗cd38 抗體之皮下給藥 - Google Patents

抗cd38 抗體之皮下給藥 Download PDF

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Publication number
TWI847979B
TWI847979B TW108110990A TW108110990A TWI847979B TW I847979 B TWI847979 B TW I847979B TW 108110990 A TW108110990 A TW 108110990A TW 108110990 A TW108110990 A TW 108110990A TW I847979 B TWI847979 B TW I847979B
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TW
Taiwan
Prior art keywords
seq
antibody
dose
amino acid
suitably
Prior art date
Application number
TW108110990A
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English (en)
Chinese (zh)
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TW202003566A (zh
Inventor
艾瑞克 菲迪克
麥可 漢利
安東尼奧 帕倫波
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日商武田藥品工業有限公司
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Publication of TW202003566A publication Critical patent/TW202003566A/zh
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061Blood cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/58Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A61K2039/585Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation wherein the target is cancer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
TW108110990A 2018-03-28 2019-03-28 抗cd38 抗體之皮下給藥 TWI847979B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862649489P 2018-03-28 2018-03-28
US62/649,489 2018-03-28

Publications (2)

Publication Number Publication Date
TW202003566A TW202003566A (zh) 2020-01-16
TWI847979B true TWI847979B (zh) 2024-07-11

Family

ID=66647425

Family Applications (2)

Application Number Title Priority Date Filing Date
TW108110990A TWI847979B (zh) 2018-03-28 2019-03-28 抗cd38 抗體之皮下給藥
TW113121338A TW202504926A (zh) 2018-03-28 2019-03-28 抗cd38抗體之皮下給藥

Family Applications After (1)

Application Number Title Priority Date Filing Date
TW113121338A TW202504926A (zh) 2018-03-28 2019-03-28 抗cd38抗體之皮下給藥

Country Status (12)

Country Link
US (1) US20210047427A1 (https=)
EP (1) EP3774915A1 (https=)
JP (2) JP7526099B2 (https=)
KR (2) KR20250117714A (https=)
CN (1) CN112154156A (https=)
AU (2) AU2019244478B2 (https=)
BR (1) BR112020019710A2 (https=)
CA (1) CA3095086A1 (https=)
CO (1) CO2020013252A2 (https=)
MX (1) MX2020010144A (https=)
TW (2) TWI847979B (https=)
WO (1) WO2019186273A1 (https=)

Families Citing this family (19)

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US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
CN107406506A (zh) 2014-12-04 2017-11-28 詹森生物科技公司 用于治疗急性髓系白血病的抗cd38抗体
EA201792546A1 (ru) 2015-05-20 2018-04-30 Янссен Байотек, Инк. Антитела к cd38 для лечения амилоидоза легких цепей и прочих cd38-положительных гематологических злокачественных опухолей
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
US10781261B2 (en) 2015-11-03 2020-09-22 Janssen Biotech, Inc. Subcutaneous formulations of anti-CD38 antibodies and their uses
CA3004152C (en) 2015-11-03 2024-04-16 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses
US20190233533A1 (en) 2016-06-28 2019-08-01 Umc Utrecht Holding B.V. Treatment Of IgE-Mediated Diseases With Antibodies That Specifically Bind CD38
MA50514A (fr) 2017-10-31 2020-09-09 Janssen Biotech Inc Méthodes de traitement du myélome multiple à haut risque
AU2019338999A1 (en) * 2018-09-11 2021-03-18 Jiangsu Hengrui Medicine Co., Ltd. Anti-CD38 antibody, antigen-binding fragment thereof, and pharmaceutical use
KR20210077725A (ko) * 2018-10-17 2021-06-25 얀센 바이오테크 인코포레이티드 항-cd38 항체의 피하 투여를 제공하는 방법
IL293563A (en) * 2019-12-05 2022-08-01 Sanofi Aventis Us Llc Formulations of anti-cd38 antibodies for subcutaneous administration
AU2021271808A1 (en) * 2020-05-15 2023-01-05 Takeda Pharmaceutical Company Limited Administration of SUMO-activating enzyme inhibitor and anti-CD38 antibodies
EP4376869A1 (en) 2021-07-28 2024-06-05 Genentech, Inc. Il15/il15r alpha heterodimeric fc-fusion proteins for the treatment of blood cancers
US20240400711A1 (en) * 2021-09-23 2024-12-05 Sound Biopharmaceuticals Co. Ltd. Cd38 monoclonal antibody and application thereof
WO2024131849A1 (zh) * 2022-12-21 2024-06-27 非同(成都)生物科技有限公司 Cd38单克隆抗体及其应用
CN121127494A (zh) 2023-01-06 2025-12-12 武田药品工业株式会社 用于治疗自身免疫性疾病的抗cd38抗体
WO2025193746A1 (en) 2024-03-12 2025-09-18 Takeda Pharmaceutical Company Limited Dosing regimens of anti-cd38 antibodies for treatment of subjects with immune thrombocytopenia
WO2025235919A1 (en) 2024-05-09 2025-11-13 Takeda Pharmaceutical Company Limited Dosing regimens of anti-cd38 antibodies for treatment of subjects with immunoglobulin a nephropathy

Citations (1)

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Publication number Priority date Publication date Assignee Title
WO2012092612A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies

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US6086875A (en) 1995-01-17 2000-07-11 The Brigham And Women's Hospital, Inc. Receptor specific transepithelial transport of immunogens
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US8084582B2 (en) 2003-03-03 2011-12-27 Xencor, Inc. Optimized anti-CD20 monoclonal antibodies having Fc variants
JP5225069B2 (ja) * 2005-03-23 2013-07-03 ゲンマブ エー/エス 多発性骨髄腫の治療のためのcd38に対する抗体
TW200745162A (en) 2005-05-24 2007-12-16 Morphosys Ag Generation and profiling of fully human hucal gold-derived therapeutic antibodies specific for human CD38
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US20150118251A1 (en) 2013-10-31 2015-04-30 Sanofi Specific anti-cd38 antibodies for treating human cancers
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CA3004152C (en) * 2015-11-03 2024-04-16 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses
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Also Published As

Publication number Publication date
EP3774915A1 (en) 2021-02-17
KR20250117714A (ko) 2025-08-05
RU2020135062A (ru) 2022-04-28
MX2020010144A (es) 2020-12-07
AU2025259859A1 (en) 2025-11-27
JP2024045121A (ja) 2024-04-02
AU2019244478A1 (en) 2020-11-12
TW202504926A (zh) 2025-02-01
US20210047427A1 (en) 2021-02-18
KR20210002499A (ko) 2021-01-08
AU2019244478B2 (en) 2025-11-06
WO2019186273A4 (en) 2019-12-19
JP7526099B2 (ja) 2024-07-31
CA3095086A1 (en) 2019-10-03
JP2021519295A (ja) 2021-08-10
TW202003566A (zh) 2020-01-16
WO2019186273A1 (en) 2019-10-03
BR112020019710A2 (pt) 2021-01-26
RU2020135062A3 (https=) 2022-04-28
CO2020013252A2 (es) 2020-11-10
CN112154156A (zh) 2020-12-29

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