JP7526099B2 - 抗ｃｄ３８抗体の皮下投薬 - Google Patents

抗ｃｄ３８抗体の皮下投薬 Download PDF

Info

Publication number
JP7526099B2
JP7526099B2 JP2020551797A JP2020551797A JP7526099B2 JP 7526099 B2 JP7526099 B2 JP 7526099B2 JP 2020551797 A JP2020551797 A JP 2020551797A JP 2020551797 A JP2020551797 A JP 2020551797A JP 7526099 B2 JP7526099 B2 JP 7526099B2
Authority
JP
Japan
Prior art keywords
seq
antibody
less
amino acid
cells
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
JP2020551797A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021519295A (ja
JP2021519295A5 (enExample
Inventor
フェディク、エリック
ハンリー、マイケル
パルンボ、アントニオ
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 JP2021519295A publication Critical patent/JP2021519295A/ja
Publication of JP2021519295A5 publication Critical patent/JP2021519295A5/ja
Priority to JP2023218600A priority Critical patent/JP2024045121A/ja
Application granted granted Critical
Publication of JP7526099B2 publication Critical patent/JP7526099B2/ja
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)
JP2020551797A 2018-03-28 2019-03-27 抗ｃｄ３８抗体の皮下投薬 Active JP7526099B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023218600A JP2024045121A (ja) 2018-03-28 2023-12-25 抗ｃｄ３８抗体の皮下投薬

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
JP2023218600A Division JP2024045121A (ja) 2018-03-28 2023-12-25 抗ｃｄ３８抗体の皮下投薬

Publications (3)

Publication Number Publication Date
JP2021519295A JP2021519295A (ja) 2021-08-10
JP2021519295A5 JP2021519295A5 (enExample) 2022-03-23
JP7526099B2 true JP7526099B2 (ja) 2024-07-31

Family

ID=66647425

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2020551797A Active JP7526099B2 (ja) 2018-03-28 2019-03-27 抗ｃｄ３８抗体の皮下投薬
JP2023218600A Pending JP2024045121A (ja) 2018-03-28 2023-12-25 抗ｃｄ３８抗体の皮下投薬

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2023218600A Pending JP2024045121A (ja) 2018-03-28 2023-12-25 抗ｃｄ３８抗体の皮下投薬

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)

* Cited by examiner, † Cited by third party
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014509837A (ja) 2010-12-30 2014-04-24 武田薬品工業株式会社 抗ｃｄ３８抗体
WO2016180958A1 (en) 2015-05-13 2016-11-17 Morphosys Ag Treatment for multiple myeloma (mm)
JP2016536314A (ja) 2013-10-31 2016-11-24 サノフイ ヒトのがんを治療するための特異的抗ｃｄ３８抗体
WO2017079150A1 (en) 2015-11-03 2017-05-11 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses

Family Cites Families (14)

* 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
EP1355919B1 (en) 2000-12-12 2010-11-24 MedImmune, LLC Molecules with extended half-lives, compositions and uses thereof
EP1411851B1 (en) 2001-08-03 2006-11-02 Tyco Healthcare Group LP Marker for use with a tissue marking apparatus
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
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
MA45674A (fr) * 2016-07-15 2019-05-22 Takeda Pharmaceuticals Co Méthodes et matériaux permettant d'évaluer une réponse à des traitements de déplétion de plasmoblastes et de plasmocytes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014509837A (ja) 2010-12-30 2014-04-24 武田薬品工業株式会社 抗ｃｄ３８抗体
JP2016536314A (ja) 2013-10-31 2016-11-24 サノフイ ヒトのがんを治療するための特異的抗ｃｄ３８抗体
WO2016180958A1 (en) 2015-05-13 2016-11-17 Morphosys Ag Treatment for multiple myeloma (mm)
WO2017079150A1 (en) 2015-11-03 2017-05-11 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses

Also Published As

Publication number Publication date
MX2020010144A (es) 2020-12-07
AU2019244478B2 (en) 2025-11-06
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
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

Similar Documents

Publication Publication Date Title
JP2024045121A (ja) 抗ｃｄ３８抗体の皮下投薬
US20260103534A1 (en) Subcutaneous administration of anti-cd38 antibodies
WO2022053656A1 (en) Bispecific antibody against cd3 and cd20 in combination therapy for treating follicular lymphoma
EP4403573A1 (en) Pharmaceutical composition comprising anti-pvrig/tigit bispecific antibody
US11795228B2 (en) Anti-CD94 antibodies and methods of use thereof
AU2021391779A1 (en) Modulating the immune response using anti-cd30 antibody-drug conjugates
RU2810953C2 (ru) Подкожное дозирование антител к cd38
TWI870415B (zh) 使用抗cd38抗體之組合療法
TW202321308A (zh) 使用抗ｔｉｇｉｔ抗體、抗ｃｄ３８抗體及ｐｄ—１軸結合拮抗劑治療血液癌症的方法
HK40036964A (en) Subcutaneous dosing of anti-cd38 antibodies
RU2782950C2 (ru) Подкожное введение анти-cd38 антител
US20250197505A1 (en) Anti-cd94 antibodies and methods of use thereof
JP2025517650A (ja) 抗ＦｃＲＨ５／抗ＣＤ３二重特異性抗体による処置のための投与

Legal Events

Date Code Title Description
A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A525

Effective date: 20201125

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220314

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220314

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230328

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20230526

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230726

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20230926

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20231225

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20240110

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240312

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20240509

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20240702

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20240719

R150 Certificate of patent or registration of utility model

Ref document number: 7526099

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150