WO2020055932A3 - Methods of treating immunotherapy-related toxicity using a gm-csf antagonist - Google Patents

Methods of treating immunotherapy-related toxicity using a gm-csf antagonist Download PDF

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Publication number
WO2020055932A3
WO2020055932A3 PCT/US2019/050494 US2019050494W WO2020055932A3 WO 2020055932 A3 WO2020055932 A3 WO 2020055932A3 US 2019050494 W US2019050494 W US 2019050494W WO 2020055932 A3 WO2020055932 A3 WO 2020055932A3
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WIPO (PCT)
Prior art keywords
csf
cells
car
subject
methods
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Application number
PCT/US2019/050494
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French (fr)
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WO2020055932A9 (en
WO2020055932A2 (en
Inventor
Cameron DURRANT
Dale CHAPPELL
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Humanigen, Inc.
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
Priority claimed from US16/149,346 external-priority patent/US10870703B2/en
Priority claimed from US16/204,220 external-priority patent/US10899831B2/en
Priority claimed from US16/248,762 external-priority patent/US10927168B2/en
Priority claimed from US16/283,694 external-priority patent/US11130805B2/en
Priority to US17/274,167 priority Critical patent/US20210290677A1/en
Priority to EP19860890.3A priority patent/EP3849572A4/en
Priority to AU2019340662A priority patent/AU2019340662A1/en
Priority to JP2021512883A priority patent/JP2022517461A/en
Priority to SG11202102317PA priority patent/SG11202102317PA/en
Priority to CN201980073595.4A priority patent/CN113164520A/en
Application filed by Humanigen, Inc. filed Critical Humanigen, Inc.
Priority to BR112021004489-2A priority patent/BR112021004489A2/en
Priority to KR1020217010585A priority patent/KR20210075090A/en
Priority to MX2021002856A priority patent/MX2021002856A/en
Priority to CA3111804A priority patent/CA3111804A1/en
Publication of WO2020055932A2 publication Critical patent/WO2020055932A2/en
Publication of WO2020055932A3 publication Critical patent/WO2020055932A3/en
Publication of WO2020055932A9 publication Critical patent/WO2020055932A9/en
Priority to IL281243A priority patent/IL281243A/en
Priority to US17/234,779 priority patent/US20210322547A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • A61K39/001111—Immunoglobulin superfamily
    • A61K39/001112—CD19 or B4
    • 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
    • A61K39/46—Cellular immunotherapy
    • A61K39/461—Cellular immunotherapy characterised by the cell type used
    • A61K39/4611—T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
    • 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
    • A61K39/46—Cellular immunotherapy
    • A61K39/463—Cellular immunotherapy characterised by recombinant expression
    • A61K39/4631—Chimeric Antigen Receptors [CAR]
    • 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
    • A61K39/46—Cellular immunotherapy
    • A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643—Vertebrate antigens
    • A61K39/4644—Cancer antigens
    • A61K39/464402—Receptors, cell surface antigens or cell surface determinants
    • A61K39/464403—Receptors for growth factors
    • A61K39/464406—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ ErbB4
    • 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
    • A61K39/46—Cellular immunotherapy
    • A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643—Vertebrate antigens
    • A61K39/4644—Cancer antigens
    • A61K39/464402—Receptors, cell surface antigens or cell surface determinants
    • A61K39/464411—Immunoglobulin superfamily
    • A61K39/464412—CD19 or B4
    • 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
    • A61K39/46—Cellular immunotherapy
    • A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643—Vertebrate antigens
    • A61K39/4644—Cancer antigens
    • A61K39/464402—Receptors, cell surface antigens or cell surface determinants
    • A61K39/464429—Molecules with a "CD" designation not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • 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
    • C07K16/243—Colony Stimulating Factors
    • 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
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55516—Proteins; Peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterized by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K39/46
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
    • A61K2239/48—Blood cells, e.g. leukemia or lymphoma
    • 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
    • C07K2317/55—Fab or Fab'
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Oncology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biotechnology (AREA)
  • Virology (AREA)
  • Biomedical Technology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Methods for neutralizing and/or removing human GM-CSF in a subject in need thereof, comprising administering to the subject CAR-T cells having a GM-CSF gene knockout (GM-CSFk/o CAR-T cells) are provided. Also provided are methods for GM-CSF gene inactivation or GM-CSF knockout (KO) in a cell comprising targeted genome editing or GM-CSF gene silencing. Methods for preventing/treating immunotherapy-related toxicity, comprising administering to the subject CAR-T cells having a GM-CSF gene inactivation or GM-CSF knockout (GM-CSFk/o CAR-T cells), wherein the GM-CSF gene is inactivated or knocked out and/or a recombinant GM-CSF antagonist are provided. Methods for reducing a level of a cytokine or chemokine other than GM-CSF in a subject having immunotherapy-related toxicity comprising administering to the subject a recombinant hGM-CSF antagonist are provided. Also provided are methods for treating or preventing immunotherapy-related toxicity in a subject, comprising administering to the subject chimeric antigen receptor-expressing T-cells (CAR-T cells), the CAR-T cells having a GM-CSF gene knockout (GM-CSFk/o CAR-T cells). Methods for preventing or reducing blood-brain barrier disruption in a subject treated with immunotherapy, the method comprising administering CAR-T cells having a GM-CSF gene knockout (GM-CSFk/o CAR-T cells) to the subject, also are provided.
PCT/US2019/050494 2017-10-02 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist WO2020055932A2 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
BR112021004489-2A BR112021004489A2 (en) 2018-09-10 2019-09-10 methods of treating immunotherapy-related toxicity using a gm-csf antagonist
KR1020217010585A KR20210075090A (en) 2018-09-10 2019-09-10 Methods of Treatment of Immunotherapy-Related Toxicity Using GM-CSF Antagonists
CA3111804A CA3111804A1 (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
EP19860890.3A EP3849572A4 (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
MX2021002856A MX2021002856A (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist.
AU2019340662A AU2019340662A1 (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a GM-CSF antagonist
JP2021512883A JP2022517461A (en) 2018-09-10 2019-09-10 Treatment of immunotherapy-related toxicity using GM-CSF antagonists
SG11202102317PA SG11202102317PA (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
CN201980073595.4A CN113164520A (en) 2018-09-10 2019-09-10 Methods of treating immunotherapy-related toxicity using GM-CSF antagonists
US17/274,167 US20210290677A1 (en) 2017-10-02 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
IL281243A IL281243A (en) 2018-09-10 2021-03-03 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
US17/234,779 US20210322547A1 (en) 2017-10-02 2021-04-19 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US201862729043P 2018-09-10 2018-09-10
US62/729,043 2018-09-10
US16/149,346 2018-10-02
US16/149,346 US10870703B2 (en) 2017-10-02 2018-10-02 Methods of treating immunotherapy-related toxicity using a GM-CSF antagonist
USPCT/US2018/053933 2018-10-02
PCT/US2018/053933 WO2019070680A2 (en) 2017-10-02 2018-10-02 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
US16/204,220 2018-11-29
US16/204,220 US10899831B2 (en) 2017-10-02 2018-11-29 Method of reducing the level of non-GM-CSF cytokines/chemokines in immunotherapy-related toxicity
US16/248,762 2019-01-15
US16/248,762 US10927168B2 (en) 2017-10-02 2019-01-15 Method of reducing tumor relapse rate in immunotherapy by administration of lenzilumab
US16/283,694 US11130805B2 (en) 2017-10-02 2019-02-22 Methods of treating CART-T cell therapy-induced neuroinflammation using a GM-CSF antagonist
US16/283,694 2019-02-22

