DK2361638T3 - Beta-1-42-specifikke monoklonale antistoffer med terapeutiske egenskaber - Google Patents

Beta-1-42-specifikke monoklonale antistoffer med terapeutiske egenskaber Download PDF

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DK2361638T3
DK2361638T3 DK10196705.7T DK10196705T DK2361638T3 DK 2361638 T3 DK2361638 T3 DK 2361638T3 DK 10196705 T DK10196705 T DK 10196705T DK 2361638 T3 DK2361638 T3 DK 2361638T3
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antibody
amyloid
disease
functional portion
peptide
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Ruth Greferath
David Hickman
Andrea Pfeifer
Claude Nicolau
Andreas Muhs
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Ac Immune Sa
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Claims (21)

1. Antistof eller funktionel del deraf, der kan genkende og binde en specifik epitop af amyloid beta, hvor antistoffet eller den funktionelle del deraf omfatter et epitop-bindende fragment af et monoklonalt antistof, der kan opnås fra hybridom-cellelinje FP 12H3-C2, deponeret 1. december 2005 som DSM ACC2750.
2. Monoklonalt antistof eller funktionel del deraf ifølge krav 1, fremstillet ved hjælp af hybridom-cellelinje FP 12FI3-C2, deponeret 1. december 2005 som DSM ACC2750.
3. Antistof ifølge et af de foregående krav eller funktionelle dele deraf, som er et monoklonalt antistof eller et kimærisk antistof.
4. Flumaniseret antistof eller funktionel del deraf, hvilket antistof eller hvilken funktionel del deraf omfatter de komplementaritetsbestemmende regioner (CDRs) af et monoklonalt antistof, der kan opnås fra hybridom-cellelinje FP 12H3-C2, deponeret 1. december 2005 som DSM ACC2750.
5. Polynukleotid, der omfatter en nukleotidsekvens, der koder for et antistof eller en funktionel del deraf ifølge et af kravene 1-4.
6. Cellelinje, der producerer et antistof eller en funktionel del deraf ifølge et af kravene 1 -4.
7. Cellelinje ifølge krav 6, der er hybridom-cellelinje FP 12H3-C2, deponeret 1. december 2005 som DSM ACC2750.
8. Fremgangsmåde til fremstilling af et antistof eller en funktionel del deraf ifølge et af kravene 1-4, hvilken fremgangsmåde omfatter at dyrke cellelinjen ifølge krav 6 eller 7.
9. Antistof eller funktionel del deraf ifølge et af kravene 1-4, der er fremstillet ved hjælp af fremgangsmåden ifølge krav 8.
10. Sammensætning, der omfatter antistoffet eller den funktionelle del deraf ifølge et af kravene 1 til 4, og eventuelt endvidere omfatter en farmaceutisk acceptabel bærer.
11. Sammensætning ifølge krav 10 til anvendelse ved behandling af sygdomme og lidelser, der er forårsaget af eller forbundet med amyloidproteiner eller amyloid-lignende proteiner, herunder amyloidose.
12. Blanding, der omfatter et antistof eller en funktionel del deraf ifølge et af kravene 1 til 4, og eventuelt et yderligere biologisk aktivt stof, der anvendes ved medicinsk behandling af sygdomme og lidelser, der er forårsaget af eller forbundet med amyloidproteiner eller amyloid-lignende proteiner, og/eller en farmaceutisk acceptabel bærer og/eller et fortyndingsmiddel og/eller en exci-piens.
13. Anvendelse af et antistof og/eller en funktionel del deraf ifølge et af kravene 1 til 4 eller en sammensætning ifølge krav 10 eller 11 eller en blanding ifølge krav 12 til fremstilling af et lægemiddel til behandling eller lindring af følgevirkningerne ved amyloidose, herunder, men ikke begrænset til: (a) neurologiske lidelser såsom Alzheimers sygdom (AD); (b) sygdomme eller tilstande, der er kendetegnet ved tab af kognitiv hukommelsesevne såsom eksempelvis let kognitiv svækkelse (MCI), Lewy Body-demens, Downs syndrom, hereditær hjerneblødning med amyloidose (hollandsk type) og Guam-Parkinson-demenskompleks; og (c) progressiv supranukleær lammelse, multipel sklerose, Creutzfeld-Jacobs sygdom, Parkinsons sygdom, HIV-relateret demens, ALS (amyotrofisk lateral sklerose), inklusionslegeme myositis (IBM), voksendiabetes, senil hjertea-myloidose, endokrine tumorer og makulær degeneration.
