DK2611832T3 - Anti-cxcl13-antistoffer og fremgangsmåder til anvendelse deraf - Google Patents

Anti-cxcl13-antistoffer og fremgangsmåder til anvendelse deraf Download PDF

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DK2611832T3
DK2611832T3 DK11822655.4T DK11822655T DK2611832T3 DK 2611832 T3 DK2611832 T3 DK 2611832T3 DK 11822655 T DK11822655 T DK 11822655T DK 2611832 T3 DK2611832 T3 DK 2611832T3
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antibody
cxcl13
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amino acid
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Ekaterina Klimatcheva
Mark Paris
Ernest S Smith
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Vaccinex Inc
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Claims (14)

1. Isoleret antistof eller antigenbindende fragment deraf, der binder specifikt til CXCL13, hvor den tunge kædes variable (VH) region af antistoffet eller fragmentet deraf omfatter variabel tung kædes komplementaritetsbestemmende region 1 (VH-CDR1)-, VH-CDR2- og VH-CDR3-aminosyresekvenser, der omfatter henholdsvis SEQ ID NO: 4, 5 og 6; og hvor den lette kædes variable (VL) region af antistoffet eller fragmentet deraf omfatter variabel let kædes komplementaritetsbestemmende region 1 (VL-CDR1)-, VL-CDR2- og VL-CDR3-aminosyresekvenser, der omfatter henholdsvis SEQ ID NO: 9 eller 16, 10 og 11.
2. Antistof eller antigenbindende fragment deraf ifølge krav 1, hvor: a) VH af antistoffet eller fragmentet deraf omfatter en aminosyresekvens, der er mindst 90 % identisk med SEQ ID NO: 13 eller SEQ ID NO: 3; b) VL af antistoffet eller fragmentet deraf omfatter en aminosyresekvens, der er mindst 90 % identisk med SEQ ID NO: 15, SEQ ID NO: 17 eller SEQ ID NO: 8; c) VH af antistoffet eller fragmentet deraf omfatter en aminosyresekvens, der bortset fra 20 eller færre konservative aminosyresubstitutioner er identisk med SEQ ID NO: 13 eller SEQ ID NO: 3; d) VL af antistoffet eller fragmentet deraf omfatter en aminosyresekvens, der bortset fra 20 eller færre konservative aminosyresubstitutioner er identisk med SEQ ID NO: 15, SEQ ID NO: 17 eller SEQ ID NO: 8; e) VH af antistoffet eller fragmentet deraf omfatter aminosyresekvensen ifølge SEQ ID NO: 13 eller SEQ ID NO: 3; f) VL af antistoffet eller fragmentet deraf omfatter aminosyresekvensen ifølge SEQ ID NO: 15, SEQ ID NO: 17 eller SEQ ID NO: 8; g) VH og VL af antistoffet eller fragmentet deraf omfatter aminosyresekvenser, der er mindst 90 % identiske med VH- og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8; h) VH og VL af antistoffet eller fragmentet deraf omfatter aminosyresekvenser, der bortset fra 20 eller færre konservative aminosyresubstitutioner hver er identiske med VH-og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8; og/eller i) VH og VL af antistoffet eller fragmentet deraf omfatter aminosyresekvenser, der er identiske med VH- og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8.
3. Antistof eller antigenbindende fragment deraf, der binder specifikt til CXCL13 og hæmmer kompetitivt et monoklonalt reference-antistof i binding til human, murin og primat CXCL13, hvor det monoklonale reference-antistof er valgt blandt: (a) et monoklonalt antistof, der består af VH-sekvenser som vist i SEQ ID NO: 13, VL-sekvenser som vist i SEQ ID NO: 15 og humane IgGl- og kappa-konstant-domæner; (b) et monoklonalt antistof, der består af VH-sekvenser som vist i SEQ ID NO: 13, VL-sekvenser som vist i SEQ ID NO: 17 og humane IgGl- og kappa-konstant-domæner; og (c) et monoklonalt antistof, der består af VH-sekvenser som vist i SEQ ID NO: 3, VL-sekvenser som vist i SEQ ID NO: 8 og humane IgGl- og kappa-konstant-domæner.
