JP2024513835A - 抗ｍｕｃ１６×抗ｃｄ３二重特異性抗体を含有する安定化製剤 - Google Patents

抗ｍｕｃ１６×抗ｃｄ３二重特異性抗体を含有する安定化製剤 Download PDF

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Publication number
JP2024513835A
JP2024513835A JP2023560404A JP2023560404A JP2024513835A JP 2024513835 A JP2024513835 A JP 2024513835A JP 2023560404 A JP2023560404 A JP 2023560404A JP 2023560404 A JP2023560404 A JP 2023560404A JP 2024513835 A JP2024513835 A JP 2024513835A
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seq
amino acid
pharmaceutical formulation
antigen
concentration
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Japanese (ja)
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JP2024513835A5 (enExample
Inventor
ダグラス・カーメン
テン－チー・ヤン
シャオビン・シュイ
ハイボ・チウ
ケネス・グレアム
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Regeneron Pharmaceuticals Inc
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Regeneron Pharmaceuticals Inc
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Publication of JP2024513835A publication Critical patent/JP2024513835A/ja
Publication of JP2024513835A5 publication Critical patent/JP2024513835A5/ja
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    • 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
    • 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
    • C07K16/3076—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 against structure-related tumour-associated moieties
    • C07K16/3092—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 against structure-related tumour-associated moieties against tumour-associated mucins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • 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
    • 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
    • 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
    • C07K2317/56—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
    • C07K2317/90—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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
JP2023560404A 2021-04-02 2022-04-01 抗ｍｕｃ１６×抗ｃｄ３二重特異性抗体を含有する安定化製剤 Pending JP2024513835A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163170320P 2021-04-02 2021-04-02
US63/170,320 2021-04-02
US202263313927P 2022-02-25 2022-02-25
US63/313,927 2022-02-25
PCT/US2022/023122 WO2022212885A1 (en) 2021-04-02 2022-04-01 Stabilized formulations containing anti-muc16 x anti-cd3 bispecific antibodies

Publications (2)

Publication Number Publication Date
JP2024513835A true JP2024513835A (ja) 2024-03-27
JP2024513835A5 JP2024513835A5 (enExample) 2025-04-08

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ID=81579790

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JP2023560404A Pending JP2024513835A (ja) 2021-04-02 2022-04-01 抗ｍｕｃ１６×抗ｃｄ３二重特異性抗体を含有する安定化製剤

Country Status (13)

Country Link
US (1) US20220332849A1 (enExample)
EP (1) EP4313008A1 (enExample)
JP (1) JP2024513835A (enExample)
KR (1) KR20230165828A (enExample)
AU (1) AU2022246687A1 (enExample)
BR (1) BR112023019096A2 (enExample)
CA (1) CA3213546A1 (enExample)
CL (1) CL2023002922A1 (enExample)
CO (1) CO2023014918A2 (enExample)
IL (1) IL306042A (enExample)
MX (1) MX2023011469A (enExample)
TW (1) TW202304507A (enExample)
WO (1) WO2022212885A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102531251B1 (ko) * 2016-09-23 2023-05-15 리제너론 파아마슈티컬스, 인크. 이특이적 항-muc16-cd3 항체 및 항-muc16 약물 접합체

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005530845A (ja) * 2002-06-21 2005-10-13 アイデック ファーマシューティカルズ コーポレイション 抗体を濃縮するための緩衝化処方物およびその使用方法
JP2013543505A (ja) * 2010-10-06 2013-12-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン−４受容体（ｉｌ−４ｒ）抗体を含有する安定化製剤
JP2019504086A (ja) * 2016-02-03 2019-02-14 オンコバイオロジクス，インコーポレイティド 抗体安定性を増大させるための緩衝液製剤
JP2019536740A (ja) * 2016-09-23 2019-12-19 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 二重特異性抗ｍｕｃ１６−ｃｄ３抗体および抗ｍｕｃ１６薬物複合体

Family Cites Families (6)

* 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
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
WO2016036678A1 (en) * 2014-09-02 2016-03-10 Medimmune, Llc Formulations of bispecific antibodies

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005530845A (ja) * 2002-06-21 2005-10-13 アイデック ファーマシューティカルズ コーポレイション 抗体を濃縮するための緩衝化処方物およびその使用方法
JP2013543505A (ja) * 2010-10-06 2013-12-05 リジェネロン・ファーマシューティカルズ・インコーポレイテッド 抗インターロイキン−４受容体（ｉｌ−４ｒ）抗体を含有する安定化製剤
JP2019504086A (ja) * 2016-02-03 2019-02-14 オンコバイオロジクス，インコーポレイティド 抗体安定性を増大させるための緩衝液製剤
JP2019536740A (ja) * 2016-09-23 2019-12-19 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 二重特異性抗ｍｕｃ１６−ｃｄ３抗体および抗ｍｕｃ１６薬物複合体

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BIOL PHARM BULL, vol. vol. 33(8), JPN6026006748, 2010, pages 1413 - 1417, ISSN: 0005802364 *
MABS, vol. vol. 9(4), JPN6026006749, 7 April 2017 (2017-04-07), pages 586 - 594, ISSN: 0005802365 *

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Publication number Publication date
WO2022212885A1 (en) 2022-10-06
CA3213546A1 (en) 2022-10-06
MX2023011469A (es) 2024-02-01
EP4313008A1 (en) 2024-02-07
CL2023002922A1 (es) 2024-03-08
AU2022246687A1 (en) 2023-10-12
AU2022246687A9 (en) 2023-10-26
KR20230165828A (ko) 2023-12-05
US20220332849A1 (en) 2022-10-20
BR112023019096A2 (pt) 2023-12-05
CO2023014918A2 (es) 2023-11-20
TW202304507A (zh) 2023-02-01
IL306042A (en) 2023-11-01

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