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
Authority
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

    • 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
    • C07K16/30—Immunoglobulins [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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/2896—Immunoglobulins [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
    • 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
    • C07K16/30—Immunoglobulins [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
    • C07K16/3061—Blood cells
    • 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
    • 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
    • A61K2039/58—Medicinal preparations containing antigens or antibodies raising an immune response against a target which is not the antigen used for immunisation
    • A61K2039/585—Medicinal 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
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • 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)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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 (19)

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Publication number Priority date Publication date Assignee Title
US9603927B2 (en) 2014-02-28 2017-03-28 Janssen Biotech, Inc. Combination therapies with anti-CD38 antibodies
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
PE20171094A1 (es) 2014-12-04 2017-08-07 Janssen Biotech Inc Anticuerpos anti-cd38 para el tratamiento de la leucemia linfoblastica aguda
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
JP7027321B2 (ja) 2015-11-03 2022-03-01 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用
US10781261B2 (en) 2015-11-03 2020-09-22 Janssen Biotech, Inc. Subcutaneous formulations of anti-CD38 antibodies and their uses
WO2018002181A1 (en) 2016-06-28 2018-01-04 Umc Utrecht Holding B.V. TREATMENT OF IgE-MEDIATED DISEASES WITH ANTIBODIES THAT SPECIFICALLY BIND CD38
US11618787B2 (en) 2017-10-31 2023-04-04 Janssen Biotech, Inc. Methods of treating high risk multiple myeloma
CN112513087B (zh) * 2018-09-11 2023-01-24 江苏恒瑞医药股份有限公司 抗cd38抗体、其抗原结合片段及医药用途
MA53920A (fr) * 2018-10-17 2021-09-15 Janssen Biotech Inc Procédé de fourniture d'administration sous-cutanée d'anticorps anti-cd38
AU2020397170A1 (en) * 2019-12-05 2022-07-21 Sanofi-Aventis U.S. Llc Formulations of anti-CD38 antibodies for subcutaneous administration
BR112022023137A2 (pt) * 2020-05-15 2023-02-07 Takeda Pharmaceuticals Co Administração de inibidor de enzima de ativação de sumo e anticorpos anti-cd38
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
US20260217850A1 (en) * 2022-12-21 2026-07-30 Sound Biopharmaceuticals Co. Ltd. Cd38 monoclonal antibody and use thereof
KR20250135226A (ko) 2023-01-06 2025-09-12 다케다 야쿠힌 고교 가부시키가이샤 자가면역 질환의 치료를 위한 항-cd38 항체
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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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

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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
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
EP1355919B1 (en) 2000-12-12 2010-11-24 MedImmune, LLC Molecules with extended half-lives, compositions and uses thereof
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US8084582B2 (en) 2003-03-03 2011-12-27 Xencor, Inc. Optimized anti-CD20 monoclonal antibodies having Fc variants
EP2551282A3 (en) * 2005-03-23 2013-02-13 Genmab A/S Antibodies against CD38 for treatment of multiple myeloma
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
MX373301B (es) 2013-10-31 2020-04-24 Sanofi Sa Anticuerpos anti-cd38 específicos para usarse para tratar cánceres humanos.
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JP7027321B2 (ja) 2015-11-03 2022-03-01 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用

Patent Citations (3)

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WO2012092612A1 (en) * 2010-12-30 2012-07-05 Takeda Pharmaceutical Company Limited Anti-cd38 antibodies
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

Also Published As

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

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