14. Fremgangsmåde til fremstilling af et antistof eller en funktionel del deraf ifølge et af kravene 1 til 4 eller en sammensætning ifølge krav 10 eller 11 eller en blanding ifølge krav 12 til anvendelse ved behandling eller lindring af følgevirkningerne ved amyloidose, herunder, men ikke begrænset til: (a) neurologiske lidelser såsom Alzheimers sygdom (AD); (b) sygdomme eller tilstande, der er kendetegnet ved tab af kognitiv hukommelsesevne såsom eksempelvis let kognitiv svækkelse (MCI), Lewy Body- demens, Downs syndrom, hereditær hjerneblødning med amyloidose (hollandsk type) og Guam-Parkinson-demenskompleks; og (c) progressiv supranukleær lammelse, multipel sklerose, Creutzfeld-Jacobs sygdom, Parkinsons sygdom, HIV-relateret demens, ALS (amyotrofisk lateral sklerose), inklusionslegeme myositis (IBM), voksendiabetes, senil hjertea-myloidose, endokrine tumorer og makulær degeneration.
15. Sammensætning ifølge krav 10 eller 11 til anvendelse ved: (a) reduktion af aflejringsbelastningen eller reduktion af mængden af aflejringer i hjernen hos et dyr, især et pattedyr, men i særdeleshed et menneske, der lider af en amyloid-relateret sygdom eller tilstand; eller (b) reduktion af mængden af aflejringer i hjernen hos et dyr, især et pattedyr, men i særdeleshed et menneske, der lider af en amyloid-relateret sygdom eller tilstand; eller (c) nedbringning af den samlede mængde af opløseligt Αβ i hjernen hos et dyr, især et pattedyr, men i særdeleshed et menneske, der lider af en amyloid-relateret sygdom eller tilstand; eller (d) forebyggelse, behandling eller lindring af følgevirkningerne ved amyloidose, herunder, men ikke begrænset til: (i) neurologiske lidelser såsom Alzheimers sygdom (AD); (ii) sygdomme eller tilstande, der er kendetegnet ved tab af kognitiv hukommelsesevne såsom eksempelvis let kognitiv svækkelse (MCI), Lewy Body-demens, Downs syndrom, hereditær hjerneblødning med amyloidose (hollandsk type) og Guam-Parkinson-demenskompleks; og (iii) progressiv supranukleær lammelse, multipel sklerose, Creutzfeld-Jacobs sygdom, Parkinsons sygdom, HIV-relateret demens, ALS (amyotrofisk lateral sklerose), inklusionslegeme myositis (IBM), voksendiabetes, senil hjertea-myloidose, endokrine tumorer og makulær degeneration; eller (e) fastholdelse eller forøgelse af kognitiv hukommelsesevne hos et pattedyr, der har en amyloid-relateret sygdom eller tilstand.
16. Cellelinje ifølge krav 6, der er en hybridom-cellelinje.
17. Fremgangsmåde til diagnosticering af en amyloid-relateret sygdom eller tilstand hos en patient, omfattende at detektere den immunspecifikke binding af et antistof eller et aktivt fragment deraf til en epitop af amyloidproteinet i en prøve, hvilken fremgangsmåde omfatter trinnene med: a) at bringe prøven, der mistænkes for at indeholde amyloidantigenet, i kontakt med et antistof eller en funktionel del deraf ifølge et af kravene 1 -4, hvilket antistof eller hvilken funktionel del deraf binder en epitop af amyloidproteinet; b) at tillade antistoffet eller den funktionelle del deraf at binde til amyloidantigenet til dannelse af et immunologisk kompleks; c) at detektere dannelsen af det immunologiske kompleks; og d) at korrelere forekomsten eller fraværet af det immunologiske kompleks med forekomsten eller fraværet af amyloidantigen i prøven.
