DK1920065T3 - Anti-alfa v beta 6-antistoffer og anvendelser deraf - Google Patents

Anti-alfa v beta 6-antistoffer og anvendelser deraf Download PDF

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DK1920065T3
DK1920065T3 DK06774580.2T DK06774580T DK1920065T3 DK 1920065 T3 DK1920065 T3 DK 1920065T3 DK 06774580 T DK06774580 T DK 06774580T DK 1920065 T3 DK1920065 T3 DK 1920065T3
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antibody
carcinoma
marker
seq
antibodies
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Shelia Violette
Paul H Weinreb
Jose Saldanha
Vlijmen Herman Van
Louise A Koopman
Kenneth J Simon
Alexey A Lugovskoy
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Biogen Ma Inc
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Claims (54)

1. Humaniseret antistof eller antigenbindende fragment deraf der specifikt binder til ανβθ, og som omfatter: (i) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 72, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 68; (ii) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 72, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 69; (iii) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 73, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 69; (iv) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 74, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 69; (v) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 74, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 70; or (vi) et variabelt tungkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 74, og et variabelt letkædedomæne, der omfatter aminosyresekvensen af SEQ ID NO: 71.
2. Antistof eller antigenbindende fragment deraf ifølge krav 1, hvor antistoffet omfatter et variabelt tungkædedomæne, der omfatter aminosyresekvensen ifølge SEQ ID NO:74 og et variabelt letkædedomæne, der omfatter aminosyresekvensen ifølge SEQ ID NO: 71.
3. Antistof eller antigenbindende fragment deraf ifølge krav 1 eller krav 2, hvor det antigenbindende fragment er udvalgt fra gruppen bestående af et Fab-, et Fab'-, et F(ab')2-, Fd-, Fv-, et scFv-, et sdFv- og et enkeltkædeantistof.
4. Isoleret nukleinsyremolekyle eller isolerede nukleinsyremolekyler, der koder for antistoffet ifølge et hvilket som helst af kravene 1-3.
5. Rekombinant vektor eller rekombinante vektorer, der omfatter nukleinsyremolekylet eller nukleinsyremolekylerne ifølge krav 4.
6. Værtscelle, der omfatter den rekombinant vektor eller de rekombinante vektorer ifølge krav 5.
7. Antistof eller antigenbindende fragment deraf ifølge et hvilket som helst af kravene 1 til 3, hvor antistoffet er konjugeret med et cytotoksisk middel.
8. Sammensætning, der omfatter antistoffet ifølge et hvilket som helst af kravene 1 til 3, og en farmaceutisk acceptabel bærer.
9. Sammensætning ifølge krav 8, hvor antistoffet et konjugeret med et cytotoksisk middel.
10. Fremgangsmåde til fremstilling af et humaniseret antistof, der omfatter dyrkning af en værtscelle, der omfatter en rekombinant vektor eller rekombinante vektorer, der omfatter nukleinsyresekvenserne ifølge SEQ ID NOs: 5 og 6, under forhold, der er egnede til ekspression af et humaniseret antistof, hvor humaniserede antistofkæder udtrykkes og et humaniseret antistof frembringes.
11. Fremgangsmåde ifølge krav 10, der endvidere omfatter isolering af det humaniserede antistof.
12. Fremgangsmåde ifølge krav 10, hvor værtscellen er en CHO-celle.
13. Antistof ifølge et hvilket som helst af kravene 1 til 3, til anvendelse som et lægemiddel.
14. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i behandling eller forebyggelse af fibrose hos et humant individ.
15. Antistof eller sammensætning til anvendelse ifølge krav 14, hvor fibrosen er lungefibrose, nyrefibrose, leverfibrose, Alports syndrom eller sklerodermi.
16. Antistof eller sammensætning til anvendelse ifølge krav 15, hvor fibrosen er lungefibrose.
17. Antistof eller sammensætning til anvendelse ifølge krav 16, hvor lungefibrosen er idiopatisk pulmonal fibrose.
18. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 til anvendelse i behandling eller forebyggelse af strålingsinduceret fibrose, kronisk obstruktiv lungesygdom (COPD), kronisk astma, silikose, asbestinduceret fibrose, akut åndedrætsnød eller psoriasis hos et humant individ.
19. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 til anvendelse af behandling af akut lungelæsion.
20. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 til anvendelse af behandling af akut nyrelæsion.
21. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i behandling eller forebyggelse af cancer hos et humant individ.
22. Antistof eller sammensætning til anvendelse ifølge krav 21, hvor canceren er epitel-, oral, hud-, cervix-, ovarie-, farynx-, larynx-, øsofageal-, lunge-, bryst-, nyre- eller kolorektal cancer.
23. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i reduktion eller forebyggelse af metastase af en primær tumor til et sekundært sted hos et humant individ.
24. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i eliminering af avp6-positive metastatiske tumorceller hos et humant individ.
25. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i eliminering af residuelle av36-positive tumorceller hos et humant individ efter kirurgisk excision af en tumor fra et væv eller organ hos det humane individ.
26. Antistof ifølge et hvilket som helst af kravene 1 til 3 eller sammensætning ifølge krav 8 eller 9 til anvendelse i reduktion eller forebyggelse af progression af en primær præmetastatisk eller præinvasiv tumor til en metastatisk eller invasiv tumor hos et humant individ.
27. Antistof eller sammensætning til anvendelse ifølge et hvilket som helst af kravene 23 til 26, hvor tumoren er et karcinom.
28. Antistof eller sammensætning til anvendelse ifølge krav 27, hvor karcinomet er udvalgt fra gruppen bestående af et brystkarcinom, et endometriekarcinom, et pankreaskarcinom, et kolorektalt karcinom, et lungekarcinom, et ovariekarcinom, et cervixkarcinom, et prostatakarcinom, et leverkarcinom, et øsofaguskarcinom, et karcinom i hoved eller hals, et mavekarcinom, et miltkarcinom og et adenokarcinom.
29. Antistof eller sammensætning til anvendelse ifølge krav 27, hvor karcinomet er et in situ-brystkarcinom.
30. Antistof eller sammensætning til anvendelse ifølge krav 29, hvor in situ-brystkarcinomet er et duktalt karcinom in situ (DOIS) eller et lobulært karcinom in situ (LOIS).
31. Antistof eller sammensætning til anvendelse ifølge et hvilket som helst af kravene 21 til 30, hvor antistoffet skal administreres til det humane individ sammen med administrationen af mindst en cytotoksisk forbindelse.
32. Antistof eller sammensætning til anvendelse ifølge krav 31, hvor den cytotoksiske forbindelse er udvalgt fra gruppen bestående af cisplatin, carboplatin, oxaplatin, paclitaxel, melphalan, doxorubicin, methotrexat, 5-fluoruracil, etoposid, mechlorethamin, cyclophosphamid, bleomycin, et calicheamicin, et maytansin, en trichothen, CC 1065, difteri A-kæde, Pseudomonas aeruginosa eksotoksin A-kæde, ricin A-kæde, abrin A-kæde, modeccin A-kæde, alpha-sarcin, et Aleuritesfordii-protein, et dianthinprotein, et Phytolaca amer/cana-protein, en Momordica charantia- hæmmer, curcin, crotin, Saponaria officinalis-hæmmer, gelonin, mitogellin, restrictocin, phenomycin, enomycin, en tricothecen, en ribonuklease, en deoxyribonuklease, et radioisotop og et prodrug-aktiverende enzym.
33. Antistof eller sammensætning til anvendelse ifølge krav 31, hvor den cytotoksiske forbindelse er en radioisotop udvalgt fra gruppen bestående af211 At 1311,1251,90Y 186Re, 153Sm, 212Bi, 32P og radioaktive isotoper af Lu.
34. Antistof eller sammensætning til anvendelse ifølge krav 31, hvor den cytotoksiske forbindelse er et prodrug-aktiverende enzym udvalgt fra gruppen bestående af alkalisk phosphatase, arylsulfatase, cytosindeaminase, en protease, en D-alanylcarboxypeptidase, et carbohydratspaltende enzym, P-lactamase og en penicillinamidase.
35. Antistof eller sammensætning til anvendelse ifølge et hvilket som helst af kravene 14 til 34, hvor antistoffet eller sammensætningen skal administreres til det humane individ via en vej, der er udvalgt fra gruppen bestående af oral administration, parenteral administration, intrakraniel administration, intrapulmonal administration og intranasal administration.
36. Antistof eller sammensætning til anvendelse ifølge et hvilket som helst af kravene 14 til 34, hvor antistoffet eller sammensætning administreres til patienten via en parenteral vej udvalgt fra gruppen bestående af intramuskulær administration, intravenøs administration, intraarteriel administration og subkutan administration.
37. Antistof eller sammensætning til anvendelse ifølge krav 36, hvor den parenterale vej omfatter administration af antistoffet eller sammensætningen til patienten ved injektion.
