HRP20191715T1 - Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 - Google Patents

Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 Download PDF

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HRP20191715T1
HRP20191715T1 HRP20191715T HRP20191715T1 HR P20191715 T1 HRP20191715 T1 HR P20191715T1 HR P20191715 T HRP20191715 T HR P20191715T HR P20191715 T1 HRP20191715 T1 HR P20191715T1
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construct
use according
patient
single chain
chain antibody
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Gerhard Zugmaier
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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
    • 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
    • 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
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3061Blood cells
    • 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
    • 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
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Oncology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Claims (14)

1. CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca za uporabu u postupku liječenja, poboljšanja ili uklanjanja dječje akutne limfoblastične leukemije (ALL) kod pedijatrijskog ALL pacijenta, naznačen time što navedena dječja ALL je refraktorna prema kemoterapiji ili alogenoj transplantaciji hematopoetskih matičnih stanica (HSCT).
2. Konstrukt za uporabu prema zahtjevu 1, naznačen time što je navedena dječja akutna limfoblastična leukemija (ALL) refraktorna prema kemoterapiji i alogenoj transplantaciji hematopoetskih matičnih stanica (HSCT).
3. Konstrukt za uporabu prema zahtjevu 1 ili 2, naznačen time što je navedena akutna limfoblastična leukemija (ALL) relapsirajuća ALL ili relapsirajuća ALL refraktorna prema kemoterapiji i/ili transplantaciji hematopoetskih matičnih stanica (HSCT).
4. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačen time što postupak za liječenje, poboljšanje ili uklanjanje minimalne rezidualne bolesti (MRD) kod pedijatrijskog ALL pacijenta.
5. Konstrukt za uporabu prema zahtjevu 4, naznačen time što navedeni dječji pacijent s ALL je MRD-pozitivan u potpunoj hematološkoj remisiji.
6. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time što su odgovarajuće varijabilne regije teškog lanca (VH) i odgovarajuće varijabilne regije laganog lanca (VL) u navedenom CD19xCD3 konstruktu protutijela bispecifičnog jednostrukog lanca posložene, od N-terminalnog kraja do C-terminalnog kraja, redoslijedom, VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3).
7. Konstrukt za uporabu prema zahtjevu 6, naznačen time što navedeni CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO. 1, ili aminokiselinsku sekvencu koja je barem 90%, poželjno 95% identična sa SEQ ID NO. 1.
8. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 7, naznačen time što se farmaceutski pripravak koji sadrži CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca treba davati kontinuiranom infuzijom najmanje četiri tjedna nakon čega slijedi interval od 2 tjedna bez tretmana.
9. Konstrukt za uporabu prema zahtjevu 8, naznačen time što se nakon određivanja negativnog statusa MRD-a navedeno davanje ponavlja najmanje dva, tri, četiri, pet, šest, sedam, osam, devet i deset puta.
10. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 10 µg do 100 µg po kvadratnom metru površine tijela pacijenta.
11. Konstrukt za uporabu prema bilo kojem od patentnih zahtjeva 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 15 µg do 30 µg po kvadratnom metru površine tijela pacijenta.
12. Konstrukt za uporabu prema patentnim zahtjevima 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dnevnoj dozi od 15 µg, 30 µg, 60 µg ili 90 µg po kvadratnom metru površine tijela pacijenta.
13. Konstrukt za uporabu prema patentnim zahtjevima 1 do 9, naznačen time što se CD19xCD3 konstrukt protutijela bispecifičnog jednostrukog lanca daje u dozi od 5 µg po kvadratnom metru površine tijela pacijenta prvog dana, nakon čega slijedi primjena 15 µg po kvadratnom metru površine tijela pacijenta tijekom slijedećeg(ih) dana, nakon čega slijedi primjena 30 µg ili 45 µg po kvadratnom metru površine tijela pacijenta kao dnevna doza tijekom preostalog razdoblja davanja od ukupno četiri tjedna.
14. Konstrukt za uporabu prema zahtjevu 13, naznačen time što se dvije početne doze daju tijekom 1, 2, 3, 4, 5, 6, ili 7 dana ili čak i duže.
HRP20191715 2008-11-07 2019-09-20 Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19 HRP20191715T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11232308P 2008-11-07 2008-11-07
US18329109P 2009-06-02 2009-06-02
US22126909P 2009-06-29 2009-06-29
EP17206868.6A EP3330293B1 (en) 2008-11-07 2009-11-06 Treatment of pediatric acute lymphoblastic leukemia with bispecific antibodies against cd3xcd19

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HRP20191715T1 true HRP20191715T1 (hr) 2019-12-13

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HRP20150400TT HRP20150400T1 (hr) 2008-11-07 2015-04-10 Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije
HRP20180426TT HRP20180426T1 (hr) 2008-11-07 2018-03-12 Liječenje pedijatrijske akutne limfoblastične leukemije
HRP20191715 HRP20191715T1 (hr) 2008-11-07 2019-09-20 Liječenje dječje akutne limfoblastične leukemije sa bispecifičnim protutijelima protiv cd3xcd19

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HRP20150400TT HRP20150400T1 (hr) 2008-11-07 2015-04-10 Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije
HRP20180426TT HRP20180426T1 (hr) 2008-11-07 2018-03-12 Liječenje pedijatrijske akutne limfoblastične leukemije

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EP2918604B1 (en) 2017-12-20
HK1215258A1 (zh) 2016-08-19
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CY1116160T1 (el) 2017-02-08
SG195549A1 (en) 2013-12-30
HUE025452T2 (en) 2016-05-30
ES2535257T3 (es) 2015-05-07
HUE036922T2 (hu) 2018-08-28
DK3330293T3 (da) 2019-10-07
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JP2012508163A (ja) 2012-04-05
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CY1122428T1 (el) 2021-01-27
EP3330293A1 (en) 2018-06-06
RU2536933C2 (ru) 2014-12-27
RS59348B1 (sr) 2019-10-31

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