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DK2289936T3 - Immunglobulinvarianter og anvendelser deraf - Google Patents

Immunglobulinvarianter og anvendelser deraf Download PDF

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Publication number
DK2289936T3
DK2289936T3 DK10179942.7T DK10179942T DK2289936T3 DK 2289936 T3 DK2289936 T3 DK 2289936T3 DK 10179942 T DK10179942 T DK 10179942T DK 2289936 T3 DK2289936 T3 DK 2289936T3
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DK
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Prior art keywords
antibody
cells
antigen
ser
antibodies
Prior art date
Application number
DK10179942.7T
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English (en)
Inventor
Camellia W Adams
Andrew C Chan
Craig W Crowley
Henry B Lowman
Gerald R Nakamura
Leonard G Presta
Original Assignee
Genentech Inc
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32685285&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2289936(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Application granted granted Critical
Publication of DK2289936T3 publication Critical patent/DK2289936T3/da

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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (22)

1. Humaniseret antistof, der binder human CD20, eller et antigenbindende fragment deraf, hvor antistoffet er virksomt til at depletere primat-B-celler in vivo, eventuelt hvor primat-B-cellerne er humane, hvilket antistof omfatter (a) en tungkæde-variabel region (VH) omfattende en CDR1-sekvens af SEQ ID NO.10, en CDR2-sekvens af SEQ ID NO.11 og en CDR3-sekvens af SEQ ID NO.12 og de humane consensus framework (FR)-rester af human tungkæde-undergruppe III (VHIII), hvor den tunge kædes variable region yderligere omfatter aminosyresubstitutioner R71V, N73K og A49G, og (b) en letkæde-variabel region (VL) omfattende en CDR1-sekvens af SEQ ID NO. 4, en CDR2-sekvens af SEQ ID NO. 5, en CDR3-sekvens af SEQ ID NO. 6 og de humane consensus framework (FR)-rester af human letkæde κ-undergruppe I (VkI), hvor den lette kædes variable region yderligere omfatter aminosyre-substitution L46P.
2. Antistof eller antigenbindende fragment ifølge krav 1, omfattende Vh-sekvensen af SEQ ID NO.8.
3. Antistof eller antigenbindende fragment ifølge krav 2, yderligere omfattende VL-sekvensen af SEQ ID NO.2.
4. Antistof eller antigenbindende fragment ifølge et hvilket som helst af de foregående krav, hvor VH-regionen er bundet til en human IgG-kæde-konstant region, eventuelt hvor det humane IgG er lgG1 eller lgG3.
5. Antistof eller antigenbindende fragment ifølge krav 3, men med aminosy-resubstitutionerne D56A og N100A i H-kæden og S92A i L-kæden.
6. Antistof eller antigenbindende fragment ifølge et hvilket som helst af de foregående krav, hvor antistoffet eller det antigenbindende fragment yderligere omfatter en Fc-region, hvor Fc-regionen omfatter mindst en aminosyre-substitution i Fc-regionen, der forbedrer ADCC- og/eller CDC-aktivitet, eventuelt hvor aminosyresubstitutionerne er S298A/E333A/K334A; eller yderligere omfattende mindst en aminosyresubstitution i Fc-regionen, der reducerer CDC-aktivitet, eventuelt omfattende mindst substitutionen K322A.
7. Antistof eller antigenbindende fragment ifølge et hvilket som helst af de foregående krav, som er konjugeret til et cytotoksisk middel, eventuelt hvor det cytotoksiske middel er en radioaktiv isotop eller et toksin.
8. Isoleret nukleinsyre eller ekspressionsvektor, der koder for antistoffet eller det antigenbindende fragment ifølge et hvilket som helst af de foregående krav.
9. Værtscelle omfattende en nukleinsyre ifølge krav 8 eller ekspressionsvektorer, der koder for antistoffet eller det antigenbindende fragment, eventuelt hvor værtscellen producerer antistoffet eller det antigenbindende fragment, og eventuelt hvor værtscellen er en CHO-celle.
10. Fremgangsmåde til fremstilling af antistoffet eller det antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7, omfattende dyrkning af cellen, der producerer antistoffet eller det antigen-bindende fragment ifølge krav 9, og udvinding af antistoffet eller det antigenbindende fragment.