18. Fremgangsmåde til diagnosticering af en prædisponering for en amyloid-relateret sygdom eller tilstand hos en patient, omfattende at detektere den immunspecifikke binding af et antistof eller et aktivt fragment deraf til en epitop af amyloidproteinet i en prøve, hvilken fremgangsmåde omfatter trinnene med: a) at bringe prøven, der mistænkes for at indeholde amyloidantigenet, i kontakt med et antistof eller en funktionel del deraf ifølge et af kravene 1-4, hvilket antistof eller hvilken funktionel del deraf binder en epitop af amyloidproteinet; b) at tillade antistoffet eller den funktionelle del deraf at binde til amyloidantigenet til dannelse af et immunologisk kompleks; c) at detektere dannelsen af det immunologiske kompleks; d) at korrelere forekomsten eller fraværet af det immunologiske kompleks med forekomsten eller fraværet af amyloidantigen i prøven; og e) at sammenligne mængden af det immunologiske kompleks med en normal kontrolværdi, hvor en forøgelse af mængden af aggregatet sammenlignet med en normal kontrolværdi indikerer, at patienten har risiko for at udvikle en amyloid-relateret sygdom eller tilstand.
19. Fremgangsmåde til overvågning af minimal restsygdom hos en patient, der bliver behandlet med et antistof eller en funktionel del deraf eller en sammensætning ifølge et af de foregående krav, hvor fremgangsmåden omfatter: a) at bringe prøven, der mistænkes for at indeholde amyloidantigenet, i kontakt med et antistof eller en funktionel del deraf ifølge et af kravene 1-4, hvilket antistof eller hvilken funktionel del deraf binder en epitop af amyloidprote-inet; b) at tillade antistoffet eller den funktionelle del deraf at binde til amyloidantigenet til dannelse af et immunologisk kompleks; c) at detektere dannelsen af det immunologiske kompleks; d) at korrelere forekomsten eller fraværet af det immunologiske kompleks med forekomsten eller fraværet af amyloidantigen i prøven; og e) at sammenligne mængden af det immunologiske kompleks med en normal kontrolværdi, hvor en forøgelse af mængden af aggregatet sammenlignet med en normal kontrolværdi indikerer, at patienten stadig lider af en minimal restsygdom.
20. Fremgangsmåde til at forudsige modtageligheden for en patient, der behandles med et antistof eller en funktionel del deraf eller en sammensætning ifølge et af de foregående krav, hvilken fremgangsmåde omfatter: a) at bringe prøven, der mistænkes for at indeholde amyloidantigenet, i kontakt med et antistof eller en funktionel del deraf ifølge et af kravene 1-4, hvilket antistof eller hvilken funktionel del deraf binder en epitop af amyloidprote-inet; b) at tillade antistoffet eller den funktionelle del deraf at binde til amyloidantigenet til dannelse af et immunologisk kompleks; c) at detektere dannelsen af det immunologiske kompleks; d) at korrelere forekomsten eller fraværet af det immunologiske kompleks med forekomsten eller fraværet af amyloidantigen i prøven; og e) at sammenligne mængden af det immunologiske kompleks før og efter påbegyndelse af behandlingen, hvor en reduktion i mængden af aggregatet indikerer, at patienten har et stort potentiale for at være modtagelig overfor behandlingen.
21. Testkit til detektering og diagnosticering af amyloid-relaterede sygdomme og tilstande, omfattende et antistof eller en funktionel del deraf ifølge et af kravene 1 -4.
DK10196705.7T 2005-12-12 2006-12-08 Beta-1-42-specifikke monoklonale antistoffer med terapeutiske egenskaber DK2361638T3 (da)

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EP05027092 2005-12-12
EP06014729 2006-07-14
EP06020766 2006-10-02
EP06829456A EP1959996A2 (en) 2005-12-12 2006-12-08 Monoclonal antibody

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