4. Antistof eller fragment deraf ifølge et hvilket som helst af kravene 1 til 3, hvor antistoffet eller fragmentet deraf: a) binder til en lineær epitop; b) binder til en ikke-lineær konformationel epitop; c) er multispecifikt; d) er bispecifikt; e) er et Fab-fragment, et F (ab)2~fragment, et Fv-fragment eller et enkeltkædet antistof; f) er multivalent og omfatter mindst to tunge kæder og mindst to lette kæder; g) omfatter en let kædes konstant region valgt fra gruppen, der består af en human kappa-konstant-region og en human lambda-konstant-region; h) omfatter en tung kædes konstant region eller et fragment deraf; i) hæmmer CXCL13 i binding til en CXCLl3-receptor, hvor CXCL13-receptoren eventuelt er CXCR5; j) er humaniseret, primatiseret eller kimært; k) yderligere omfatter et heterologt polypeptid, der er fusioneret dertil; og/eller l) er konjugeret til et middel valgt fra gruppen, der består af et cytotoksisk middel, et terapeutisk middel, et cytostatisk middel, et biologisk toksin, et prodrug, et peptid, et protein, et enzym, et virus, et lipid, et biologisk respons-modificeringsmiddel, et farmaceutisk middel, et lymfokin, et heterologt antistof eller et fragment deraf, et påviseligt mærke, polyethylenglycol (PEG) og en kombination af to eller flere af hvilke som helst af midlerne; hvor det cytotoksiske middel eventuelt er valgt fra gruppen, der består af et radionuklid, et biotoksin, et enzymatisk aktivt toksin eller en kombination af to eller flere af hvilke som helst af de cytotoksiske midler; og hvor det påviselige mærke eventuelt er valgt fra gruppen, der består af et enzym, et fluorescerende mærke, et kemiluminescerende mærke, et bioluminescerende mærke, et radioaktivt mærke eller en kombination af to eller flere af hvilke som helst af de påviselige mærker.
5. Isoleret antistof eller fragment deraf ifølge krav 4, hvor antistoffet eller fragmentet deraf omfatter en human kappa-let kædes konstant region og en human IgGl-tung kædes konstant region.
6. Sammensætning, der omfatter antistoffet eller fragmentet deraf ifølge et hvilket som helst af kravene 1 til 5 og et bæremiddel, hvor bæremidlet eventuelt er valgt fra gruppen, der består af saltvand, bufferet saltvand, dextrose, vand, glycerol og kombinationer deraf.
7. Sammensætning, der omfatter: a) et første polynukleotid, der koder for et antistofs tung kæde-variabelt (VH) polypeptid, hvor VH-polypeptidet omfatter tung kædes variabel komplementaritetsbestemmende region 1 (CDR1)-, VH-CDR2- og VH-CDR3-aminosyresekvenser, der omfatter henholdsvis SEQ ID NO: 4, 5 og 6; og b) et andet polynukleotid, der koder for et antistofs let kæde-variabelt (VL) polypeptid, hvor VL-polypeptidet omfatter let kædes variabel komplementaritetsbestemmende region 1 (CDR1)-, VL-CDR2- og VL-CDR3-aminosyresekvenser, der omfatter henholdsvis SEQ ID NO: 9 eller 16, 10 og 11; hvor et antistof eller et antigenbindende fragment deraf, der omfatter VH-polypeptidet og VL-polypeptidet, binder specifikt til CXCL13.
8. Sammensætning ifølge krav 7, hvor: a) aminosyresekvensen for VH-polypeptidet er mindst 90 % identisk med SEQ ID NO: 13 eller SEQ ID NO: 3; b) det første polynukleotid omfatter en nukleotidsekvens ifølge SEQ ID NO: 12 eller SEQ ID NO: 2; c) aminosyresekvensen for VH-polypeptidet bortset fra 20 eller færre konservative aminosyresubstitutioner er identisk med SEQ ID NO: 3 eller SEQ ID NO: 13; d) VH-polypeptidet omfatter aminosyresekvensen ifølge SEQ ID NO: 13 eller SEQ ID NO: 3; e) aminosyresekvensen for VL-polypeptidet er mindst 90 % identisk med SEQ ID NO: 15, SEQ ID NO: 8 eller SEQ ID NO: 17; f) det andet polynukleotid omfatter en nukleotidsekvens ifølge SEQ ID NO: 14, SEQ ID NO: 7 eller SEQ ID NO: 18; g) aminosyresekvensen for VL-polypeptidet bortset fra 20 eller færre konservative aminosyresubstitutioner er identisk med SEQ ID NO: 15, SEQ ID NO: 8 eller SEQ ID NO: 17; h) VL-polypeptidet omfatter aminosyresekvensen ifølge SEQ ID NO: 15, SEQ ID NO: 8 eller SEQ ID NO: 17; i) VH-polypeptidet og VL-polypeptidet omfatter aminosyresekvenser, der er mindst 90 % identiske med VH- og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8; j) VH-polypeptidet og VL-polypeptidet omfatter aminosyresekvenser, der bortset fra 20 eller færre konservative aminosyresubstitutioner hver er identiske med VH-og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8; og/eller k) VH-polypeptidet og VL-polypeptidet omfatter aminosyresekvenser, der er identiske med VH- og VL-sekvenser valgt blandt: i) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 15; ii) henholdsvis SEQ ID NO: 13 og SEQ ID NO: 17; og iii) henholdsvis SEQ ID NO: 3 og SEQ ID NO: 8.
