DK2802668T3 - Fremgangsmåder til reduktion af immunogenicitet mod faktor viii hos individer, der gennemgår faktor viii-terapi - Google Patents

Fremgangsmåder til reduktion af immunogenicitet mod faktor viii hos individer, der gennemgår faktor viii-terapi Download PDF

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DK2802668T3
DK2802668T3 DK13735995.6T DK13735995T DK2802668T3 DK 2802668 T3 DK2802668 T3 DK 2802668T3 DK 13735995 T DK13735995 T DK 13735995T DK 2802668 T3 DK2802668 T3 DK 2802668T3
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fviii
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chimeric polypeptide
polypeptide
rfvihfc
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Haiyan Jiang
Tongyao Liu
Neil Josephson
Pierce Glenn
Sriram Krishnamoorthy
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Bioverativ Therapeutics Inc
Puget Sound Blood Center
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    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
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    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
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    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
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    • A61K38/36—Blood coagulation or fibrinolysis factors
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    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
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Claims (15)

1. Kimært polypeptid, der omfatter en faktor VIIl-del og en Fc-del til anvendelse ved reduktion afen inhiberende faktor Vlll-immunrespons hos et menneskeindivid, hvor individet har udviklet en inhiberende immunrespons mod faktor VIII.
2. Kimært polypeptid til anvendelse ifølge krav 1, hvor faktor Vlll-delen omfatter processeret faktor VIII eller enkeltkædet faktor VIII eller en kombination deraf.
3. Kimært polypeptid til anvendelse ifølge krav 1 eller 2, hvor den inhiberende faktor Vlll-immunrespons omfatter produktion af inhiberende antistoffer mod faktor VIII, en cellemedieret immunrespons eller et klinisk symptom, der er valgt fra gruppen bestående af øget blødningstendens, høj faktor Vlll-konsumption, manglen på respons på faktor VI11-terapi, nedsat virkningsgrad af faktor VI Il-terapi, afkortet halveringstid for faktor VIII.
4. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor den inhiberende faktor Vlll-immunrespons omfatter produktion af inhiberende anti-faktor Vlll-antistoffer.
5. Kimært polypeptid til anvendelse ifølge krav 4, hvor koncentrationen af anti-faktor VI11-antistofferne er mindst 0,6 Bethesda-enheder (BU).
6. Kimært polypeptid til anvendelse ifølge krav 4 eller 5, hvor koncentrationen af anti-faktor VI Il-antistofferne er mindst 1,0 BU.
7. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 6, hvor individet er et foster.
8. Kimært polypeptid til anvendelse ifølge krav 7, hvor det kimære polypeptid skal administreres til fosterets moder.
9. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor den inhiberende faktor Vlll-immunrespons er valgt fra gruppen bestående af: a) frigivelse af IL-12; b) frigivelse af IL-4; og c) frigivelse af TNF-a.
10. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 9, hvilket polypeptid (a) reducerer antallet af anti-faktor VIIl-antistoffer hos individet sammenlignet med antallet inden administration af det kimære polypeptid; (b) reducerer titeren for anti-faktor VII l-antistoffer hos individet sammenlignet med titeren inden administration af det kimære polypeptid; og/eller (c) reducerer niveauet af et cytokin hos individet sammenlignet med niveauet inden administration af det kimære polypeptid.
11. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 10, hvor individet er identificeret til at have ét eller flere karakteristika, der er valgt fra gruppen bestående af: (a) har en mutation eller deletion i det gen, der koder for faktor VIII; (b) haren omlejring i det gen, der koder for faktor VIII; (c) har et familiemedlem, som tidligere har udviklet en inhiberende immunrespons mod faktor VIII; (d) modtager interferonterapi; (e) modtager antiviral terapi; og (f) har en genetisk mutation i et andet gen end det gen, der koder for faktor VIII, hvilken mutation er forbundet med en forøget risiko for at udvikle en inhiberende immunrespons.
12. Kimært polypeptid til anvendelse ifølge krav 11, hvor den genetiske mutation i et andet gen end det gen, der koder for faktor VIII, omfatter en mutation, som er valgt fra gruppen bestående af: a) en genetisk polymorfisme, der er associeret med forøget TNF-α; og b) en genetisk polymorfisme, der er associeret med forøget IL10.
13. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 12, hvor faktor Vlll-delen omfatter human FVIII med en hel eller delvis deletion af B-domænet.
14. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 13, hvilket polypeptid er en monomer dimerhybrid, der omfatter et første polypeptid, der omfatter faktor Vlll-delen og Fc-delen, og et andet polypeptid bestående afen Fc-del.
15. Kimært polypeptid til anvendelse ifølge et hvilket som helst af kravene 1 til 14, hvilket polypeptid er egnet til at mindske en blødningsepisode, behandle en blødningslidelse eller begge dele.
DK13735995.6T 2012-01-12 2013-01-12 Fremgangsmåder til reduktion af immunogenicitet mod faktor viii hos individer, der gennemgår faktor viii-terapi DK2802668T3 (da)

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US201261586103P 2012-01-12 2012-01-12
US201261668961P 2012-07-06 2012-07-06
PCT/US2013/021332 WO2013106789A1 (en) 2012-01-12 2013-01-12 Methods of reducing immunogenicity against factor viii in individuals undergoing factor viii therapy

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JP (4) JP6234378B2 (da)
CN (2) CN108465106B (da)
AU (2) AU2016210768B2 (da)
BR (1) BR112014017111A8 (da)
CA (1) CA2863329C (da)
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DK (1) DK2802668T3 (da)
EA (2) EA038705B1 (da)
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HR (1) HRP20181714T1 (da)
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PL (2) PL3453402T3 (da)
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