JP2023540025A - 二重特異性ｅｇｆｒ／ｃ－ｍｅｔ抗体を含む安定な製剤 - Google Patents

二重特異性ｅｇｆｒ／ｃ－ｍｅｔ抗体を含む安定な製剤 Download PDF

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JP2023540025A
JP2023540025A JP2023513278A JP2023513278A JP2023540025A JP 2023540025 A JP2023540025 A JP 2023540025A JP 2023513278 A JP2023513278 A JP 2023513278A JP 2023513278 A JP2023513278 A JP 2023513278A JP 2023540025 A JP2023540025 A JP 2023540025A
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storage
pharmaceutical composition
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amino acid
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JP2023540025A5 (https=
Inventor
クペック，ジェシカ
シュライアー，メリッサ
スタール，パトリック
トルネ，サチェン
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ヤンセン バイオテツク，インコーポレーテツド
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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
    • C07K16/2863—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2023513278A 2020-08-26 2021-08-26 二重特異性ｅｇｆｒ／ｃ－ｍｅｔ抗体を含む安定な製剤 Pending JP2023540025A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063070440P 2020-08-26 2020-08-26
US63/070,440 2020-08-26
PCT/IB2021/057802 WO2022043900A1 (en) 2020-08-26 2021-08-26 Stable formulations comprising a bispecific egfr/c-met antibody

Publications (2)

Publication Number Publication Date
JP2023540025A true JP2023540025A (ja) 2023-09-21
JP2023540025A5 JP2023540025A5 (https=) 2024-09-02

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ID=80352835

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JP2023513278A Pending JP2023540025A (ja) 2020-08-26 2021-08-26 二重特異性ｅｇｆｒ／ｃ－ｍｅｔ抗体を含む安定な製剤

Country Status (17)

Country Link
US (1) US20220064307A1 (https=)
EP (1) EP4204456A4 (https=)
JP (1) JP2023540025A (https=)
KR (1) KR20230057400A (https=)
CN (1) CN116194485A (https=)
AR (2) AR123340A1 (https=)
AU (1) AU2021333882A1 (https=)
BR (1) BR112023003373A2 (https=)
CA (1) CA3192630A1 (https=)
CR (1) CR20230102A (https=)
EC (1) ECSP23013655A (https=)
IL (1) IL300895A (https=)
JO (1) JOP20230040A1 (https=)
MX (1) MX2023002367A (https=)
PE (1) PE20231370A1 (https=)
TW (1) TWI907491B (https=)
WO (1) WO2022043900A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202308689A (zh) * 2021-04-21 2023-03-01 美商健生生物科技公司 高濃度的雙特異性抗體調配物
WO2024003837A1 (en) 2022-06-30 2024-01-04 Janssen Biotech, Inc. Use of anti-egfr/anti-met antibody to treat gastric or esophageal cancer
AU2024287954A1 (en) * 2023-07-07 2026-01-22 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Egfr/c-met bispecific binding protein and use thereof
WO2025079020A1 (en) 2023-10-12 2025-04-17 Janssen Biotech, Inc. First line treatment in egfr exon 20 insertion-mutated advanced non-small cell lung cancer
CN121045388A (zh) * 2024-05-30 2025-12-02 英百瑞(杭州)生物医药有限公司 针对人c-Met和人EGFR的双特异性抗体及其用途

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016505537A (ja) * 2012-11-21 2016-02-25 ヤンセン バイオテツク，インコーポレーテツド 二重特異性ＥＧＦＲ／ｃ−Ｍｅｔ抗体
US20190092853A1 (en) * 2017-09-25 2019-03-28 Janssen Biotech, Inc. Safe and Effective Method of Treating Lupus with Anti-IL12/IL23 Antibody
US20190099489A1 (en) * 2017-09-29 2019-04-04 Janssen Biotech, Inc. Novel Formulations Which Stabilize Low Dose Antibody Compositions

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2569409T3 (es) * 2005-03-08 2016-05-10 Pfizer Products Inc. Composiciones de anticuerpo anti-CTLA-4
TW202308689A (zh) * 2021-04-21 2023-03-01 美商健生生物科技公司 高濃度的雙特異性抗體調配物

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016505537A (ja) * 2012-11-21 2016-02-25 ヤンセン バイオテツク，インコーポレーテツド 二重特異性ＥＧＦＲ／ｃ−Ｍｅｔ抗体
US20190092853A1 (en) * 2017-09-25 2019-03-28 Janssen Biotech, Inc. Safe and Effective Method of Treating Lupus with Anti-IL12/IL23 Antibody
US20190099489A1 (en) * 2017-09-29 2019-04-04 Janssen Biotech, Inc. Novel Formulations Which Stabilize Low Dose Antibody Compositions

Also Published As

Publication number Publication date
CA3192630A1 (en) 2022-03-03
AU2021333882A1 (en) 2023-05-11
CN116194485A (zh) 2023-05-30
ECSP23013655A (es) 2023-03-31
AR124067A2 (es) 2023-02-08
EP4204456A1 (en) 2023-07-05
KR20230057400A (ko) 2023-04-28
WO2022043900A1 (en) 2022-03-03
AR123340A1 (es) 2022-11-23
PE20231370A1 (es) 2023-09-07
IL300895A (en) 2023-04-01
JOP20230040A1 (ar) 2023-02-23
TWI907491B (zh) 2025-12-11
US20220064307A1 (en) 2022-03-03
MX2023002367A (es) 2023-05-22
AU2021333882A9 (en) 2023-07-13
EP4204456A4 (en) 2024-09-04
BR112023003373A2 (pt) 2023-04-11
CR20230102A (es) 2023-06-23
TW202227129A (zh) 2022-07-16

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