AU2019244478B2 - Subcutaneous dosing of anti-CD38 antibodies - Google Patents

Subcutaneous dosing of anti-CD38 antibodies

Info

Publication number
AU2019244478B2
AU2019244478B2 AU2019244478A AU2019244478A AU2019244478B2 AU 2019244478 B2 AU2019244478 B2 AU 2019244478B2 AU 2019244478 A AU2019244478 A AU 2019244478A AU 2019244478 A AU2019244478 A AU 2019244478A AU 2019244478 B2 AU2019244478 B2 AU 2019244478B2
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AU
Australia
Prior art keywords
seq
less
cells
antibody
amino acid
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.)
Active
Application number
AU2019244478A
Other languages
English (en)
Other versions
AU2019244478A1 (en
Inventor
Eric FEDYK
Michael Hanley
Antonio Palumbo
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
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
Application filed by Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of AU2019244478A1 publication Critical patent/AU2019244478A1/en
Priority to AU2025259859A priority Critical patent/AU2025259859A1/en
Application granted granted Critical
Publication of AU2019244478B2 publication Critical patent/AU2019244478B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

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)
  • 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)
AU2019244478A 2018-03-28 2019-03-27 Subcutaneous dosing of anti-CD38 antibodies Active AU2019244478B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025259859A AU2025259859A1 (en) 2018-03-28 2025-10-29 Subcutaneous dosing of anti-CD38 antibodies

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862649489P 2018-03-28 2018-03-28
US62/649,489 2018-03-28
PCT/IB2019/000314 WO2019186273A1 (en) 2018-03-28 2019-03-27 Subcutaneous dosing of anti-cd38 antibodies

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025259859A Division AU2025259859A1 (en) 2018-03-28 2025-10-29 Subcutaneous dosing of anti-CD38 antibodies

Publications (2)

Publication Number Publication Date
AU2019244478A1 AU2019244478A1 (en) 2020-11-12
AU2019244478B2 true AU2019244478B2 (en) 2025-11-06

Family

ID=66647425

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2019244478A Active AU2019244478B2 (en) 2018-03-28 2019-03-27 Subcutaneous dosing of anti-CD38 antibodies
AU2025259859A Pending AU2025259859A1 (en) 2018-03-28 2025-10-29 Subcutaneous dosing of anti-CD38 antibodies

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025259859A Pending AU2025259859A1 (en) 2018-03-28 2025-10-29 Subcutaneous dosing of anti-CD38 antibodies

Country Status (12)

Country Link
US (1) US20210047427A1 (enExample)
EP (1) EP3774915A1 (enExample)
JP (2) JP7526099B2 (enExample)
KR (2) KR20210002499A (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)

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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
EP3227338A4 (en) 2014-12-04 2018-05-16 Janssen Biotech, Inc. Anti-cd38 antibodies for treatment of acute myeloid leukemia
CR20170526A (es) 2015-05-20 2018-04-03 Janssen Biotech Inc ANTICUERPOS ANTI-CD38 PARA EL TRATAMIENTO DE AMILOIDOSIS DE CADENA LIGERA y OTRAS ENFERMEDADES MALIGNAS HEMATOLÓGICAS POSITIVAS PARA CD38
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
PL3827845T3 (pl) 2015-11-03 2022-07-11 Janssen Biotech, Inc. Formulacje podskórne przeciwciał anty-cd38 i ich zastosowania
US10781261B2 (en) 2015-11-03 2020-09-22 Janssen Biotech, Inc. Subcutaneous formulations of anti-CD38 antibodies and their uses
CA3079242A1 (en) 2017-10-31 2019-05-09 Janssen Biotech, Inc. Methods of treating high risk multiple myeloma
BR112021004130A2 (pt) * 2018-09-11 2021-05-25 Jiangsu Hengrui Medicine Co., Ltd. anticorpo anti-cd38, fragmento de ligação ao antígeno do mesmo, e uso farmacêutico
JP2022512722A (ja) * 2018-10-17 2022-02-07 ヤンセン バイオテツク,インコーポレーテツド 抗cd38抗体の皮下投与を提供する方法
KR20230010659A (ko) * 2020-05-15 2023-01-19 다케다 야쿠힌 고교 가부시키가이샤 Sumo-활성화 효소 억제제 및 항-cd38 항체의 투여
WO2023010031A1 (en) 2021-07-28 2023-02-02 Genentech, Inc. Il15/il15r alpha heterodimeric fc-fusion proteins for the treatment of blood cancers
WO2023045859A1 (zh) * 2021-09-23 2023-03-30 非同(成都)生物科技有限公司 Cd38单克隆抗体及其应用
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 (2)

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WO2012092616A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Conjugated anti-cd38 antibodies
WO2018013917A1 (en) * 2016-07-15 2018-01-18 Takeda Pharmaceutical Company Limited Methods and materials for assessing response to plasmablast- and plasma cell-depleting therapies

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EP0672142B1 (en) 1992-12-04 2001-02-28 Medical Research Council Multivalent and multispecific binding proteins, their manufacture and use
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
PT1355919E (pt) 2000-12-12 2011-03-02 Medimmune Llc Moléculas com semivida longa, composições que as contêm e suas utilizações
US7497862B2 (en) 2001-08-03 2009-03-03 Tyco Healthcare Group Lp Tissue marking apparatus and method
US8188231B2 (en) 2002-09-27 2012-05-29 Xencor, Inc. Optimized FC variants
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US8084582B2 (en) 2003-03-03 2011-12-27 Xencor, Inc. Optimized anti-CD20 monoclonal antibodies having Fc variants
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EA015584B1 (ru) * 2005-03-23 2011-10-31 Генмаб А/С Антитело к cd38 человека и его применение
AR053489A1 (es) 2005-05-24 2007-05-09 Morphosys Ag Generacion perfilado de anticuerpos terapeuticos totalmente derivados de hucal gold humanos especificos para cd38 humano
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Patent Citations (3)

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WO2012092616A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Conjugated anti-cd38 antibodies
WO2012092612A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies
WO2018013917A1 (en) * 2016-07-15 2018-01-18 Takeda Pharmaceutical Company Limited Methods and materials for assessing response to plasmablast- and plasma cell-depleting therapies

Also Published As

Publication number Publication date
US20210047427A1 (en) 2021-02-18
TW202504926A (zh) 2025-02-01
KR20250117714A (ko) 2025-08-05
MX2020010144A (es) 2020-12-07
AU2019244478A1 (en) 2020-11-12
CN112154156A (zh) 2020-12-29
JP2024045121A (ja) 2024-04-02
JP2021519295A (ja) 2021-08-10
WO2019186273A1 (en) 2019-10-03
EP3774915A1 (en) 2021-02-17
TWI847979B (zh) 2024-07-11
TW202003566A (zh) 2020-01-16
WO2019186273A4 (en) 2019-12-19
RU2020135062A3 (enExample) 2022-04-28
AU2025259859A1 (en) 2025-11-27
BR112020019710A2 (pt) 2021-01-26
CO2020013252A2 (es) 2020-11-10
CA3095086A1 (en) 2019-10-03
JP7526099B2 (ja) 2024-07-31
RU2020135062A (ru) 2022-04-28
KR20210002499A (ko) 2021-01-08

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