TWI907491B - 包括雙特異性egfr/c-met抗體之穩定調配物 - Google Patents

包括雙特異性egfr/c-met抗體之穩定調配物

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Publication number
TWI907491B
TWI907491B TW110131219A TW110131219A TWI907491B TW I907491 B TWI907491 B TW I907491B TW 110131219 A TW110131219 A TW 110131219A TW 110131219 A TW110131219 A TW 110131219A TW I907491 B TWI907491 B TW I907491B
Authority
TW
Taiwan
Prior art keywords
approximately
longer
months
seq
amino acid
Prior art date
Application number
TW110131219A
Other languages
English (en)
Chinese (zh)
Other versions
TW202227129A (zh
Inventor
傑西卡 庫佩克
梅麗莎 施萊爾
帕特里克 斯塔爾
薩蒂 托恩
Original Assignee
美商健生生物科技公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 美商健生生物科技公司 filed Critical 美商健生生物科技公司
Publication of TW202227129A publication Critical patent/TW202227129A/zh
Application granted granted Critical
Publication of TWI907491B publication Critical patent/TWI907491B/zh

Links

Classifications

    • 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
    • A61K47/16—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
    • A61K47/22—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
    • A61K9/0012—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
    • 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
    • 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

Landscapes

  • 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)
TW110131219A 2020-08-26 2021-08-24 包括雙特異性egfr/c-met抗體之穩定調配物 TWI907491B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063070440P 2020-08-26 2020-08-26
US63/070,440 2020-08-26

Publications (2)

Publication Number Publication Date
TW202227129A TW202227129A (zh) 2022-07-16
TWI907491B true TWI907491B (zh) 2025-12-11

Family

ID=80352835

Family Applications (1)

Application Number Title Priority Date Filing Date
TW110131219A TWI907491B (zh) 2020-08-26 2021-08-24 包括雙特異性egfr/c-met抗體之穩定調配物

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

Family Cites Families (5)

* 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
MX361088B (es) * 2012-11-21 2018-11-26 Janssen Biotech Inc Anticuerpos del receptor del factor de crecimiento epidérmico aislado/del receptor del factor de crecimiento de hepatocitos (egfr/c-met) biespecíficos.
TW201922780A (zh) * 2017-09-25 2019-06-16 美商健生生物科技公司 以抗ｉｌ１２／ｉｌ２３抗體治療狼瘡之安全且有效之方法
JP2020535181A (ja) * 2017-09-29 2020-12-03 ヤンセン バイオテツク，インコーポレーテツド 低用量抗体組成物を安定化する新規製剤
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
網路文獻 Jichao Kang, Xi Lin, Jason Penera. "Rapid Formulation Development for Monoclonal Antibodies" BIOPROCESS INTERNATIONAL, INFORMA LIFE SCIENCES GROUP 12 April 2016 https://www.bioprocessintl.com/formulation/rapid-formulation-development-for-monoclonal-antibodies

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
US20220064307A1 (en) 2022-03-03
JP2023540025A (ja) 2023-09-21
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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