IL301948B2 - Anti-cd3 antibody formulations - Google Patents

Anti-cd3 antibody formulations

Info

Publication number
IL301948B2
IL301948B2 IL301948A IL30194823A IL301948B2 IL 301948 B2 IL301948 B2 IL 301948B2 IL 301948 A IL301948 A IL 301948A IL 30194823 A IL30194823 A IL 30194823A IL 301948 B2 IL301948 B2 IL 301948B2
Authority
IL
Israel
Prior art keywords
formulation
antibody
formulations
trehalose
administered
Prior art date
Application number
IL301948A
Other languages
English (en)
Hebrew (he)
Other versions
IL301948A (en
IL301948B1 (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 IL301948A publication Critical patent/IL301948A/en
Publication of IL301948B1 publication Critical patent/IL301948B1/en
Publication of IL301948B2 publication Critical patent/IL301948B2/en

Links

Classifications

    • 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]

Landscapes

  • 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)
IL301948A 2016-08-29 2017-08-29 Anti-cd3 antibody formulations IL301948B2 (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
IL301948A IL301948A (en) 2023-06-01
IL301948B1 IL301948B1 (en) 2024-05-01
IL301948B2 true IL301948B2 (en) 2024-09-01

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 Before (1)

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

Country Status (10)

Country Link
US (3) US10688186B2 (enExample)
EP (2) EP3504241B1 (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
ES2986900T3 (es) 2016-08-29 2024-11-13 Tiziana Life Sciences Plc Formulaciones de anticuerpos anti-cd3
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
WO2020073087A1 (en) * 2018-10-09 2020-04-16 Monash University Combination therapy for treatment and prevention of autoimmune and inflammatory diseases
AU2019373663A1 (en) 2018-10-31 2021-04-08 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
EP4017526A1 (en) 2019-08-20 2022-06-29 Precision BioSciences, Inc. Lymphodepletion dosing regimens for cellular immunotherapies
WO2021180821A2 (en) * 2020-03-10 2021-09-16 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
MX2022015872A (es) 2020-06-11 2023-05-16 Provention Bio Inc Metodos y composiciones para prevenir diabetes tipo 1.
IL299744A (en) * 2020-07-30 2023-03-01 Tiziana Life Sciences Plc Antibodies to CD-3 for the treatment of the corona virus
PH12023550213A1 (en) * 2020-07-31 2023-10-16 Glaxosmithkline Ip Dev Ltd Antigen binding protein
EP4323404A1 (en) * 2021-04-16 2024-02-21 Tiziana Life Sciences PLC Subcutaneous administration of antibodies for the treatment of disease
JP2025515781A (ja) * 2022-05-13 2025-05-20 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 フォラルマブの経鼻製剤
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
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
WO2024190892A1 (ja) * 2023-03-16 2024-09-19 小野薬品工業株式会社 抗体製剤
JP7548475B1 (ja) * 2023-03-16 2024-09-10 小野薬品工業株式会社 抗体製剤

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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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
AU2007212147A1 (en) * 2006-02-03 2007-08-16 Medimmune, Llc Protein formulations
WO2007113648A2 (en) * 2006-04-05 2007-10-11 Pfizer Products Inc. Ctla4 antibody combination therapy
EP2225275A4 (en) * 2007-11-28 2013-04-03 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
MX2011013722A (es) * 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
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.
US20120269826A1 (en) * 2009-10-20 2012-10-25 Mckee Charlotte 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
WO2011080209A2 (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
ES2986900T3 (es) 2016-08-29 2024-11-13 Tiziana Life Sciences Plc Formulaciones de anticuerpos anti-cd3

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
DK3504241T3 (da) 2024-08-19
IL301948A (en) 2023-06-01
EP3504241B1 (en) 2024-05-15
IL264502B1 (en) 2023-05-01
AU2024278457A1 (en) 2025-01-09
CN109843920B (zh) 2023-01-13
CA3032596A1 (en) 2018-03-08
IL301948B1 (en) 2024-05-01
JP7057360B2 (ja) 2022-04-19
CN116617387A (zh) 2023-08-22
JP2024075713A (ja) 2024-06-04
JP2022082757A (ja) 2022-06-02
IL264502A (en) 2019-02-28
AU2017319318B2 (en) 2024-09-19
AU2017319318A1 (en) 2019-02-21
US10688186B2 (en) 2020-06-23
US20180177880A1 (en) 2018-06-28
JP2019526627A (ja) 2019-09-19
EP4406554A3 (en) 2024-10-30
CN109843920A (zh) 2019-06-04
EP4406554A2 (en) 2024-07-31
IL264502B2 (en) 2023-09-01
EP3504241A1 (en) 2019-07-03
US20250228946A1 (en) 2025-07-17
WO2018044948A1 (en) 2018-03-08
US20210000957A1 (en) 2021-01-07
JP7461401B2 (ja) 2024-04-03
ES2986900T3 (es) 2024-11-13

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