11. Antistof eller antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandling af en autoimmun sygdom, hvilken fremgangsmåde omfatter at indgive en terapeutisk virksom mængde af antistoffet til en patient, der lider af den autoimmune sygdom, eventuelt hvor den autoimmune sygdom er udvalgt fra gruppen bestående af multipel sklerose, reumatoid artritis, juvenil reumatoid artritis, systemisk lupus erythematosus (SLE), Wegeners sygdom, inflammatorisk tarmsygdom, idiopatisk thrombocy-topenisk purpura (ITP), trombotisk trombocytopenisk purpura (TTP), autoimmun trombocytopeni, psoriasis, IgA-nefropati, IgM-polyneuropatier, myasthenia gravis, vaskulitis, diabetes mellitus, Reynauds syndrom, Sjørgens syndrom og glomerulonefritis.
12. Antistof eller antigenbindende fragment til anvendelse ifølge krav 11, hvor den autoimmune sygdom er multipel sklerose.
13. Antistof eller antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 til anvendelse i en fremgangsmåde til depletering af B-celler in vivo, hvilken fremgangsmåde omfatter at bringe B-cellerne i kontakt med antistoffet ifølge et hvilket som helst af de foregående krav, hvorved B-cellerne depleteres.
14. Antistof eller antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 til anvendelse ved behandling af en CD20-positiv cancer, omfattende at indgive en terapeutisk virksom mængde af antistoffet til en patient, der lider af canceren, eventuelt hvor den CD20-positive cancer er et B-celle-lymfom, leukæmi, non-Hodgkins lymfom (NHL), LPHD (lymphocyte predominant Hodgkin's disease), kronisk lymfatisk leukæmi eller SLL.
15. Antistof eller antigenbindende fragment til anvendelse ifølge krav 14, hvor den CD20-positive cancer er et B-celle-lymfom eller leukæmi, og antistoffet indgives i et dosisområde på ca. 275-375 mg/m2.
16. Antistof eller antigenbindende fragment til anvendelse ifølge krav 14, idet fremgangsmåden yderligere omfatter at indgive mindst ét kemoterapeutisk middel til patienten, eventuelt hvor canceren er non-Hodgkins lymfom (NHL), og det kemoterapeutiske middel er udvalgt fra gruppen bestående af doxorubicin, cyclophosphamid, vineristin og prednisolon.
17. Anvendelse af antistoffet eller det antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 i fremstillingen af et medikament til anvendelse i en fremgangsmåde til behandling af en autoimmun sygdom, hvilken fremgangsmåde omfatter at indgive en terapeutisk virksom mængde af antistoffet til en patient, der lider af den autoimmune sygdom, eventuelt hvor den autoimmune sygdom er udvalgt fra gruppen bestående af multipel sklerose, reumatoid artritis, juvenil reumatoid artritis, systemisk lupus erythematosus (SLE), Wegeners sygdom, inflammatorisk tarmsygdom, idiopatisk thrombocy-topenisk purpura (ITP), trombotisk trombocytopenisk purpura (TTP), autoimmun trombocytopeni, psoriasis, IgA-nefropati, IgM-polyneuropatier, myasthenia gravis, vaskulitis, diabetes mellitus, Reynauds syndrom, Sjørgens syndrom og glomerulonefritis.
18. Anvendelse ifølge krav 17, hvor den autoimmune sygdom er multipel sklerose.
19. Anvendelse af antistoffet eller det antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 i fremstillingen af et medikament til anvendelse i en fremgangsmåde til depletering af B-celler in vivo, hvilken fremgangsmåde omfatter at bringe B-celler i kontakt med antistoffet ifølge et hvilket som helst af de foregående krav, hvorved B-cellerne depleteres.
20. Anvendelse af antistoffet eller det antigenbindende fragment ifølge et hvilket som helst af kravene 1 til 7 i fremstillingen af et medikament til anvendelse i en fremgangsmåde til behandling af en CD20-positiv cancer, omfattende at indgive en terapeutisk virksom mængde af antistoffet til en patient, der lider af canceren, eventuelt hvor den CD20-positive cancer er et B-celle-lymfom eller leukæmi, eventuelt hvor den CD20-positive cancer er non-Hodgkins lymfom (NHL) eller LPHD (lymphocyte predominant Hodgkin's disease), og eventuelt hvor canceren er kronisk lymfatisk leukæmi eller SLL.
21. Anvendelse af antistoffet eller det antigenbindende fragment ifølge krav 20, hvor den CD20-positive cancer er et B-celle-lymfom eller leukæmi, og antistoffet indgives i et dosisområde på ca. 275-375 mg/m2.
22. Anvendelse af antistoffet eller det antigenbindende fragment ifølge krav 21, hvilken fremgangsmåde yderligere omfatter at indgive mindst ét kemoterapeutisk middel til patienten, eventuelt hvor canceren er non-Hodgkins lymfom (NHL), og det kemoterapeutiske middel er udvalgt fra gruppen bestående af doxorubicin, cyclophosphamid, vineristin og prednisolon.
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