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)
  • 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)
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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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)

Country Link
US (3) US10688186B2 (https=)
EP (2) EP3504241B1 (https=)
JP (3) JP7057360B2 (https=)
CN (2) CN116617387A (https=)
AU (2) AU2017319318B2 (https=)
CA (1) CA3032596A1 (https=)
DK (1) DK3504241T3 (https=)
ES (1) ES2986900T3 (https=)
IL (2) IL264502B2 (https=)
WO (1) WO2018044948A1 (https=)

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IL264502B2 (en) 2016-08-29 2023-09-01 Tiziana Life Sciences Plc Anti-cd3 antibody formulations
EP3634478A4 (en) * 2017-06-06 2021-03-24 The Brigham and Women's Hospital, Inc. METHOD OF SUPPRESSION OF MICROGLIA ACTIVATION
EP3488851A1 (en) * 2018-10-03 2019-05-29 AVM Biotechnology, LLC Immunoablative therapies
WO2020073087A1 (en) * 2018-10-09 2020-04-16 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
IL322315A (en) 2019-05-14 2025-09-01 Provention Bio Inc Methods and preparations for preventing type 1 diabetes
AU2020333851A1 (en) 2019-08-20 2022-03-31 Precision Biosciences, Inc. Lymphodepletion dosing regimens for cellular immunotherapies
CN115697403A (zh) * 2020-03-10 2023-02-03 迪赞纳生命科学公开有限公司 Il-6/il-6r抗体的组合物及其使用方法
GB2595299B (en) 2020-05-21 2022-08-03 Mabsolve Ltd Modified immunoglobulin FC regions
AU2021287998B2 (en) 2020-06-11 2026-03-12 Benaroya Research Institute At Virginia Mason Methods and compositions for preventing type 1 diabetes
EP4188440A2 (en) * 2020-07-30 2023-06-07 Tiziana Life Sciences PLC Cd-3 antibodies for the treatment of coronavirus
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
US12565529B2 (en) 2021-05-24 2026-03-03 Provention Bio, Inc. Methods for treating type 1 diabetes
AU2023269309A1 (en) * 2022-05-13 2024-11-07 Tiziana Life Sciences Plc Nasal formulations of foralumab
US20260055193A1 (en) * 2022-07-27 2026-02-26 Celldex Therapeutics, Inc. Anti-kit antibody formulations and methods
CN120112292A (zh) 2022-09-09 2025-06-06 爱杜西亚药品有限公司 包含抗-cd3抗体及cxcr3拮抗剂的药物组合
EP4662230A1 (en) 2023-02-08 2025-12-17 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
KR20250156121A (ko) 2023-03-16 2025-10-31 오노 야꾸힝 고교 가부시키가이샤 항체 제제
WO2024190892A1 (ja) 2023-03-16 2024-09-19 小野薬品工業株式会社 抗体製剤

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Also Published As

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

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