DK2780371T3 - Anti-adrenomedullin- (adm) antistof eller anti-adm-antistoffragment eller anti-adm-ikke-ig-skabelon til regulering af væskebalancen hos en patient med en kronisk eller akut sygdom - Google Patents

Anti-adrenomedullin- (adm) antistof eller anti-adm-antistoffragment eller anti-adm-ikke-ig-skabelon til regulering af væskebalancen hos en patient med en kronisk eller akut sygdom Download PDF

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DK2780371T3
DK2780371T3 DK12788518.4T DK12788518T DK2780371T3 DK 2780371 T3 DK2780371 T3 DK 2780371T3 DK 12788518 T DK12788518 T DK 12788518T DK 2780371 T3 DK2780371 T3 DK 2780371T3
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adrenomedullin
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Andreas Bergmann
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Adrenomed Ag
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Claims (21)

1. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient der lider af væskeubalance, og hvor antistoffet eller antistoffragmentet eller ikke-Ig-skabelonen binder til en region med mindst 4 aminosyrer inden i sekvensen af aa 1-21 af modent humant ADM: YRQSMNNFQGLRSFGCRFGTC (SEQ ID NO. 23).
2. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge krav 1, hvor patienten er en patient der har behov for regulering af væskebalancen.
3. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 2 til at forhindre eller reducere ødemer hos patienten.
4. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 3, hvor antistoffet eller antistoffragmentet eller ikke-Ig-skabelonen er monospecifikt.
5. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 4, endvidere kendetegnet ved, at antistoffet eller fragmentet eller skabelonen udviser en bindingsaffinitet til ADM på mindst 10'7 M, hvor bindingsaffiniteten er bestemt ifølge eksempel 1.
6. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 5, hvor antistoffet eller fragmentet eller skabelonen ikke er ADM-bindings-protein-1, komplement faktor H.
7. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 6, hvor antistoffet eller fragmentet eller skabelonen genkender og binder til en epitop indeholdende aminosyre 1 af N-terminal enden af modent humant ADM, og hvor antistoffet eller fragmentet eller skabelonen ikke vil binde til hverken N-terminal forlænget eller N-terminal modificeret adrenomedullin eller N-terminal nedbrudt adrenomedullin.
8. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 7, hvor antistoffet eller fragmentet eller skabelonen er et stabiliserende ADM-antistof eller et stabiliserende ADM-antistoffragment eller en stabiliserende ADM-ikke-Ig-skabelon der øger halveringstiden, t% halveringsopholdstiden, af adrenomedullin i serum, blod, plasma mindst 10 %, fortrinsvis mindst 50 %, mere fortrinsvis > 50 %, mest fortrinsvis >100 %.
9. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 8, hvor antistoffet eller fragmentet eller skabelonen ikke blokerer den cirkulerende ADM-bioaktivitet mere end 80 %, fortrinsvis ikke mere end 50 %, hvor bioaktiviteten af ADM er bestemt i et humant rekombinant adrenomedullin-receptor-cAMP-funktionsassay ifølge eksempel 2.
10. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 9, hvor patienten lider af en sygdom der er valgt fra gruppen bestående af SIRS, sepsis, diabetes, kræft, hjertesvigt, chok og nyresvigt.
11. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 10, hvor antistoffet eller fragmentet er et antistof eller fragment der binder til ADM, hvor tungkæden omfatter sekvensen: SEQ ID NO: 1 GYTFSRYW SEQ ID NO: 2 ILPGSGST SEQ ID NO: 3 TEGYEYDGFDY, og hvor letkæden omfatter sekvensen: SEQ ID NO: 4 QSIVYSNGNTY SEQ ID NO: 5 RVS SEQ ID NO: 6 FQGSHIPYT.
