DK2046833T5 - Humaniseret antistof mod amyloid beta - Google Patents

Humaniseret antistof mod amyloid beta Download PDF

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DK2046833T5
DK2046833T5 DK07840408.4T DK07840408T DK2046833T5 DK 2046833 T5 DK2046833 T5 DK 2046833T5 DK 07840408 T DK07840408 T DK 07840408T DK 2046833 T5 DK2046833 T5 DK 2046833T5
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antibody
fragment
amino acid
amyloid
seq
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DK2046833T3 (da
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Andrea Pfeifer
Maria Pihlgren
Andreas Muhs
Ryan Watts
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Ac Immune Sa
Genentech Inc
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Priority claimed from PCT/US2007/073504 external-priority patent/WO2008011348A2/en
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
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    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical 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
    • G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
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    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4709—Amyloid plaque core protein
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Claims (23)

1. Humaniseret antistof eller et fragment deraf, som genkender og binder β-amyloidprotein, hvor det humaniserede antistof eller fragmentet deraf omfatter: i) et tung-kæde variabelt område (HCVR), der omfatter aminosyresekvensen af SEQ ID NO: 15, og ii) et let-kæde variabelt område (LCVR), der omfatter aminosyresekvensen af SEQ ID NO: 12.
2. Humaniseret antistof eller et fragment deraf ifølge krav 1, der omfatter: en tung kæde omfattende aminosyresekvensen af SEQ ID NO: 16 og en let kæde omfattende aminosyresekvensen af SEQ ID NO: 13.
3. Humaniseret antistof eller et fragment deraf ifølge krav 2, hvor det tungkæde konstante områdes C-terminale Lys er blevet fjernet.
4. Humaniseret antistof eller et fragment deraf ifølge krav 1, hvilket humaniserede antistof eller et fragment deraf er af isotypen lgG1, lgG2, lgG3 eller lgG4.
5. Nukleinsyremolekyle, omfattende en nukleotidsekvens, der koder for det humaniserede antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1 -4.
6. Nukleinsyremolekyle ifølge krav 5, der omfatter nukleotidsekvensen af SEQ ID NO: 22 eller nukleotidsekvensen af SEQ ID NO: 21.
7. Nukleinsyremolekyle ifølge krav 5, der omfatter nukleotidsekvensen af SEQ ID NO: 25 eller nukleotidsekvensen af SEQ ID NO: 24.
8. Ekspressionsvektor, der omfatter nukleotidsekvensen ifølge et hvilket som helst af kravene 5-7.
9. Celle, der omfatter ekspressionsvektoren ifølge krav 8.
10. Farmaceutisk sammensætning, der omfatter det humaniserede antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1 til 4, og som eventuelt yderligere omfatter en farmaceutisk acceptabel bærer.
11. Farmaceutisk sammensætning ifølge krav 10, der eventuelt yderligere omfatter én eller flere af følgende: et biologisk aktivt stof, et fortyndingsmiddel eller en excipiens.
12. Farmaceutisk sammensætning ifølge krav 11, yderligere omfattende et biologisk aktivt stof, som er en forbindelse, der anvendes i behandlingen af amyloidose.
13. Farmaceutisk sammensætning ifølge krav 11, der omfatter mindst én af følgende forbindelser: en forbindelse mod oxidativt stress; en anti-apoptotisk forbindelse; en metalchelator; en inhibitor af DNA-reparation, såsom pirenzepin og metabolitter; 3-amino-1 -propansulfonsyre (3 APS); 1,3-propandisulfonat (1,3PDS); a-sekretaseaktivator, Αβ-sekretaseinhibitor; en y-sekretaseinhibitor; et tau-protein; en neurotransmitter; en β-foldeblad-breaker; en attraktant til amyloid-beta eliminering/depletering af cellulære komponenter; en inhibitor af N-terminal trunkeret amyloid-beta, såsom pyroglutamat-modificeret amyloid-beta 3-42; et antiinflammatorisk molekyle; eller en cholinesteraseinhibitor (ChEl), såsom tacrin, rivastigmin, donepezil og/eller galantamin; en Ml-agonist; eller et andet lægemiddel, såsom et amyloid- eller tau-modificerende lægemiddel eller næringssupplement.
