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DK2260111T3 - Genetiske variationer, der er forbundet med lægemiddelresistens - Google Patents

Genetiske variationer, der er forbundet med lægemiddelresistens Download PDF

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DK2260111T3
DK2260111T3 DK09719560.6T DK09719560T DK2260111T3 DK 2260111 T3 DK2260111 T3 DK 2260111T3 DK 09719560 T DK09719560 T DK 09719560T DK 2260111 T3 DK2260111 T3 DK 2260111T3
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abcc3
antibody
antimitotic agent
antibody conjugate
gene
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Mark Lackner
Lukas C Amler
Guy Cavet
Carol O'brien
Ajay Pandita
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Genentech Inc
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    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6855—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from breast cancer cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
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Claims (31)

1. Fremgangsmåde til bestemmelse af om brystkræft hos en patient er resistent overfor behandling med et antimitotisk middel-antistofkonjugat, omfattende et antimitotisk middel, der er valgt blandt en auristatin og et maytansi-noid, der er kovalent bundet til et antistof, hvilken fremgangsmåde omfatter at detektere om ABCC3-genet forstærkes eller overeksprimeres i en testbryst-kræftprøve fra patienten, hvor forstærkning eller overekspression af ABCC3-genet indikerer, at brystkræften er resistent overfor behandling med antimitotisk middel-antistofkonjugatet.
2. Fremgangsmåde ifølge krav 1, omfattende at detektere om ABCC3-genet forstærkes, hvor detektering af forstærkningen af ABCC3-genet omfatter at fastslå ABCC3-genets eksemplarnummer, hvor et eksemplarnummer på mindst 3 indikerer ABCC3-genforstærkning.
3. Fremgangsmåde ifølge krav 2, hvor et eksemplarnummer på mindst 5 indikerer ABCC3-genforstærkning.
4. Fremgangsmåde ifølge krav 1, omfattende at detektere om ABCC3-genet overeksprimeres, hvor detektering af overekspressionen af ABCC3-genet omfatter at fastslå niveauet af mRNA-transkription ud fra ABCC3-genet.
5. Fremgangsmåde ifølge krav 4, hvor overekspression af ABCC3-genet indikeres af en mindst 5-dobbelt forøgelse af mRNA-transkriptionsniveauet ud fra ABCC3-genet i testkræftprøven i forhold til en kontrolprøve.
6. Fremgangsmåde ifølge krav 5, hvor overekspression af ABCC3-genet indikeres af en mindst 25-dobbelt forøgelse af mRNA-transkriptionsniveauet ud fra ABCC3-genet i testkræftprøven i forhold til en kontrolprøve.
7. Fremgangsmåde ifølge krav 1, omfattende at detektere, om ABCC3-genet overeksprimeres, hvor detektering af overekspression af ABCC3-genet omfatter at fastslå niveauet af ABCC3-polypeptidekspression.
8. Fremgangsmåde ifølge krav 7, hvor bestemmelse af niveauet af ABCC3-polypeptidekspression omfatter at bringe testbrystkræftprøven i kontakt med et anti-ABCC3-antistof og detektere binding af anti-ABCC3-antistoffet til ABCC3-polypeptid.
9. Fremgangsmåde ifølge krav 7, hvor overekspression af ABCC3-genet indikeres af en mindst dobbelt forøgelse i niveauet af ekspression af ABCC3-polypeptid i testbrystkræftprøven i forhold til en kontrolprøve.
10. Fremgangsmåde ifølge krav 7, hvor overekspression af ABCC3-genet indikeres af en mindst 10-dobbelt forøgelse i niveauet af ekspression af ABCC3-polypeptid i testbrystkræftprøven i forhold til en kontrolprøve.
11. Fremgangsmåde ifølge krav 2 eller 3, hvor eksemplarnummeret af ABCC3-genet fastslås ved FISH (fluorescence in situ hybridization), Southern Blot, immunhistokemi (IHC), polymerasekædereaktion (PCR), kvantitativ PCR (qPCR), kvantitativ realtids-PCR (qRT-PCR), komparativ genomisk hybridisering, mikroarraybaseret komparativ genomisk hybridisering eller li-gasekædereakiton (LCR).
12. Fremgangsmåde ifølge krav 1, hvor brystkræfttypen er Her2-positiv brystkræft.
13. Fremgangsmåde ifølge krav 1, hvor det antimitotiske middel er: (a) en auristatin, der er valgt fra gruppen bestående af monomethyl-auristatin E (MMAE) og monomethyl-auristatin F (MMAF); eller (b) et maytansinoid, der er valgt fra gruppen bestående af DM1 og DM4.
14. Fremgangsmåde ifølge krav 1 eller 13, hvor antimitotisk middel-antistofkonjugatet er et maytansinoid-anti-Her2-antistofkonjugat.
15. Fremgangsmåde ifølge krav 14, hvor maytansinoid-anti-Fler2-antistofkonjugatet er trastuzumab-DM1.
16. Antimitotisk middel-antistofkonjugat, omfattende et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, der er konvalent bundet til et antistof, til anvendelse i en fremgangsmåde til behandling af en patient med en brystkræfttype, der er resistent overfor antimitotisk middel-antistofkonjugatet, hvilken fremgangsmåde omfatter at administrere en antagonist af ABCC3 og antimitotisk middel-antistofkonjugatet til patienten, hvor patientens brystkræft er blevet fastslået som resistent overfor antimitotisk middel-antistofkonjugatet ved detektering af, at ABCC3-genet er forstærket eller overeksprimeret i en testbrystkræftprøve fra patienten.
