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
JPWO2019186273A5 (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 JPWO2019186273A5 publication Critical patent/JPWO2019186273A5/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

    • 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)
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
JPWO2019186273A5 JPWO2019186273A5 (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 (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
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 (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
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
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
US20070148170A1 (en) 2005-10-03 2007-06-28 Desjarlais John R Fc Variants With Optimized Fc Receptor Binding Properties
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
BR112019000544A2 (pt) * 2016-07-15 2019-04-24 Takeda Pharmaceutical Company Limited métodos e materiais para avaliar resposta a terapias de plasmoblasto- e depleção celular plasmática

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
US20210047427A1 (en) 2021-02-18
TW202504926A (zh) 2025-02-01
AU2019244478B2 (en) 2025-11-06
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
RU2020135062A (ru) 2022-04-28
KR20210002499A (ko) 2021-01-08

Similar Documents

Publication Publication Date Title
JP7526099B2 (ja) 抗cd38抗体の皮下投薬
US12371506B2 (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
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