DK2922875T3 - Anti-ceacam5-antistoffer og anvendelser deraf - Google Patents

Anti-ceacam5-antistoffer og anvendelser deraf Download PDF

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DK2922875T3
DK2922875T3 DK13794894.9T DK13794894T DK2922875T3 DK 2922875 T3 DK2922875 T3 DK 2922875T3 DK 13794894 T DK13794894 T DK 13794894T DK 2922875 T3 DK2922875 T3 DK 2922875T3
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sequence
seq
antibody
amino acid
ceacam5
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DK13794894.9T
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Pierre-Francois Berne
Francis Blanche
Hervé Bouchard
Béatrice Cameron
Tarik Dabdoubi
Stéphanie Decary
Paul Ferrari
Alexey Rak
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Sanofi Sa
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    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
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    • C07K16/461—Igs containing Ig-regions, -domains or -residues form different species
    • C07K16/464—Igs containing CDR-residues from one specie grafted between FR-residues from another
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Claims (37)

1. Isoleret antistof, som: a) binder sig til A3-B3 domæne af menneskelig og Macaca fascicularis CEACAM5 proteiner; og b) ikke signifikant krydsreagerer med menneskelig CEACAM1, menneskelig CEACAM6, menneskelig CEACAM7, menneskelig CEACAM8, Macaca fascicularis CEACAM1, Macaca fascicularis CEACAM6 og Macaca fascicularis CEACAM8.
2. Isoleret antistof ifølge krav 1, som konkurrerer om at binde til A3-B3 domæne af menneskelig og Macaca fascicularis CEACAM5 proteiner med et antistof, der omfatter de variable tunge og lette kæder af et antistof, der er udvalgt fra gruppen bestående af a) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 31 og et variabelt domæne af let kæde med sekvens SEQ ID NO:32; b) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 33 og et variabelt domæne af let kæde med sekvens SEQ ID NO:34; c) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 33 og et variabelt domæne af let kæde med sekvens SEQ ID NO: 34, i hvilken K ved position 52 er blevet erstattet med R; d) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 35 og et variabelt domæne af let kæde med sekvens SEQ ID NO:36; e) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 37 og et variabelt domæne af let kæde med sekvens SEQ ID NO:38; og f) et antistof, der omfatter et variabelt domæne af tung kæde med sekvens SEQ ID NO: 39 og et variabelt domæne af let kæde med sekvens SEQ ID NO:40.
3. Antistof ifølge et hvilket som helst af kravene 1 eller 2, som binder sig til A3-B3 domæne af menneskelig og Macaca fascicularis CEACAM5: a) med et forhold af affinitet for menneskelig CEACAM5 til affiniteten for Macaca fascicularis CEACAM5, som er < 12; eller b) med en affinitet for menneskelig CEACAM5 og/eller Macaca fascicularis CEACAM5, som er < lOnM, eller c) både a og b.
4. Antistof ifølge et hvilket som helst af kravene 1 til 3, hvor antistoffet binder sig til to områder af A3-B3 domænet af menneskelig CEACAM5 protein, der henholdsvis omfatter sekvenserne SEQ ID NO:76 og SEQ ID NO:77.
5. Antistof ifølge et hvilket som helst af kravene 1 til 4, der omfatter: a) en CDR1-H, der består af sekvensen X1X2X3X4X5X6YD (SEQ ID NO:83), hvor hver af Xi, X2, X3, X4, Xs og Xs er en hvilken som helst aminosyre; og en CDR2-H, der består af en 6 til 10 aminosyre-lang sekvens, i hvilken enhver aminosyre kan være til stede i en hvilken som helst position; og en CDR3-H, der består af sekvensen X1X2HX3FGX4X5GPX6AX7 (SEQ ID NO: 84), hvor hver af Xi, X4, Xs, Χε, og X7 er en hvilken som helst aminosyre, X2 er A eller S, og X3 er Y, F eller W; eller b) en C DR 1-L, der består af sekvensen X1X2X3X4X5Y (SEQ ID NO:85), hvor hver af Xi, X2, X3 og X5 er en hvilken som helst aminosyre, og X4 er Y, F eller W; og en C DR 2-L, der består af sekvensen NX1X2, hvor hver af Xi og X2 er en hvilken som helst aminosyre; og en C DR 3-L, der består af sekvensen X1X2HX3X4X5PX6X7 (SEQ ID NO: 86), hvor hver af Xi, X2, X4, Xs, X&amp; og Xy er en hvilken som helst aminosyre, X3 er Y, F eller W, eller c) både a og b.