12. Humant monospecifikt anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge krav 11, hvor antistoffet eller fragmentet omfatter en sekvens valgt fra gruppen omfattende: SEQ ID NO: 7 (AM-VH-C) QVQLQQSGAELMKPGASVKISCKATGYTFSRYWIEWVKQRPGHGLEWIGEIL PGSGSTNYNEKFKGKATITADTSSNTAYMQLSSLTSEDSAVYYCTEGYEYDGF DYWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTK VDKRVEPKHHHHHH SEQ ID NO: 8 (AM-VH1) QVQLVQSGAEVKKPGSSVKVSCKASGYTFSRYWISWVRQAPGQGLEWMGRI LPGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDG FDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNT KVDKRVEPKHHHHHH SEQ ID NO: 9 (AM-VH2-E40) QVQLVQSGAEVKKPGSSVKVSCKASGYTFSRYWIEWVRQAPGQGLEWMGRI LPGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDG FDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNT KVDKRVEPKHHHHHH SEQ ID NO: 10 (AM-VH3-T26-E55) QVQLVQSGAEVKKPGSSVKVSCKATGYTFSRYWISWVRQAPGQGLEWMGEI LPGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDG FDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNT KVDKRVEPKHHHHHH SEQ ID NO: 11 (AM-VH4-T26-E40-E55) QVQLVQSGAEVKKPGSSVKVSCKATGYTFSRYWIEWVRQAPGQGLEWMGEI LPGSGSTNYAQKFQGRVTITADESTSTAYMELSSLRSEDTAVYYCTEGYEYDG FDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNT KVDKRVEPKHHHHHH SEQ ID NO: 12 (AM-VL-C) DVLLSQTPLSLPVSLGDQATISCRSSQSIVYSNGNTYLEWYLQKPGQSPKLLIY RVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDLGVYYCFQGSHIPYTFGGGTK LEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNEYPREAKVQWKVDNALQS GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSF NRGEC SEQ ID NO: 13 (AM-VL1) DVVMTQSPLSLPVTLGQPASISCRSSQSIVYSNGNTYLNWFQQRPGQSPRRLIY RVSNRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHIPYTFGQGT KLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKS FNRGEC SEQ ID NO: 14 (AM-VL2-E40) DVVMTQSPLSLPVTLGQPASISCRSSQSIVYSNGNTYLEWFQQRPGQSPRRLIY RVSNRDSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCFQGSHIPYTFGQGT KLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKS FNRGEC.
13. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 12, hvor antistoffet eller fragmentet eller skabelonen er et modulerende antistof eller modulerende fragment eller en modulerende skabelon der øger halveringstiden, t% halveringsopholdstiden, af adrenomedullin i serum, blod, plasma mindst 10 %, fortrinsvis mindst 50 %, mere fortrinsvis > 50 %, mest fortrinsvis > 100 %, og der ikke blokerer bioaktiviteten af ADM mere end 80 %, fortrinsvis ikke mere end 50 %, når bioaktiviteten af ADM er bestemt i et humant rekombinant adrenomedullin-receptor-CAMP-funktionsassay ifølge eksempel 2.
14. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 13, endvidere kendetegnet ved, at antistoffet, antistoffragmentet eller ikke-Ig-skabelonen ikke binder til C-terminal delen af ADM, som er aa 43-52 af ADM: PRSKISPQGY-NH2 (SEQ ID NO:25).
15. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 14, der skal anvendes i kombination med katekolamin og/eller væsker indgivet intravenøst.
16. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 1 til 14 eller en kombination til anvendelse ifølge krav 15, der skal anvendes i kombination med ADM-bindingsprotein og/eller yderligere aktive bestanddele.
17. Anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient der lider af væskeubalance ifølge et hvilket som helst af de foregående krav, kendetegnet ved, at behandlingen ikke er en primær behandlingsmetode af den akutte sygdom eller af den akutte tilstand.
18. Farmaceutisk formulering omfattende et anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-scaffold der binder til adrenomedullin ifølge et hvilket som helst af kravene 1 til 17 til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient der lider af væskeubalance.
19. Farmaceutisk formulering omfattende et anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge krav 18, hvor den farmaceutiske formulering er en opløsning, fortrinsvis en opløsning der er klar til brug.
20. Farmaceutisk formulering omfattende et anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM-ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge krav 19, hvor den farmaceutiske formulering er i en frysetørret tilstand.
21. Farmaceutisk formulering omfattende et anti-adrenomedullin- (ADM) antistof eller et anti-ADM-antistoffragment der binder til adrenomedullin eller anti-ADM- ikke-Ig-skabelon der binder til adrenomedullin til anvendelse til behandling af en akut sygdom eller akut tilstand hos en patient ifølge et hvilket som helst af kravene 18 til 20, hvor den farmaceutiske formulering skal indgives til en patient der lider af væskeubalance med det forbehold at patienten har behov for at væskebalancen reguleres.
DK12788518.4T 2011-11-16 2012-11-16 Anti-adrenomedullin- (adm) antistof eller anti-adm-antistoffragment eller anti-adm-ikke-ig-skabelon til regulering af væskebalancen hos en patient med en kronisk eller akut sygdom DK2780371T3 (da)

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