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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JP2023560404A
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Japanese (ja)
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JP2024513835A5 (https=
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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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 (https=) 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 (https=)
EP (1) EP4313008A1 (https=)
JP (1) JP2024513835A (https=)
KR (1) KR20230165828A (https=)
AU (1) AU2022246687A1 (https=)
BR (1) BR112023019096A2 (https=)
CA (1) CA3213546A1 (https=)
CL (1) CL2023002922A1 (https=)
CO (1) CO2023014918A2 (https=)
IL (1) IL306042A (https=)
MX (1) MX2023011469A (https=)
TW (1) TW202304507A (https=)
WO (1) WO2022212885A1 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7066690B2 (ja) * 2016-09-23 2022-05-13 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ｍｕｃ１６（ムチン１６）抗体

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 *

Also Published As

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

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