IL264502B2 - Anti-cd3 antibody formulations - Google Patents

Anti-cd3 antibody formulations

Info

Publication number
IL264502B2
IL264502B2 IL264502A IL26450219A IL264502B2 IL 264502 B2 IL264502 B2 IL 264502B2 IL 264502 A IL264502 A IL 264502A IL 26450219 A IL26450219 A IL 26450219A IL 264502 B2 IL264502 B2 IL 264502B2
Authority
IL
Israel
Prior art keywords
formulation
antibody
formulations
trehalose
oral
Prior art date
Application number
IL264502A
Other languages
English (en)
Hebrew (he)
Other versions
IL264502A (en
IL264502B1 (en
Original Assignee
Tiziana Life Sciences Plc
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 Tiziana Life Sciences Plc filed Critical Tiziana Life Sciences Plc
Publication of IL264502A publication Critical patent/IL264502A/en
Publication of IL264502B1 publication Critical patent/IL264502B1/en
Publication of IL264502B2 publication Critical patent/IL264502B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Transplantation (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Nutrition Science (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
IL264502A 2016-08-29 2017-08-29 Anti-cd3 antibody formulations IL264502B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662380652P 2016-08-29 2016-08-29
PCT/US2017/049211 WO2018044948A1 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations

Publications (3)

Publication Number Publication Date
IL264502A IL264502A (en) 2019-02-28
IL264502B1 IL264502B1 (en) 2023-05-01
IL264502B2 true IL264502B2 (en) 2023-09-01

Family

ID=59858782

Family Applications (2)

Application Number Title Priority Date Filing Date
IL264502A IL264502B2 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations
IL301948A IL301948B2 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL301948A IL301948B2 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations

Country Status (10)

Country Link
US (3) US10688186B2 (enExample)
EP (2) EP4406554A3 (enExample)
JP (3) JP7057360B2 (enExample)
CN (2) CN109843920B (enExample)
AU (2) AU2017319318B2 (enExample)
CA (1) CA3032596A1 (enExample)
DK (1) DK3504241T3 (enExample)
ES (1) ES2986900T3 (enExample)
IL (2) IL264502B2 (enExample)
WO (1) WO2018044948A1 (enExample)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3032596A1 (en) 2016-08-29 2018-03-08 Tiziana Life Sciences Plc Anti-cd3 antibody formulations
EP3634478A4 (en) * 2017-06-06 2021-03-24 The Brigham and Women's Hospital, Inc. MICROGLIAL ACTIVATION INHIBITION METHODS
EP3488851A1 (en) * 2018-10-03 2019-05-29 AVM Biotechnology, LLC Immunoablative therapies
US20220220202A1 (en) * 2018-10-09 2022-07-14 Monash University Combination therapy for treatment and prevention of autoimmune and inflammatory diseases
US20220008533A1 (en) * 2018-10-31 2022-01-13 Tiziana Life Sciences Plc Composition and methods of treating inflammatory and autoimmune diseases
JOP20210298A1 (ar) 2019-05-14 2023-01-30 Provention Bio Inc طرق وتركيبات للوقاية من مرض السكري من النوع الأول
CA3148179A1 (en) 2019-08-20 2021-02-25 Bruce J. Mccreedy Jr. Lymphodepletion dosing regimens for cellular immunotherapies
IL296276A (en) * 2020-03-10 2022-11-01 Tiziana Life Sciences Plc Compositions of il-6/il-6r antibodies and methods of use thereof
GB2595299B (en) 2020-05-21 2022-08-03 Mabsolve Ltd Modified immunoglobulin FC regions
KR20230092863A (ko) 2020-06-11 2023-06-26 프로벤션 바이오, 인코포레이티드 제1형 당뇨병을 예방하기 위한 방법 및 조성물
JP2023535792A (ja) * 2020-07-30 2023-08-21 ティジアーナ ライフ サイエンシズ パブリック リミティド カンパニー コロナウイルス治療のための抗cd3抗体
CN116507638A (zh) * 2020-07-31 2023-07-28 葛兰素史密斯克莱知识产权发展有限公司 抗原结合蛋白
US20220332822A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
EP4522115A1 (en) * 2022-05-13 2025-03-19 Tiziana Life Sciences PLC Nasal formulations of foralumab
WO2024026355A1 (en) * 2022-07-27 2024-02-01 Celldex Therapeutics, Inc. Anti-kit antibody formulations and methods
AU2023337529A1 (en) 2022-09-09 2025-04-17 Idorsia Pharmaceuticals Ltd Pharmaceutical combination comprising an anti-cd3 antibody and a cxcr3 antagonist
WO2024165671A1 (en) 2023-02-08 2024-08-15 Immunos Therapeutics Ag FUSION PROTEINS OF ß2 MICROGLOBULIN, HLA HEAVY CHAIN POLYPEPTIDES, AND INHIBITOR OF CD47-SIRPA
TW202448505A (zh) 2023-03-01 2024-12-16 美商普泛森生技公司 用於治療第1型糖尿病的方法及組成物
TW202502380A (zh) * 2023-03-16 2025-01-16 日商小野藥品工業股份有限公司 抗體製劑
AU2024237533A1 (en) * 2023-03-16 2025-09-18 Ono Pharmaceutical Co., Ltd. Antibody preparation

