JP7813703B2 - 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤 - Google Patents

抗cd20×抗cd3二重特異性抗体を含有する安定化製剤

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Publication number
JP7813703B2
JP7813703B2 JP2022535058A JP2022535058A JP7813703B2 JP 7813703 B2 JP7813703 B2 JP 7813703B2 JP 2022535058 A JP2022535058 A JP 2022535058A JP 2022535058 A JP2022535058 A JP 2022535058A JP 7813703 B2 JP7813703 B2 JP 7813703B2
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JP
Japan
Prior art keywords
antibody
human
amino acid
seq
acid sequence
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Active
Application number
JP2022535058A
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English (en)
Japanese (ja)
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JP2023507561A5 (enExample
JP2023507561A (ja
Inventor
ユアン・チェン
シャオリン・タン
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.)
Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Application filed by Regeneron Pharmaceuticals Inc filed Critical Regeneron Pharmaceuticals Inc
Publication of JP2023507561A publication Critical patent/JP2023507561A/ja
Publication of JP2023507561A5 publication Critical patent/JP2023507561A5/ja
Priority to JP2025175127A priority Critical patent/JP2026016480A/ja
Application granted granted Critical
Publication of JP7813703B2 publication Critical patent/JP7813703B2/ja
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Classifications

    • 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
    • A61K47/22—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
    • A61K9/08—Solutions
    • 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
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • 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
    • C07K2317/72—Increased effector function due to an Fc-modification
    • 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)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2022535058A 2019-12-10 2020-12-09 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤 Active JP7813703B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025175127A JP2026016480A (ja) 2019-12-10 2025-10-17 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962946207P 2019-12-10 2019-12-10
US62/946,207 2019-12-10
PCT/US2020/064025 WO2021119135A1 (en) 2019-12-10 2020-12-09 Stabilized formulations containing anti-cd20 x anti-cd3 bispecific antibodies

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025175127A Division JP2026016480A (ja) 2019-12-10 2025-10-17 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤

Publications (3)

Publication Number Publication Date
JP2023507561A JP2023507561A (ja) 2023-02-24
JP2023507561A5 JP2023507561A5 (enExample) 2023-12-18
JP7813703B2 true JP7813703B2 (ja) 2026-02-13

Family

ID=74141846

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022535058A Active JP7813703B2 (ja) 2019-12-10 2020-12-09 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤
JP2025175127A Pending JP2026016480A (ja) 2019-12-10 2025-10-17 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025175127A Pending JP2026016480A (ja) 2019-12-10 2025-10-17 抗cd20×抗cd3二重特異性抗体を含有する安定化製剤

Country Status (15)

Country Link
US (2) US20210206870A1 (enExample)
EP (1) EP4072585A1 (enExample)
JP (2) JP7813703B2 (enExample)
KR (1) KR20220113417A (enExample)
CN (1) CN115003331A (enExample)
AU (1) AU2020402030A1 (enExample)
BR (1) BR112022011150A2 (enExample)
CA (1) CA3161059A1 (enExample)
CL (3) CL2022001495A1 (enExample)
CO (1) CO2022008684A2 (enExample)
IL (1) IL293372A (enExample)
MY (1) MY210570A (enExample)
PH (1) PH12022551275A1 (enExample)
TW (1) TW202135860A (enExample)
WO (1) WO2021119135A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202400228A (zh) 2022-02-25 2024-01-01 美商再生元醫藥公司 減輕細胞激素釋放症候群的給藥方案

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019023102A1 (en) 2017-07-24 2019-01-31 Regeneron Pharmaceuticals, Inc. STABILIZED ANTIBODY COMPOSITIONS AND METHODS FOR PRODUCING SAME

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JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
US6629949B1 (en) 2000-05-08 2003-10-07 Sterling Medivations, Inc. Micro infusion drug delivery device
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
ES2537738T3 (es) * 2003-06-05 2015-06-11 Genentech, Inc. Terapia de combinación para trastornos de células B
EP2225275A4 (en) * 2007-11-28 2013-04-03 Medimmune Llc PROTEIN FORMULATION
JP2012041317A (ja) * 2010-08-23 2012-03-01 Panasonic Corp フェロセン修飾抗体
WO2012135408A1 (en) * 2011-03-31 2012-10-04 Merck Sharp & Dohme Corp. Stable formulations of antibodies to human programmed death receptor pd-1 and related treatments
JOP20200236A1 (ar) 2012-09-21 2017-06-16 Regeneron Pharma الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها
HUE050159T2 (hu) * 2013-12-17 2020-11-30 Genentech Inc Anti-CD3 antitestek és alkalmazási eljárások
ES2809455T3 (es) * 2014-11-17 2021-03-04 Regeneron Pharma Métodos para tratamiento tumoral usando anticuerpo biespecífico CD3xCD20
CN108602889A (zh) * 2015-12-22 2018-09-28 瑞泽恩制药公司 医治急性成淋巴细胞性白血病的双特异性抗cd20/抗cd3抗体
MA49960A (fr) * 2017-08-25 2021-06-02 Omeros Corp Formulations d'anticorps inhibiteurs de masp-2 hautement concentrées à faible viscosité, kits et méthodes de traitement de sujets souffrant d'un syndrome hémolytique atypique
CA3202891A1 (en) * 2021-01-28 2022-08-04 Kara Olson Compositions and methods for treating cytokine release syndrome

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019023102A1 (en) 2017-07-24 2019-01-31 Regeneron Pharmaceuticals, Inc. STABILIZED ANTIBODY COMPOSITIONS AND METHODS FOR PRODUCING SAME

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SCIENTIFIC REPORTS,2015年11月11日,Vol. 5, 17943,p. 1-12,DOI: 10.1038/srep17943

Also Published As

Publication number Publication date
CA3161059A1 (en) 2021-06-17
MY210570A (en) 2025-09-30
WO2021119135A1 (en) 2021-06-17
US20210206870A1 (en) 2021-07-08
CN115003331A (zh) 2022-09-02
TW202135860A (zh) 2021-10-01
EP4072585A1 (en) 2022-10-19
JP2026016480A (ja) 2026-02-03
IL293372A (en) 2022-07-01
US20250236677A1 (en) 2025-07-24
KR20220113417A (ko) 2022-08-12
BR112022011150A2 (pt) 2022-08-23
PH12022551275A1 (en) 2024-01-08
JP2023507561A (ja) 2023-02-24
AU2020402030A1 (en) 2022-07-28
CL2022001495A1 (es) 2023-01-13
CL2024001536A1 (es) 2024-10-18
CL2024003444A1 (es) 2025-04-11
CO2022008684A2 (es) 2022-06-30

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