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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    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Transplantation (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Hospice & Palliative Care (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)

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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CN116617387A (zh) 2016-08-29 2023-08-22 迪赞纳生命科学公开有限公司 抗cd3抗体制剂
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
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
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
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
IL298999A (en) 2020-06-11 2023-02-01 Provention Bio Inc Methods and compositions for the prevention of type 1 diabetes
CN116406274B (zh) * 2020-07-30 2026-02-17 迪赞纳生命科学公开有限公司 用于治疗冠状病毒的cd3抗体
EP4188543A1 (en) * 2020-07-31 2023-06-07 GlaxoSmithKline Intellectual Property Development Limited Antigen binding protein
US20220332822A1 (en) * 2021-04-16 2022-10-20 Tiziana Life Sciences Plc Subcutaneous administration of antibodies for the treatment of disease
JP2024520444A (ja) 2021-05-24 2024-05-24 プロヴェンション・バイオ・インコーポレイテッド １型糖尿病を治療するための方法
WO2023218100A1 (en) * 2022-05-13 2023-11-16 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
US20250381184A1 (en) 2022-09-09 2025-12-18 Idorsia Pharmaceuticals Ltd Pharmaceutical combination comprising an anti-cd3 antibody and a cxcr3 antagonist
CN121002056A (zh) 2023-02-08 2025-11-21 免疫标记治疗股份公司 β2微球蛋白、HLA重链多肽、和CD47–SIRPα抑制剂的融合蛋白
WO2024182767A1 (en) 2023-03-01 2024-09-06 Provention Bio, Inc. Methods and compositions for treating type 1 diabetes comprising teplizumab and verapamil
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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WO2007033230A2 (en) * 2005-09-12 2007-03-22 Novimmune S.A. Anti-cd3 antibody formulations

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JP2012530721A (ja) 2009-06-18 2012-12-06 ワイス・エルエルシー 小モジュール免疫薬のための凍結乾燥製剤
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.
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Publication number Publication date
WO2018044948A1 (en) 2018-03-08
EP3504241A1 (en) 2019-07-03
IL264502B2 (en) 2023-09-01
US10688186B2 (en) 2020-06-23
JP2022082757A (ja) 2022-06-02
US20180177880A1 (en) 2018-06-28
IL264502A (en) 2019-02-28
ES2986900T3 (es) 2024-11-13
AU2017319318A1 (en) 2019-02-21
IL264502B1 (en) 2023-05-01
CN116617387A (zh) 2023-08-22
DK3504241T3 (da) 2024-08-19
CN109843920B (zh) 2023-01-13
JP2019526627A (ja) 2019-09-19
CN109843920A (zh) 2019-06-04
EP3504241B1 (en) 2024-05-15
IL301948B2 (en) 2024-09-01
EP4406554A3 (en) 2024-10-30
US20210000957A1 (en) 2021-01-07
EP4406554A2 (en) 2024-07-31
JP2024075713A (ja) 2024-06-04
IL301948B1 (en) 2024-05-01
JP7057360B2 (ja) 2022-04-19
JP7461401B2 (ja) 2024-04-03
IL301948A (en) 2023-06-01
CA3032596A1 (en) 2018-03-08
US20250228946A1 (en) 2025-07-17
AU2024278457A1 (en) 2025-01-09

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