AU2020261039A1 - Anti-CD38 antibodies and formulations - Google Patents

Anti-CD38 antibodies and formulations Download PDF

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Publication number
AU2020261039A1
AU2020261039A1 AU2020261039A AU2020261039A AU2020261039A1 AU 2020261039 A1 AU2020261039 A1 AU 2020261039A1 AU 2020261039 A AU2020261039 A AU 2020261039A AU 2020261039 A AU2020261039 A AU 2020261039A AU 2020261039 A1 AU2020261039 A1 AU 2020261039A1
Authority
AU
Australia
Prior art keywords
amino acid
antibody
seq
acid sequence
heavy chain
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
AU2020261039A
Other languages
English (en)
Inventor
Béatrice Cameron
Marielle CHIRON BLONDEL
Jacques Dumas
Alain Fournier
Jonathan KINGSBURY
Cendrine Lemoine
Brian Murray
Nathan OSTBERG
Sanket PATKE
Angela VIRONE-ODDOS
Zichuan ZHANG
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 SA
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 AU2020261039A1 publication Critical patent/AU2020261039A1/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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/567—Framework region [FR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72—Increased effector function due to an Fc-modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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)
  • 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)
AU2020261039A 2019-04-23 2020-04-23 Anti-CD38 antibodies and formulations Pending AU2020261039A1 (en)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201962837518P 2019-04-23 2019-04-23
US62/837,518 2019-04-23
US201962859699P 2019-06-10 2019-06-10
US62/859,699 2019-06-10
EP20305146 2020-02-17
EP20305146.1 2020-02-17
EP20305145 2020-02-17
EP20305145.3 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
AU2020261039A1 true AU2020261039A1 (en) 2021-12-09

Family

ID=70739160

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2020261039A Pending AU2020261039A1 (en) 2019-04-23 2020-04-23 Anti-CD38 antibodies and formulations

Country Status (15)

Country Link
EP (1) EP3958898A1 (https=)
JP (1) JP7602485B2 (https=)
KR (1) KR20220003562A (https=)
CN (2) CN114269375A (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
WO2023109928A1 (zh) * 2021-12-16 2023-06-22 上海宝济药业有限公司 抗免疫球蛋白降解酶酶切的Fc变体
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
DE602005016683D1 (de) 2004-07-10 2009-10-29 Fox Chase Cancer Ct Genetisch modifizierte, menschliche, natürliche killerzellenlinien:
CN103172731A (zh) * 2004-07-15 2013-06-26 赞科股份有限公司 优化的Fc变体
EP1914242A1 (en) * 2006-10-19 2008-04-23 Sanofi-Aventis Novel anti-CD38 antibodies for the treatment of cancer
SG10201603411WA (en) * 2011-10-28 2016-07-28 Teva Pharmaceuticals Australia Pty Ltd Polypeptide constructs and uses thereof
US10617757B2 (en) * 2014-08-08 2020-04-14 The Regents Of The University Of California Methods for treating multiple myeloma
DK3827845T3 (da) * 2015-11-03 2022-05-23 Janssen Biotech Inc Subkutane formuleringer af anti-cd38-antistoffer og anvendelser deraf
GEP20217249B (en) * 2016-06-30 2021-04-26 Inc Celltrion Stable liquid pharmaceutical preparation
SG11201910134SA (en) * 2017-05-02 2019-11-28 Merck Sharp & Dohme Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
WO2019064263A1 (en) * 2017-09-29 2019-04-04 Janssen Biotech, Inc. NOVEL FORMULATIONS FOR STABILIZING LOW DOSE ANTIBODY COMPOSITIONS
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
JP7602485B2 (ja) 2024-12-18
CN120757645A (zh) 2025-10-10
BR112021021060A2 (pt) 2021-12-14
IL287477A (en) 2021-12-01
WO2020219681A1 (en) 2020-10-29
MX2021012967A (es) 2022-01-18
KR20220003562A (ko) 2022-01-10
EP3958898A1 (en) 2022-03-02
CO2021015462A2 (es) 2021-12-10
MA55761A (fr) 2022-03-02
JP2022529502A (ja) 2022-06-22
CN114269375A (zh) 2022-04-01
CA3137365A1 (en) 2020-10-29
MY206426A (en) 2024-12-17
SG11202111602YA (en) 2021-11-29
TW202104269A (zh) 2021-02-01
TWI878289B (zh) 2025-04-01

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