6. Antistof ifølge et hvilket som helst af kravene 1 til 5, der omfatter: a) en CDR1-H, der består af sekvensen GFXiFSSYD (SEQ ID NO:78), hvor Xi er T, A eller V; og en CDR 2-H, der består af sekvensen IX1SX2GGX3T (SEQ ID NO:79), hvor Xi er S eller N, X2 er Y eller G, X3 er R eller I; og en CDR3-H, der består af sekvensen X1AHYFGX2SGPFAY (SEQ ID NO:80), hvor Xi er A eller T, og X2 er T eller S; eller b) en CDR 1-L, der består af sekvensen ENIFSY (SEQ ID NO: 10) eller ENIYSY (SEQ ID NO:22); og en CDR 2-L, der består af sekvensen NX1X2, hvor Xi er A eller T, og X2 er K eller R; og en CDR 3-L, der består af sekvensen QHHYGTPFT (SEQ ID NO: 12) eller QHHYGIPFT (SEQ ID NO:24), eller c) både a og b.
7. Antistof ifølge et hvilket som helst af kravene 1 til 4, der omfatter: a) en CDR1-H, der består af sekvensen GFTFSX1YX2 (SEQ ID NO:81), hvor Xi er R eller S, og X2 er A eller D; og en CDR 2-H, der består af sekvensen ISSGGX1X2X3 (SEQ ID NO:82), hvor Xi er manglende, S eller G, X2 er D, Y eller I, og X3 er T eller I; og en CDR3-H, der består af sekvensen ARPAYYGNPAMDY (SEQ ID NO:3) eller ARVNYYDSSFLDW (SEQ ID NO:15); eller b) en CDR 1-L, der består af sekvensen QNVGTN (SEQ ID NO:4); og en CDR 2-L, der består af sekvensen SAS; og en CDR 3-L, der består af sekvensen QQYNSYPLYT (SEQ ID NO: 6) eller QQYNNYPLYT (SEQ ID N0:18), eller c) både a og b.
8. Antistof ifølge et hvilket som helst af kravene 1 til 4, der omfatter: a) en CDR 1-H af sekvensen SEQ ID NO:l eller en sekvens, der er forskellig fra SEQ ID NO:l med en aminosyresubstitution; CDR2-H af sekvensen SEQ ID NO: 2 eller en sekvens, der er forskellig fra SEQ ID NO: 2 med en eller flere aminosyresubstitutioner; CDR3-H af sekvensen SEQ ID NO:3 eller en sekvens, der er forskellig fra SEQ ID NO:3 med en aminosyresubstitution; CDR1-L af sekvensen SEQ ID NO: 4 eller en sekvens, der er forskellig fra SEQ ID NO:4 med en aminosyresubstitution; CDR2-L af sekvensen SAS eller en sekvens, der er forskellig fra SAS med en aminosyresubstitution and CDR3-L af sekvensen SEQ ID NO: 6 eller en sekvens, der er forskellig fra SEQ ID NO: 6 med en aminosyresubstitution; eller b) en CDR 1-H af sekvensen SEQ ID NO: 7 eller en sekvens, der er forskellig fra SEQ ID NO: 7 med en aminosyresubstitution; CDR2-H af sekvensen SEQ ID NO: 8 eller en sekvens, der er forskellig fra SEQ ID NO: 8 med en eller flere aminosyresubstitutioner; CDR3-H af sekvensen SEQ ID NO:9 eller en sekvens, der er forskellig fra SEQ ID NO: 9 med en eller flere aminosyresubstitutioner; CDR1-L af sekvensen SEQ ID NO:10 eller en sekvens, der er forskellig fra SEQ ID NO:10 med en aminosyresubstitution; CDR2-L af sekvensen NTK eller NTR eller en sekvens, der er forskellig fra NTK eller NTR med en aminosyresubstitution og CDR3-L af sekvensen SEQ ID NO: 12 eller en sekvens, der er forskellig fra SEQ ID NO: 12 med en aminosyresubstitution; eller c) en CDR 1-H af sekvensen SEQ ID NO:13 eller en sekvens, der er forskellig fra SEQ ID NO:13 med en aminosyresubstitution; CDR2-H af sekvensen SEQ ID NO:14 eller en sekvens, der er forskellig fra SEQ ID NO:14 med en eller flere aminosyresubstitutioner; CDR3-H af sekvensen SEQ ID NO:15 eller en sekvens, der er forskellig fra SEQ ID NO: 15 med