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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Japan
Prior art keywords
antibody
human
amino acid
seq
acid sequence
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JP2022535058A
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English (en)
Japanese (ja)
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JP2023507561A (ja
JP2023507561A5 (https=
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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Publication of JP2023507561A publication Critical patent/JP2023507561A/ja
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Priority to JP2025175127A priority Critical patent/JP2026016480A/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2809Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/10Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14Specific host cells or culture conditions, e.g. components, pH or temperature
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • 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
    • C07K2317/72Increased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, 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 (https=) 2023-12-18
JP7813703B2 true JP7813703B2 (ja) 2026-02-13

Family

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

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

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US6659982B2 (en) 2000-05-08 2003-12-09 Sterling Medivations, Inc. Micro infusion drug delivery device
US6629949B1 (en) 2000-05-08 2003-10-07 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
JP2007526220A (ja) * 2003-06-05 2007-09-13 ジェネンテック・インコーポレーテッド B細胞疾患の併用療法
WO2009070642A1 (en) * 2007-11-28 2009-06-04 Medimmune, Llc Protein formulation
JP2012041317A (ja) * 2010-08-23 2012-03-01 Panasonic Corp フェロセン修飾抗体
PT2691112T (pt) * 2011-03-31 2018-07-10 Merck Sharp & Dohme Formulações estáveis de anticorpos para o recetor pd-1 humano de morte programada e tratamentos relacionados
JOP20200236A1 (ar) 2012-09-21 2017-06-16 Regeneron Pharma الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها
IL263466B2 (en) * 2013-12-17 2023-10-01 Genentech Inc Anti-CD3 antibodies and methods of using them
KR102614189B1 (ko) * 2014-11-17 2023-12-18 리제너론 파아마슈티컬스, 인크. Cd3xcd20 이특이적 항체를 이용한 종양의 치료 방법
AU2016378573A1 (en) * 2015-12-22 2018-07-19 Regeneron Pharmaceuticals, Inc. Bispecific anti-CD20/anti-CD3 antibodies to treat acute lymphoblastic leukemia
KR20200037863A (ko) * 2017-08-25 2020-04-09 오메로스 코포레이션 고도로 농축된 저점도 masp-2 억제 항체 제제, 키트, 및 비정형 용혈성 증후군을 앓고 있는 대상체의 치료 방법
AU2022214319A1 (en) * 2021-01-28 2023-08-03 Regeneron Pharmaceuticals, Inc. 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
PH12022551275A1 (en) 2024-01-08
US20250236677A1 (en) 2025-07-24
KR20220113417A (ko) 2022-08-12
CN115003331A (zh) 2022-09-02
CL2024001536A1 (es) 2024-10-18
CL2024003444A1 (es) 2025-04-11
TW202135860A (zh) 2021-10-01
MY210570A (en) 2025-09-30
US20210206870A1 (en) 2021-07-08
CA3161059A1 (en) 2021-06-17
EP4072585A1 (en) 2022-10-19
JP2023507561A (ja) 2023-02-24
JP2026016480A (ja) 2026-02-03
BR112022011150A2 (pt) 2022-08-23
WO2021119135A1 (en) 2021-06-17
CL2022001495A1 (es) 2023-01-13
IL293372A (en) 2022-07-01
AU2020402030A1 (en) 2022-07-28
CO2022008684A2 (es) 2022-06-30

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