BR112021021060A2 - Anticorpos anti-cd38 e formulações - Google Patents

Anticorpos anti-cd38 e formulações

Info

Publication number
BR112021021060A2
BR112021021060A2 BR112021021060A BR112021021060A BR112021021060A2 BR 112021021060 A2 BR112021021060 A2 BR 112021021060A2 BR 112021021060 A BR112021021060 A BR 112021021060A BR 112021021060 A BR112021021060 A BR 112021021060A BR 112021021060 A2 BR112021021060 A2 BR 112021021060A2
Authority
BR
Brazil
Prior art keywords
antibodies
formulations
methods
preparing
human
Prior art date
Application number
BR112021021060A
Other languages
English (en)
Portuguese (pt)
Inventor
Alain Fournier
Angela Virone-Oddos
Brian Murray
Béatrice Cameron
Cendrine Lemoine
Jacques Dumas
Jonathan Kingsbury
Chiron Blondel Marielle
Nathan Ostberg
Sanket Patke
Zichuan Zhang
Original Assignee
Sanofi Sa
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 Sa filed Critical Sanofi Sa
Publication of BR112021021060A2 publication Critical patent/BR112021021060A2/pt

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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/567Framework region [FR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72Increased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734Complement-dependent cytotoxicity [CDC]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
BR112021021060A 2019-04-23 2020-04-23 Anticorpos anti-cd38 e formulações BR112021021060A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201962837518P 2019-04-23 2019-04-23
US201962859699P 2019-06-10 2019-06-10
EP20305145 2020-02-17
EP20305146 2020-02-17
PCT/US2020/029531 WO2020219681A1 (en) 2019-04-23 2020-04-23 Anti-cd38 antibodies and formulations

Publications (1)

Publication Number Publication Date
BR112021021060A2 true BR112021021060A2 (pt) 2021-12-14

Family

ID=70739160

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021021060A BR112021021060A2 (pt) 2019-04-23 2020-04-23 Anticorpos anti-cd38 e formulações

Country Status (15)

Country Link
EP (1) EP3958898A1 (https=)
JP (1) JP7602485B2 (https=)
KR (1) KR20220003562A (https=)
CN (2) CN120757645A (https=)
AU (1) AU2020261039A1 (https=)
BR (1) BR112021021060A2 (https=)
CA (1) CA3137365A1 (https=)
CO (1) CO2021015462A2 (https=)
IL (1) IL287477A (https=)
MA (1) MA55761A (https=)
MX (1) MX2021012967A (https=)
MY (1) MY206426A (https=)
SG (1) SG11202111602YA (https=)
TW (1) TWI878289B (https=)
WO (1) WO2020219681A1 (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2024546152A (ja) * 2021-12-16 2024-12-17 上海宝済薬業股▲ふん▼有限公司 免疫グロブリン分解酵素による切断に対抗するFc変異体
WO2024023843A1 (en) * 2022-07-26 2024-02-01 Dr. Reddy’S Laboratories Limited A pharmaceutical formulation of a therapeuticantibody and preparations thereof
WO2025245526A1 (en) * 2024-05-24 2025-11-27 Research Institute At Nationwide Children's Hospital Cd-38 protein binding compositions and methods related thereto
CN120535629B (zh) * 2025-04-22 2026-01-23 西安市中心血站(陕西省血液中心) 一种用于抑制cd38单抗对输血相容性检测干扰的抗体

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2005277831B2 (en) 2004-07-10 2012-11-22 The Institute For Cancer Research Genetically modified human natural killer cell lines
EP2471813B1 (en) * 2004-07-15 2014-12-31 Xencor, Inc. Optimized Fc variants
EP1914242A1 (en) * 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
EP3559049B1 (en) * 2011-10-28 2025-06-11 Teva Pharmaceuticals Australia Pty Ltd Polypeptide constructs and uses thereof
WO2016022589A2 (en) * 2014-08-08 2016-02-11 The Regents Of The University Of California Methods for treating multiple myeloma
CA3004152C (en) * 2015-11-03 2024-04-16 Janssen Biotech, Inc. Subcutaneous formulations of anti-cd38 antibodies and their uses
EP3479819B1 (en) * 2016-06-30 2024-01-24 Celltrion Inc. Stable liquid pharmaceutical preparation
JP2020518598A (ja) * 2017-05-02 2020-06-25 メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. 単独およびプログラム死受容体1(pd−1)抗体と組み合わされた抗ctla4抗体の安定な製剤、ならびにその使用方法
JP2020535181A (ja) * 2017-09-29 2020-12-03 ヤンセン バイオテツク,インコーポレーテツド 低用量抗体組成物を安定化する新規製剤
CN108752475B (zh) * 2018-06-14 2021-07-30 北京智仁美博生物科技有限公司 抗人cd38抗体及其用途

Also Published As

Publication number Publication date
KR20220003562A (ko) 2022-01-10
TWI878289B (zh) 2025-04-01
JP7602485B2 (ja) 2024-12-18
WO2020219681A1 (en) 2020-10-29
IL287477A (en) 2021-12-01
EP3958898A1 (en) 2022-03-02
JP2022529502A (ja) 2022-06-22
CA3137365A1 (en) 2020-10-29
MA55761A (fr) 2022-03-02
CN120757645A (zh) 2025-10-10
CO2021015462A2 (es) 2021-12-10
SG11202111602YA (en) 2021-11-29
MY206426A (en) 2024-12-17
AU2020261039A1 (en) 2021-12-09
MX2021012967A (es) 2022-01-18
TW202104269A (zh) 2021-02-01
CN114269375A (zh) 2022-04-01

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