en aminosyresubstitution; CDR1-L af sekvensen SEQ ID NO:16 eller en sekvens, der er forskellig fra SEQ ID NO:16 med en aminosyresubstitution; CDR2-L af sekvensen SAS eller en sekvens, der er forskellig fra SAS med en aminosyresubstitution og CDR3-L af sekvensen SEQ ID NO: 18 eller en sekvens, der er forskellig fra SEQ ID NO: 18 med en aminosyresubstitution; eller d) en CDR 1-H af sekvensen SEQ ID NO:19 eller en sekvens, der er forskellig fra SEQ ID NO:19 med en aminosyresubstitution; CDR2-H af sekvensen SEQ ID NO:20 eller en sekvens, der er forskellig fra SEQ ID NO:20 med en eller flere aminosyresubstitutioner; CDR3-H af sekvensen SEQ ID NO: 21 eller en sekvens, der er forskellig fra SEQ ID NO:21 med en eller flere aminosyresubstitutioner; CDR1-L af sekvensen SEQ ID NO:22 eller en sekvens, der er forskellig fra SEQ ID NO:22 med en aminosyresubstitution; CDR2-L af sekvensen NAK eller en sekvens, der er forskellig fra NAK med en eller flere aminosyresubstitutioner og CDR3-L af sekvensen SEQ ID NO: 24 eller en sekvens, der er forskellig fra SEQ ID NO:24 med en aminosyresubstitution; eller e) en CDR 1-H af sekvensen SEQ ID NO:25 eller en sekvens, der er forskellig fra SEQ ID NO:25 med en aminosyresubstitution; CDR2-H af sekvensen SEQ ID NO:26 eller en sekvens, der er forskellig fra SEQ ID NO:26 med en eller flere aminosyresubstitutioner; CDR3-H af sekvensen SEQ ID NO: 27 eller en sekvens, der er forskellig fra SEQ ID NO:27 med en eller flere aminosyresubstitutioner; CDR1-L af sekvensen SEQ ID NO:28 eller en sekvens, der er forskellig fra SEQ ID NO:28 med en aminosyresubstitution; CDR2-L af sekvensen NAK eller en sekvens, der er forskellig fra NAK med en eller flere aminosyresubstitutioner og CDR3-L af sekvensen SEQ ID NO: 30 eller en sekvens, der er forskellig fra SEQ ID NO:30 med en aminosyresubstitution.
9. Antistof ifølge krav 8, hvor aminosyresubstitutionen er en konservativ aminosyresubstitution.
10. Antistof ifølge et hvilket som helst af kravene 1 til 9, der omfatter: a) et variabelt domæne af tung kæde med sekvens SEQ ID NO: 31 eller en sekvens, der er mindst 85 % identisk dermed, og/eller et variabelt domæne af let kæde med sekvens SEQ ID NO: 32, eller en sekvens, der er mindst 85 % identisk dermed; eller b) et variabelt domæne af tung kæde med sekvens SEQ ID NO: 33, eller en sekvens, der er mindst 85 % identisk dermed, og/eller et variabelt domæne af let kæde med sekvens SEQ ID NO:34, eller en sekvens, der er mindst 85 % identisk dermed; eller c) et variabelt domæne af tung kæde med sekvens SEQ ID NO: 35, eller en sekvens, der er mindst 85 % identisk dermed, og/eller et variabelt domæne af let kæde med sekvens SEQ ID NO: 36, eller en sekvens, der er mindst 85 % identisk dermed; eller d) et variabelt domæne af tung kæde med sekvens SEQ ID NO: 37, eller en sekvens, der er mindst 85 % identisk dermed, og/eller et variabelt domæne af let kæde med sekvens SEQ ID NO:38, eller en sekvens, der er mindst 85 % identisk dermed; eller e) et variabelt domæne af tung kæde med sekvens SEQ ID NO: 39, eller en sekvens, der er mindst 85 % identisk dermed, og/eller et variabelt domæne af let kæde med sekvens SEQ ID NO:40, eller en sekvens, der er mindst 85 % identisk dermed.
