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DK2539366T3 - Protofibril-bindende antistoffer og deres anvendelse i terapeutiske og diagnostiske fremgangsmåder for parkinsons sygdom, demens med lewy body og andre alpha-synukleinopatier - Google Patents

Protofibril-bindende antistoffer og deres anvendelse i terapeutiske og diagnostiske fremgangsmåder for parkinsons sygdom, demens med lewy body og andre alpha-synukleinopatier Download PDF

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DK2539366T3
DK2539366T3 DK11713058.3T DK11713058T DK2539366T3 DK 2539366 T3 DK2539366 T3 DK 2539366T3 DK 11713058 T DK11713058 T DK 11713058T DK 2539366 T3 DK2539366 T3 DK 2539366T3
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Eva Nordstroem
Alex Kasrayan
Monica Ekberg
Lars Lannfelt
Mats Holmquist
Sundquist Valentina Screpanti
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Bioarctic Neuroscience Ab
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Claims (15)

1. Antistof eller fragment deraf, der binder human α-synuklein-protofibriller med en molekylevægt i et område på fra 1000 til 5000 kDa, hvor binding af antistoffet eller fragmentet til hver af a-synuklein-monomerer og β-synuklein-monomerer er mindst 100 gange mindre end binding af antistoffet eller fragmentet til human a-synuklein-protofibriller, hvor antistoffet eller fragmentet har tre variable tunge (VH) CDR-sekvenser (VH-CDR-1, VH-CDR-2, og VH-CDR-3) og tre variable lette (VL) CDR-sekvenser (VL-CDR-1, VL-CDR-2, og VL-CDR-3), og hvor antistoffet eller fragmentet deraf har en CDR-sekvenskombination valgt fra de følgende kombinationer: (a) VH-CDR-1: SEQ ID NO: 22, VH-CDR-2: SEQ ID NO: 28, VH-CDR-3: SEQ ID NO: 35, VL-CDR-1: SEQ ID NO: 41, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 50, (b) VH-CDR-1: SEQ ID NO: 23, VH-CDR-2: SEQ ID NO: 29, VH-CDR-3: SEQ ID NO: 36, VL-CDR-1: SEQ ID NO: 42, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 50, (c) VH-CDR-1: SEQ ID NO: 24, VH-CDR-2: SEQ ID NO: 30, VH-CDR-3: SEQ ID NO: 37, VL-CDR-1: SEQ ID NO: 43, VL-CDR-2: SEQ ID NO: 48 og VL-CDR-3: SEQ ID NO: 51, (d) VH-CDR-1: SEQ ID NO: 25, VH-CDR-2: SEQ ID NO: 31, VH-CDR-3: SEQ ID NO: 38, VL-CDR-1: SEQ ID NO: 44, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 52, (e) VH-CDR-1: SEQ ID NO: 26, VH-CDR-2: SEQ ID NO: 32, VH-CDR-3: SEQ ID NO: 39, VL-CDR-1: SEQ ID NO: 45, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 53, (f) VH-CDR-1: SEQ ID NO: 23, VH-CDR-2: SEQ ID NO: 33, VH-CDR-3: SEQ ID NO: 37, VL-CDR-1: SEQ ID NO: 43, VL-CDR-2: SEQ ID NO: 48 og VL-CDR-3: SEQ ID NO: 54, og (g) VH-CDR-1: SEQ ID NO: 27, VH-CDR-2: SEQ ID NO: 34, VH-CDR-3: SEQ ID NO: 40, VL-CDR-1: SEQ ID NO: 46, VL-CDR-2: SEQ ID NO: 49 og VL-CDR-3: SEQ ID NO: 55.
2. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 22, VH-CDR-2: SEQ ID NO: 28, VH-CDR-3: SEQ ID NO: 35, VL-CDR-1: SEQ ID NO:
41, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 50.
3. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 23, VH-CDR-2: SEQ ID NO: 29, VH-CDR-3: SEQ ID NO: 36, VL-CDR-1: SEQ ID NO:
42, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 50.
4. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 24, VH-CDR-2: SEQ ID NO: 30, VH-CDR-3: SEQ ID NO: 37, VL-CDR-1: SEQ ID NO:
43, VL-CDR-2: SEQ ID NO: 48 og VL-CDR-3: SEQ ID NO: 51.
5. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 25, VH-CDR-2: SEQ ID NO: 31, VH-CDR-3: SEQ ID NO: 38, VL-CDR-1: SEQ ID NO:
44, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 52.
6. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 26, VH-CDR-2: SEQ ID NO: 32, VH-CDR-3: SEQ ID NO: 39, VL-CDR-1: SEQ ID NO:
45, VL-CDR-2: SEQ ID NO: 47 og VL-CDR-3: SEQ ID NO: 53.
7. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 23, VH-CDR-2: SEQ ID NO: 33, VH-CDR-3: SEQ ID NO: 37, VL-CDR-1: SEQ ID NO: 43, VL-CDR-2: SEQ ID NO: 48 og VL-CDR-3: SEQ ID NO: 54.
8. Antistoffet eller fragmentet deraf ifølge krav 1, hvor de seks CDR-sekvenser af antistoffet eller fragmentet deraf har sekvenserne af VH-CDR-1: SEQ ID NO: 27, VH-CDR-2: SEQ ID NO: 34, VH-CDR-3: SEQ ID NO: 40, VL-CDR-1: SEQ ID NO: 46, VL-CDR-2: SEQ ID NO: 49 og VL-CDR-3: SEQ ID NO: 55.
9. Farmaceutisk sammensætning omfattende et antistof eller fragment ifølge et hvilket som helst af kravene 1-8, og en farmaceutisk acceptabel bærer.
10. In vitro-fremgangsmåde til at detektere α-synuklein-protofibriller, omfattende trinnene: - at tilsætte antistoffet eller fragmentet ifølge et hvilket som helst af kravene 1-8 eller sammensætningen ifølge krav 9 til en biologisk prøve omfattende eller mistænkt for at omfatte α-synuklein-protofibriller, og - at detektere tilstedeværelsen af et kompleks dannet mellem a-synuklein-protofibril og antistoffet eller fragmentet.
11. Antistof eller fragment ifølge et hvilket som helst af kravene 1-8 eller en farmaceutisk sammensætning omfattende et antistof eller fragment ifølge et hvilket som helst af kravene 1-8 og en farmaceutisk acceptabel bærer til anvendelse i forebyggelse, til at forsinke indtræden af eller behandling afen neurodegenerativ lidelse med α-synuklein-patologi i et individ, hvor lidelsen med α-synuklein-patologi er kendetegnet ved aflejring af Lewy bodies og Lewy neuritter.
12. Antistoffet, fragmentet eller sammensætningen til anvendelse ifølge krav 11, hvor den neurodegenerative lidelse er Parkinsons sygdom (PD), demens med Lewy bodies (DLB), Lewy Body-varianten af Alzheimers sygdom, eller multipel systematrofi.
13. Anvendelse af et antistof eller fragment ifølge et hvilket som helst af kravene 1-8 eller en sammensætning ifølge krav 9 til in vitro-diagnosen eller -overvågningen af udviklingen afen neurodegenerativ lidelse med a-synuklein-patologi, hvor lidelsen med α-synuklein-patologi er kendetegnet ved aflejring af Lewy bodies og Lewy neuritter.
14. Anvendelsen ifølge krav 13 til in Wfro-diagnosen eller -overvågningen af udviklingen af Parkinsons sygdom (PD), demens med Lewy bodies (DLB), Lewy Body-varianten af Alzheimers sygdom, eller multipel systematrofi.
15. Antistoffet eller fragmentet ifølge et hvilket som helst af kravene 1-8 eller en sammensætning ifølge krav 9 til anvendelse i behandling afen a-synukleinopati-lidelse i et individ ved at binde α-synuklein-protofibriller i hjernen af individet.
DK11713058.3T 2010-02-26 2011-02-25 Protofibril-bindende antistoffer og deres anvendelse i terapeutiske og diagnostiske fremgangsmåder for parkinsons sygdom, demens med lewy body og andre alpha-synukleinopatier DK2539366T3 (da)

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US30863810P 2010-02-26 2010-02-26
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PCT/IB2011/050826 WO2011104696A1 (en) 2010-02-26 2011-02-25 Protofibril-binding antibodies and their use in therapeutic and diagnostic methods for parkinson's disease, dementia with lewy bodies and other alpha-synucleinopathies

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