AU2017319318B2 - Anti-CD3 antibody formulations - Google Patents

Anti-CD3 antibody formulations Download PDF

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Publication number
AU2017319318B2
AU2017319318B2 AU2017319318A AU2017319318A AU2017319318B2 AU 2017319318 B2 AU2017319318 B2 AU 2017319318B2 AU 2017319318 A AU2017319318 A AU 2017319318A AU 2017319318 A AU2017319318 A AU 2017319318A AU 2017319318 B2 AU2017319318 B2 AU 2017319318B2
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Australia
Prior art keywords
antibody
formulation
formulations
amino acid
acid sequence
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AU2017319318A
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AU2017319318A1 (en
Inventor
Kunwar Shailubhai
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Tiziana Life Sciences Ltd
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Tiziana Life Sciences Ltd
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Priority to AU2024278457A priority Critical patent/AU2024278457A1/en
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    • 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
    • A61K47/20—Organic 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/16—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
    • A61K47/26—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
    • A61K9/0043—Nose
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], 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
    • C07K16/2809—Immunoglobulins [IG], 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
    • 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
    • C07K2317/565—Complementarity 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)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Transplantation (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Psychiatry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
AU2017319318A 2016-08-29 2017-08-29 Anti-CD3 antibody formulations Active AU2017319318B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2024278457A AU2024278457A1 (en) 2016-08-29 2024-12-16 Anti-CD3 antibody formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662380652P 2016-08-29 2016-08-29
US62/380,652 2016-08-29
PCT/US2017/049211 WO2018044948A1 (en) 2016-08-29 2017-08-29 Anti-cd3 antibody formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024278457A Division AU2024278457A1 (en) 2016-08-29 2024-12-16 Anti-CD3 antibody formulations

Publications (2)

Publication Number Publication Date
AU2017319318A1 AU2017319318A1 (en) 2019-02-21
AU2017319318B2 true AU2017319318B2 (en) 2024-09-19

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AU2017319318A Active AU2017319318B2 (en) 2016-08-29 2017-08-29 Anti-CD3 antibody formulations
AU2024278457A Pending AU2024278457A1 (en) 2016-08-29 2024-12-16 Anti-CD3 antibody formulations

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AU2024278457A Pending AU2024278457A1 (en) 2016-08-29 2024-12-16 Anti-CD3 antibody formulations

Country Status (10)

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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)

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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
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EP3873521A2 (en) * 2018-10-31 2021-09-08 Tiziana Life Sciences PLC Composition and methods of treating inflammatory and autoimmune diseases
JP7137696B2 (ja) 2019-05-14 2022-09-14 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を予防するための方法および組成物
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
KR20230092863A (ko) 2020-06-11 2023-06-26 프로벤션 바이오, 인코포레이티드 제1형 당뇨병을 예방하기 위한 방법 및 조성물
US20230227555A1 (en) * 2020-07-30 2023-07-20 Tiziana Life Sciences Plc Cd-3 antibodies for the treatment of coronavirus
MX2023001238A (es) * 2020-07-31 2023-03-03 Glaxosmithkline Ip Dev Ltd Proteina de union a antigeno.
US20220332822A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
MX2023013851A (es) 2021-05-24 2023-12-08 Provention Bio Inc Metodos para el tratamiento de diabetes tipo 1.
CA3251421A1 (en) * 2022-05-13 2023-11-16 Tiziana Life Sciences Plc FORALUMAB NASAL FORMULATIONS
CN119948056A (zh) * 2022-07-27 2025-05-06 塞尔德克斯医疗公司 抗kit抗体制剂和方法
EP4583878A1 (en) 2022-09-09 2025-07-16 Idorsia Pharmaceuticals Ltd Pharmaceutical combination comprising an anti-cd3 antibody and a cxcr3 antagonist
JP2026514293A (ja) 2023-02-08 2026-05-08 イムノス セラピューティクス アーゲー β２ミクログロブリン、ＨＬＡ重鎖ポリペプチド及びＣＤ４７－ＳＩＲＰαの阻害剤の融合タンパク質
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
JP7548475B1 (ja) * 2023-03-16 2024-09-10 小野薬品工業株式会社 抗体製剤

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Publication number Publication date
EP3504241B1 (en) 2024-05-15
US20250228946A1 (en) 2025-07-17
CA3032596A1 (en) 2018-03-08
ES2986900T3 (es) 2024-11-13
CN109843920B (zh) 2023-01-13
IL264502A (en) 2019-02-28
AU2024278457A1 (en) 2025-01-09
US20210000957A1 (en) 2021-01-07
EP4406554A3 (en) 2024-10-30
IL301948A (en) 2023-06-01
IL301948B2 (en) 2024-09-01
JP2019526627A (ja) 2019-09-19
EP4406554A2 (en) 2024-07-31
EP3504241A1 (en) 2019-07-03
JP7461401B2 (ja) 2024-04-03
CN109843920A (zh) 2019-06-04
JP2022082757A (ja) 2022-06-02
IL264502B2 (en) 2023-09-01
US10688186B2 (en) 2020-06-23
IL264502B1 (en) 2023-05-01
CN116617387A (zh) 2023-08-22
IL301948B1 (en) 2024-05-01
JP2024075713A (ja) 2024-06-04
DK3504241T3 (da) 2024-08-19
JP7057360B2 (ja) 2022-04-19
WO2018044948A1 (en) 2018-03-08
AU2017319318A1 (en) 2019-02-21
US20180177880A1 (en) 2018-06-28

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