DK3504241T3 - Anti-cd3-antistofformuleringer - Google Patents

Anti-cd3-antistofformuleringer Download PDF

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Publication number
DK3504241T3
DK3504241T3 DK17765519.8T DK17765519T DK3504241T3 DK 3504241 T3 DK3504241 T3 DK 3504241T3 DK 17765519 T DK17765519 T DK 17765519T DK 3504241 T3 DK3504241 T3 DK 3504241T3
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Prior art keywords
antibody formulations
antibody
formulations
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DK17765519.8T
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Danish (da)
English (en)
Inventor
Kunwar Shailubhai
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Tiziana Life Sciences Plc
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    • 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
    • A61K39/39533Antibodies; 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
    • 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]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (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)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK17765519.8T 2016-08-29 2017-08-29 Anti-cd3-antistofformuleringer DK3504241T3 (da)

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 (1)

Publication Number Publication Date
DK3504241T3 true DK3504241T3 (da) 2024-08-19

Family

ID=59858782

Family Applications (1)

Application Number Title Priority Date Filing Date
DK17765519.8T DK3504241T3 (da) 2016-08-29 2017-08-29 Anti-cd3-antistofformuleringer

Country Status (10)

Country Link
US (3) US10688186B2 (enExample)
EP (2) EP3504241B1 (enExample)
JP (3) JP7057360B2 (enExample)
CN (2) CN116617387A (enExample)
AU (2) AU2017319318B2 (enExample)
CA (1) CA3032596A1 (enExample)
DK (1) DK3504241T3 (enExample)
ES (1) ES2986900T3 (enExample)
IL (2) IL301948B2 (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
EP3504241B1 (en) 2016-08-29 2024-05-15 Tiziana Life Sciences PLC Anti-cd3 antibody formulations
WO2018226833A1 (en) * 2017-06-06 2018-12-13 The Brigham And Women's Hospital, Inc. Methods of suppressing microglial activation
EP3488851A1 (en) * 2018-10-03 2019-05-29 AVM Biotechnology, LLC Immunoablative therapies
AU2019358875B2 (en) * 2018-10-09 2025-08-21 Monash University Combination therapy for treatment and prevention of autoimmune and inflammatory diseases
JP2022512709A (ja) * 2018-10-31 2022-02-07 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 炎症性疾患及び自己免疫疾患を処置する組成物及び方法
KR102503349B1 (ko) 2019-05-14 2023-02-23 프로벤션 바이오, 인코포레이티드 제1형 당뇨병을 예방하기 위한 방법 및 조성물
WO2021035054A1 (en) 2019-08-20 2021-02-25 Precision Biosciences, Inc. Lymphodepletion dosing regimens for cellular immunotherapies
JP2023517611A (ja) * 2020-03-10 2023-04-26 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 Il-6/il-6r抗体の組成物及びその使用方法
GB2595299B (en) 2020-05-21 2022-08-03 Mabsolve Ltd Modified immunoglobulin FC regions
US12006366B2 (en) 2020-06-11 2024-06-11 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
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
IL300088A (en) * 2020-07-31 2023-03-01 Glaxosmithkline Ip Dev Ltd Antigen binding protein
WO2022221767A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
US20230365689A1 (en) * 2022-05-13 2023-11-16 Tiziana Life Sciences Plc Nasal formulations of foralumab
IL318326A (en) * 2022-07-27 2025-03-01 Celldex Therapeutics Inc Anti-Kit Antibody Formulations and Methods
KR20250067152A (ko) 2022-09-09 2025-05-14 이도르시아 파마슈티컬스 리미티드 항-cd3 항체 및 cxcr3 길항제를 포함하는 약학 병용물
AU2024217729A1 (en) 2023-02-08 2025-08-21 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
CN120752054A (zh) 2023-03-16 2025-10-03 小野药品工业株式会社 抗体制剂
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

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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
WO2005048935A2 (en) * 2003-11-14 2005-06-02 Brigham And Women's Hospital, Inc. Methods of modulating immunity
US20100209437A1 (en) * 2005-09-12 2010-08-19 Greg Elson Anti-CD3 Antibody Fromulations
AU2007212147A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
EP2007423A2 (en) * 2006-04-05 2008-12-31 Pfizer Products Incorporated 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.
CA2778334A1 (en) * 2009-10-20 2011-04-28 Charlotte Mckee Anti-cd3 antibody dosing in autoimmune disease
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
CA2783715A1 (en) 2009-12-29 2011-07-07 F. Hoffmann-La Roche Ag Novel antibody formulation
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
EP3504241B1 (en) 2016-08-29 2024-05-15 Tiziana Life Sciences PLC Anti-cd3 antibody formulations

Also Published As

Publication number Publication date
IL301948B2 (en) 2024-09-01
JP7057360B2 (ja) 2022-04-19
CN109843920B (zh) 2023-01-13
JP2022082757A (ja) 2022-06-02
US20210000957A1 (en) 2021-01-07
EP4406554A3 (en) 2024-10-30
JP2024075713A (ja) 2024-06-04
US20250228946A1 (en) 2025-07-17
EP4406554A2 (en) 2024-07-31
US20180177880A1 (en) 2018-06-28
ES2986900T3 (es) 2024-11-13
IL301948A (en) 2023-06-01
AU2017319318B2 (en) 2024-09-19
IL301948B1 (en) 2024-05-01
CA3032596A1 (en) 2018-03-08
US10688186B2 (en) 2020-06-23
CN116617387A (zh) 2023-08-22
IL264502B2 (en) 2023-09-01
CN109843920A (zh) 2019-06-04
JP7461401B2 (ja) 2024-04-03
IL264502A (en) 2019-02-28
WO2018044948A1 (en) 2018-03-08
EP3504241A1 (en) 2019-07-03
JP2019526627A (ja) 2019-09-19
IL264502B1 (en) 2023-05-01
EP3504241B1 (en) 2024-05-15
AU2024278457A1 (en) 2025-01-09
AU2017319318A1 (en) 2019-02-21

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