11. Antistof ifølge et hvilket som helst af kravene 1 til 10, som er et kimært eller et menneskeliggjort antistof.
12. Antistof ifølge et hvilket som helst af kravene 1 til 11, som er et antistof, der omfatter: a) en tung kæde af sekvensen SEQ ID NO:41 og/eller en let kæde af sekvensen af sekvensen SEQ ID NO:42; eller b) en tung kæde af sekvensen SEQ ID NO:43 og/eller en let kæde af sekvensen af sekvensen SEQ ID NO:44; eller c) en tung kæde af sekvensen SEQ ID NO:45 og/eller en let kæde af sekvensen af sekvensen SEQ ID NO:46; eller d) en tung kæde af sekvensen SEQ ID NO:47 og/eller en let kæde af sekvensen af sekvensen SEQ ID NO:48; eller e) en tung kæde af sekvensen SEQ ID NO:49 og/eller en let kæde af sekvensen af sekvensen SEQ ID NO:50.
13. Antistof ifølge et hvilket som helst af kravene 1 til 11, der omfatter: a) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO:51, SEQ ID NO:5, eller SEQ ID NO: 74; og/eller b) et variabelt domæne af en let kæde af sekvensen SEQ ID NO:17, SEQ ID NO:23, SEQ ID NO:29, SEQ ID NO:55, eller SEQ ID NO: 75.
14. Antistof ifølge et hvilket som helst af kravene 1 til 11, der omfatter: a) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO: 51 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:17, eller b) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO:5 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:23, eller c) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO:5 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:29, eller d) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO: 51 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:55, eller e) et variabelt domæne af en tung kæde af sekvensen SEQ ID NO: 74 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:75.
15. Antistof ifølge krav 1 til 6, 8, 10, 11, 13 og 14, der omfatter a) en tung kæde, der består af sekvensen SEQ ID NO:87 eller en sekvens, der er mindst 85 % identisk dermed; og/eller b) en let kæde, der består af sekvensen SEQ ID NO:88 eller en sekvens, der er mindst 85 % identisk dermed.
16. Antistof ifølge et hvilket som helst af kravene 1 til 15, som er et antistoffragment.
17. Antistof ifølge et hvilket som helst af kravene 1 til 16, som er en variabel tung kæde af et enkelt domæneantistof (VHH).
18. Antistof ifølge et hvilket som helst af kravene 1 til 17, som er et bispecifikt eller et multispecifikt antistof.
19. Antistof ifølge et hvilket som helst af kravene 1 til 18, som er et fragment, der er udvalgt fra gruppen bestående af Fv, Fab, F(ab')2, Fab', dsFv, (dsFv)2, scFv, sc(Fv)2 og diabodies.
20. Isoleret nukleinsyre, der omfatter en sekvenskodning af et antistof ifølge et hvilket som helst af kravene 1 to 19.
21. Værtscelle, der er blevet omdannet af en nukleinsyre ifølge krav 20.
22. Immunokonjugat, der omfatter et antistof ifølge et hvilket som helst af kravene 1 til 19, der er konjugeret eller bundet til i det mindste et væksthæmmende middel.
