DK2342227T3 - Behandling af akut lymfoblastær leukæmi - Google Patents

Behandling af akut lymfoblastær leukæmi Download PDF

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DK2342227T3
DK2342227T3 DK09760483.9T DK09760483T DK2342227T3 DK 2342227 T3 DK2342227 T3 DK 2342227T3 DK 09760483 T DK09760483 T DK 09760483T DK 2342227 T3 DK2342227 T3 DK 2342227T3
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chain antibody
bispecific single
single chain
cd19xcd3 bispecific
patient
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Gerhard Zugmaier
Evelyn Degenhard
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Amgen Res Munich Gmbh
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    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • C07K16/2809Immunoglobulins [IGs], 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 the T-cell receptor (TcR)-CD3 complex
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46Hybrid immunoglobulins
    • C07K16/468Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • 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
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31Immunoglobulins specific features characterized by aspects of specificity or valency multispecific

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biotechnology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Biomedical Technology (AREA)
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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (17)

  1. BEHANDLING AF AKUT LYMFOBLASTÆR LEUKÆMI Patentkrav
    1. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse i en fremgangsmåde til behandling, lindring eller eliminering af akut lymfoblastær leukæmi (ALL) hos en voksen patient.
  2. 2. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 1, hvor den akutte lymfoblastære leukæmi (ALL) er B-cellelinje akut lymfoblastær leukæmi, fortrinsvis B-forstadie akut lymfoblastær leukæmi.
  3. 3. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 1 eller 2, hvor den akutte lymfoblastære leukæmi (ALL) er refraktær over for kemoterapi, hos patienter, der er uegnet til allogen hæmatopoietisk stamcelletransplantation.
  4. 4. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 1 eller 2 efterfulgt af allogen hæmatopoietisk stamcelletransplantation, eller hvor fremgangsmåden erstatter allogen hæmatopoietisk stamcelletransplantation, hos patienter, der er egnet til allogen hæmatopoietisk stamcelletransplantation.
  5. 5. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 4, hvor fremgangsmåden er til behandling, lindring eller eliminering af minimal restsygdom (MRD) hos en patient med akut lymfoblastær leukæmi (ALL).
  6. 6. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 5, hvor patienten er MRD-positiv i komplet hæmatologisk remission.
  7. 7. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 5 eller 6, hvor administrationen af det farmaceutiske præparat resulterer i stabil disease eller ændring af MRD-positiv akut lymfoblastær leukæmi (ALL) til en MRD-negativ status.
  8. 8. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 5 til 7, hvor MRD måles ved hjælp af kvantitativ detektion af individuelle omlejringer af immunoglobulingener eller T-cellereceptor (TCR)-omlejringer eller ved hjælp af bcr/abl-fusionstranskripter eller ved hjælp af t(4;ll)-translokationer ved anvendelse af PCR- eller FACS-an alyse.
  9. 9. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 8, hvor de modsvarende variable regioner af tung kæde (VH) og let kæde (VL) i den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion er placeret fra N-terminus til C-terminus i rækkefølgen V.l.(CD19)-V.h.(CD19)-V.h.(CD3)-V.l.(CD3).
  10. 10. CD 19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 9, hvor den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion omfatter en aminosyresekvens ifølge SEQ ID NO: 1 eller en aminosyresekvens, der er mindst 90 %, fortrinsvis 95 % identisk med SEQ ID NO: 1.
  11. 11. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 10, hvor én behandlingscyklus er en 4-ugers kontinuert infusion, efterfulgt af gentagne cyklusser efter et 2-ugers behandlingsfrit interval.
  12. 12. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 11, hvor behandlingscyklussen gentages mindst tre gange efter bestemmelse af en MRD-negativ status (konsolidering).
  13. 13. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 12, hvor den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion skal administreres i en daglig dosis på 10 pg o til 100 pg pr. m kropsoverfladeareal hos patienten.
  14. 14. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 13, hvor den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion skal administreres i en daglig dosis på 15 pg til 30 pg pr. m.2 kropsoverfladeareal hos patienten.
  15. 15. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 12, hvor den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion skal administreres i en daglig dosis på 15 pg, 30 pg, 60 pg eller 90 pg pr. m2 kropsoverfladeareal hos patienten.
  16. 16. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge et hvilket som helst af kravene 1 til 12, hvor den CD19xCD3-bispecifikke enkeltkædede antistofkonstruktion skal administreres ved en dosis på 5 pg pr. m2 kropsoverfladeareal hos patienten de(n) første dag(e) af infusionsperioden, 2 efterfulgt af administration of 15 μg pr. m kropsoverfladeareal hos patienten de(n) følgende dag(e) af infusionsperioden, efterfulgt af administration of 45 pg pr. m kropsoverfladeareal hos patienten som daglig dosis i den resterende behandlingsperiode.
  17. 17. CD19xCD3-bispecifik enkeltkædet antistofkonstruktion til anvendelse ifølge krav 16, hvor den initiale dosis skal administreres i én, to eller flere dage eller i syv dage.
DK09760483.9T 2008-11-07 2009-11-06 Behandling af akut lymfoblastær leukæmi DK2342227T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11232308P 2008-11-07 2008-11-07
US18329109P 2009-06-02 2009-06-02
PCT/EP2009/007970 WO2010052014A1 (en) 2008-11-07 2009-11-06 Treatment of acute lymphoblastic leukemia

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DK2342227T3 true DK2342227T3 (da) 2016-02-15

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DK15185767.9T DK2982696T3 (da) 2008-11-07 2009-11-06 Behandling af akut lymfoblastær leukæmi
DK09760483.9T DK2342227T3 (da) 2008-11-07 2009-11-06 Behandling af akut lymfoblastær leukæmi

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EP (2) EP2982696B1 (da)
JP (2) JP5647132B2 (da)
KR (1) KR101695327B1 (da)
CN (2) CN107184977A (da)
AU (4) AU2009313040B2 (da)
BR (1) BRPI0921482B1 (da)
CA (1) CA2742249C (da)
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CY1122366T1 (el) 2021-01-27
KR20110091668A (ko) 2011-08-12
US20240109964A1 (en) 2024-04-04
AU2009313040B2 (en) 2015-07-09
WO2010052014A1 (en) 2010-05-14
CA2742249A1 (en) 2010-05-14
PL2982696T3 (pl) 2019-08-30
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HRP20151168T1 (hr) 2015-12-04
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