KR20220159947A - 피하 투여를 위한 항-cd38 항체의 제형 - Google Patents

피하 투여를 위한 항-cd38 항체의 제형 Download PDF

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Publication number
KR20220159947A
KR20220159947A KR1020227022845A KR20227022845A KR20220159947A KR 20220159947 A KR20220159947 A KR 20220159947A KR 1020227022845 A KR1020227022845 A KR 1020227022845A KR 20227022845 A KR20227022845 A KR 20227022845A KR 20220159947 A KR20220159947 A KR 20220159947A
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South Korea
Prior art keywords
formulation
cdr
antibody
sucrose
viscosity
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KR1020227022845A
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English (en)
Korean (ko)
Inventor
토마스 발렛
키란 방가리
라비 차리
실뱅 휠레
베르나르도 페레즈-라미레즈
바스코 필리페
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사노피-아벤티스 유.에스. 엘엘씨
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Publication of KR20220159947A publication Critical patent/KR20220159947A/ko
Pending legal-status Critical Current

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    • 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
    • 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
    • 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)
KR1020227022845A 2019-12-05 2020-12-04 피하 투여를 위한 항-cd38 항체의 제형 Pending KR20220159947A (ko)

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

Publications (1)

Publication Number Publication Date
KR20220159947A true KR20220159947A (ko) 2022-12-05

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ID=74130308

Family Applications (1)

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KR1020227022845A Pending KR20220159947A (ko) 2019-12-05 2020-12-04 피하 투여를 위한 항-cd38 항체의 제형

Country Status (13)

Country Link
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=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (25)

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US5449345A (en) 1989-03-17 1995-09-12 Merit Medical Systems, Inc. Detachable and reusable digital control unit for monitoring balloon catheter data in a syringe inflation system
US5064413A (en) 1989-11-09 1991-11-12 Bioject, Inc. Needleless hypodermic injection device
US5722956A (en) 1995-08-24 1998-03-03 The General Hospital Corporation Multi-dose syringe driver
US6645177B1 (en) 1999-02-09 2003-11-11 Alaris Medical Systems, Inc. Directly engaged syringe driver system
US6428509B1 (en) 1999-07-29 2002-08-06 Alaris Medical Systems, Inc. Syringe plunger driver system and method
US7195610B1 (en) 2001-09-17 2007-03-27 Cardinal Health 303, Inc. Pneumatic syringe driver
US7150724B2 (en) 2002-06-05 2006-12-19 Cardinal Health 303, Inc. Syringe plunger driver system
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
EP2191842A1 (en) 2008-11-28 2010-06-02 Sanofi-Aventis Antitumor combinations containing antibodies recognizing specifically CD38 and cytarabine
EP2191840A1 (en) 2008-11-28 2010-06-02 Sanofi-Aventis Antitumor combinations containing antibodies recognizing specifically CD38 and melphalan
EP2191841A1 (en) 2008-11-28 2010-06-02 Sanofi-Aventis Antitumor combinations containing antibodies recognizing specifically CD38 and vincristine
UA112170C2 (uk) 2010-12-10 2016-08-10 Санофі Протипухлинна комбінація, що містить антитіло, яке специфічно розпізнає cd38, і бортезоміб
UA118255C2 (uk) 2012-12-07 2018-12-26 Санофі Композиція, яка містить антитіло до cd38 і леналідомід
SG10201913777XA (en) 2013-03-13 2020-03-30 Sanofi Sa Compositions comprising anti-cd38 antibodies and carfilzomib
US20150118251A1 (en) 2013-10-31 2015-04-30 Sanofi Specific anti-cd38 antibodies for treating human cancers
WO2016109822A1 (en) * 2014-12-31 2016-07-07 Novelmed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
CA3004152C (en) * 2015-11-03 2024-04-16 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses
MA45674A (fr) * 2016-07-15 2019-05-22 Takeda Pharmaceuticals Co Méthodes et matériaux permettant d'évaluer une réponse à des traitements de déplétion de plasmoblastes et de plasmocytes
US10646569B2 (en) * 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
KR20250117714A (ko) * 2018-03-28 2025-08-05 다케다 야쿠힌 고교 가부시키가이샤 항-cd38 항체의 피하 투약
JP7712206B2 (ja) * 2019-01-28 2025-07-23 サノフィ－アベンティス・ユー・エス・エルエルシー 多発性骨髄腫の処置方法
BR112021021099A2 (pt) * 2019-04-23 2021-12-14 Sanofi Sa Formulações de anticorpos estáveis, de baixa viscosidade, e usos das mesmas

Also Published As

Publication number Publication date
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
JP7670713B2 (ja) 2025-04-30
EP4069743A1 (en) 2022-10-12
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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