CN114269375A - 抗cd38抗体和配制品 - Google Patents

抗cd38抗体和配制品 Download PDF

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Publication number
CN114269375A
CN114269375A CN202080030148.3A CN202080030148A CN114269375A CN 114269375 A CN114269375 A CN 114269375A CN 202080030148 A CN202080030148 A CN 202080030148A CN 114269375 A CN114269375 A CN 114269375A
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CN
China
Prior art keywords
amino acid
antibody
seq
acid sequence
ser
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
CN202080030148.3A
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English (en)
Chinese (zh)
Inventor
B·卡梅伦
B·M·凯龙
J·杜马斯
A·福尼尔
J·金斯伯里
C·莱莫因
B·穆雷
N·奥斯特伯格
S·帕克
A·瓦罗内-奥多斯
Z·张
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.)
Sanofi SA
Original Assignee
Sanofi SA
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 Sanofi SA filed Critical Sanofi SA
Priority to CN202510964194.5A priority Critical patent/CN120757645A/zh
Publication of CN114269375A publication Critical patent/CN114269375A/zh
Pending legal-status Critical Current

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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)
CN202080030148.3A 2019-04-23 2020-04-23 抗cd38抗体和配制品 Pending CN114269375A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202510964194.5A CN120757645A (zh) 2019-04-23 2020-04-23 抗cd38抗体和配制品

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202510964194.5A Division CN120757645A (zh) 2019-04-23 2020-04-23 抗cd38抗体和配制品

Publications (1)

Publication Number Publication Date
CN114269375A true CN114269375A (zh) 2022-04-01

Family

ID=70739160

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202080030148.3A Pending CN114269375A (zh) 2019-04-23 2020-04-23 抗cd38抗体和配制品
CN202510964194.5A Pending CN120757645A (zh) 2019-04-23 2020-04-23 抗cd38抗体和配制品

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202510964194.5A Pending CN120757645A (zh) 2019-04-23 2020-04-23 抗cd38抗体和配制品

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=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120535629A (zh) * 2025-04-22 2025-08-26 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

Families Citing this family (3)

* 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

Citations (4)

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Publication number Priority date Publication date Assignee Title
CN101616933A (zh) * 2006-10-19 2009-12-30 赛诺菲-安万特 用于治疗癌症的新型抗-cd38抗体
CN104203982A (zh) * 2011-10-28 2014-12-10 特瓦制药澳大利亚私人有限公司 多肽构建体及其用途
CN108472369A (zh) * 2015-11-03 2018-08-31 詹森生物科技公司 抗cd38抗体的皮下制剂及其用途
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

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DE602005016683D1 (de) 2004-07-10 2009-10-29 Fox Chase Cancer Ct Genetisch modifizierte, menschliche, natürliche killerzellenlinien:
CN103172731A (zh) * 2004-07-15 2013-06-26 赞科股份有限公司 优化的Fc变体
US10617757B2 (en) * 2014-08-08 2020-04-14 The Regents Of The University Of California Methods for treating multiple myeloma
GEP20217249B (en) * 2016-06-30 2021-04-26 Inc Celltrion Stable liquid pharmaceutical preparation
SG11201910134SA (en) * 2017-05-02 2019-11-28 Merck Sharp & Dohme 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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101616933A (zh) * 2006-10-19 2009-12-30 赛诺菲-安万特 用于治疗癌症的新型抗-cd38抗体
CN104203982A (zh) * 2011-10-28 2014-12-10 特瓦制药澳大利亚私人有限公司 多肽构建体及其用途
CN108472369A (zh) * 2015-11-03 2018-08-31 詹森生物科技公司 抗cd38抗体的皮下制剂及其用途
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

Non-Patent Citations (2)

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Title
DAVID J. DILILLO ET AL.: "Differential Fc-Receptor Engagement Drives an Anti-tumor Vaccinal Effect", CELL, 11 May 2015 (2015-05-11), pages 1039 *
XINHUA WANG ET AL.: "IgG Fc engineering to modulate antibody effector functions", PROTEIN ＆ CELL, 6 October 2017 (2017-10-06), pages 64 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120535629A (zh) * 2025-04-22 2025-08-26 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
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

Also Published As

Publication number Publication date
JP7602485B2 (ja) 2024-12-18
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
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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