SI2468770T1 - Humanizirano protitelo proti amiloidu beta. - Google Patents

Humanizirano protitelo proti amiloidu beta. Download PDF

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SI2468770T1
SI2468770T1 SI200732012T SI200732012T SI2468770T1 SI 2468770 T1 SI2468770 T1 SI 2468770T1 SI 200732012 T SI200732012 T SI 200732012T SI 200732012 T SI200732012 T SI 200732012T SI 2468770 T1 SI2468770 T1 SI 2468770T1
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amino acid
seq
fragment
acid sequence
humanized antibody
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Andrea Pfeifer
Bosch Maria Pihlgren
Andreas Muhs
Ryan Watts
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Ac Immune S.A.
Genentech, Inc.
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Priority claimed from EP11192705.9A external-priority patent/EP2468770B1/en
Publication of SI2468770T1 publication Critical patent/SI2468770T1/sl

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    • 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
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    • G01N2333/4709—Amyloid plaque core protein
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Claims (24)

  1. Humanizirano protitelo proti amiloidu beta. PATENTNI ZAHTEVKI
    1. Humanizirano protitelo ali njegov fragment, kjer protitelo ali njegov fragment obsega: (A) (i) variabilno regijo težke verige (HCVR) z aminokislinsko sekvenco, ki je 96%, 97%, 98%, 99%, ali 100% identična aminokislinski sekvenci SEQ ID NO: 15, kjer HCVR obsega komplementarnost determinirajočo regijo 1 (CDR1) težke verige, kot je navedeno v SEQ ID NO: 1, CDR2 težke verige, kot je podana v SEQ ID NO: 2 in CDR3 težke verige, kot je navedeno v SEQ ID NO: 3, in (ii) variabilno regijo lahke verige (LCVR), ki obsega CDR1 lahke verige, kot je podana v SEQ ID NO: 4, CDR2 lahke verige, kot je navedeno v SEQ ID NO: 5, RVSNRFS ali KVSSRFS in CDR3 lahke verige, kot je navedeno v SEQ ID NO: 6 ali (B) (i) HCVR, ki vsebuje CDR1 težke verige, kot je podana v SEQ ID NO: 1, CDR2 težke verige, kot je navedeno v SEQ ID NO: 2 in CDR3 težke verige, kot je navedeno v SEQ ID NO: 3 in (ii) LCVR z aminokislinsko sekvenco, ki je 96%, 97%, 98%, 99% ali 100% identična aminokislinski sekvenci SEQ ID NO: 12, kjer LCVR obsega CDR1 lahke verige, kot je podano v SEQ ID NO: 4, CDR2 lahke verige, kot je navedeno v SEQ ID NO: 5, RVSNRFS ali KVSSRFS in CDR3 lahke verige, kot je navedeno v SEQ ID NO: 6, kjer se omenjeno protitelo ali njegov fragment specifično veže na β-amiloidni protein.
  2. 2. Humanizirano protitelo ali njegov fragment po zahtevku 1(A), kjer ima LCVR aminokislinsko sekvenco to je 96%, 97%, 98%, 99% ali 100% identično aminokislinski sekvenci SEQ ID NO: 12.
  3. 3. Humanizirano protitelo ali njegov fragment po zahtevku 1(B), kjer ima HCVR aminokislinsko sekvenco to je 96%, 97%, 98%, 99% ali 100% identično aminokislinski sekvenci SEQ ID NO: 15.
  4. 4. Humanizirano protitelo ali njegov fragment po kateremkoli od zahtevkov 1-3, ki obsega: i) HCVR, ki ima aminokislinsko sekvenco SEQ ID NO: 15 ali aminokislinsko sekvenco, ki je 97%, 98%, ali 99% identična aminokislinski sekvenci SEQ ID NO: 15; ali ii) LCVR, ki ima aminokislinsko sekvenco SEQ ID NO: 12 ali aminokislinsko sekvenco, ki je 97%, 98%, ali 99% identična aminokislinski sekvenci SEQ ID NO: 12; ali iii) HCVR, ki ima aminokislinsko sekvenco SEQ ID NO: 15 ali aminokislinsko sekvenco, ki je 97%, 98%, ali 99% identično aminokislinski sekvenci SEQ ID NO: 15 in LCVR, ki ima aminokislinsko sekvenco SEQ ID NO: 12 ali aminokislinsko sekvenco, ki je 97%, 98% ali 99% identična aminokislinski sekvenci SEQ ID NO: 12.