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US16/283,694 Continuation-In-Part US11130805B2 (en) 2017-10-02 2019-02-22 Methods of treating CART-T cell therapy-induced neuroinflammation using a GM-CSF antagonist

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US17/274,167 A-371-Of-International US20210290677A1 (en) 2017-10-02 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist
US17/234,779 Continuation-In-Part US20210322547A1 (en) 2017-10-02 2021-04-19 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist

Publications (3)

Publication Number Publication Date
WO2020055932A2 WO2020055932A2 (en) 2020-03-19
WO2020055932A3 true WO2020055932A3 (en) 2020-05-22
WO2020055932A9 WO2020055932A9 (en) 2020-07-09

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PCT/US2019/050494 WO2020055932A2 (en) 2017-10-02 2019-09-10 Methods of treating immunotherapy-related toxicity using a gm-csf antagonist

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EP (1) EP3849572A4 (en)
JP (1) JP2022517461A (en)
KR (1) KR20210075090A (en)
CN (1) CN113164520A (en)
AU (1) AU2019340662A1 (en)
BR (1) BR112021004489A2 (en)
CA (1) CA3111804A1 (en)
IL (1) IL281243A (en)
MX (1) MX2021002856A (en)
SG (1) SG11202102317PA (en)
WO (1) WO2020055932A2 (en)

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WO2020092850A1 (en) * 2018-10-31 2020-05-07 Humanigen, Inc. Materials and methods for treating cancer
US20220331425A1 (en) * 2019-06-03 2022-10-20 Kiniksa Pharmaceuticals, Ltd. Treatment of cancers with gm-csf antagonists
WO2021204649A1 (en) * 2020-04-06 2021-10-14 Glaxosmithkline Intellectual Property Development Limited Gm-csf antagonists for use in the treatment of severe pulmonary covid-19, cytokine release syndrome and/or acute respiratory distress syndrome
CN113402620B (en) * 2021-07-30 2021-12-10 中山大学 Fusion protein of cytokine combined chimeric antigen receptor and application thereof
CN116887856A (en) * 2022-01-20 2023-10-13 舒泰神（北京）生物制药股份有限公司 Antibody preparation for specifically recognizing granulocyte-macrophage colony stimulating factor receptor and application thereof
CN114606237A (en) * 2022-05-11 2022-06-10 上海优替济生生物医药有限公司 GM-CSF inhibitors and uses thereof

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Publication number Publication date
EP3849572A4 (en) 2022-07-13
MX2021002856A (en) 2021-05-28
KR20210075090A (en) 2021-06-22
WO2020055932A9 (en) 2020-07-09
BR112021004489A2 (en) 2021-07-20
EP3849572A2 (en) 2021-07-21
WO2020055932A2 (en) 2020-03-19
JP2022517461A (en) 2022-03-09
AU2019340662A1 (en) 2021-05-06
IL281243A (en) 2021-04-29
SG11202102317PA (en) 2021-04-29
CN113164520A (en) 2021-07-23
CA3111804A1 (en) 2020-03-19

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