HRP20201422T1 - Ljudska anti-tau antitijela - Google Patents

Ljudska anti-tau antitijela Download PDF

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Publication number
HRP20201422T1
HRP20201422T1 HRP20201422TT HRP20201422T HRP20201422T1 HR P20201422 T1 HRP20201422 T1 HR P20201422T1 HR P20201422T T HRP20201422T T HR P20201422TT HR P20201422 T HRP20201422 T HR P20201422T HR P20201422 T1 HRP20201422 T1 HR P20201422T1
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Croatia
Prior art keywords
tau
binding fragment
antibody
disease
seq
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HRP20201422TT
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English (en)
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Paul H. Weinreb
Feng Chen
Ellen A. Garber
Jan Grimm
Fabio Montrasio
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Biogen Ma Inc.
Biogen International Neuroscience Gmbh
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Application filed by Biogen Ma Inc., Biogen International Neuroscience Gmbh filed Critical Biogen Ma Inc.
Publication of HRP20201422T1 publication Critical patent/HRP20201422T1/hr

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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • 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
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
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    • A61K49/08Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by the carrier
    • A61K49/10Organic compounds
    • A61K49/14Peptides, e.g. proteins
    • A61K49/16Antibodies; Immunoglobulins; Fragments thereof
    • AHUMAN NECESSITIES
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G01N33/6896Neurological disorders, e.g. Alzheimer's disease
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • G01MEASURING; TESTING
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    • G01N2800/28Neurological disorders
    • G01N2800/2814Dementia; Cognitive disorders

Claims (12)

