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

Subcutaneous dosing of anti-cd38 antibodies Download PDF

Info

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
Authority
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
Other languages
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

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
    • 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
    • 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
    • C07K16/30—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)
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 (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

Family Cites Families (18)

* 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
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.
US10533057B2 (en) 2015-05-13 2020-01-14 Morphosys Ag Treatment for multiple myeloma (MM)
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
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

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
JP7526099B2 (ja) 2024-07-31
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
AU2019244478B2 (en) Subcutaneous dosing of anti-CD38 antibodies
US20260103534A1 (en) Subcutaneous administration of anti-cd38 antibodies
TWI564304B (zh) 抗ｃｄ３８抗體
JP2024522360A (ja) 抗ｃｃｒ８抗体及びその使用
IL301764A (en) Anti-CD94 antibodies and methods of using them
RU2810953C2 (ru) Подкожное дозирование антител к cd38
HK40036964A (en) Subcutaneous dosing of anti-cd38 antibodies
EP3980064A1 (en) Combination therapies using cd-38 antibodies
US20250197505A1 (en) Anti-cd94 antibodies and methods of use thereof
RU2782950C2 (ru) Подкожное введение анти-cd38 антител
EP4598962A1 (en) Combination of a btn3a activating antibody, a bcl2 inhibitor and hypomethylating agent for use in treating cancer

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20240315

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250227

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20250227

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250227

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20251006