HRP20180358T1 - Postupci povećavanja djelotvornosti terapije raka usmjerene protiv folr1 - Google Patents

Postupci povećavanja djelotvornosti terapije raka usmjerene protiv folr1 Download PDF

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HRP20180358T1
HRP20180358T1 HRP20180358TT HRP20180358T HRP20180358T1 HR P20180358 T1 HRP20180358 T1 HR P20180358T1 HR P20180358T T HRP20180358T T HR P20180358TT HR P20180358 T HRP20180358 T HR P20180358T HR P20180358 T1 HRP20180358 T1 HR P20180358T1
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Croatia
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folr1
immunoconjugate
intended
antibody
amino acid
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HRP20180358TT
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Christina N. Carrigan
Kathleen R. Whiteman
Gillian Payne
Sharron LADD
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Immunogen, Inc.
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Publication of HRP20180358T1 publication Critical patent/HRP20180358T1/hr

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    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
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    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
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    • A61K47/6807—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug or compound being a sugar, nucleoside, nucleotide, nucleic acid, e.g. RNA antisense
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    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6817—Toxins
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    • A61K47/6869—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 a cell of the reproductive system: ovaria, uterus, testes, prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • G—PHYSICS
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    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N33/57492—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving compounds localized on the membrane of tumor or cancer cells
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Claims (17)