  5. 5. Humanizirano protitelo ali njegov fragment po katerem koli od zahtevkov 1-3, ki obsega: i) težko verigo, ki obsega aminokislinsko sekvenco SEQ ID NO: 16 ali aminokislinsko sekvenco, ki je 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ali 99% identična aminokislinski sekvenci SEQ ID NO: 16; ali ii) lahko verigo, ki obsega aminokislinsko sekvenco SEQ ID NO: 13 ali aminokislinsko sekvenco, ki je 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ali 99% identična aminokislinski sekvenci SEQ ID NO: 13; ali iii) težko verigo, ki obsega aminokislinsko sekvenco SEQ ID NO: 16 ali aminokislinsko sekvenco, ki je 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ali 99% identična aminokislinski sekvenci SEQ ID NO: 16 in lahko verigo, ki obsega aminokislinsko sekvenco SEQ ID NO: 13 ali aminokislinsko sekvenco, ki je 93%, 92%, 93%, 94%, 95%, 96%, 97%, 98% ali 99% identična aminokislinski sekvenci iz SEQ ID NO: 13.
  6. 6. Humanizirano protitelo ali njegov fragment po kateremkoli od predhodnih zahtevkov, pri čemer je protitelo je izotip lgG4.
  7. 7. Humanizirano protitelo ali njegov fragment po katerem koli izmed predhodnih zahtevkov, kjer je omenjeno humanizirano protitelo ali njegov fragment sposoben inhibirati agregacijo β-amiloidnih monomerov do visoko molekularno polimernih fibril in desagregacije predoblikovanih polimernih fibril ali filamentov.
  8. 8. Humanizirano protitelo ali njegov fragment po kateremkoli od predhodnih zahtevkov, kjer se navedeno protitelo ali njegov fragment veže na vlakno Αβ, fibril ali filament z vezavno afiniteto, ki je vsaj 10-krat, vsaj 15-krat vsaj 20-krat, ali vsaj 25-krat višja od vezavne afinitete omenjenega protitelesa ali njegovega fragmenta do monomer Αβ.
  9. 9. Humanizirano protitelo ali njegov fragment po kateremkoli od predhodnih zahtevkov, kjer je (a) aminokislina na položaju Kabat 47 okvirnih regij variabilne regije težke verige je aminokislina Leu; in/ali (b) aminokislina na položaju Kabat 94 okvirnih regij variabilne regije težke verige je aminokislina Ser; in/ali (c) aminokislina na položaju Kabat 87 okvirnih regij variabilne regije lahke verige je aminokislina Tyr, Phe, Leu, Val, lle ali Ala.
  10. 10. Molekula nukleinske kisline, ki obsega nukleotidno sekvenco, ki kodira humanizirano protitelo ali njegov fragment po kateremkoli od zahtevkov 1-9.
  11. 11. Ekspresijski vektor, ki obsega molekulo nukleinske kisline po zahtevku 10.
  12. 12. Celica, ki obsega ekspresijski vektor po zahtevku 11.
  13. 13. Sestavek, ki obsega humanizirano protitelo ali njegov fragment po kateremkoli od zahtevkov 1-9, in nadalje obsega farmacevtsko sprejemljiv nosilec, razredčilo in/ali ekscipient.
  14. 14. Mešanica, ki obsega humanizirano protitelo ali njegov fragment po kateremkoli od zahtevkov 1-9 in nadalje, ki obsega biološko aktivno snov, farmacevtsko sprejemljiv nosilec, razredčilo in/ali ekscipient.
  15. 15. Mešanica po zahtevku 14, ki obsega: (i) biološko aktivno snov, ki je spojina, uporabljena pri zdravljenju amiloidoze, ali (ii) vsaj eno od naslednjih spojin: spojino proti antioksidativnemu stresu; anti-apoptotično spojino; kovinski kelator; inhibitor popravljanja DNA, kot sta pirenzepin in metaboliti; 3-amino-1-propansulfonska kislina (3 APS); 1,3-propandisulfonat (1.3PDS); aktivator α-sekretaze; inhibitor β-sekretaze; inhibitor γ-sekretaze; tau protein; nevrotransmiter; prekinjevalnik ploskve β; privlačevalno sredstvo za amiloid beta za ločevanje / odstranjevanje celičnih komponent; inhibitor na N-koncu skrajšanega amiloida beta, kot je piroglutamirani amiloid beta 3-42; protivnetna molekula; inhibitor holinesteraze (ChEl), kot na primer takrin, rivastigmin, donepezil in/ali galantamin; Ml agonist; ali drugo zdravilo, kot je amiloidno modificirno ali tau-modificirno zdravilo ali prehranski dodatek.