14. Anvendelse af det humaniserede antistof eller fragmentet deraf ifølge et hvilket som helst af kravene 1 til 4 og/eller den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 10 til 13 til fremstilling af et medikament til behandling eller lindring af virkningerne af amyloidose, såsom sekundær amyloidose, aldersrelateret amyloidose, neurologiske forstyrrelser, såsom Alzheimers sygdom (AD), Lewy body demens, Downs syndrom og arvelig hjerneblødning med amyloidose (hollandsk type); Guam-Parkinson-demens-kompleks; sygdomme baseret på eller forbundet med amyloid-lignende proteiner, såsom progressiv supranukleær lammelse, multipel sklerose, Creutzfeldt-Jakobs-sygdom, Parkinsons sygdom, HIV-relateret demens, ALS (amyotrofisk lateral sklerose), aldersdiabetes; senil kardial amyloidose; endokrine tumorer og makuladegeneration.
15. Anvendelse ifølge krav 14, hvor behandlingen af dyret, såsom pattedyret eller mennesket, fører til en eller flere af følgende: i) en forhøjelse af den kognitive hukommelseskapacitet; ii) retention af kognitiv hukommelseskapacitet; og/eller iii) fuldstændig restoration af den kognitive hukommelseskapacitet.
16. Farmaceutisk sammensætning ifølge krav 10 eller 13 til anvendelse i en fremgangsmåde til forebyggelse, behandling eller lindring af virkningerne af amyloidose, såsom sekundær amyloidose og aldersrelateret amyloidose, såsom sygdomme omfattende, men ikke begrænset til, neurologiske forstyrrelser, såsom Alzheimers sygdom (AD), Lewy body demens, Downs syndrom, arvelig hjerneblødning med amyloidose (hollandsk type), Guam-Parkinson-demens-kompleks, sygdomme, som er baseret på eller forbundet med amyloid-lignende proteiner, såsom progressiv supranukleær lammelse og multipel sklerose, Creutzfeldt-Jakobs-sygdom, Parkinsons sygdom, HIV-relateret demens, ALS (amyotrofisk lateral sklerose), aldersdiabetes, senil kardial amyloidose, endokrine tumorer og makuladegeneration.
17. Farmaceutisk sammensætning til anvendelse ifølge krav 16, hvor behandlingen af dyret, såsom pattedyret eller mennesket, fører til: i) en forhøjelse af den kognitive hukommelseskapacitet, ii) retention af kognitiv hukommelseskapacitet og/eller iii) reversering af den kognitive hukommelseskapacitet og komplet restoration af den kognitive hukommelseskapacitet.
18. Fremgangsmåde til bestemmelse af omfanget af belastningen af amyloidogen plak i en vævsprøve og/eller kropsvæskeprøve, omfattende: a) testning af en vævsprøve eller kropsvæskeprøve for tilstedeværelse af amyloidprotein med det humaniserede antistof eller antistoffragment ifølge et hvilket som helst af kravene 1-4; b) bestemmelse af mængden af antistof eller antistoffragment, der er bundet til proteinet, og c) udregning af plak-belastningen i vævsprøven eller kropsvæskeprøven.
19. Kit til detektering og diagnosticering af amyloid-associerede sygdomme og tilstande, der i en eller flere beholdere omfatter det humaniserede antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1-4, et detektionsreagens og instruktioner til anvendelse af antistofferne.
20. Humaniseret antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1-4 til anvendelse til disaggregering af fibre til opløselige poly- og monomere former.
21. In vitro fremgangsmåde til disaggregering af foruddannede beta-amyloid fibre, omfattende etablering af kontakt mellem antistoffet eller fragmentet deraf ifølge et hvilket som helst af kravene 2 og 3 og foruddannede beta-amyloidfibre.
22. Humaniseret antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1-4, hvilket antistof eller et fragment deraf er til anvendelse til beskyttelse af neuroner mod Αβ-induceret degradation.
23. Anvendelse af det humaniserede antistof eller et fragment deraf ifølge et hvilket som helst af kravene 1-4 til fremstilling af et medikament til forebyggelse af degeneration af neuroner ved udsættelse for Αβ-oligomer.
DK07840408.4T 2006-07-14 2007-07-13 Humaniseret antistof mod amyloid beta DK2046833T5 (da)

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EP06014730 2006-07-14
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US94328907P 2007-06-11 2007-06-11
US94349907P 2007-06-12 2007-06-12
PCT/US2007/073504 WO2008011348A2 (en) 2006-07-14 2007-07-13 Humanized antibody against amyloid beta

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