BR112022010905A2 - Formulações de anticorpos anti-cd38 para administração subcutânea - Google Patents

Formulações de anticorpos anti-cd38 para administração subcutânea

Info

Publication number
BR112022010905A2
BR112022010905A2 BR112022010905A BR112022010905A BR112022010905A2 BR 112022010905 A2 BR112022010905 A2 BR 112022010905A2 BR 112022010905 A BR112022010905 A BR 112022010905A BR 112022010905 A BR112022010905 A BR 112022010905A BR 112022010905 A2 BR112022010905 A2 BR 112022010905A2
Authority
BR
Brazil
Prior art keywords
antibody
subcutaneous administration
formulations
antibody formulations
certain embodiments
Prior art date
Application number
BR112022010905A
Other languages
English (en)
Inventor
Ballet Thomas
Bangari Kiran
Chari Ravi
Huille Sylvain
Perez-Ramirez Bernardo
Filipe Vasco
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 BR112022010905A2 publication Critical patent/BR112022010905A2/pt

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

FORMULAÇÕES DE ANTICORPOS ANTICD38 PARA ADMINISTRAÇÃO SUBCUTÂNEA. A presente invenção refere-se a formulações de anticorpos anti-CD38 adequados para administração subcutânea a um indivíduo em necessidade das mesmas. As formulações incluem uma alta concentração de anticorpo, um agente redutor de viscosidade, um agente estabilizador, um agente tamponante e um tensoativo. Em certas modalidades, a viscosidade da solução é de no máximo 25 mPa?s e o pH da solução é de 5,9 a 7,0. Em certas modalidades, o anticorpo anti-CD38 é isatuximabe. As formulações encontrarão uso no tratamento de malignidades hematológicas de CD38+, incluindo mieloma múltiplo, bem como doenças autoimunes e inflamatórias, em humanos.
BR112022010905A 2019-12-05 2020-12-04 Formulações de anticorpos anti-cd38 para administração subcutânea BR112022010905A2 (pt)

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
BR112022010905A2 true BR112022010905A2 (pt) 2022-09-06

Family

ID=74130308

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112022010905A BR112022010905A2 (pt) 2019-12-05 2020-12-04 Formulações de anticorpos anti-cd38 para administração subcutânea

Country Status (13)

Country Link
US (1) US20210188996A1 (pt)
EP (1) EP4069743A1 (pt)
JP (1) JP2023505217A (pt)
KR (1) KR20220159947A (pt)
CN (1) CN115698064A (pt)
AU (1) AU2020397170A1 (pt)
BR (1) BR112022010905A2 (pt)
CA (1) CA3160502A1 (pt)
CO (1) CO2022009089A2 (pt)
IL (1) IL293563A (pt)
MX (1) MX2022006882A (pt)
TW (1) TW202133879A (pt)
WO (1) WO2021113739A1 (pt)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11655302B2 (en) 2019-06-10 2023-05-23 Sanofi Anti-CD38 antibodies and formulations
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

Family Cites Families (23)

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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
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SI2567976T1 (sl) 2005-03-23 2017-11-30 Genmab A/S Protitelesa usmerjena proti cd38 za zdravljenje multiplega mieloma
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EP1914242A1 (en) 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
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
EP2191843A1 (en) 2008-11-28 2010-06-02 Sanofi-Aventis Antitumor combinations containing antibodies recognizing specifically CD38 and cyclophosphamide
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
RU2723937C2 (ru) 2013-03-13 2020-06-18 Санофи Композиции, включающие антитела к cd38 и карфилзомиб
PL3063173T3 (pl) 2013-10-31 2021-01-11 Sanofi Swoiste przeciwciała anty-cd38 do leczenia nowotworów u ludzi
EP3240571A4 (en) * 2014-12-31 2018-06-13 NovelMed Therapeutics, Inc. Formulation of aglycosylated therapeutic antibodies
CN108472369A (zh) * 2015-11-03 2018-08-31 詹森生物科技公司 抗cd38抗体的皮下制剂及其用途
SG11202003754YA (en) * 2017-05-16 2020-05-28 Bhamis Research Laboratory Pvt Ltd High concentration protein formulations with reduced viscosity
MA54860A (fr) * 2019-01-28 2022-05-04 Sanofi Sa Méthodes de traitement du myélome multiple
MX2021012968A (es) * 2019-04-23 2022-01-18 Sanofi Sa Formulaciones de anticuerpo de baja viscosidad, estables y usos de las mismas.

Also Published As

Publication number Publication date
CN115698064A (zh) 2023-02-03
CA3160502A1 (en) 2021-06-10
JP2023505217A (ja) 2023-02-08
CO2022009089A2 (es) 2022-07-08
IL293563A (en) 2022-08-01
EP4069743A1 (en) 2022-10-12
AU2020397170A1 (en) 2022-07-21
TW202133879A (zh) 2021-09-16
WO2021113739A1 (en) 2021-06-10
MX2022006882A (es) 2022-11-08
US20210188996A1 (en) 2021-06-24
KR20220159947A (ko) 2022-12-05

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