38. Fremgangsmåde in vitro til diagnosticering af et karcinom, der vil være mere tilbøjeligt vil progrediere til et invasivt karcinom, hvilken fremgangsmåde omfatter: (a) etablering af kontakt mellem en malign epitelvævsprøve, der omfatter en tumor eller del deraf opnået fra en patient, og en ikke-malign epitelvævsprøve opnået fra en patient med et antistof ifølge et hvilket som helst af kravene 1 til 3, der binder til den ene eller flere underenheder af integrin ανβθ; og (b) bestemmelse af ekspressionsniveauet af integrin ανβθ i vævsprøverne, hvor en stigning i ekspressionsniveauet af integrin ανβθ i den maligne vævsprøve i forhold til ekspressionsniveauet af integrin ανβθ i den ikke-maligne vævsprøve indikerer tilstedeværelsen hos patienten af et karcinom, der vil være mere tilbøjeligt til at progrediere til et invasivt karcinom.
39. Fremgangsmåde ifølge krav 38, hvor antistoffet er konjugeret med mindst en detekterbar markør.
40. Fremgangsmåde ifølge krav 39, hvor den detekterbare markør er udvalgt fra gruppen bestående af en kromogen markør, en enzymmarkør, en radioisotopisk markør, en ikke-radioaktiv isotopisk markør, en fluorescerende markør, en toksisk markør, en chemiluminescerende markør, en røntgenradiografisk markør, en spinmarkør og en nukleær magnetisk resonanskontrastmiddelmarkør.
41. Fremgangsmåde ifølge krav 40, hvor den kromogene markør er diaminobenzidin eller 4-hydroxyazo-benzen-2-carboxylsyre.
42. Fremgangsmåde ifølge krav 40, hvor enzymmarkøren er udvalgt fra gruppen bestående af malatedehydrogenase, stafylokoknuklease, delta-5-steroid isomerase, gær-alkohol-dehydrogenase, alpha-glycerolphosphat dehydrogenase, triosephosphateisomerase, peroxidase, alkalisk phosphatase, asparaginase, glucoseoxidase, β-galactosidase, ribonuklease, urease, catalase, glucose-6-phosphatdehydrogenase, glucoamylase og acetylcholinesterase.
43. Fremgangsmåde ifølge krav 40, hvor den radioisotope markør er udvalgt fra gruppen bestående af 3H, 111ln, 125l, 131l, 32P, 35S, 14C, 51Cr, 57Co, 58Co, 59Fe, 75Se, 152Eu, 90Y, 67Cu, 217Ci, 211At, 212Pb, 47Sc og 109Pd.
44. Fremgangsmåde ifølge krav 40, hvor den ikke-radioaktive isotopiske markør er udvalgt fra gruppen bestående af 157Gd, 55Mn, 162Dy, 52Tr, 56Fe, 99mTc og 112ln.
45. Fremgangsmåde ifølge krav 40, hvor den fluorescerende markør er udvalgt fra gruppen bestående af en 152Eu-markør, en fluoresceinmarkør, en isothiocyanatmarkør, en rhodaminmarkør, en phycoerythrinmarkør, en phycocyaninmarkør, en allophycocyaninmarkør, en Green Fluorescent Protein- (GFP) markør, en o-phthaldehydmarkør og en fluorescaminmarkør.
46. Fremgangsmåde ifølge krav 40, hvor den toksiske markør er udvalgt fra gruppen bestående afen difteritoksinmarkør, en ricinmarkør og en koleratoksinmarkør.
47. Fremgangsmåde ifølge krav 40, hvor den kemiluminescerende markør er udvalgt fra gruppen bestående af etluminolmarkør, en isoluminolmarkør, en aromatisk acridiniumestermarkør, en imidazolmarkør, en acridmiumsaltmarkør, en oxalatestermarkør, en luciferinmarkør, en luciferasemarkør og en equorinmarkør.
48. Fremgangsmåde ifølge krav 40, hvor den røntgenradiografiske markør er barium eller cesium.
49. Fremgangsmåde ifølge krav 40, hvor spinmarkøren er deuterium.
50. Fremgangsmåde ifølge krav 40, hvor den nukleære magnetiske resonanskontrastmiddelmarkør er udvalgt fra gruppen bestående af Gd, Mn og Fe.
51. Fremgangsmåde ifølge krav 38, hvor tumoren er et karcinom.
52. Fremgangsmåde ifølge krav 51, hvor karcinomet er udvalgt fra gruppen bestående af et brystkarcinom og endometriekarcinom, et pankreaskarcinom, et koloreltalt karcinom, et lungekarcinom, et ovariekarcinom, et cervixkarcinom, et prostatakarcinom, et leverkarcinom, et øsophaguskarcinom, et karcinom i hoved eller hals, et mavekarcinom, et miltkarcinom og en adenokarcinom.
53. Fremgangsmåde ifølge krav 51, hvor karcinomet er et in s/Yu-brystkarcinom.
54. Fremgangsmåde ifølge krav 53, hvor in s/Yu-brystkarcinomet er et duktalt karcinom in situ (DOIS) eller et lobulært karcinom in situ (LOIS).
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