DK2502938T3 - Antistoffer og immunkonjugater og anvendelser deraf - Google Patents

Antistoffer og immunkonjugater og anvendelser deraf Download PDF

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DK2502938T3
DK2502938T3 DK12167198T DK12167198T DK2502938T3 DK 2502938 T3 DK2502938 T3 DK 2502938T3 DK 12167198 T DK12167198 T DK 12167198T DK 12167198 T DK12167198 T DK 12167198T DK 2502938 T3 DK2502938 T3 DK 2502938T3
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antibody
seq
amino acid
acid sequence
steap
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DK12167198T
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Mark S Dennis
Bonnee Rubinfeld
Paul Polakis
Aya Jakobovits
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Genentech Inc
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    • A61K51/1045—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants
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    • A61K51/1045—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants
    • A61K51/1072—Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants the tumor cell being from the reproductive system, e.g. ovaria, uterus, testes or prostate
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Claims (16)

1. Polynukleotid, der koder for: (i) et humaniseret monoklonalt antistof, der binder til STEAP-1, hvor antistoffet omfatter en tung kæde (HC), omfattende: (1) en HVR-H1, der omfatter aminosyresekvensen med SEQ ID NO:14; (2) en HVR-H2, der omfatter aminosyresekvensen med SEQ ID NO:15; (3) en HVR-H3, der omfatter aminosyresekvensen med SEQ ID NO:16; og (4) en HC-FR1, der omfatter aminosyresekvensen med SEQ ID NO:25; og en let kæde (LC), omfattende: (1) en HVR-L1, der omfatter aminosyresekvensen med SEQ ID NO:11; (2) en HVR-L2, der omfatter aminosyresekvensen med SEQ ID NO:12; og (3) en HVR-L3, der omfatter aminosyresekvensen med SEQ ID NO:13, hvor den lette kæde eventuelt omfatter: (1) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:90; (2) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:91; (3) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:92; (4) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:93; (5) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:94; (6) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:95; (7) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:96; (8) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:97; (9) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:98; (10) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:99; (11) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:100; eller (12) en letkæderegion, der omfatter aminosyresekvensen med SEQ ID NO:101.
2. Polynukleotid ifølge krav 1 (i), hvor det monoklonale antistof endvidere omfatter mindst en, to eller tre HC-framework-regioner (FRs), valgt blandt: (1) en HC-FR2, der omfatter aminosyresekvensen med SEQ ID NO:22; (2) en HC-FR3, der omfatter aminosyresekvensen med SEQ ID NO:23; og (3) en HC-FR4, der omfatter aminosyresekvensen med SEQ ID NO:24.
3. Polynukleotid ifølge krav 1 (i), hvor: (i) det monoklonale antistof omfatter en let kæde (LC) med SEQ ID NO:6 og/eller en tung kæde (HC) med SEQ ID NO:10, (ii) antistoffet er et antistoffragment, der er valgt fra et Fab-, Fab'-SH-, Fv-, scFv- eller (Fab’)2-fragment, eller (iii) antistoffet er et bispecifikt antistof.
4. Vektor, omfattende polynukleotidet ifølge et af kravene 1-3.
5. Værtscelle, omfattende vektoren ifølge krav 4 eller polynukleotidet ifølge et af kravene 1-3, hvor værtscellen eventuelt er en bakterie-, gær-, insekt- eller en eukaryotisk celle.
6. Fremgangsmåde til fremstilling af et anti-STEAP-1-antistof, hvor fremgangsmåden omfatter a) at dyrke værtscellen ifølge krav 5 under betingelser, der er egnede til ekspression af polynukleotidet, der koder for antistoffet, og b) at isolere antistoffet.
7. Humaniseret monoklonalt antistof, der binder til STEAP-1, hvor antistoffet omfatter en tung kæde (HC), omfattende: (1) en HVR-H1, der omfatter aminosyresekvensen med SEQ ID NO:14; (2) en HVR-H2, der omfatter aminosyresekvensen med SEQ ID NO:15; (3) en HVR-H3, der omfatter aminosyresekvensen med SEQ ID NO:16; og (4) en HC-FR1, der omfatter aminosyresekvensen med SEQ ID NO:25; og en let kæde (LC), omfattende: (1) en HVR-L1, der omfatter aminosyresekvensen med SEQ ID NO:11; (2) en HVR-L2, der omfatter aminosyresekvensen med SEQ ID NO:12; og (3) en HVR-L3, der omfatter aminosyresekvensen med SEQ ID NO:13, og hvor antistoffet er kovalent bundet til en detektionsmarkering, indfangningsmarkering eller en fast bærer, hvor detektionsmarkeringen eventuelt er valgt blandt en radionuklid, en fluorescerende farve, en kemiluminescerende farve, en bioluminescens-udløsende substratenhed, en kemiluminescens-udløsende substratenhed og et enzym.
