DK2178916T3 - Humane antistoffer mod human cd20 og fremgangsmåde til anvendelse deraf - Google Patents

Humane antistoffer mod human cd20 og fremgangsmåde til anvendelse deraf Download PDF

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DK2178916T3
DK2178916T3 DK08796917.6T DK08796917T DK2178916T3 DK 2178916 T3 DK2178916 T3 DK 2178916T3 DK 08796917 T DK08796917 T DK 08796917T DK 2178916 T3 DK2178916 T3 DK 2178916T3
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Erin M Allison
Joel H Martin
Li-Hsien Wang
Sean Stevens
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Regeneron Pharma
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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
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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Claims (12)

1. Humant antistof eller antigen-bindende fragment af et antistof, som specifikt binder human CD20 og er i stand til at inducere komplementafhængig cytotoksicitet (CDC) i en human non-Hodgkins B-celle-lymfom-cellelinje med en antistofkoncentration 1 nM eller mindre, har en EC50 på 0,2 nM eller mindre som målt i Daudi-celler eller en EC5o på 0,4 nM eller mindre som målt ved RL-celler og øger symptomfri overlevelsestid nidobbelt eller mere ved intravenøs indgivelse ved en dosis på 10 mg/kg til mus podet med den humane non-Hodgkins B-celle-lymfom-cellelinje Raji i forhold til SCID-mus podet med den humane non-Hodgkins B-celle-lymfom-cellelinje Raji, som modtager 10 mg/kg af en human Fc-kontrol, hvor antistoffet eller antistoffragmentet omfatter: - en komplementært bestemmende region 1 med en tung kæde (HCDR1) og en let kæde CDR1 (LCDR1), hvor HCDR1 og LCDR1 er SEQ ID NO:341 og 349; - en komplementært bestemmende region 2 med en tung kæde (HCDR2) og en let kæde CDR2 (LCDR2), hvor HCDR2 og LCDR2 er SEQ ID NO:343 og 351;og - en komplementært bestemmende region 3 med en tung kæde (HCDR3) og en let kæde CDR3 (LCDR3), hvor HCDR3 og LCDR3 er SEQ ID NO:345 og 353.
2. Humant antistof eller antigen-bindende fragment af et antistof, som specifikt binder human CD20 og er i stand til at inducere komplementafhængig cytotoksicitet (CDC) med en antistofkoncentration på 5 nM eller mindre i en human non-Hodgkins B-celle-lymfom-cellelinje, hvor antistoffet eller fragmentet deraf omfatter en sekvens af en variabel region med tung kæde (HCVR) og en sekvens af variabel region med let kæde (LCVR), hvor HCVR- og LCVR-sekvensen er SEQ ID NO:339 og 347.
3. Humant antistof eller antigen-bindende fragment ifølge krav 2, hvor den nødvendige antistofkoncentrationen til induktion af CDC er 1 nM eller mindre.
4. Humant antistof eller antigen-bindende fragment ifølge krav 3, yderligere kendetegnet ved at have en EC50 på 0,2 nM eller mindre som målt i Daudi- celler eller en EC50 på 0,4 nM eller mindre som målt ved RL-celler.
5. Humant antistof eller antigen-bindende fragment ifølge et af kravene 1 til 4, kendetegnet ved at have en KD eller EC5o på mindst 10'11 M ved måling ved binding til et antigen vist på en celleoverflade.
6. Nukleinsyremolekyle, der koder for det humane antistof eller antistoffragmentet ifølge krav 5.
7. Ekspressionsvektor omfattende nukleinsyremolekylet ifølge krav 6.
8. Fremgangsmåde til fremstilling af et anti-humant CD20-antistof eller antigen-bindende fragment af et antistof, hvilken fremgangsmåde omfatter trinnene med at indføre ekspressionsvektoren ifølge krav 7 i en isoleret værtscelle, dyrkning af cellen under forhold, der gør det muligt at fremstille antistoffet eller antistoffragmentet, og indvinding af antistoffet eller antistoffragmentet, der således er fremstillet.
9. Fremgangsmåde ifølge krav 8, hvorved værtscellen er en E. coli-celle, CHO-celle eller en COS-celle.
10. Farmaceutisk sammensætning omfattende et antistof eller antigenbindende fragment deraf ifølge et af kravene 1 til 5.
11. Antistof eller antigen-bindende fragment af et antistof ifølge et af kravene 1 til 5 til anvendelse med henblik på at svække eller hæmme en CD20-medieret sygdom eller tilstand i et menneske, hvor sygdommen eller tilstanden er udvalgt fra gruppen bestående af non-Hodgkins lymfom, reumatoid artritis, systemisk lupus erythematosus, Crohns sygdom, kronisk lymfatisk leukæmi og en inflammatorisk sygdom.
12. Anvendelse af et antistof eller antigen-bindende fragment af et antistof ifølge et af kravene 1 til 5 ved fremstilling af et medikament til anvendelse med henblik på at svække eller hæmme en CD20-medieret sygdom eller tilstand i et menneske, hvor sygdommen eller tilstanden er udvalgt fra gruppen bestående af non-Hodgkins lymfom, reumatoid artritis, systemisk lupus eryt- hematosus, Crohns sygdom, kronisk lymfom leukæmi og inflammatoriske sygdomme.
DK08796917.6T 2007-07-31 2008-07-31 Humane antistoffer mod human cd20 og fremgangsmåde til anvendelse deraf DK2178916T3 (da)

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PCT/US2008/071709 WO2009018411A1 (en) 2007-07-31 2008-07-31 Human antibodies to human cd20 and method of using thereof

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