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007033230A2 (en) * 2005-09-12 2007-03-22 Novimmune S.A. Anti-cd3 antibody formulations

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030235583A1 (en) 2002-06-14 2003-12-25 Jeppe Sturis Combined use of a modulator of CD3 and a beta cell resting compound
US20040037826A1 (en) 2002-06-14 2004-02-26 Michelsen Birgitte Koch Combined use of a modulator of CD3 and a GLP-1 compound
US7883703B2 (en) * 2003-11-14 2011-02-08 The Brigham And Women's Hospital, Inc. Methods of modulating immunity
US20080071063A1 (en) * 2006-02-03 2008-03-20 Medimmune, Inc. Protein Formulations
CA2647282A1 (en) * 2006-04-05 2007-10-11 Pfizer Products Inc. Ctla4 antibody combination therapy
US9308257B2 (en) 2007-11-28 2016-04-12 Medimmune, Llc Protein formulation
CN102164960A (zh) * 2008-09-26 2011-08-24 罗氏格黎卡特股份公司 双特异性抗-egfr/抗-igf-1r抗体
WO2010148337A1 (en) * 2009-06-18 2010-12-23 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
JP2013508391A (ja) * 2009-10-20 2013-03-07 グラクソ グループ リミテッド 体重増加を予防するために抗cd3抗体を使用する方法
US20120269826A1 (en) * 2009-10-20 2012-10-25 Mckee Charlotte Anti-cd3 antibody dosing in autoimmune disease
KR20120110175A (ko) * 2009-12-29 2012-10-09 에프. 호프만-라 로슈 아게 항체 제제
WO2012098238A1 (en) * 2011-01-21 2012-07-26 Novimmune S.A. Combination therapies and methods using anti-cd3 modulating agents and anti-il-6 antagonists
UA118028C2 (uk) * 2013-04-03 2018-11-12 Рош Глікарт Аг Біспецифічне антитіло, специфічне щодо fap і dr5, антитіло, специфічне щодо dr5, і спосіб їх застосування
CA3032596A1 (en) 2016-08-29 2018-03-08 Tiziana Life Sciences Plc Anti-cd3 antibody formulations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007033230A2 (en) * 2005-09-12 2007-03-22 Novimmune S.A. Anti-cd3 antibody formulations

Also Published As

Publication number Publication date
US10688186B2 (en) 2020-06-23
IL301948A (en) 2023-06-01
JP7461401B2 (ja) 2024-04-03
IL301948B1 (en) 2024-05-01
EP4406554A2 (en) 2024-07-31
US20250228946A1 (en) 2025-07-17
WO2018044948A1 (en) 2018-03-08
US20180177880A1 (en) 2018-06-28
IL301948B2 (en) 2024-09-01
AU2017319318B2 (en) 2024-09-19
CN109843920A (zh) 2019-06-04
ES2986900T3 (es) 2024-11-13
US20210000957A1 (en) 2021-01-07
EP3504241A1 (en) 2019-07-03
AU2017319318A1 (en) 2019-02-21
CN116617387A (zh) 2023-08-22
DK3504241T3 (da) 2024-08-19
IL264502A (en) 2019-02-28
IL264502B1 (en) 2023-05-01
EP3504241B1 (en) 2024-05-15
AU2024278457A1 (en) 2025-01-09
JP2019526627A (ja) 2019-09-19
JP2024075713A (ja) 2024-06-04
EP4406554A3 (en) 2024-10-30
JP7057360B2 (ja) 2022-04-19
JP2022082757A (ja) 2022-06-02
CN109843920B (zh) 2023-01-13
CA3032596A1 (en) 2018-03-08

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