DK2279004T3 - Anvendelse af biomarkører til vurdering af behandling af gastrointestinale inflammatoriske forstyrrelser med beta7-integrinantagonister - Google Patents

Anvendelse af biomarkører til vurdering af behandling af gastrointestinale inflammatoriske forstyrrelser med beta7-integrinantagonister Download PDF

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DK2279004T3
DK2279004T3 DK09747765.7T DK09747765T DK2279004T3 DK 2279004 T3 DK2279004 T3 DK 2279004T3 DK 09747765 T DK09747765 T DK 09747765T DK 2279004 T3 DK2279004 T3 DK 2279004T3
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antibody
amino acid
seq
group
lymphocytes
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Thomas Richard Gelzleichter
Hajime Hiraragi
Eric Gary Stefanich
Hong Wang
Marna Bromberg Williams
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Hoffmann La Roche
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    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
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    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/70546—Integrin superfamily, e.g. VLAs, leuCAM, GPIIb/GPIIIa, LPAM
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    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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Claims (10)

1. Fremgangsmåde til at bestemme doseringen af en integrin-beta7-antagonist til behandling af en gastrointestinal inflammatorisk lidelse hos en patient, hvor integrin-beta7-antagonisten er et anti-beta7-antistof, hvilken fremgangsmåde omfatter justeringen af dosis af integrin-beta7-antagonisten baseret på en sammenligning af mængden af en biomarkør fra en prøve opnået fra patienten efter eller under behandling med en dosis eller doseringsplan af integrin-beta7-antagonisten, til en mængde af biomarkøren fra en prøve opnået fra patienten før behandlingen, hvor en ændring i mængden af biomarkøren efter eller under behandlingen, som sammenlignet med før behandlingen, er indikation for virkningsfuldheden af eller modtageligheden for den dosis eller doseringsplan af integrin-beta7-antagonisten til behandling af gastrointestinale forstyrrelser hos patienten, og hvor biomarkøren er valgt fra en gruppe bestående af tarm-søgende ("gut-homing") lymfocytter i patientens perifere blod, integrin-beta7-antagonist besat på de tarm-søgende lymfocytter, og beta7-integrin-receptorer på tarm-søgende lymfocytter, hvor de tarmsøgende lymfocytter er en distinkt undergruppe af lymfocytter identificeret som CD45RA' 37highCD4+.
2. Fremgangsmåden ifølge krav 1, hvor den gastrointestinale inflammatoriske lidelse er en inflammatorisk tarmsygdom.
3. Fremgangsmåden ifølge krav 2, hvor den inflammatoriske tarmsygdom er Crohn's sygdom (CD) eller ulcerativ colitis (UC).
4. Fremgangsmåden ifølge krav 3, hvor patienten er et menneske.
5. Fremgangsmåden ifølge krav 2, hvor integrin-beta7-antagonisten er et monoklonalt anti-beta7-antistof.
6. Fremgangsmåden ifølge krav 5, hvor antistoffet er et kimært, humant eller humaniseret antistof.
7. Fremgangsmåden ifølge krav 1, hvor antistoffet er et antistof fragment.
8. Fremgangsmåden ifølge krav 5, hvor antistoffet omfatter seks hypervariable regioner (HVR'er) valgt fra gruppen bestående af HVR-L1, HVR-L2, HVR-L3, HVR-H1, HVR-H2, og HVR-H3, hvori: (i) HVR-L1 omfatter aminosyresekvens Al-Al 1, hvori Al-Al 1 er RASESVDTYLH (SEQ ID NO: 1); RASESVDSLLH (SEQ ID NO:7), RASESVDTLLH (SEQ ID NO:8), eller RASESVDDLLH (SEQ ID NO:9) eller en variant af SEQ ID NO:l, 7, 8 eller 9 hvori aminosyre A2 vælges fra gruppen bestående af A, G, S, T, og V og/eller aminosyre A3 vælges fra gruppen bestående af S, G, I, K, N, P, Q, R, og T, og/eller A4 vælges fra gruppen