JP7670713B2 - 皮下投与のための抗ｃｄ３８抗体の製剤 - Google Patents

皮下投与のための抗ｃｄ３８抗体の製剤 Download PDF

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JP7670713B2
JP7670713B2 JP2022533413A JP2022533413A JP7670713B2 JP 7670713 B2 JP7670713 B2 JP 7670713B2 JP 2022533413 A JP2022533413 A JP 2022533413A JP 2022533413 A JP2022533413 A JP 2022533413A JP 7670713 B2 JP7670713 B2 JP 7670713B2
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formulation
antibody
cdr
sucrose
isatuximab
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JP2023505217A5 (https=
JP2023505217A (ja
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トマ・バレエ
キラン・バンガリ
ラヴィ・チャリ
シルヴァン・ユイエ
ベルナルド・ペレス－ラミレス
ヴァスコ・フィリペ
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サノフィ－アベンティス・ユー・エス・エルエルシー
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    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • 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]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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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)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2022533413A 2019-12-05 2020-12-04 皮下投与のための抗ｃｄ３８抗体の製剤 Active JP7670713B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025067240A JP2025156294A (ja) 2019-12-05 2025-04-16 皮下投与のための抗ｃｄ３８抗体の製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962944082P 2019-12-05 2019-12-05
US62/944,082 2019-12-05
PCT/US2020/063452 WO2021113739A1 (en) 2019-12-05 2020-12-04 Formulations of anti-cd38 antibodies for subcutaneous administration

Related Child Applications (1)

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JP2025067240A Division JP2025156294A (ja) 2019-12-05 2025-04-16 皮下投与のための抗ｃｄ３８抗体の製剤

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JP2023505217A JP2023505217A (ja) 2023-02-08
JP2023505217A5 JP2023505217A5 (https=) 2023-12-08
JP7670713B2 true JP7670713B2 (ja) 2025-04-30

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JP2022533413A Active JP7670713B2 (ja) 2019-12-05 2020-12-04 皮下投与のための抗ｃｄ３８抗体の製剤
JP2025067240A Pending JP2025156294A (ja) 2019-12-05 2025-04-16 皮下投与のための抗ｃｄ３８抗体の製剤

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US (2) US20210188996A1 (https=)
EP (1) EP4069743A1 (https=)
JP (2) JP7670713B2 (https=)
KR (1) KR20220159947A (https=)
CN (1) CN115698064A (https=)
AU (1) AU2020397170A1 (https=)
BR (1) BR112022010905A2 (https=)
CA (1) CA3160502A1 (https=)
CO (1) CO2022009089A2 (https=)
IL (1) IL293563A (https=)
MX (1) MX2022006882A (https=)
TW (1) TW202133879A (https=)
WO (1) WO2021113739A1 (https=)

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KR20210030411A (ko) * 2018-07-10 2021-03-17 사노피 Cd38 및 tgf-베타를 표적으로 하는 암에 대한 병용 요법
US11655302B2 (en) 2019-06-10 2023-05-23 Sanofi Anti-CD38 antibodies and formulations
MX2022010012A (es) * 2020-02-13 2022-09-07 Amgen Inc Formulaciones de anticuerpos anti-tslp humanos y métodos de tratamiento de una enfermedad inflamatoria.
WO2023212526A1 (en) * 2022-04-26 2023-11-02 Keystone Bio, Inc. Formulation for antigen-binding molecules that bind to porphyromonas gingivalis
WO2024023843A1 (en) * 2022-07-26 2024-02-01 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2025240486A1 (en) * 2024-05-14 2025-11-20 Enable Injections, Inc. Device and method for subcutaneous administration of anti-cd38 antibodies
WO2026046348A1 (zh) * 2024-08-30 2026-03-05 杭州九源基因生物医药股份有限公司 抗cd38抗体的稳定药物制剂及其用途

Citations (1)

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JP2018537525A (ja) 2015-11-03 2018-12-20 ヤンセン バイオテツク，インコーポレーテツド 抗ｃｄ３８抗体の皮下製剤及びその使用

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US5722956A (en) 1995-08-24 1998-03-03 The General Hospital Corporation Multi-dose syringe driver
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US7195610B1 (en) 2001-09-17 2007-03-27 Cardinal Health 303, Inc. Pneumatic syringe driver
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JP5225069B2 (ja) 2005-03-23 2013-07-03 ゲンマブ エー／エス 多発性骨髄腫の治療のためのｃｄ３８に対する抗体
US7867197B2 (en) 2006-03-29 2011-01-11 The General Hospital Corporation Single-dose syringe driver
EP1914242A1 (en) 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
EP2191843A1 (en) 2008-11-28 2010-06-02 Sanofi-Aventis Antitumor combinations containing antibodies recognizing specifically CD38 and cyclophosphamide
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IL293563A (en) 2022-08-01
AU2020397170A1 (en) 2022-07-21
CN115698064A (zh) 2023-02-03
JP2023505217A (ja) 2023-02-08
BR112022010905A2 (pt) 2022-09-06
TW202133879A (zh) 2021-09-16
EP4069743A1 (en) 2022-10-12
KR20220159947A (ko) 2022-12-05
US20260042861A1 (en) 2026-02-12
CA3160502A1 (en) 2021-06-10
WO2021113739A1 (en) 2021-06-10
JP2025156294A (ja) 2025-10-14
MX2022006882A (es) 2022-11-08
CO2022009089A2 (es) 2022-07-08
US20210188996A1 (en) 2021-06-24

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