TW202535466A - 抗-il-23p19抗體調配物 - Google Patents

抗-il-23p19抗體調配物

Info

Publication number
TW202535466A
TW202535466A TW113142787A TW113142787A TW202535466A TW 202535466 A TW202535466 A TW 202535466A TW 113142787 A TW113142787 A TW 113142787A TW 113142787 A TW113142787 A TW 113142787A TW 202535466 A TW202535466 A TW 202535466A
Authority
TW
Taiwan
Prior art keywords
formulation
antibody
less
storage
months
Prior art date
Application number
TW113142787A
Other languages
English (en)
Chinese (zh)
Inventor
派翠克 嘉理道爾
法登瑞齊特 托斯坦 史丘茲
Original Assignee
德商百靈佳殷格翰國際股份有限公司
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 德商百靈佳殷格翰國際股份有限公司 filed Critical 德商百靈佳殷格翰國際股份有限公司
Publication of TW202535466A publication Critical patent/TW202535466A/zh

Links

Classifications

    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
TW113142787A 2019-09-09 2020-09-08 抗-il-23p19抗體調配物 TW202535466A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962897930P 2019-09-09 2019-09-09
US62/897,930 2019-09-09

Publications (1)

Publication Number Publication Date
TW202535466A true TW202535466A (zh) 2025-09-16

Family

ID=72615913

Family Applications (2)

Application Number Title Priority Date Filing Date
TW109130792A TW202123965A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物
TW113142787A TW202535466A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物

Family Applications Before (1)

Application Number Title Priority Date Filing Date
TW109130792A TW202123965A (zh) 2019-09-09 2020-09-08 抗-il-23p19抗體調配物

Country Status (14)

Country Link
US (1) US20210070852A1 (enExample)
EP (1) EP4028419A1 (enExample)
JP (2) JP2022547162A (enExample)
KR (1) KR20220062359A (enExample)
CN (1) CN114340674A (enExample)
AU (1) AU2020345071A1 (enExample)
BR (1) BR112022003169A2 (enExample)
CA (1) CA3147328A1 (enExample)
CL (1) CL2024002086A1 (enExample)
IL (1) IL291131A (enExample)
MX (1) MX2022002850A (enExample)
PH (1) PH12022550558A1 (enExample)
TW (2) TW202123965A (enExample)
WO (1) WO2021048743A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL307578A (en) 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
CA3164996A1 (en) 2019-12-20 2021-06-14 Novarock Biotherapeutics, Ltd. Anti-interleukin-23 p19 antibodies and methods of use thereof
WO2023019556A1 (zh) * 2021-08-20 2023-02-23 齐鲁制药有限公司 一种高浓度抗her2的抗体制剂及其用途
AU2023292491A1 (en) * 2022-06-15 2024-12-19 Abbvie Inc. Risankizumab compositions
KR20240058012A (ko) * 2022-10-21 2024-05-03 주식회사 종근당 안정한 항체 조성물
WO2025071362A1 (ko) * 2023-09-27 2025-04-03 삼성바이오에피스 주식회사 항-il-23 항체의 안정한 액상 제형
WO2025137347A1 (en) * 2023-12-20 2025-06-26 Abbvie Inc. High concentration risankizumab formulations

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE216590T1 (de) * 1995-02-06 2002-05-15 Genetics Inst Arzneimittelformulierungen für il-12
IL161677A0 (en) * 2001-11-08 2004-09-27 Protein Design Labs Stable liquid pharmaceutical formulation of igg antibodies
ES2410406T3 (es) * 2005-06-30 2013-07-01 Janssen Biotech, Inc. Anticuerpos anti-IL-23, composiciones, procedimientos y usos
WO2010027766A1 (en) * 2008-08-27 2010-03-11 Schering Corporation Lyophilized formulatons of engineered anti-il-23p19 antibodies
US9265834B2 (en) * 2009-03-05 2016-02-23 Ablynx N.V. Stable formulations of polypeptides and uses thereof
EP2635601B1 (en) * 2010-11-04 2016-07-20 Boehringer Ingelheim International GmbH Anti-il-23 antibodies
WO2013165791A1 (en) * 2012-05-03 2013-11-07 Boehringer Ingelheim International Gmbh Anti-il-23p19 antibodies
UA117466C2 (uk) * 2012-12-13 2018-08-10 Мерк Шарп Енд Доме Корп. СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19
IL307578A (en) * 2015-02-04 2023-12-01 Boehringer Ingelheim Int Methods of treating inflammatory diseases
GB201612317D0 (en) * 2016-07-15 2016-08-31 Philogen Spa Antibody compositions
EP3526252A2 (en) * 2016-10-14 2019-08-21 Boehringer Ingelheim International GmbH Methods of treating diseases with il-23a antibody
EP3810268A1 (en) * 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor

Also Published As

Publication number Publication date
AU2020345071A1 (en) 2022-03-24
PH12022550558A1 (en) 2023-02-20
CL2024002086A1 (es) 2025-01-10
MX2022002850A (es) 2022-04-06
WO2021048743A1 (en) 2021-03-18
US20210070852A1 (en) 2021-03-11
CN114340674A (zh) 2022-04-12
KR20220062359A (ko) 2022-05-16
JP2025163108A (ja) 2025-10-28
TW202123965A (zh) 2021-07-01
IL291131A (en) 2022-05-01
BR112022003169A2 (pt) 2022-05-17
JP2022547162A (ja) 2022-11-10
EP4028419A1 (en) 2022-07-20
CA3147328A1 (en) 2021-03-18

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