KR20230035355A - 인자 xii 항원 결합 단백질의 고농도 제형 - Google Patents

인자 xii 항원 결합 단백질의 고농도 제형 Download PDF

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Publication number
KR20230035355A
KR20230035355A KR1020237003982A KR20237003982A KR20230035355A KR 20230035355 A KR20230035355 A KR 20230035355A KR 1020237003982 A KR1020237003982 A KR 1020237003982A KR 20237003982 A KR20237003982 A KR 20237003982A KR 20230035355 A KR20230035355 A KR 20230035355A
Authority
KR
South Korea
Prior art keywords
formulation
seq
set forth
sequence set
antibody
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
KR1020237003982A
Other languages
English (en)
Korean (ko)
Inventor
마이클 존스톤
다이애나 그레이스 구달
나탄 애론 에드워드
Original Assignee
씨에스엘 이노베이션 피티와이 엘티디
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 씨에스엘 이노베이션 피티와이 엘티디 filed Critical 씨에스엘 이노베이션 피티와이 엘티디
Publication of KR20230035355A publication Critical patent/KR20230035355A/ko
Pending legal-status Critical Current

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
    • A61K39/39591—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
    • A61K47/22—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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • C07K16/36—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020237003982A 2020-07-03 2021-07-05 인자 xii 항원 결합 단백질의 고농도 제형 Pending KR20230035355A (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP20184004.8 2020-07-03
EP20184004 2020-07-03
PCT/AU2021/050714 WO2022000046A1 (en) 2020-07-03 2021-07-05 High concentration formulation of factor xii antigen binding proteins

Publications (1)

Publication Number Publication Date
KR20230035355A true KR20230035355A (ko) 2023-03-13

Family

ID=71514949

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237003982A Pending KR20230035355A (ko) 2020-07-03 2021-07-05 인자 xii 항원 결합 단백질의 고농도 제형

Country Status (12)

Country Link
US (1) US20240277839A1 (enExample)
EP (1) EP4175669A4 (enExample)
JP (1) JP7880827B2 (enExample)
KR (1) KR20230035355A (enExample)
CN (1) CN116322764A (enExample)
AU (1) AU2021302684A1 (enExample)
BR (1) BR112022026482A2 (enExample)
CA (1) CA3183508A1 (enExample)
CL (1) CL2023000004A1 (enExample)
IL (1) IL298989A (enExample)
MX (1) MX2022016365A (enExample)
WO (1) WO2022000046A1 (enExample)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4337257A1 (en) * 2021-05-12 2024-03-20 AnaptysBio, Inc. Antibody composition
US20250042984A1 (en) * 2021-12-20 2025-02-06 CSL Innovation Pty Ltd Protein formulations and uses thereof

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20250164T1 (hr) 2011-07-22 2025-04-11 Csl Behring Gmbh Inhibitorna monoklonska antitijela protiv faktora xii/xiia i njihove uporabe
JP5859148B2 (ja) * 2012-03-08 2016-02-10 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft Aβ抗体製剤
US9592297B2 (en) 2012-08-31 2017-03-14 Bayer Healthcare Llc Antibody and protein formulations
US8613919B1 (en) * 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
EP3325516B1 (en) * 2015-07-21 2021-12-15 Takeda Pharmaceutical Company Limited A monoclonal antibody inhibitor of factor xiia
EP3433274A1 (en) * 2016-03-25 2019-01-30 Visterra, Inc. Formulation of antibody molecules to dengue virus
EP3440107A4 (en) * 2016-04-06 2020-02-19 CSL Limited METHOD FOR TREATING ATHEROSCLEROSIS
JOP20170170B1 (ar) * 2016-08-31 2022-09-15 Omeros Corp صيغ لجسم مضاد تثبيطية لـ masp-2 بتركيز عالي ولزوجة منخفضة وأطقم، وطرق
BR112019011900A2 (pt) 2016-12-23 2019-11-26 Serum Institute Of India Private Limited métodos melhorados para aumentar a produtividade de anticorpos na cultura de células de mamíferos e minimizar a agregação durante os processos downs-tream, processos de formulação, e formulações de anticorpos estáveis obtidas dos mesmos
US11603407B2 (en) 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
EA202190056A1 (ru) * 2018-06-19 2021-05-28 Ридженерон Фармасьютикалз, Инк. АНТИТЕЛА ПРОТИВ ФАКТОРА XII/XIIa И ИХ ПРИМЕНЕНИЕ
US12134657B2 (en) 2018-11-28 2024-11-05 Oregon Health & Science University Therapeutic factor XII antibody
US20230390418A1 (en) * 2020-10-29 2023-12-07 Regenxbio Inc. Vectorized factor xii antibodies and administration thereof

Also Published As

Publication number Publication date
WO2022000046A1 (en) 2022-01-06
CA3183508A1 (en) 2022-01-06
CL2023000004A1 (es) 2023-08-25
AU2021302684A1 (en) 2023-02-23
EP4175669A1 (en) 2023-05-10
BR112022026482A2 (pt) 2023-01-31
JP7880827B2 (ja) 2026-06-26
MX2022016365A (es) 2023-01-30
US20240277839A1 (en) 2024-08-22
EP4175669A4 (en) 2025-11-12
JP2023531315A (ja) 2023-07-21
CN116322764A (zh) 2023-06-23
IL298989A (en) 2023-02-01

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Legal Events

Date Code Title Description
PA0105 International application

Patent event date: 20230202

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20240704

Comment text: Request for Examination of Application