1. Monoklonsko anti-tau antitijelo ili njegov tau-vezujući fragment, naznačeno time što: (a) varijabilna regija teškog lanca (VH) sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 48 i varijabilna regija lakog lanca (VL) sadrži aminokiselinsku sekvencu naveden u SEQ ID NO: 49, ili (b) VH sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 47, a VL sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 49.
2. Anti-tau antitijelo ili njegov tau-vezujući fragment prema zahtjevu 1, naznačeno time što je anti-tau antitijelo ili tau-vezujući fragment odabran iz skupine koja sadrži Fab, Fab', F (ab')2, i Fd, i Fv, jednolančani Fv (scFv), i jednolančano antitijelo i Fv (sdFv).
3. Anti-tau antitijelo ili njegov tau-vezujući fragment prema zahtjevu 1 ili 2, naznačeno time što anti-tau antitijelo ili njegov tau-vežući fragment sadrži polietilen glikol ili detektirajuću etiketu odabranu iz skupine koja se sastoji od enzima, radioizotopa, fluorescentnog spoja, kemiluminiscentnog spoja, bioluminescentnog spoja i teškog metala.
4. Farmaceutski pripravak koji sadrži anti-tau antitijelo ili njegov tau-vežući fragment prema bilo kojem od zahtjeva 1-3, i farmaceutski prihvatljiv nosač.
5. Izolirani polinukleotid ili polinukleotidi koji sadrže nukleotidnu sekvencu ili nukleotidne sekvence koji kodiraju anti-tau antitijelo ili njegov tau-vezujući fragment prema zahtjevu 1 ili 2.
6. Polinukleotid ili polinukleotidi prema zahtjevu 5, naznačeni time što sadrže niz sekvenca nukleinskih kiselina naveden u SEQ ID NO: 173 i SEQ ID NO: 174.
7. Ekspresijski vektor ili vektori koji sadrže polinukleotid ili polinukleotide prema zahtjevu 5 ili 6.
8. Izolirana stanica domaćina koja sadrži ekspresijski vektor ili vektore prema zahtjevu 7 ili polinukleotid ili polinukleotide prema zahtjevu 5 ili 6.
9. Postupak za pripremu anti-tau antitijela ili njegovog tau-vezujućeg fragmenta, postupak sadrži: uzgoj stanice domaćina prema zahtjevu 8 u staničnoj kulturi, i izoliranje anti-tau antitijela ili njegovog tau-vezujućeg fragmenta iz stanične kulture.
10. Anti-tau antitijelo ili tau-vežući fragment prema bilo kojim od zahtjeva 1-3 ili farmaceutski pripravak prema zahtjevu 4, naznačen time što se upotrebljava u liječenju neurodegenerativne taupatije kod ljudskog subjekta kojem je to potrebno, poželjno gdje je neurodegenerativna taupatija odabrana iz skupine koji se sastoji od Alzheimerove bolesti, kompleksa amiotrofične lateralne skleroze / parldonizam-demencije, demencije argirofilnih zrnaca, amiloidne angiopatije britanskog tipa, cerebralne amiloidne angiopatije, kortikobazalne degeneracije, bolesti Creutzfeldta-Jakoba, pugilističke demencije, difuzne neurofibrilarne zapetljanosti s kalcifikacijom, Downovog sindroma, frontotemporalne demencije, frontotemporalne demencije parkinsonizma povezanog sa kromosomom 17, frontotemporalne lobarne degeneracije, GerstmannStréiussler-Scheinker bolesti, Hallervorden-Spatz bolesti, inkluzijskog miozitisa tijela, atrofije više sustava, miotonske distrofije, Niemann-Pickove bolesti tipa C, ne-gvamske bolesti motornog neurona s neurofibrilarnim zapetljanjima, Pickove bolesti, postencefalitičkog parkinsonizama, prethodne proteinske cerebralne amiloidne angiopatije, progresivne subkortikalne glioze, progresivne supranuklearne paralize, subkutanog sklerozirajućeg panencefalitisa, demencije samo sa zapetljanjima, demencije multi-infarkta i ishemičnog moždanog udara.
11. Anti-tau antitijelo ili tau-vežući fragment prema bilo kojem od zahtjeva 1-3 za uporabu u in vivo dijagnostici tauopatije kod ljudskog pacijenta kojem je to potrebno.
12. In vitro metoda dijagnosticiranja ili praćenja progresije neurodegenerativne taupatije, postupak sadrži: (a) mjerenje razine patološki modificiranog ili agregiranog tau-a u uzorku dobivenom od ljudskog subjekta s anti-tau antitijelom ili njegovim tau-vezujućim fragmentom prema bilo kojem od zahtjeva 1-3, imunohistokemijom (IHC), i (b) uspoređivanje razine modificiranog ili agregiranog tau-a s referentnim standardom koji pokazuje razinu patološki modificiranog ili agregiranog tau-a u jednom ili više kontrolnih subjekata, pri čemu je razlika ili sličnost između nivoa patološki modificiranog ili agregiranog tau-a i norma referentne vrijednosti pokazuje da ljudski subjekt ima neurodegenerativnu taupatiju.
HRP20201422TT 2012-12-21 2020-09-07 Ljudska anti-tau antitijela HRP20201422T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261745410P 2012-12-21 2012-12-21
PCT/US2013/076952 WO2014100600A2 (en) 2012-12-21 2013-12-20 Human anti-tau antibodies
EP13818637.4A EP2935326B1 (en) 2012-12-21 2013-12-20 Human anti-tau antibodies

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US (4) US9598484B2 (hr)
EP (2) EP2935326B1 (hr)
JP (1) JP6284548B2 (hr)
KR (1) KR102234324B1 (hr)
CN (2) CN111205368B (hr)
AU (1) AU2013361107B2 (hr)
BR (1) BR112015014751A8 (hr)
CA (1) CA2896066C (hr)
CY (1) CY1123518T1 (hr)
DK (1) DK2935326T3 (hr)
EA (1) EA035932B1 (hr)
ES (1) ES2816700T3 (hr)
HK (1) HK1216538A1 (hr)
HR (1) HRP20201422T1 (hr)
HU (1) HUE051320T2 (hr)
IL (1) IL239556B (hr)
LT (1) LT2935326T (hr)
MX (1) MX2015008024A (hr)
MY (1) MY184251A (hr)
PH (2) PH12015501420B1 (hr)
PT (1) PT2935326T (hr)
RS (1) RS60899B1 (hr)
SG (2) SG10201705104UA (hr)
SI (1) SI2935326T1 (hr)
WO (1) WO2014100600A2 (hr)
ZA (1) ZA201504898B (hr)

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