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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Taiwan
Prior art keywords
seq
antibody
dose
amino acid
suitably
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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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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], 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

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  • 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)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (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
TW113121338A TW202504926A (zh) 2018-03-28 2019-03-28 抗cd38抗體之皮下給藥
TW108110990A TWI847979B (zh) 2018-03-28 2019-03-28 抗cd38 抗體之皮下給藥

Family Applications Before (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 (enExample)
EP (1) EP3774915A1 (enExample)
JP (2) JP7526099B2 (enExample)
KR (2) KR20250117714A (enExample)
CN (1) CN112154156A (enExample)
AU (2) AU2019244478B2 (enExample)
BR (1) BR112020019710A2 (enExample)
CA (1) CA3095086A1 (enExample)
CO (1) CO2020013252A2 (enExample)
MX (1) MX2020010144A (enExample)
TW (2) TW202504926A (enExample)
WO (1) WO2019186273A1 (enExample)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EA202092609A1 (ru) 2014-12-04 2021-10-29 Янссен Байотек, Инк. Антитела к cd38 для лечения острого миелолейкоза
CN108136218B (zh) 2015-05-20 2022-12-13 詹森生物科技公司 用于治疗轻链淀粉样变性及其它cd38阳性血液恶性肿瘤的抗cd38抗体
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
RS61651B1 (sr) 2015-11-03 2021-04-29 Janssen Biotech Inc Potkožne formulacije anti-cd38 antitela i njihova upotreba
US10781261B2 (en) 2015-11-03 2020-09-22 Janssen Biotech, Inc. Subcutaneous formulations of anti-CD38 antibodies and their uses
JP2021502961A (ja) 2017-10-31 2021-02-04 ヤンセン バイオテツク,インコーポレーテツド 高リスク多発性骨髄腫の治療方法
EP3851456A4 (en) * 2018-09-11 2022-06-08 Jiangsu Hengrui Medicine Co., Ltd. ANTI-CD38 ANTIBODY, ANTIGEN-BINDING FRAGMENT THEREOF AND PHARMACEUTICAL APPLICATION
CA3116878A1 (en) * 2018-10-17 2020-04-23 Janssen Biotech, Inc. Method of providing subcutaneous administration of anti-cd38 antibodies
KR20230010659A (ko) * 2020-05-15 2023-01-19 다케다 야쿠힌 고교 가부시키가이샤 Sumo-활성화 효소 억제제 및 항-cd38 항체의 투여
IL310372A (en) 2021-07-28 2024-03-01 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
WO2024147934A1 (en) 2023-01-06 2024-07-11 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies for the treatment of autoimmune diseases
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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012092612A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE199392T1 (de) 1992-12-04 2001-03-15 Medical Res Council Multivalente und multispezifische bindungsproteine, deren herstellung und verwendung
US6086875A (en) 1995-01-17 2000-07-11 The Brigham And Women's Hospital, Inc. Receptor specific transepithelial transport of immunogens
US6737056B1 (en) 1999-01-15 2004-05-18 Genentech, Inc. Polypeptide variants with altered effector function
IT1320715B1 (it) 2000-10-19 2003-12-10 Cselt Centro Studi Lab Telecom Modulo generatore di circuiti per la decodifica di codiciconvoluzionali, metodo per la generazione di tale tipo di circuito e
DK1355919T3 (da) 2000-12-12 2011-03-14 Medimmune Llc Molekyler med længere halveringstider, sammensætninger og anvendelser deraf
JP4166691B2 (ja) 2001-08-03 2008-10-15 タイコ ヘルスケア グループ エルピー 組織マーキング装置および方法
US8188231B2 (en) 2002-09-27 2012-05-29 Xencor, Inc. Optimized FC variants
US7317091B2 (en) 2002-03-01 2008-01-08 Xencor, Inc. Optimized Fc variants
US20060235208A1 (en) 2002-09-27 2006-10-19 Xencor, Inc. Fc variants with optimized properties
US8084582B2 (en) 2003-03-03 2011-12-27 Xencor, Inc. Optimized anti-CD20 monoclonal antibodies having Fc variants
MX2007011064A (es) * 2005-03-23 2008-02-19 Genmab As Anticuerpos contra cd38 para tratamiento de mieloma multiple.
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
DK1931709T3 (en) 2005-10-03 2017-03-13 Xencor Inc FC VARIETIES WITH OPTIMIZED FC RECEPTOR BINDING PROPERTIES
TW201522378A (zh) * 2013-10-31 2015-06-16 Sanofi Sa 用於治療人類癌症的特異性抗cd38抗體
RU2723047C2 (ru) * 2015-05-13 2020-06-08 МорфоСис АГ Средство для лечения множественной миеломы (ММ)
RS61651B1 (sr) * 2015-11-03 2021-04-29 Janssen Biotech Inc Potkožne formulacije anti-cd38 antitela i njihova upotreba
CN109689690B (zh) * 2016-07-15 2023-10-03 武田药品工业株式会社 用于评估对于成浆细胞和浆细胞耗竭性疗法的应答的方法和材料

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012092612A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies

Also Published As

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

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