bestående af E, V, Q, A, D, G, Η, I, K, L, N, og R, og/eller aminosyre A5 vælges fra gruppen bestående af S, Y, A, D, G, Η, I, K, N, P, R, T, og V, og/eller aminosyre A6 vælges fra gruppen bestående af V, R, I, A, G, K, L, M, og Q, og/eller aminosyre A7 vælges fra gruppen bestående af D, V, S, A, E, G, Η, I, K, L, N, P, S, og T, og/eller aminosyre A8 vælges fra gruppen bestående af D, G, N, E, T, P og S, og/eller aminosyre A9 vælges fra gruppen bestående af L, Y, I og M, og/eller aminosyre A10 vælges fra gruppen bestående af L, A, I, M, og V og/eller aminosyre All vælges fra gruppen bestående af Η, Y, F, og S; (ii) HVR-L2 omfatter aminosyresekvens B1-B8, hvori B1-B8 er KYASQSIS (SEQ ID NO:2), RYASQSIS (SEQ ID NO:67, eller XaaYASOSIS (SEQ ID NO:68, hvor Xaa betegner en hvilken som helst aminosyre) eller en variant af SEQ ID NO:2, 67 eller 68, hvori aminosyre Bl vælges fra gruppen bestående af K, R, N, V, A, F, Q, Η, P, I, L, Y og Xaa (hvor Xaa betegner en hvilken som helst aminosyre), og/eller aminosyre B4 vælges fra gruppen bestående af S og D, og/eller aminosyre B5 vælges fra gruppen bestående af Q og S, og/eller aminosyre B6 vælges fra gruppen bestående af S, D, L, og R, og/eller aminosyre B7 vælges fra gruppen bestående af I, V, E, og K; (iii) HVR-L3 omfatter aminosyresekvens C1-C9, hvori C1-C9 er QQGNSLPNT (SEQ ID NO:3) eller en variant af SEQ ID NO:3 hvori aminosyre C8 vælges fra gruppen bestående af N, V, W, Y, R, S, T, A, F, Η, I L, M, og Y; (iv) HVR-H1 omfatter aminosyresekvens D1-D10, hvori D1-D10 er GFFITNNYWG (SEQ ID NO:4); (v) HVR-H2 omfatter aminosyresekvens E1-E17, hvori E1-E17 er GYISYSGSTSYNPSLKS (SEQ ID NO:5), eller en variant af SEQ ID NO:5 hvori aminosyre E2 vælges fra gruppen bestående af Y, F, V, og D, og/eller aminosyre E6 vælges fra gruppen bestående af S og G, og/eller aminosyre E10 vælges fra gruppen bestående af S og Y, og/eller aminosyre E12 vælges fra gruppen bestående af N, T, A, og D, og/eller aminosyre 13 vælges fra gruppen bestående af P, H, D, og A, og/eller aminosyre E15 vælges fra gruppen bestående af L og V, og/eller aminosyre E17 vælges fra gruppen bestående af S og G; og (vi) HVR-H3 omfatter aminosyresekvens F2-F11 hvori F2 -Fil er MTGSSGYFDF (SEQ ID NO:6) eller RTGSSGYFDF (SEQ ID NO:66); eller omfatter aminosyresekvens Fl-Fll, hvori Fl-Fll er AMTGSSGYFDF (SEQ ID NO:63), ARTGSSGYFDF (SEQ ID NO:64), eller AQTGSSGYFDF (SEQ ID NO:65), eller en variant af SEQ ID NOs:6, 63, 64, 65, eller 66 hvori aminosyre F2 er R, M, A, E, G, Q, S, og/eller aminosyre Fil vælges fra gruppen bestående af F og Y.
9. Fremgangsmåden ifølge krav 8, hvor antistoffet omfatter tre hypervariable regioner med tung kæde (HVR-Hl-H3)-sekvenser og tre hypervariable regioner med let kæde (HVR-Ll-L3)-sekvenser, hvori (i) HVR-Ll omfatter SEQ ID NO: 7, SEQ ID NO:8 eller SEQ ID NO:9; (ii) HVR-L2 omfatter SEQ ID NO: 2; (iii) HVR-L3 omfatter SEQ ID NO:3; (iv) HVR-Hl omfatter SEQ ID NO:4; (v) HVR-H2 omfatter SEQ ID NO:5; og (vi) HVR-H3 omfatter SEQ ID NO:6 eller SEQ NO:63 eller SEQ ID NO:64 eller SEQ ID NO:66.
10. Fremgangsmåde ifølge krav 1, hvor prøven er en perifer blodprøve fra patienten.
DK09747765.7T 2008-05-16 2009-05-18 Anvendelse af biomarkører til vurdering af behandling af gastrointestinale inflammatoriske forstyrrelser med beta7-integrinantagonister DK2279004T3 (da)

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US5411508P 2008-05-16 2008-05-16
PCT/US2009/044375 WO2009140684A2 (en) 2008-05-16 2009-05-18 Use of biomarkers for assessing treatment of gastrointestinal inflammatory disorders with beta7integrin antagonists

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EP (1) EP2279004B1 (da)
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