JP7602485B2 - 抗ｃｄ３８抗体および製剤 - Google Patents

抗ｃｄ３８抗体および製剤 Download PDF

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JP7602485B2
JP7602485B2 JP2021562989A JP2021562989A JP7602485B2 JP 7602485 B2 JP7602485 B2 JP 7602485B2 JP 2021562989 A JP2021562989 A JP 2021562989A JP 2021562989 A JP2021562989 A JP 2021562989A JP 7602485 B2 JP7602485 B2 JP 7602485B2
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antibody
amino acid
seq
acid sequence
heavy chain
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JPWO2020219681A5 (https=
JP2022529502A5 (https=
JP2022529502A (ja
Inventor
ベアトリス・カメロン
マリエル・シロン・ブロンデル
ジャック・デュマ
アラン・フルニエ
ジョナサン・キングスベリー
センドリーヌ・レモワーヌ
ブライアン・マリー
ネイサン・オストバーグ
サンケット・パッケ
アンジェラ・ヴィロン－オッドス
ジシュアン・ジャン
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Sanofi SA
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Sanofi SA
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    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/72—Increased effector function due to an Fc-modification
    • 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
    • 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
    • C07K2317/70—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
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
JP2021562989A 2019-04-23 2020-04-23 抗ｃｄ３８抗体および製剤 Active JP7602485B2 (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962837518P 2019-04-23 2019-04-23
US62/837,518 2019-04-23
US201962859699P 2019-06-10 2019-06-10
US62/859,699 2019-06-10
EP20305146 2020-02-17
EP20305146.1 2020-02-17
EP20305145 2020-02-17
EP20305145.3 2020-02-17
PCT/US2020/029531 WO2020219681A1 (en) 2019-04-23 2020-04-23 Anti-cd38 antibodies and formulations

Publications (4)

Publication Number Publication Date
JP2022529502A JP2022529502A (ja) 2022-06-22
JPWO2020219681A5 JPWO2020219681A5 (https=) 2023-05-01
JP2022529502A5 JP2022529502A5 (https=) 2023-05-01
JP7602485B2 true JP7602485B2 (ja) 2024-12-18

Family

ID=70739160

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2021562989A Active JP7602485B2 (ja) 2019-04-23 2020-04-23 抗ｃｄ３８抗体および製剤

Country Status (15)

Country Link
EP (1) EP3958898A1 (https=)
JP (1) JP7602485B2 (https=)
KR (1) KR20220003562A (https=)
CN (2) CN114269375A (https=)
AU (1) AU2020261039A1 (https=)
BR (1) BR112021021060A2 (https=)
CA (1) CA3137365A1 (https=)
CO (1) CO2021015462A2 (https=)
IL (1) IL287477A (https=)
MA (1) MA55761A (https=)
MX (1) MX2021012967A (https=)
MY (1) MY206426A (https=)
SG (1) SG11202111602YA (https=)
TW (1) TWI878289B (https=)
WO (1) WO2020219681A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023109928A1 (zh) * 2021-12-16 2023-06-22 上海宝济药业有限公司 抗免疫球蛋白降解酶酶切的Fc变体
WO2024023843A1 (en) * 2022-07-26 2024-02-01 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2025245526A1 (en) * 2024-05-24 2025-11-27 Research Institute At Nationwide Children's Hospital Cd-38 protein binding compositions and methods related thereto
CN120535629B (zh) * 2025-04-22 2026-01-23 西安市中心血站（陕西省血液中心） 一种用于抑制cd38单抗对输血相容性检测干扰的抗体

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008505174A (ja) 2004-07-15 2008-02-21 ゼンコー・インコーポレイテッド 最適化Ｆｃ変異体
JP2010506582A (ja) 2006-10-19 2010-03-04 サノフイ−アベンテイス 癌の治療のための新規抗ｃｄ３８抗体
US20170224817A1 (en) 2014-08-08 2017-08-10 The Regents Of The University Of California Methods for treating multiple myeloma
CN108752475A (zh) 2018-06-14 2018-11-06 北京智仁美博生物科技有限公司 抗人cd38抗体及其用途
WO2018204343A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2019064263A1 (en) 2017-09-29 2019-04-04 Janssen Biotech, Inc. NOVEL FORMULATIONS FOR STABILIZING LOW DOSE ANTIBODY COMPOSITIONS

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE602005016683D1 (de) 2004-07-10 2009-10-29 Fox Chase Cancer Ct Genetisch modifizierte, menschliche, natürliche killerzellenlinien:
SG10201603411WA (en) * 2011-10-28 2016-07-28 Teva Pharmaceuticals Australia Pty Ltd Polypeptide constructs and uses thereof
DK3827845T3 (da) * 2015-11-03 2022-05-23 Janssen Biotech Inc Subkutane formuleringer af anti-cd38-antistoffer og anvendelser deraf
GEP20217249B (en) * 2016-06-30 2021-04-26 Inc Celltrion Stable liquid pharmaceutical preparation

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008505174A (ja) 2004-07-15 2008-02-21 ゼンコー・インコーポレイテッド 最適化Ｆｃ変異体
JP2010506582A (ja) 2006-10-19 2010-03-04 サノフイ−アベンテイス 癌の治療のための新規抗ｃｄ３８抗体
US20170224817A1 (en) 2014-08-08 2017-08-10 The Regents Of The University Of California Methods for treating multiple myeloma
WO2018204343A1 (en) 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2019064263A1 (en) 2017-09-29 2019-04-04 Janssen Biotech, Inc. NOVEL FORMULATIONS FOR STABILIZING LOW DOSE ANTIBODY COMPOSITIONS
CN108752475A (zh) 2018-06-14 2018-11-06 北京智仁美博生物科技有限公司 抗人cd38抗体及其用途

Also Published As

Publication number Publication date
CN120757645A (zh) 2025-10-10
BR112021021060A2 (pt) 2021-12-14
IL287477A (en) 2021-12-01
WO2020219681A1 (en) 2020-10-29
MX2021012967A (es) 2022-01-18
KR20220003562A (ko) 2022-01-10
EP3958898A1 (en) 2022-03-02
CO2021015462A2 (es) 2021-12-10
MA55761A (fr) 2022-03-02
JP2022529502A (ja) 2022-06-22
CN114269375A (zh) 2022-04-01
CA3137365A1 (en) 2020-10-29
MY206426A (en) 2024-12-17
SG11202111602YA (en) 2021-11-29
AU2020261039A1 (en) 2021-12-09
TW202104269A (zh) 2021-02-01
TWI878289B (zh) 2025-04-01

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