CA3095086A1 - Subcutaneous dosing of anti-cd38 antibodies - Google Patents

Subcutaneous dosing of anti-cd38 antibodies Download PDF

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Publication number
CA3095086A1
CA3095086A1 CA3095086A CA3095086A CA3095086A1 CA 3095086 A1 CA3095086 A1 CA 3095086A1 CA 3095086 A CA3095086 A CA 3095086A CA 3095086 A CA3095086 A CA 3095086A CA 3095086 A1 CA3095086 A1 CA 3095086A1
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CA
Canada
Prior art keywords
seq
less
antibody
amino acid
suitably
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
CA3095086A
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English (en)
French (fr)
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 CA3095086A1 publication Critical patent/CA3095086A1/en
Pending legal-status Critical Current

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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
    • 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
    • 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
    • C07K16/30Immunoglobulins [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)
  • 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)
CA3095086A 2018-03-28 2019-03-27 Subcutaneous dosing of anti-cd38 antibodies Pending CA3095086A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3095086A1 true CA3095086A1 (en) 2019-10-03

Family

ID=66647425

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3095086A Pending CA3095086A1 (en) 2018-03-28 2019-03-27 Subcutaneous dosing of anti-cd38 antibodies

Country Status (12)

Country Link
US (1) US20210047427A1 (cg-RX-API-DMAC7.html)
EP (1) EP3774915A1 (cg-RX-API-DMAC7.html)
JP (2) JP7526099B2 (cg-RX-API-DMAC7.html)
KR (2) KR20210002499A (cg-RX-API-DMAC7.html)
CN (1) CN112154156A (cg-RX-API-DMAC7.html)
AU (2) AU2019244478B2 (cg-RX-API-DMAC7.html)
BR (1) BR112020019710A2 (cg-RX-API-DMAC7.html)
CA (1) CA3095086A1 (cg-RX-API-DMAC7.html)
CO (1) CO2020013252A2 (cg-RX-API-DMAC7.html)
MX (1) MX2020010144A (cg-RX-API-DMAC7.html)
TW (2) TW202504926A (cg-RX-API-DMAC7.html)
WO (1) WO2019186273A1 (cg-RX-API-DMAC7.html)

Families Citing this family (18)

* 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
PE20171094A1 (es) 2014-12-04 2017-08-07 Janssen Biotech Inc Anticuerpos anti-cd38 para el tratamiento de la leucemia linfoblastica aguda
BR112017024877A2 (pt) 2015-05-20 2019-09-17 Janssen Biotech, Inc. anticorpo anti-cd38 e seu uso no tratamento de amiloidose de cadeia leve e outras malignidades 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
US10781261B2 (en) 2015-11-03 2020-09-22 Janssen Biotech, Inc. Subcutaneous formulations of anti-CD38 antibodies and their uses
ES2912729T3 (es) 2015-11-03 2022-05-27 Janssen Biotech Inc Formulaciones subcutáneas de anticuerpos anti-CD38 y sus usos
CN111565751A (zh) 2017-10-31 2020-08-21 詹森生物科技公司 治疗高危多发性骨髓瘤的方法
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
CA3116878A1 (en) * 2018-10-17 2020-04-23 Janssen Biotech, Inc. Method of providing subcutaneous administration of anti-cd38 antibodies
EP4069743A1 (en) * 2019-12-05 2022-10-12 Sanofi-Aventis U.S. LLC Formulations of anti-cd38 antibodies for subcutaneous administration
MX2022014297A (es) * 2020-05-15 2023-02-09 Takeda Pharmaceuticals Co Administración del inhibidor de la enzima activadora (sae) del modificador similar a la ubiquitina pequeña (sumo) y anticuerpos anti cúmulo de diferenciación 38 (cd38).
EP4376869A1 (en) 2021-07-28 2024-06-05 Genentech, Inc. Il15/il15r alpha heterodimeric fc-fusion proteins for the treatment of blood cancers
AU2022350815A1 (en) * 2021-09-23 2024-05-02 Sound Biopharmaceuticals Co. Ltd. Cd38 monoclonal antibody and application thereof
AU2023412139A1 (en) * 2022-12-21 2025-06-19 Sound Biopharmaceuticals Co. Ltd. Cd38 monoclonal antibody and use thereof
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

Family Cites Families (18)

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JP3720353B2 (ja) 1992-12-04 2005-11-24 メディカル リサーチ カウンシル 多価および多重特異性の結合タンパク質、それらの製造および使用
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
US7317091B2 (en) 2002-03-01 2008-01-08 Xencor, Inc. Optimized Fc variants
US8188231B2 (en) 2002-09-27 2012-05-29 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
CA2602375C (en) * 2005-03-23 2018-07-24 Genmab A/S Antibodies against cd38 for treatment of multiple myeloma
EP2799451A1 (en) 2005-05-24 2014-11-05 MorphoSys AG Generation and profiling of fully human HuCAL GOLD®-derived therapeutic antibodies specific for human CD38
EP1931709B1 (en) 2005-10-03 2016-12-07 Xencor, Inc. Fc variants with optimized fc receptor binding properties
JOP20210044A1 (ar) * 2010-12-30 2017-06-16 Takeda Pharmaceuticals Co الأجسام المضادة لـ cd38
MX373301B (es) * 2013-10-31 2020-04-24 Sanofi Sa Anticuerpos anti-cd38 específicos para usarse para tratar cánceres humanos.
HRP20210552T1 (hr) * 2015-05-13 2021-05-14 Morphosys Ag Liječenje multiplog mijeloma (mm)
ES2912729T3 (es) * 2015-11-03 2022-05-27 Janssen Biotech Inc Formulaciones subcutáneas de anticuerpos anti-CD38 y sus usos
JP7316930B2 (ja) * 2016-07-15 2023-07-28 武田薬品工業株式会社 形質芽細胞及び形質細胞枯渇療法に対する応答を評価するための方法及び材料

Also Published As

Publication number Publication date
KR20250117714A (ko) 2025-08-05
RU2020135062A3 (cg-RX-API-DMAC7.html) 2022-04-28
TW202504926A (zh) 2025-02-01
BR112020019710A2 (pt) 2021-01-26
MX2020010144A (es) 2020-12-07
JP2021519295A (ja) 2021-08-10
CO2020013252A2 (es) 2020-11-10
AU2019244478A1 (en) 2020-11-12
EP3774915A1 (en) 2021-02-17
KR20210002499A (ko) 2021-01-08
JP7526099B2 (ja) 2024-07-31
AU2019244478B2 (en) 2025-11-06
US20210047427A1 (en) 2021-02-18
WO2019186273A1 (en) 2019-10-03
TW202003566A (zh) 2020-01-16
CN112154156A (zh) 2020-12-29
RU2020135062A (ru) 2022-04-28
JP2024045121A (ja) 2024-04-02
AU2025259859A1 (en) 2025-11-27
WO2019186273A4 (en) 2019-12-19
TWI847979B (zh) 2024-07-11

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