HRP20150400T1 - Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije - Google Patents

Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije Download PDF

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Publication number
HRP20150400T1
HRP20150400T1 HRP20150400TT HRP20150400T HRP20150400T1 HR P20150400 T1 HRP20150400 T1 HR P20150400T1 HR P20150400T T HRP20150400T T HR P20150400TT HR P20150400 T HRP20150400 T HR P20150400T HR P20150400 T1 HRP20150400 T1 HR P20150400T1
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Croatia
Prior art keywords
construct
accordance
intended
chain antibody
bispecific single
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HRP20150400TT
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Gerhard Zugmaier
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Amgen Research (Munich) Gmbh
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Publication of HRP20150400T1 publication Critical patent/HRP20150400T1/hr

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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
    • 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
    • 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
    • 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)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Oncology (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 (19)

1. CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt, naznačeno time što je namijenjeno upotrebi u postupku liječenja, ublažavanja ili otklanjanja pedijatrijske akutne limfoblastične leukemije (ALL) kod pedijatrijskog pacijenta s ALL.
2. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1, naznačen time što je navedena pedijatrijska akutna limfoblastična leukemija (ALL) pedijatrijska akutna limfoblastična leukemija (ALL) B-loze, po mogućnosti pedijatrijska akutna limfoblastična leukemija ALL preteča B-stanica, poželjnije pedijatrijska pro-B ALL, pre-B ALL ili zajednička ALL (cALL).
3. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je navedena akutna limfoblastična leukemija (ALL) refrakterna i/ili recidiv ALL.
4. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je postupak namijenjen liječenju, ublažavanju ili otklanjanju minimalne preostale bolesti (MRD) kod pedijatrijskog pacijenta s ALL.
5. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 4, naznačen time što je navedeni pedijatrijski pacijent s ALL pozitivnom na MRD kod potpunog hematološkog povlačenja.
6. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 4 ili 5, naznačen time što se MRD mjeri kvantitativnim opažanjem najmanje jedne od citogenetičkih abnormalnosti ili pregradnji, koje se bira iz skupine koju čine: t(12;21)[TEL-AML1]; t(1;19)[E2A-PBX]; t(4;11)[AF4-MLL]; t(9;22)[BCR-ABL]; hiperdiploidnost ili trisomije kromosoma 4, 10 i 17; hipodiploidnost; pregradnje imunoglobulinskih gena; i pregradnje receptora T-stanica (TCR).
7. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što su odgovarajuća varijabilna područja teškog lanca (VH) i odgovarajuća varijabilna područja lakog lanca (VL) u navedenom CD19xCD3 bispecifičnom jednolančanom protutijelu kao konstruktu posložena, od N-kraja do C-kraja, ovim redoslijedom: VL(CD19)-VH(CD19)-VH(CD3)-VL(CD3).
8. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 7, naznačen time što navedeno CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt ima aminokiselinski slijed kako što je iznijet u SEQ ID NO. 1, ili aminokiselinski slijed koji je najmanje 90%, po mogućnosti 95%, istovjetan sa SEQ ID NO. 1.
9. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što farmaceutski pripravak koji sadrži CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primjenjivati kontinuiranom infuzijom najmanje četiri tjedna, za čim slijedi dvotjedni interval bez liječenja.
10. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9, naznačen time što navedenu primjenu treba ponoviti najmanje dva, tri, četiri, pet, šest, sedam, osam, devet ili deset puta, nakon što se odredi status negativnosti na MRD.
11. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9 ili 10, naznačen time što se postupak provodi prije alogenog presađivanja matičnih stanica (HSCT) kako bi se promijenilo ALL pozitivnu na MRD u status negativnosti na MRD.
12. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 9 ili 10, naznačen time što se postupak provodi nakon alogenog presađivanja krvotvornih matičnih stanica (HSCT).
13. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 12, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt potiče učinak presatka prema leukemiji (GvL).
14. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 10 µg do 100 µg/m2 tjelesne površine pacijenta.
15. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 15 µg do 30 µg/m2 tjelesne površine pacijenta.
16. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt treba primijeniti u dnevnoj dozi od 15 µg, 30 µg, 60 µg ili 90 µg/m2 tjelesne površine pacijenta.
17. Konstrukt namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što CD19xCD3 bispecifično jednolančano protutijelo kao konstrukt prvog ili prvih dana treba primijeniti u dozi od 5 µg, sljedećeg ili sljedećih dana u dozi od 15 µg, a preostali period primjene od ukupno 4 tjedna u dozi od 30 ili 45 µg/m2 tjelesne površine pacijenta kao dnevnoj dozi.
18. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 17, naznačen time što se dvije početne doze primjenjuje 2, 3, 4, 5, 6 ili 7 dana ili čak i dulje.
19. Konstrukt namijenjen upotrebi u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedeni pacijent nije prikladan za alogeno presađivanje matičnih stanica.
HRP20150400TT 2008-11-07 2015-04-10 Lijeäśenje pedijatrijske akutne limfoblastiäśne leukemije HRP20150400T1 (hr)

Applications Claiming Priority (5)

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
PCT/EP2009/007969 WO2010052013A1 (en) 2008-11-07 2009-11-06 Treatment of pediatric acute lymphoblastic leukemia
EP09764710.1A EP2344539B1 (en) 2008-11-07 2009-11-06 Treatment of pediatric acute lymphoblastic leukemia

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HRP20150400T1 true HRP20150400T1 (hr) 2015-05-08

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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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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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EP (4) EP2918604B1 (hr)
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RS53980B1 (en) 2015-10-30
RU2018144313A3 (hr) 2020-06-15
CN102209729B (zh) 2016-05-25
HK1215258A1 (zh) 2016-08-19
JP6130451B2 (ja) 2017-05-17
US20230235053A1 (en) 2023-07-27
US20110262440A1 (en) 2011-10-27
CA2742242C (en) 2023-01-10
BRPI0921341A2 (pt) 2016-04-26
KR20110091669A (ko) 2011-08-12
NZ591312A (en) 2012-09-28
DK2344539T3 (en) 2015-05-04
HUE025452T2 (en) 2016-05-30
SI2344539T1 (sl) 2015-06-30
ES2748126T3 (es) 2020-03-13
CY1116160T1 (el) 2017-02-08
PL3330293T3 (pl) 2020-02-28
PL2918604T3 (pl) 2018-05-30
PT2918604T (pt) 2018-03-02
CY1120022T1 (el) 2018-12-12
HRP20191715T1 (hr) 2019-12-13
EP3330293B1 (en) 2019-07-24
HUE046222T2 (hu) 2020-02-28
JP5798036B2 (ja) 2015-10-21
RS59348B1 (sr) 2019-10-31
RU2677324C2 (ru) 2019-01-16
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SMT201500104B (it) 2015-07-09
EP2918604A1 (en) 2015-09-16
AU2009313039A1 (en) 2010-05-14
LT3330293T (lt) 2019-10-10
CY1122428T1 (el) 2021-01-27
RU2014141180A (ru) 2016-05-10
RU2011122827A (ru) 2012-12-20
PL2344539T3 (pl) 2015-07-31
IL212651A (en) 2015-03-31
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