8. Humaniseret monoklonalt antistof, der binder til STEAP-1, til anvendelse i en fremgangsmåde til afbildning af en tumor i et individ, omfattende at administrere det humaniserede monoklonale antistof, der binder til STEAP-1, til individet, hvor antistoffet omfatter en tung kæde (HC), omfattende: (1) en HVR-H1, der omfatter aminosyresekvensen med SEQ ID NO:14; (2) en HVR-H2, der omfatter aminosyresekvensen med SEQ ID NO:15; (3) en HVR-H3, der omfatter aminosyresekvensen med SEQ ID NO:16; og (4) en HC-FR1, der omfatter aminosyresekvensen med SEQ ID NO:25; og en let kæde (LC), omfattende: (1) en HVR-L1, der omfatter aminosyresekvensen med SEQ ID NO:11; (2) en HVR-L2, der omfatter aminosyresekvensen med SEQ ID NO:12; og (3) en HVR-L3, der omfatter aminosyresekvensen med SEQ ID NO:13, og at detektere antistoffet, der er bundet til STEAP-1, eller en naturligt forekommende allelvariant deraf, i individet.
9. Humaniseret monoklonalt antistof, der binder til STEAP-1, til anvendelse ifølge krav 8, hvor antistoffet er kovalent bundet til en detektionsmarkering, hvor detektionsmarkeringen eventuelt er valgt blandt en radionuklid, en fluorescerende farve, en kemiluminescerende farve, en bioluminescens-udløsende substratenhed, en kemiluminescens-udløsende substratenhed og et enzym.
10. Humaniseret monoklonalt antistof, der binder til STEAP-1, til anvendelse ifølge krav 8, hvor tumoren er en prostata-, lunge-, colon-, blære- eller æggestoktumor eller Ewings sarkom.
11. Cysteingensplejset antistof, omfattende et humaniseret monoklonalt antistof, der binder til STEAP-1, hvor antistoffet omfatter en tung kæde (HC), omfattende: (1) en HVR-H1, der omfatter aminosyresekvensen med SEQ ID NO:14; (2) en HVR-H2, der omfatter aminosyresekvensen med SEQ ID NO:15; (3) en HVR-H3, der omfatter aminosyresekvensen med SEQ ID NO:16; og (4) en HC-FR1, der omfatter aminosyresekvensen med SEQ ID NO:25; og en let kæde (LC), omfattende: (1) en HVR-L1, der omfatter aminosyresekvensen med SEQ ID NO:11; (2) en HVR-L2, der omfatter aminosyresekvensen med SEQ ID NO:12; og (3) en HVR-L3, der omfatter aminosyresekvensen med SEQ ID NO:13; hvor en eller flere aminosyrerester udskiftes med en eller flere frie cysteinaminosyrer med en thiolreaktivitetsværdi i området 0,6 til 1,0.
12. Immunkonjugat, omfattende det cysteingensplejsede antistof ifølge krav 11, der er kovalent bundet til et cytotoksisk middel, hvor det cytotoksiske middel eventuelt er valgt blandt et toksin, et kemoterapeutisk middel, en lægemiddelenhed, et antibiotikum, en radioaktiv isotop og et nukleolytisk enzym.
13. Cystei ngensplejset antistof ifølge krav 11, hvor: (i) antistoffet er kovalent bundet til en indfangningsmarkering, en detektions-markering eller en fast bærer, eller (ii) antistoffet omfatter en cystein i en eller flere positioner, der er valgt blandt 15, 43, 110, 144, 168 og 205 i den lette kæde i henhold til Kabat-nummerering og 41,88, 115, 118, 120, 171, 172, 282, 375 og 400 i den tunge kæde i henhold til EU-nummereringskonventionen.
14. Antistof-lægemiddel-konjugat: (i) omfattende det cysteingensplejsede antistof ifølge krav 11, hvor antistoffet er kovalent bundet til en auristatin- eller maytansinoid-lægemiddelenhed, eller (ii) omfattende det cysteingensplejsede antistof ifølge krav 11 (Ab), og en auristatin- eller maytansinoid-lægemiddelenhed (D), hvor det cysteingensplejsede antistof er bundet til D via en eller flere frie cysteinaminosyrer ved hjælp af en linkerenhed (L); hvor forbindelsen har formlen I:
I hvor p ligger i området fra 1 til 4 hvor D eventuelt er MMAE med strukturen:
hvor den bølgede linje angiver bindingsstedet til linkeren L, eller (iii) valgt blandt strukturerne:
Ab-MC-vc-PAB-MMAF
Ab-MC-vc-PAB-MMAE
Ab-MC-MMAE
Ab-MC-MMAF
Ab-BMPEO-DM 1 hvor Val er valin; Cit er citrullin; p er 1,2, 3 eller 4; og Ab er et anti-STEAP-1 -antistof ifølge krav 11.
15. Farmaceutisk formulering, omfattende antistof-lægemiddel-konjugatet ifølge krav 14 (i) og farmaceutisk acceptabelt fortyndingsmiddel, bærer eller excipiens.
16. Farmaceutisk formulering ifølge krav 15 til anvendelse i en fremgangsmåde til behandling af prostata-, lunge- eller koloncancer, hvilken fremgangsmåde omfatter at administrere en virksom mængde af den farmaceutiske formulering til en person, hvor der eventuelt administreres et kemoterapeutisk middel i kombination med antistof-lægemiddel-konjugatforbindelsen til patienten, hvor det kemote-rapeutiske middel er valgt blandt letrozol, cisplatin, carboplatin, taxol, pacli-taxel, oxaliplatin, doxetaxel, 5-FU, leucovorin, lapatinib og gemcitabin.
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