DK2567976T3 - Antistoffer mod cd38 til behandling af multipelt myelom - Google Patents

Antistoffer mod cd38 til behandling af multipelt myelom Download PDF

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DK2567976T3
DK2567976T3 DK12178778.2T DK12178778T DK2567976T3 DK 2567976 T3 DK2567976 T3 DK 2567976T3 DK 12178778 T DK12178778 T DK 12178778T DK 2567976 T3 DK2567976 T3 DK 2567976T3
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antibody
seq
sequence
human
cell
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Yvo Graus
Paul Parren
De Winkel Jan Van
Weers Michel De
Judith Oprins
Vugt Martine Van
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Genmab As
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Claims (31)

1. Antistof, der binder til humant CD38, hvor antistoffet omfatter variable humane letkæde- og humane tungkæderegioner, hvor den variable letkæderegion omfatter et Vl CDR1 med sekvensen ifølge SEQ ID NO: 13, en Vl CDR2 med sekvensen ifølge SEQ ID NO: 14 og en VL CDR3 med sekvensen ifølge SEQ ID NO: 15, og den variable tungkæderegion omfatter en Vh CDR1 med sekvensen ifølge SEQ ID NO: 18, en VH CDR2 med sekvensen ifølge SEQ Π) NO: 19 og en VH CDR3 med sekvensen ifølge SEQ ID NO: 20.
2. Antistof ifølge krav 1, der er et humant monoklonalt antistof.
3. Antistof ifølge et hvilket som helst af kravene 1 og 2, kendetegnet, ved at det er et fuldlængde IgGl-, IgG2-, IgG3-, IgG4-, IgD-, IgA-, IgE- eller IgM-antistof.
4. Antistof ifølge krav 3, der er er IgGl-antistof.
5. Antistof ifølge krav 4, der er et IgGl,K-antistof.
6. Antistof ifølge krav 3, der er et IgM-antistof.
7. Antistof ifølge krav 6, der er et IgM,K-antistof.
8. Antistof ifølge et hvilket som helst af kravene 1 til 7, der omfatter en Vn-region med aminosyresekvensen ifølge SEQ ID NO: 17.
9. Antistof ifølge et hvilket som helst af kravene 1 til 7, der omfatter en Vn-region, der omfatter aminosyresekvensen, der spænder over VH CDR1-Vh CDR3-regionen ifølge SEQ ID NO: 17.
10. Antistof ifølge et hvilket som helst af kravene 1 til 9, der omfatter en VL-region med aminosyresekvensen ifølge SEQ ID NO: 12.
11. Antistof ifølge krav 1, hvor antistoffet er kodet for af (i) humane letkæde- og humane tungkædenukleinsyrer, der omfatter nukleotidsekvenser i deres variable regioner ifølge henholdsvis SEQ ID NO: 11 og SEQ ID NO: 16; eller (ii) humane letkæde- og humane tungkædenukleinsyrer, der omfatter nukleotidsekvenser i deres variable regioner, som er konservative sekvensmodifikationer af sekvenserne ifølge (i).
12. Antistof ifølge et hvilket som helst af de foregående krav, der er et antistoffragment eller et enkeltkædeantistof.
13. Antistof ifølge et hvilket som helst af de foregående krav, der er i en i det væsentlige isoleret form.
14. Antistof ifølge et hvilket som helst af de foregående krav, der endvidere omfatter en chelator-linker til binding af en radioisotop.
15. Isoleret nukleinsyre, der koder for et antistof ifølge et hvilket som helst af kravene 1 til 12.
16. Ekspressions vektor, der omfatter en nukleinsyresekvens, der koder for et antistof ifølge et hvilket som helst af kravene 1 til 12.
17. Eukaryotisk eller prokaryotisk værtscelle, der fremstiller et antistof ifølge et hvilket som helst af kravene 1 til 12.
18. Immunkonjugat, der omfatteret antistof ifølge et hvilket som helst af kravene 1 til 13 bundet til et cytotoksisk middel, en radioisotop eller et lægemiddel.
19. Bispecifikt eller multispecifikt molekyle, der omfatter antistoffet ifølge et hvilket som helst af kravene 1 til 14 og en bindingsspecificitet for en human effektorcelle.
20. Farmaceutisk sammensætning, der omfatter antistoffet ifølge et hvilket som helst af kravene 1 til 14, immunkonjugatet ifølge krav 18, eller det bispecifikke eller multispecifikke molekyle ifølge krav 19 og en farmaceutisk acceptabel bærer.
21. Antistof ifølge et hvilket som helst af kravene 1 til 14, immunkonjugat ifølge krav 18, et bispecifikt eller multispecifikt molekyle ifølge krav 19 eller en ekspressions vektor ifølge krav 16 til anvendelse som et medikament.
