CO2022009089A2 - Formulaciones de anticuerpos anti-cd38 para administración subcutánea - Google Patents

Formulaciones de anticuerpos anti-cd38 para administración subcutánea

Info

Publication number
CO2022009089A2
CO2022009089A2 CONC2022/0009089A CO2022009089A CO2022009089A2 CO 2022009089 A2 CO2022009089 A2 CO 2022009089A2 CO 2022009089 A CO2022009089 A CO 2022009089A CO 2022009089 A2 CO2022009089 A2 CO 2022009089A2
Authority
CO
Colombia
Prior art keywords
antibody
subcutaneous administration
formulations
antibody formulations
viscosity
Prior art date
Application number
CONC2022/0009089A
Other languages
English (en)
Spanish (es)
Inventor
Sylvain Huille
Thomas Ballet
Kiran Bangari
Ravi Chari
Bernardo Perez-Ramirez
Vasco Filipe
Original Assignee
Sanofi Aventis Us Llc
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 Sanofi Aventis Us Llc filed Critical Sanofi Aventis Us Llc
Publication of CO2022009089A2 publication Critical patent/CO2022009089A2/es

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [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
    • 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
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61P35/00Antineoplastic agents
    • 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
    • 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
    • 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]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • 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)
CONC2022/0009089A 2019-12-05 2022-06-29 Formulaciones de anticuerpos anti-cd38 para administración subcutánea CO2022009089A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962944082P 2019-12-05 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
CO2022009089A2 true CO2022009089A2 (es) 2022-07-08

Family

ID=74130308

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2022/0009089A CO2022009089A2 (es) 2019-12-05 2022-06-29 Formulaciones de anticuerpos anti-cd38 para administración subcutánea

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
US20210188996A1 (en) 2021-06-24

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