HRP20191999T1 - Monoklonska protutijela anti-faktora xi i postupci njihove uporabe - Google Patents

Monoklonska protutijela anti-faktora xi i postupci njihove uporabe Download PDF

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HRP20191999T1
HRP20191999T1 HRP20191999TT HRP20191999T HRP20191999T1 HR P20191999 T1 HRP20191999 T1 HR P20191999T1 HR P20191999T T HRP20191999T T HR P20191999TT HR P20191999 T HRP20191999 T HR P20191999T HR P20191999 T1 HRP20191999 T1 HR P20191999T1
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seq
antibody
antigen
polynucleotide
binding fragment
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HRP20191999TT
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Andras Gruber
Erik Ian Tucker
Stephen Raymond Hanson
David Gailani
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Oregon Health & Science University
Vanderbilt University
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Application filed by Oregon Health & Science University, Vanderbilt University filed Critical Oregon Health & Science University
Publication of HRP20191999T1 publication Critical patent/HRP20191999T1/hr

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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
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    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • A61P35/00Antineoplastic agents
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/32Immunoglobulins specific features characterized by aspects of specificity or valency specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (15)

1. Izolirano monoklonsko protutijelo ili njegov fragment koji veže antigen, naznačeno time, da se specifično veže na ljudski faktor koagulacije XI (FXI) opisan u SEQ ID NO: 1, pri čemu protutijelo ili fragment inhibira trombozu bez nanošenja štete sustavu hemostaze, te time da navedeno protutijelo: (i) obuhvaća varijabilnu domenu (VH) teškog lanca, koja sadrži tri regije određivanja komplementarnosti (CDR - engl. complementarity determining region), gdje tri CDR-regije sadrže tri CDR-sekvence od SEQ ID NO: 3 ili SEQ ID NO: 7, kao što se određuje uporabom Kabat sustava numeriranja; i varijabilnu domenu (VL) lakog lanca, koja sadrži tri CDR-regije, gdje tri CDR-regije sadrže tri CDR-sekvence od SEQ ID NO: 5 ili SEQ ID NO: 9, kao što se određuje uporabom Kabat sustava numeriranja; ili (ii) kompetitivno inhibira vezanje protutijela koje obuhvaća varijabilnu domenu (VH) teškog lanca od SEQ ID NO: 3 i varijabilnu domenu (VL) lakog lanca od SEQ ID NO: 5 na ljudski FXI s barem 90%, pri čemu se kompetitivno inhibiranje određuje pomoću kompetitivnog testiranja imunosorpcije povezane s enzimom (ELISA- engl. enzyme-linked immunosorbent assay).
2. Izolirano monoklonsko protutijelo ili njegov fragment koji veže antigen, prema patentnom zahtjevu 1, naznačeno time, da barem jedna od tri CDR-regije VH domene obuhvaća aminokiselinsku sekvencu od SEQ ID NO: 10, SEQ ID NO: 11 ili SEQ ID NO: 12, gdje prema potrebi tri CDR-regije od VH domene sadrže aminokiselinske sekvence od SEQ ID NO: 10, SEQ ID NO: 11 i SEQ ID NO: 12, i/ili barem jedna od tri CDR-regije VL domene obuhvaća aminokiselinsku sekvencu od SEQ ID NO: 13, SEQ ID NO: 14 ili SEQ ID NO: 15, gdje prema potrebi tri CDR-regije od VL domene sadrže aminokiselinske sekvence od SEQ ID NO: 13, SEQ ID NO: 14 i SEQ ID NO: 15.
3. Izolirano monoklonsko protutijelo ili njegov fragment koji veže antigen, prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time, da je aminokiselinska sekvenca od VH domene najmanje 90% identična sa SEQ ID NO: 3 ili SEQ ID NO: 7, dok prema potrebi aminokiselinska sekvenca od VH domene sadrži SEQ ID NO: 3 i SEQ ID NO: 7; i/ili je aminokiselinska sekvenca od VL domene najmanje 90% identična sa SEQ ID NO: 5 ili SEQ ID NO: 9, dok prema potrebi aminokiselinska sekvenca od VL domene sadrži SEQ ID NO: 5 i SEQ ID NO: 9.