22. Antistof ifølge et hvilket som helst af kravene 1 til 14, immunkonjugat ifølge krav 18, farmaceutisk sammensætning ifølge krav 20, bispecifikt eller multispecifikt molekyle ifølge krav 19 eller ekspressionsvektor ifølge krav 16 til anvendelse i en fremgangsmåde til behandling eller forebyggelse af en sygdom eller forstyrrelse, der involverer celler, der udtrykker CD38, hvor sygdommen eller forstyrrelsen er udvalgt fra gmppen bestående af B-celle-lymfom/leukæmi, herunder præcursor lymfoblastisk B-celleleukæmi/lymfom og non-Hodgkins B-cellelymfomer; akut lymfoblastisk leukæmi; mature B-celleneoplasmer, herunder kronisk lymfocytisk B-celleleukæmi(CLL)/småcellet lymfocytisk lymfom (SLL); akut lymfocytisk B-celleleukæmi; prolymfocytisk B-celleleukæmi; lymfoplasmacytisk lymfom; mantlecellelymfom (MCL); follikulært lymfom (FL), herunder FL af lav grad, mellemgrad eller høj grad; kutant follikelcenterlymfom; marginal zone B-cellelymfom, herunder af MALT-typen, knude- og splenium-typen; hårcelleleukæmi; diffus stor B-cellelymfom; Burkitts lymfom; plasmacytom; plasmacellemyelom; plasmacelleleukæmi; lymfoproliferativ forstyrrelse efter transplantation; Waldenstroms makroglobulinæmi; plasmacelleleukæmi; anaplastisk storcellet lymfom (ALCL); multipelt myelom; Hodgkins lymfom; mature T-celle og NK-celleneoplasmer, herunder prolymfocytisk T-celleleukæmi; T-celle storcellet granulær lymfocytisk leukæmi; aggressiv NK-celleleukæmi; adult T-celleleukæmi/lymfom; extranodal NK/T-cellelymfom; nasal type, enteropati-type T-cellelymfom; hepatosplenisk T-cellelymfom; subkutant panniculitis-lignende T-cellelymfom; biastisk NK-cellelymfom; Mycosis Fungoides/Sézary-syndrom; primære kutane CD30-positive lymfoproliferative T-celleforstyrrelser, herunder kutant anaplastisk storcellelymfom C-ALCL, lymfomatoid papulose og borderline-læsioer; angioimmunoblastisk T-cellelymfom, perifert T-cellelymfom, uspecificeret; anaplastisk storcellet lymfom; akut myeloid leukæmi, herunder akut promyelocytisk leukæmi; og kroniske myeloproliferative sygdomme, herunder kronisk myeloid leukæmi.
23. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelsen ifølge krav 22, hvor sygdommen er non-Hodgkins B-cellelymfom.
24. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelsen ifølge krav 22, hvor sygdommen er multipelt myelom.
25. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelsen ifølge krav 22, hvor sygdommen er akut lymfoblastisk leukæmi.
26. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelsen ifølge krav 22, hvor sygdommen er kronisk, lymfocytisk B-celleleukæmi.
27. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressions vektor til anvendelse ifølge et hvilket som helst af kravene 21 til 26, hvor fremgangsmåden omfatter administration af ét eller flere yderligere terapeutiske midler til personen.
28. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelse ifølge krav 27, hvor det ene eller flere yderligere terapeutiske midler er udvalgt blandt et kemoterapeutisk middel, et anti-inflammatorisk middel, eller et immunosuppressivt og/eller immunmodulerende middel.
29. Antistof, immunkonjugat, farmaceutisk sammensætning, bispecifikt eller multispecifikt molekyle eller ekspressionsvektor til anvendelse ifølge krav 27, hvor det ene eller flere yderligere terapeutiske midler er udvalgt blandt gruppen bestående af cisplatin, gefitinib, cetuximab, rituximab, bevacizumab, erlotinib, bortezomib, thalidomid, pamidronat, zoledronic acid, clodronat, risendronat, ibandronat, etidronat, alendronat, tiludronat, arsentrioxid, lenalidomid, filgrastim, pegfilgrastim, sargramostim, suberoylanilid hydroxamsyre og SCIO-469.
30. Fremgangsmåde in vitro til detektering af tilstedeværelsen af CD38-antigen, eller en celle, der udtrykker CD38, i en prøve, hvilken fremgangsmåde omfatter: a) etablering af kontakt mellem prøven og antistoffet ifølge et hvilket som helst af kravene 1 til 11 under forhold, der muliggør dannelse af et kompleks mellem peptidet og CD38; og b) detektering af dannelsen af et kompleks.
31. Anti-idiotypisk antistof, der binder til et antistof ifølge et hvilket som helst af kravene 1 til 12.
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