  16. 16. Humanizirano protitelo ali njegov fragment, kot je definiran v kateremkoli od zahtevkov 1-9, sestavek, kot je definiran v zahtevku 13 ali mešanica, kot je definirana v zahtevku 14 ali 15, za uporabo pri postopku zdravljenja ali blaženja učinkov amiloidoze pri živalih, kot je sesalec ali človek.
  17. 17. Humanizirano protitelo ali njegov fragment, mešanica ali sestavek za uporabo po zahtevku 16, kjer je amiloidoza sekundama amiloidoza, starostno povezana amiloidoza, nevrološka motnja, Alzheimerjeva bolezen (AD), demenca z Lewyjevimi telesci, Dovvnov sindrom, dedno cerebralna krvavitev z amiloidozo (nizozemski tip), kompleks Guam Parkinson-demenca, progresivna supranuklearna paraliza, multipla skleroza, Creutzfeld Jakobova bolezen, Parkinsonova bolezen, demenca, povezana z virusom HIV, ALS (amiotrofična lateralna skleroza), diabetes, ki nastopi pri odraslem, senilna srčna amiloidoza, endokrini tumorji ali makularna degeneracija.
  18. 18. Humanizirano protitelo ali njegov fragment, mešanica ali sestavek za uporabo po zahtevku 17, kjer je amiloidoza Alzheimerjeva bolezen.
  19. 19. Humanizirano protitelo ali njegov fragment, mešanica ali sestavek za uporabo po zahtevku 16, kjer zdravljenje živali privede k i) povečanju kapacitete kognitivnega spomina in/ali; ii) retenciji kognitivnega spomina; in/ali iii) popolni vzpostavitvi kapacitete kognitivnega spomina.
  20. 20. Postopek diagnoze amiloidoze pri pacientu, ki obsega: i) kontaktiranje vzorca, dela telesa ali telesne površine, ki vsebuje amiloidni protein s humaniziranim protitelesom ali njegov fragment po kateremkoli od zahtevkov 1-9 pod pogoji, ki omogočajo vezavo protitelesa ali njegovega fragmenta na amiloidni protein; in ii) odkrivanje protitelesa ali njegovega fragmenta vezanega na protein, kjer prisotnost ali odsotnost protitelesa ali njegovega fragmenta, vezanega na amiloidni protein, nakazuje prisotnost ali osdsotnost amiloidnega proteina v omenjenem vzorcu, delu telesa ali površini telesa.
  21. 21. Postopek za določanje obsega obremenitve z amiloidogenim bremena plakom v vzorcu tkiva ali vzorcu telesne tekočine, ki obsega: i) testiranje vzorca tkiva ali vzorca telesne tekočine za prisotnost amiloidnega proteina s humaniziranim protitelesom ali njegovim fragmentom po katerem koli od zahtevkov 1-9; ii) določanje količine protitelesa ali njegovega fragmenta, vezanega na amiloidni protein; in iii) izračunavanje obremenitve s plakom v vzorcu tkiva ali vzorcu telesne tekočine.
  22. 22. Komplet za detekcijo in diagnosticiranje z amiloidom povezanih bolezni in stanj, ki obsega humanizirano protitelo ali njegov fragment po katerem koli od zahtevkov 1-9, pri čemer omenjeni komplet obsega vsebnik, ki ima eno ali več protiteles ali fragmentov le-teh po katerem koli od zahtevkov 1-9 in navodila za uporabo navedenih protiteles ali njihovih fragmentov.
  23. 23. Humanizirano protitelo ali njegov fragment, kot je definiran v kateremkoli od zahtevkov 1-9, sestavek, kot je definiran v zahtevku 13 ali mešanica, kot je definirana v zahtevku 14 ali 15, za uporabo pri postopku preprečevanja degeneracije nevronov pri izpostavljenosti β-amiloidnim oligomerjem ali za uporabo pri postopku zaščite nevronov pri β-amiloidno inducirani degradaciji.
  24. 24. Postopek za pripravo humaniziranega protitelesa ali njegovega fragmenta, kot je definirano v kateremkoli od zahtevkov 1-9, kjer metoda obsega gojenje celice po zahtevku 12 in čiščenje protitelesa ali njegovega fragmenta.
SI200732012T 2006-07-14 2007-07-13 Humanizirano protitelo proti amiloidu beta. SI2468770T1 (sl)

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EP06014730 2006-07-14
EP06020765 2006-10-02
US94328907P 2007-06-11 2007-06-11
US94349907P 2007-06-12 2007-06-12
EP11192705.9A EP2468770B1 (en) 2006-07-14 2007-07-13 Humanized antibody against amyloid beta.

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