AU2020397170A1 - Formulations of anti-CD38 antibodies for subcutaneous administration - Google Patents

Formulations of anti-CD38 antibodies for subcutaneous administration Download PDF

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Publication number
AU2020397170A1
AU2020397170A1 AU2020397170A AU2020397170A AU2020397170A1 AU 2020397170 A1 AU2020397170 A1 AU 2020397170A1 AU 2020397170 A AU2020397170 A AU 2020397170A AU 2020397170 A AU2020397170 A AU 2020397170A AU 2020397170 A1 AU2020397170 A1 AU 2020397170A1
Authority
AU
Australia
Prior art keywords
formulation
cdr
antibody
certain embodiments
sucrose
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
AU2020397170A
Other languages
English (en)
Inventor
Thomas Ballet
Kiran BANGARI
Ravi Chari
Vasco Filipe
Sylvain Huille
Bernardo Perez-Ramirez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis US LLC
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 AU2020397170A1 publication Critical patent/AU2020397170A1/en
Pending legal-status Critical Current

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Classifications

    • 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

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)
AU2020397170A 2019-12-05 2020-12-04 Formulations of anti-CD38 antibodies for subcutaneous administration Pending AU2020397170A1 (en)

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
AU2020397170A1 true AU2020397170A1 (en) 2022-07-21

Family

ID=74130308

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020397170A Pending AU2020397170A1 (en) 2019-12-05 2020-12-04 Formulations of anti-CD38 antibodies for subcutaneous administration

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
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
CO2022009089A2 (es) 2022-07-08
US20210188996A1 (en) 2021-06-24

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