4. Protutijelo ili njegov fragment koji veže antigen, prema bilo kojem od patentnih zahtjeva 1 do 3, naznačeno time, da se upotrebljava u postupku liječenja tromboze povezane s koagulopatijom kod pojedinca kojemu je to potrebno, pri čemu postupak obuhvaća davanje pojedincu učinkovite doze protutijela ili fragmenta, gdje je prema potrebi pojedinac sisavac, a opcijski je to primat koji nije čovjek.
5. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema patentnom zahtjevu 4, naznačeno time, da pojedinac je čovjek.
6. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema patentnom zahtjevu 4 ili zahtjevu 5, naznačeno time, da se u navedenom postupku spomenuto protutijelo ili fragment primjenjuje kod navedenog pojedinca u jedinstvenoj dozi od 0,01 mg/kg do 10 mg/kg, prema potrebi u jedinstvenoj dozi od 2 mg/kg.
7. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema bilo kojem od patentnih zahtjeva 4 do 6, naznačeno time, da koagulopatija obuhvaća diseminiranu intravaskularnu koagulaciju (DIK).
8. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema bilo kojem od patentnih zahtjeva 4 do 6, naznačeno time, da koagulopatija obuhvaća akutni respiratorni distresni sindrom (ARDS).
9. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema patentnom zahtjevu 7 ili zahtjevu 8, naznačeno time, da pojedinac ima infekciju, pri čemu je opcijski ta infekcija virusna infekcija.
10. Protutijelo ili njegov fragment koji veže antigen, za uporabu prema patentnom zahtjevu 7 ili zahtjevu 8, naznačeno time, da pojedinac ima rak.
11. Izolirani polinukleotid, naznačen time, da kodira protutijelo ili njegov fragment koji veže antigen, prema bilo kojem od patentnih zahtjeva 1 do 3.
12. Izolirani polinukleotid prema patentnom zahtjevu 11, naznačen time, da obuhvaća polinukleotidnu sekvencu odabranu iz skupine koja se sastoji od: a) polinukleotidne sekvence prikazane u SEQ ID NO: 2 ili 6; b) polinukleotidne sekvence koja ima najmanje 85% identiteta sekvence od polinukleotidne sekvence prikazane u SEQ ID NO: 2 ili 6.
13. Izolirani polinukleotid prema patentnom zahtjevu 11, naznačen time, da obuhvaća polinukleotidnu sekvencu odabranu iz skupine koja se sastoji od: a) polinukleotidne sekvence prikazane u SEQ ID NO: 4 ili 8; b) polinukleotidne sekvence koja ima najmanje 85% identiteta sekvence od polinukleotidne sekvence prikazane u SEQ ID NO: 4 ili 8.
14. Pripravak ili stanica domaćina, naznačen/a time, da obuhvaća polinukleotid u skladu s bilo kojim od patentnih zahtjeva 11 do 13.
15. Vektor, naznačen time, da obuhvaća polinukleotid u skladu s bilo kojim od patentnih zahtjeva 11 do 13, pri čemu je navedeni polinukleotid, prema potrebi, operativno povezan s promotorom.
HRP20191999TT 2007-11-21 2019-11-05 Monoklonska protutijela anti-faktora xi i postupci njihove uporabe HRP20191999T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US98952307P 2007-11-21 2007-11-21
EP15189714.7A EP3002298B1 (en) 2007-11-21 2008-11-21 Anti-factor xi monoclonal antibodies and methods of use thereof

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HRP20191999T1 true HRP20191999T1 (hr) 2020-02-07

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US (7) US8236316B2 (hr)
EP (2) EP3002298B1 (hr)
JP (1) JP2011504371A (hr)
AU (1) AU2008326348B2 (hr)
CA (1) CA2705851C (hr)
CY (1) CY1122270T1 (hr)
DK (2) DK3002298T3 (hr)
ES (2) ES2566963T3 (hr)
HK (1) HK1223114A1 (hr)
HR (1) HRP20191999T1 (hr)
HU (1) HUE046564T2 (hr)
LT (1) LT3002298T (hr)
PL (1) PL3002298T3 (hr)
PT (1) PT3002298T (hr)
SI (1) SI3002298T1 (hr)
WO (1) WO2009067660A2 (hr)

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