23. Immunokonjugat ifølge krav 22, hvor det væksthæmmende middel er et cytotoksisk middel eller en radioaktiv isotop.
24. Immunokon j ugat ifølge krav 22 eller 23, hvor det væksthæmmende middel er udvalgt fra gruppen bestående af kemoterapeutiske midler, enzymer, antibiotika, og toksiner såsom små molekyle toksiner eller enzymatisk aktive toksiner, taxoider, vincas, taxaner, maytansinoid eller maytansinoid-analoger, tomaymycin eller pyrrolobenzodiazepin- derivater, cryptophycin- derivater, leptomycin- derivater, auristatin eller dolastatin- analoger, prodrugs, topoisomeras-II inhibitorer, DNA alkyleringsmidler, anti-tubulin middel og CC-1065 eller CC-1065 analoger.
25. Immunokon j ugat ifølge kravene 22 til 24, hvor det væksthæmmende middel er (N2'-deacetyl-N2'-(3-mercapto-l-oxopropyl)-maytansin) DM1 eller N2'-deacetyl-N-2'(4-methyl-4-mercapto-l-oxopentyl)-maytansin (DM4).
26. Immunokonjugat ifølge et hvilket som helst af kravene 22 til 25, hvor antistoffet er kovalent bundet via en spaltelig eller ikke-spaltelig linker til det i det mindste ene væksthæmmende middel.
27. Immunokonjugat ifølge krav 26, hvor den nævnte linker er udvalgt fra gruppen bestående af N-succinimidyl pyridyldithiobutyrat (SPDB), 4-(Pyridin-2-yldisulfanyl)-2-sulfo-smørsyre (sulfo-SPDB) og succinimidyl (N-maleimidomethyl) cyclohexane-l-carboxylat (SMCC).
28. Immunokonjugat ifølge et hvilket som helst af kravene 22 til 27, hvor antistoffet omfatter et variabelt domæne af en tung kæde af sekvensen SEQ ID NO: 5 og et variabelt domæne af en let kæde af sekvensen SEQ ID NO:29.
29. Immunokonjugat ifølge et hvilket som helst af kravene 22 til 28, hvor antistoffet omfatter en tung kæde, der består af sekvensen SEQ ID NO:87 eller en sekvens, der er mindst 85 % identisk dermed, og en let kæde, der består af sekvensen SEQ ID NO:88, eller en sekvens, der er mindst 85 % identisk dermed.
30. Immunokonjugat ifølge et hvilket som helst af kravene 22 til 29, hvor te immunokonjugatet er kendetegnet ved et lægemiddel-til-antistofforhold (DAR), der spænder fra 1 til 10 .
31. Farmaceutisk sammensætning, der omfatter et antistof ifølge et hvilket som helst af kravene 1 til 19 eller et immunokonjugat ifølge et hvilket som helst af kravene 22 til 30 og en farmaceutisk acceptabel bærer.
32. Antistof ifølge et hvilket som helst af kravene 1 til 19, eller et immunokonjugat ifølge et hvilket som helst af kravene 22 til 30, eller en farmaceutisk sammensætning ifølge krav 31 til anvendelse til behandling af kræft.
33. Antistof, immunokonjugat eller farmaceutisk sammensætning til anvendelsen ifølge krav 32, hvor kræften er CEACAM5, der udtrykker kræft.
34. Antistof, immunokonjugat eller farmaceutisk sammensætning til anvendelsen ifølge krav 32 eller 33, hvor kræften er kolorektal-, mave-, lunge-, livmoderhals-, bugspytkirtel-, spiserørs-, æggestok-, skjoldbruskkirtel-, blære-, endometrium-, bryst-, lever, prostata- eller hudkræft.
35. Antistof ifølge et hvilket som helst af kravene 1 til 19 til anvendelse for ex vivo detektering af CEACAM5 udtrykt i en biologisk prøve fra et individ.
36. Antistof til anvendelsen ifølge krav 35, hvor antistoffet er mærket med en detekterbar molekyle eller substans.
37. Antistof til anvendelsen ifølge krav 35 eller 36, hvor anvendelsen er til diagnosticering af tilstedeværelsen af en kræft i et individ til bestemmelse af modtagelighed for en patient, der har kræft, af et terapeutisk middel, der er målrettet CEACAM5, eller overvågning af effektiviteten af en anti-CEACAM5 kræftterapi eller detektering af tilbagefald af kræft efter en anti-CEACAM5 kræftterapi.
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