17. Antagonist af ABCC3 til anvendelse i en fremgangsmåde til behandling af en patient med en brystkræfttype, der er resistent overfor et antimitotisk middel-antistofkonjugat, omfattende et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, der er kovalent bundet til et antistof, hvilken fremgangsmåde omfatter at administrere antagonisten af ABCC3 og antimitotisk middel-antistofkonjugatet til patienten, hvor patientens kræft er blevet fastslået som resistent overfor antimitotisk middel-antistofkonjugatet ved detektering af, at ABCC3-genet er forstærket eller overeksprimeret i en testbrystkræftprøve fra patienten.
18. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 16 eller antagonist af ABCC3 til Anvendelse ifølge krav 17, hvor antagonisten er valgt fra gruppen bestående af et ABCC3-antistof og et siRNA, der binder til ABCC3.
19. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 16 eller antagonist af ABCC3 til anvendelse ifølge krav 17, hvor brystkræfttypen er Her2-positiv brystkræft.
20. Anti-mitotisk middel-antistofkkonjugat, omfattende et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, som er kovalent bundet til et antistof til anvendelse i en fremgangsmåde til behandling af brystkræft, hvilken fremgangsmåde omfatter a) at vælge en patient baseret på fraværet af ABCC3-forstærkning eller -overekspression i patientens kræft, og b) at administrere en terapeutisk virksom mængde af det antimitotiske mid-del-antistifkonjugat.
21. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 20, hvor den valgte patient har Her2-positiv brystkræft.
22. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 20 eller 21, hvor det antimitotiske middel er et anti-Her2-antistof-antimitotisk middel-konjugat.
23. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 22, hvor anti-Her2-antistof-antimitotisk middel-konjugatet er trastuzumab-DM1 eller trastuzumab-MMAE.
24. Fremgangsmåde ifølge krav 1 til bestemmelse af, om en brystkræfttype hos en patient er resistent overfor behandling med et antimitotisk middel-antistofkonjugat, hvor antimitotisk middel-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, der er kovalent bundet til trastuzumab.
25. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 16, omfattende et antimitotisk middel, der er valgt blandt en auristatin og et maytansi-noid, der er kovalent bundet til trastuzumab.
26. Antagonist af ABCC3 til anvendelse ifølge krav 17, hvor antimitotisk mid-del-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, der er kovalent bundet til trastuzumab.
27. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 20, hvor antimitotisk middel-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt en auristatin og et maytansinoid, der er kovalent bundet til trastuzumab.
28. Fremgangsmåde ifølge krav 1 til bestemmelse af, om en brystkræfttype hos en patient er resistent overfor behandling med et antimitotisk middel-antistofkonjugat, hvor antimitotisk middel-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt monomethyl-auristatin E (MMAE), mono-methyl-auristatin F (MMAF), DM1 og DM4.
29. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 16, omfattende et antimitotisk middel, der er valgt blandt monomethyl-auristatin E (MMAE) , monomethyl-auristatin F (MMAF), DM1 og DM4.
30. Antagonist af ABCC3 til anvendelse ifølge krav 17, hvor antimitotisk middel-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt monomethyl-auristatin E (MMAE), monomethyl-auristatin F (MMAF), DM1 og DM4.
31. Antimitotisk middel-antistofkonjugat til anvendelse ifølge krav 20, hvor antimitotisk middel-antistofkonjugatet omfatter et antimitotisk middel, der er valgt blandt monomethyl-auristatin E (MMAE), monomethyl-auristatin F (MMAF) , DM1 og DM4.
DK09719560.6T 2008-03-14 2009-03-12 Genetiske variationer, der er forbundet med lægemiddelresistens DK2260111T3 (da)

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US3687408P 2008-03-14 2008-03-14
US5406408P 2008-05-16 2008-05-16
PCT/US2009/036985 WO2009114711A2 (en) 2008-03-14 2009-03-12 Genetic variations associated with drug resistance

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EP (1) EP2260111B2 (da)
JP (5) JP2011517555A (da)
KR (2) KR101881168B1 (da)
CN (1) CN102027135B (da)
AU (1) AU2009223124B2 (da)
BR (1) BRPI0906049A8 (da)
CA (1) CA2715319A1 (da)
DK (1) DK2260111T3 (da)
ES (1) ES2544682T3 (da)
HU (1) HUE025102T2 (da)
IL (1) IL207538A (da)
MX (1) MX2010009940A (da)
PL (1) PL2260111T3 (da)
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JP2015133963A (ja) 2015-07-27
BRPI0906049A8 (pt) 2018-06-26
EP2260111B1 (en) 2015-06-17
WO2009114711A2 (en) 2009-09-17
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