1. Protutijelo protiv Folatnog receptora 1 (FOLR1) ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u terapiji raka kod subjekta, gdje je pojačano eksprimiranje gena za FOLR1 ili proteina u uzorku raka iz navedenog subjekta detektirano postupkom detektiranja koji razlikuje između intenziteta bojanja ili jednoličnosti bojanja u uzorku raka koji eksprimira FOLR1 u usporedbi s intenzitetom bojanja ili jednoličnošću bojanja u jednom ili više referentnih uzoraka, čime je povećana djelotvornost terapije raka protutijelom protiv FOLR1 ili imunokonjugatom protiv FOLR1; naznačeni time što protutijelo protiv FOLR1, namijenjeno upotrebi u terapiji raka, sadrži: (i) varijabilnu domenu teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 3 (huMov19 vHC) i varijabilnu domenu lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 4 (huMov1 9 vLCv1.00) ili (ii) varijabilnu domenu teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 3 (huMov19 vHC) i varijabilnu domenu lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 5 (huMov19 vLCv1.60); te gdje imunokonjugat protiv FOLR1, namijenjen upotrebi u terapiji raka, sadrži protutijelo protiv FOLR1, spojnicu, te citotoksin, gdje protutijelo protiv FOLR1 u imunokonjugatu protiv FOLR1 sadrži: (i) varijabilnu domenu teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 3 (huMov19 vHC) i varijabilnu domenu lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 4 (huMov19 vLCv1.00) ili (ii) varijabilnu domenu teškog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 3 (huMov19 vHC) i varijabilnu domenu lakog lanca koja sadrži aminokiselinski slijed SEQ ID NO: 5 (huMov19 vLCv1.60).
2. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što varijabilna domena lakog lanca protutijela protiv FOLR1, namijenjenog upotrebi u terapiji raka, sadrži aminokiselinski slijed SEQ ID NO: 5 (huMov19 vLCv1.60), osobito gdje protutijelo protiv FOLR1, namijenjeno upotrebi u terapiji raka, sadrži (i) teški lanac koji sadrži isti aminokiselinski slijed kao aminokiselinski slijed teškog lanca kojeg kodira plazmid deponiran kod American Type Culture Collection (Američka zbirka tipskih kultura) (ATCC) kao PTA-10772, i (ii) laki lanac koji sadrži isti aminokiselinski slijed kao aminokiselinski slijed lakog lanca kojeg kodira plazmid deponiran kod ATCC kao PTA-10774 ; i što varijabilna domena lakog lanca protutijela protiv FOLR1 u imunokonjugatu protiv FOLR1 sadrži aminokiselinski slijed SEQ ID NO: 5 (huMov19 vLCv1.60), osobito gdje protutijelo protiv FOLR1 u imunokonjugatu protiv FOLR1, namijenjeni upotrebi u terapiji raka, sadrži (i) teški lanac koji sadrži isti aminokiselinski slijed kao aminokiselinski slijed teškog lanca kojeg kodira plazmid deponiran kod American Type Culture Collection (ATCC) kao PTA-10772, i (ii) laki lanac koji sadrži isti aminokiselinski slijed kao aminokiselinski slijed lakog lanca kojeg kodira plazmid deponiran kod ATCC kao PTA-10774.
3. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što je postupak detektiranja imunohistokemija (IHC), osobito gdje je navedeni IHC tako kalibriran IHC da može razlikovati između različitih razine eksprimiranja FOLR1.
4. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 3, naznačeni time što postupak detektiranja daje raspon jednoličnosti bojanja za uzorke sa žarišnom raspodjelom FOLR1 (obojeno < 25% stanica), heterogenom raspodjelom FOLR1 (obojeno 25-75% stanica) ili homogenom raspodjelom FOLR1 (obojeno > 75% stanica).
5. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što postupak detektiranja razlikuje između intenziteta bojanja i jednoličnosti bojanja u uzorku raka koji eksprimira FOLR1 u usporedbi u referentnim uzorkom.
6. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 5, naznačeni time što se uzorak raka oboji jednolično heterogeno ili homogeno, a intenzitet bojanja se boduje s 1, 2, 3 ili 3+ na eksprimiranje FOLR1 s IHC, osobito s IHC na uzorku fiksiranom formalinom i uklopljenom u parafin.
7. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 5, naznačeni time što intenzitet bojanja uzorka raka se boduje s 1 ili više na eksprimiranje FOLR1 s IHC, osobito a) gdje se uzorak raka oboji jednolično na eksprimiranje FOLR1 koje je heterogeno; b) gdje se uzorak raka oboji jednolično na eksprimiranje FOLR1 koje je homogeno; c) gdje se 25-75% stanica u uzorku raka oboji na eksprimiranje FOLR1; ili d) gdje se više od 75% stanica u uzorku raka oboji na eksprimiranje FOLR1.
8. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 7, naznačeni time što intenzitet bojanja uzorka raka se boduje s 2 ili više na eksprimiranje FOLR1 s IHC, osobito a) gdje se uzorak raka oboji jednolično na eksprimiranje FOLR1 koje je heterogeno; b) gdje se uzorak raka oboji jednolično na eksprimiranje FOLR1 koje je homogeno; c) gdje se 25-75% stanica u uzorku raka oboji na eksprimiranje FOLR1; ili d) gdje se više od 75% stanica u uzorku raka oboji na eksprimiranje FOLR1.
9. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što se IHC provodi ručno ili automatiziranim sustavom.
10. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što je navedeni referentni uzorak pozitivni referentni uzorak ili negativni referentni uzorak, osobito gdje navedeni referentni uzorak sadrži stanice, stanične pelete ili tkivo.
11. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što se postupak detektiranja sastoji u detektiranje eksprimiranja FOLR1 protutijelom BN3.2.
12. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 1, naznačeni time što subjekt ima a rak koji se bira iz skupine koju čine: rak jajnika, rak endometrija, rak potrbušnice ili rak pluća.
13. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 12, naznačeni time što se spojnicu za imunokonjugat protiv FOLR1 bira iz skupine koju čine: odcjepljiva spojnica, neodcjepljiva spojnica, hidrofilna spojnica i spojnica na bazi dikarboksilne kiseline, osobito gdje se navedenu spojnicu bira iz skupine koju čine: N-sukcinimidil-4-(2-piridilditio)pentanoat (SPP); N-sukcinimidil-4-(2-piridilditio)-2-sulfopentanoat (sulfo-SPP); N-sukcinimidil-4-(2-piridilditio)butanoat (SPDB); N-sukcinimidil-4-(2-piridilditio)-2-sulfobutanoat (sulfo-SPDB); N-sukcinimidil-4-(maleimidometil)cikloheksanekarboksilat (SMCC); N-sulfosukcinimidil 4-(maleimidometil) cikloheksanekarboksilat (sulfoSMCC); N-sukcinimidil-4-(jodacetil)aminobenzoat (SIAB); te N-sukcinimidil-[(N-maleimidopropionamido)tetraetilen-glikolni] ester (NHS-PEG4-maleimid).
14. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 13, naznačeni time što je spojnica za imunokonjugat protiv FOLR1 N-sukcinimidil-4-(2-piridilditio)-2-sulfobutanoat (sulfo-SPDB).
15. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 13, naznačeni time što se citotoksično sredstvo u imunokonjugatu protiv FOLR1 bira iz skupine koju čine: maitansinoid, maitansinoidni analog, benzodiazepin, taksoid, CC-1065, analog CC-1065, duocarmicin, duocarmicin analog, calicheamicin, dolastatin, dolastatin analog, auristatin, derivat tomajmicina, te derivat leptomicina ili predlijek sredstva, osobito gdje je navedeno citotoksično sredstvo maitansinoid, osobito gdje je navedeno citotoksično sredstvo N(2’)-deacetil-N(2’)-(3-merkapto-1-oksopropil)maitansin (DM1) ili N(2’)-deacetil-N(2’)-(4-merkapto-4-metil-1-oksopentil)maitansin (DM4).
16. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 15, naznačeni time što je citotoksično sredstvo u imunokonjugatu protiv FOLR1 N(2’)-deacetil-N(2’)-(4-merkapto-4-metil-1-oksopentil)maitansin (DM4).
17. Protutijelo protiv FOLR1 ili imunokonjugat protiv FOLR1, namijenjeni upotrebi u skladu s patentnim zahtjevom 15, naznačeni time što je spojnica za imunokonjugat protiv FOLR1 N-sukcinimidil-4-(2-piridilditio)-2-sulfobutanoat (sulfo-SPDB), te što je citotoksično sredstvo u imunokonjugatu protiv FOLR1 N(2’)-deacetil-N(2’)-(4-merkapto-4-metil-1-oksopentil)maitansin (DM4).
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