9. Sammensætning ifølge krav 7 eller 8, hvor: a) det første polynukleotid yderligere omfatter en nukleinsyre, der koder for et signalpeptid, der er fusioneret til antistof-VH-polypeptidet; b) det andet polynukleotid yderligere omfatter en nukleinsyre, der koder for et signalpeptid, der er fusioneret til antistof-VL-polypeptidet; c) det første polynukleotid yderligere omfatter en nukleinsyre, der koder for et tung kædes konstant region CH1-domæne, der er fusioneret til VH-polypeptidet; d) det første polynukleotid yderligere omfatter en nukleinsyre, der koder for et tung kædes konstant region CH2-domæne, der er fusioneret til VH-polypeptidet; e) det første polynukleotid yderligere omfatter en nukleinsyre, der koder for et tung kædes konstant region CH3-domæne, der er fusioneret til VH-polypeptidet; f) det første polynukleotid yderligere omfatter en nukleinsyre, der koder for en tung kædes hængselregion, der er fusioneret til VH-polypeptidet; g) det andet polynukleotid yderligere omfatter en nukleinsyre, der koder for et let kædes konstant region-domæne, der er fusioneret til VL-polypeptidet, hvor den lette kædes konstante region eventuelt er human kappa; h) det første polynukleotid og det andet polynukleotid er indeholdt på en enkelt vektor; i) det første polynukleotid er indeholdt på en første vektor, og det andet polynukleotid er indeholdt på en anden vektor, der er ikke-identisk med den første vektor; hvor den første vektor og den anden vektor er indeholdt i en enkelt værtscelle, eller hvor den første vektor og den anden vektor er indeholdt i separate værtsceller; og/eller j) det første polynukleotid er operabelt forbundet med en første promotor, og det andet polynukleotid er operabelt forbundet med en anden promotor; hvor den første og anden promotor er kopier af den samme promotor, eller hvor den første og anden promotor er ikke-identiske.
10. Sammensætning ifølge krav 9, hvor det første polynukleotid yderligere omfatter en nukleinsyre, der koder for en human IgGl-tung kædes konstant region, der er fusioneret til VH-polypeptidet, og hvor det andet polynukleotid yderligere omfatter en nukleinsyre, der koder for en human kappa-let kædes konstant region, der er fusioneret til VL-polypeptidet.
11. Isoleret antistof eller fragment deraf ifølge et hvilket som helst af kravene 1 til 5 eller sammensætning ifølge krav 6 til anvendelse til behandling af cancer, autoimmunsygdom eller inflammationssygdom, hvor autoimmunsygdommen eller inflammationssygdommen eventuelt er multipel sklerose, systemisk lupus erythematosus (SLE) eller arthritis, hvor arthritis eventuelt er rheumatoid arthritis; og hvor canceren eventuelt er prostata- eller coloncancer.
12. Isoleret antistof eller fragment deraf ifølge et hvilket som helst af kravene 1 til 5 eller sammensætning ifølge krav 6 til anvendelse til behandling af gastriske lymfoide follikler hos et dyr, hvor dyret er blevet inficeret med en Helicobacter-bakterie.
13. Isoleret antistof eller fragment deraf ifølge et hvilket som helst af kravene 1 til 5 eller sammensætning ifølge krav 6 til anvendelse i en fremgangsmåde til forebyggelse eller behandling af mucosa-forbundet lymfevæv (MALT)-lymfom eller et gastrisk eller duodenalt ulcus hos et dyr, der har brug for forebyggelse eller behandling, hvor dyret eventuelt er blevet inficeret med en Helicobacter-bakterie .
14. Antistof, fragment deraf eller sammensætning til anvendelse i fremgangsmåden ifølge et hvilket som helst af kravene 11 til 13, hvor dyret er et pattedyr, og hvor pattedyret eventuelt er et menneske.
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