DK2573114T3 - Identificering og fremstilling af antistoffer med en variant af Fc-regioner og fremgangsmåder til anvendelse af samme - Google Patents

Identificering og fremstilling af antistoffer med en variant af Fc-regioner og fremgangsmåder til anvendelse af samme Download PDF

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DK2573114T3
DK2573114T3 DK12171813.4T DK12171813T DK2573114T3 DK 2573114 T3 DK2573114 T3 DK 2573114T3 DK 12171813 T DK12171813 T DK 12171813T DK 2573114 T3 DK2573114 T3 DK 2573114T3
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antibody
substitution
variant
leucine
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DK12171813.4T
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Sergey Gorlatov
Christopher Rankin
Nadine Tuaillon
Jeffery Stavenhagen
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Macrogenics Inc
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/575—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biotechnology (AREA)
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  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Veterinary Medicine (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Claims (23)

1
1. Polypeptid, som omfatter en variant afen lgG1 Fc-region, hvor varianten afen Fc-region omfatter mindst én aminosyremodifikation i forhold til en vildtype-lgG1 Fc-region, således at: (I) varianten af Fc-regionen af polypeptidet binder: (A) FcyRMIA med en større affinitet og (B) FcyRIIB med ændret bindingsaffinitet; hvor den større og den ændrede bindingsaffinitet er i forhold til de bindingsaffiniteter, som udvises af et sådant polypeptid overfor disse FcyR’er, hvis de omfatter en vildtype-Fc-region; og (II) hvor den mindst ene aminosyremodifikation omfatter et sæt af substitutioner, som er valgt fra gruppen bestående af: (1) en substitution i position 243 med leucin og i position 292 med prolin; (2) en substitution i position 243 med leucin, i position 292 med prolin og i position 305 med isoleucin; (3) en substitution i position 243 med leucin, i position 292 med prolin og i position 396 med leucin; (4) en substitution i position 243 med leucin, i position 292 med prolin og i position 300 med leucin; og (5) en substitution i position 243 med leucin, i position 292 med prolin, i position 300 med leucin og i position 396 med leucin; hvor positionerne er nummereret i overensstemmelse med EU-indekset som i Kabat.
2. Polypeptid ifølge krav 1, hvor polypeptidet er et antistof eller et fragment af et antistof, som indeholder varianten af Fc-regionen.
3. Antistof eller fragment deraf ifølge krav 2, hvor antistoffet er et monoklonalt antistof, et humaniseret antistof eller et humant antistof.
4. Antistof eller fragment deraf ifølge krav 2, hvor antistoffet omfatter et variabelt domæne, som binder til CD16A eller CD32B. 2
5. Antistof eller fragment deraf ifølge krav 2, hvor antistoffet er antistof 2B6, der produceres af det hybridom, som har ATCC-deponeringsnr. PTA-4591.
6. Antistof eller fragment deraf ifølge krav 3, hvor antistoffet er en humaniseret version af antistof 2B6, der produceres af det hybridom, som har ATCC-deponeringsnr. PTA-4591.
7. Antistof eller fragment deraf ifølge krav 2, hvor antistoffet kompetitivt inhiberer bindingen af antistof 2B6, der produceres af det hybridom, som har ATCC-deponeringsnr. PTA-4591, til CD32B.
8. Nukleinsyre, der omfatter en nukleotidsekvens, som koder for polypeptidet ifølge krav 1.
9. Vektor, der omfatter nukleinsyren ifølge krav 8.
10. Isoleret værtscelle, der omfatter nukleinsyren ifølge krav 9.
11. Fremgangsmåde til rekombinant produktion af polypeptidet ifølge krav 1, hvilken fremgangsmåde omfatter: (i) dyrkning i et medium af en værtscelle, der omfatter en nukleinsyre, som koder for polypeptidet, under betingelser, der er egnede til ekspression af polypeptidet; og (ii) udvinding af polypeptidet fra mediet.
12. Antistof eller fragment deraf ifølge krav 2, hvor antistoffet eller fragmentet desuden specifikt binder et cancerantigen eller et antigen af et infektiøst middel.
13. Antistof eller fragment deraf ifølge krav 12, hvor antistoffet medierer forøget antistofafhængig cellemedieret cytotoksicitet i forhold til et sammenligneligt antistof, der omfatter en vildtype-Fc-region.
14. Anvendelse af et antistof eller et fragment deraf ifølge krav 12 til fremstilling af et lægemiddel til behandling af cancer i en patient, som har en cancer, der er kendetegnet af cancerantigenet. 3
15. Antistof eller fragment deraf ifølge krav 12 eller anvendelse ifølge krav 14, hvor cancerantigenet er MAGE-1, MAGE-3, BAGE, GAGE-1, GAGE-2, N-acetyl-glucosaminyltransferase, p15, beta-catenin, MUM-1, CDK4, HER-2/neu, humant papil-lomavirus-E6, humant papillomavirus-E7 eller MUC-1.
16. Antistof eller fragment deraf ifølge krav 12 eller anvendelse ifølge krav 14, hvor cancerantigenet er et bryst-, ovarie-, prostata-, livmoderhals- eller pankreas-carcinom-antigen.
17. Anvendelse af et polypeptid ifølge krav 1 til fremstilling af et lægemiddel til behandling af en inflammatorisk sygdom.
18. Præparat, der omfatter en terapeutisk effektiv mængde af et polypeptid ifølge krav 1 eller af et antistof eller et fragment deraf ifølge et hvilket som helst af kravene 2-7, 12-13 eller 15-16 og en farmaceutisk acceptabel bærer.
19. Nukleinsyre, der omfatter en nukleotidsekvens, som koder for en tung kæde af et antistof ifølge krav 2.
20. Vektor, der omfatter nukleinsyren ifølge krav 19.
21. Isoleret værtscelle, der omfatter nukleinsyren ifølge krav 19.
22. Antistof ifølge krav 2, hvor antistoffet har en forøget ADCC-aktivitet i forhold til ADCC-aktiviteten af antistoffet, hvis det omfatter en vildtype-Fc-region.
23. Polypeptid ifølge krav 1, hvor varianten af Fc-regionen desuden omfatter én eller flere af de aminosyremodifikationer, der er angivet i tabel 5, 6, 7 eller 8.
DK12171813.4T 2005-08-10 2006-08-10 Identificering og fremstilling af antistoffer med en variant af Fc-regioner og fremgangsmåder til anvendelse af samme DK2573114T3 (da)

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US70741905P 2005-08-10 2005-08-10
EP06801146.9A EP1919503B1 (en) 2005-08-10 2006-08-10 Identification and engineering of antibodies with variant fc regions and methods of using same

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CA (1) CA2618681C (da)
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