BR112022008097A2 - Formulação de anticorpo que contém crizanlizumabe - Google Patents

Formulação de anticorpo que contém crizanlizumabe

Info

Publication number
BR112022008097A2
BR112022008097A2 BR112022008097A BR112022008097A BR112022008097A2 BR 112022008097 A2 BR112022008097 A2 BR 112022008097A2 BR 112022008097 A BR112022008097 A BR 112022008097A BR 112022008097 A BR112022008097 A BR 112022008097A BR 112022008097 A2 BR112022008097 A2 BR 112022008097A2
Authority
BR
Brazil
Prior art keywords
crizanlizumab
formulation containing
antibody formulation
antibody
seg101
Prior art date
Application number
BR112022008097A
Other languages
English (en)
Inventor
BICKEL Fabian
BOADO Lina
Chelius Dirk
GRIAUD Francois
HILBERT Caroline
KROENER Frieder
Sigg Juergen
Paul Rajsekhar
ANKO Maja
JELENKO Aljosa
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Publication of BR112022008097A2 publication Critical patent/BR112022008097A2/pt

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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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]
    • 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
    • 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
    • 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
    • A61P7/06—Antianaemics
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • C07K16/2854—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72 against selectins, e.g. CD62
    • 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
    • C07K2317/20—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
    • C07K2317/56—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)
  • 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)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Inorganic Chemistry (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

FORMULAÇÃO DE ANTICORPO QUE CONTÉM CRIZANLIZUMABE. A presente invenção refere-se a formulações farmacêuticas de um anticorpo contra P-selectina humana; especialmente, SEG101, ou um anticorpo que tem, no máximo, diferença de 3 aminoácidos do crizanlizumabe e a processos para a preparação dos mesmos e usos das formulações.
BR112022008097A 2019-10-30 2020-10-29 Formulação de anticorpo que contém crizanlizumabe BR112022008097A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962927716P 2019-10-30 2019-10-30
US201962927720P 2019-10-30 2019-10-30
US201962933692P 2019-11-11 2019-11-11
US201962936269P 2019-11-15 2019-11-15
PCT/US2020/057868 WO2021087050A1 (en) 2019-10-30 2020-10-29 Crizanlizumab containing antibody formulation

Publications (1)

Publication Number Publication Date
BR112022008097A2 true BR112022008097A2 (pt) 2022-08-02

Family

ID=73544317

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022008097A BR112022008097A2 (pt) 2019-10-30 2020-10-29 Formulação de anticorpo que contém crizanlizumabe

Country Status (17)

Country Link
US (1) US20220378912A1 (pt)
EP (1) EP4051236A1 (pt)
JP (1) JP2023501155A (pt)
KR (1) KR20220092917A (pt)
CN (1) CN114828826A (pt)
AU (1) AU2020373017B2 (pt)
BR (1) BR112022008097A2 (pt)
CA (1) CA3158921A1 (pt)
CL (1) CL2022001085A1 (pt)
CO (1) CO2022005207A2 (pt)
EC (1) ECSP22033601A (pt)
IL (1) IL292403A (pt)
JO (1) JOP20220097A1 (pt)
MX (1) MX2022005044A (pt)
PE (1) PE20221276A1 (pt)
TW (1) TW202128221A (pt)
WO (1) WO2021087050A1 (pt)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2662091B1 (en) 2006-12-01 2018-08-22 Selexys Pharmaceuticals Corporation Anti-P-selectin antibodies and methods of using the same to treat inflammatory diseases
JOP20190101A1 (ar) 2016-11-03 2019-05-05 Novartis Ag أنظمة علاج
WO2018211517A1 (en) * 2017-05-16 2018-11-22 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
RU2020132460A (ru) * 2018-03-08 2022-04-08 Новартис Аг Применение антитела к p-селектину

Also Published As

Publication number Publication date
PE20221276A1 (es) 2022-09-05
WO2021087050A1 (en) 2021-05-06
JOP20220097A1 (ar) 2023-01-30
ECSP22033601A (es) 2022-05-31
AU2020373017B2 (en) 2024-06-06
MX2022005044A (es) 2022-05-16
US20220378912A1 (en) 2022-12-01
JP2023501155A (ja) 2023-01-18
CL2022001085A1 (es) 2023-02-03
IL292403A (en) 2022-06-01
AU2020373017A1 (en) 2022-05-19
CA3158921A1 (en) 2021-05-06
KR20220092917A (ko) 2022-07-04
CO2022005207A2 (es) 2022-05-10
CN114828826A (zh) 2022-07-29
TW202128221A (zh) 2021-08-01
EP4051236A1 (en) 2022-09-07

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