HRP20150143T1 - Imunokonjugati koji ciljaju na cd138 i njihova upotreba - Google Patents

Imunokonjugati koji ciljaju na cd138 i njihova upotreba Download PDF

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HRP20150143T1
HRP20150143T1 HRP20150143AT HRP20150143T HRP20150143T1 HR P20150143 T1 HRP20150143 T1 HR P20150143T1 HR P20150143A T HRP20150143A T HR P20150143AT HR P20150143 T HRP20150143 T HR P20150143T HR P20150143 T1 HRP20150143 T1 HR P20150143T1
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Croatia
Prior art keywords
immunoconjugate
tumor
intended
immunoconjugate according
seq
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HRP20150143AT
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Elmar Kraus
Christoph Bruecher
Benjamin Daelken
Steffen Zeng
Frank Osterroth
Christoph Uherek
Silke Aigner
Matthias Germer
Gregor Schulz
Thomas Haeder
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Biotest Ag
Immunogen, Inc.
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Publication of HRP20150143T1 publication Critical patent/HRP20150143T1/hr

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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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—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
    • A61K47/50—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
    • A61K47/51—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
    • A61K47/68—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
    • 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
    • A61K47/6807—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
    • A61K47/6809—Antibiotics, e.g. antitumor antibiotics anthracyclins, adriamycin, doxorubicin or daunomycin
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • A—HUMAN NECESSITIES
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    • A61K47/51—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
    • A61K47/68—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
    • A61K47/6835—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
    • A61K47/6849—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 receptor, a cell surface antigen or a cell surface determinant
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    • A61K47/6835—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61K47/6867—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 a blood cancer
    • A—HUMAN NECESSITIES
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    • A61K47/00—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
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    • A61K47/6877—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 being a hybrid immunoglobulin the antibody being an immunoglobulin containing regions, domains or residues from different species
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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Claims (18)

1. Imunokonjugat koji može ciljati stanice koje eksprimiraju CD138, naznačen time što se sastoji od: (a) konstruiranog ciljajućeg protutijela protiv CD1 38, koje sadrži: (i) teški lanac imunoglobulina, koji sadrži varijabilno područje koje sadrži aminokiselinske ostatke 31 do 35 (CDR1), 51 do 68 (CDR2) i 99 do 111 (CDR3) u SEQ ID NO: 1, i (ii) laki lanac, koji sadrži varijabilno područje koje sadrži aminokiselinske ostatke 24 do 34 (CDR1), 50 do 56 (CDR2) i 89 do 97 (CDR3) u SEQ ID NO: 2; i (b) efektorske molekule koja izaziva staničnu smrt, gdje je konstantno područje navedenog teškog lanca imunoglobulina konstantno područje izotipa IgG4.
2. Imunokonjugat u skladu s patentnim zahtjevom 1, naznačen time što je navedena efektorska molekula vezana spojnicom na navedeno konstruirano ciljajuće protutijelo preko, gdje je po mogućnosti navedena spojnica odvojiva spojnica, a najpoželjnije sadrži disulfidnu vezu.
3. Imunokonjugat u skladu s patentnim zahtjevom 1, naznačen time što: – navedeni imunokonjugat ima vrijednost KD manju od 2,6 nM.
4. Imunokonjugat u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je efektorska molekula najmanje jedan maitansinoid, taksan ili CC1065, ili njegov analog, gdje je po mogućnosti efektorska molekula najmanje jedan maitansinoid, gdje je najpoželjnije najmanje jedan maitansinoid DM1, DM3 ili DM4.
5. Imunokonjugat u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeno konstruirano ciljajuće protutijelo dodatno sadrži: (a) aminokiselinske ostatke 123 do 448 u SEQ ID NO: 1 i/ili (b) aminokiselinske ostatke 108 do 214 u SEQ ID NO: 2, te njihove mutacije koje (i) zadržavaju ili smanjuju citotoksičnost vezanu uz protutijelo i/ili uz komplement konstruiranog ciljajućeg protutijela i/ili (ii) stabiliziraju konstruirano ciljajuće protutijelo.
6. Imunokonjugat u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što slijed lakog lanca ima najmanje 70% identičnosti slijeda s SEQ ID NO: 2.
7. Imunokonjugat u skladu s patentnim zahtjevom 6, naznačen time što konstruirano ciljajuće protutijelo sadrži teški lanac imunoglobulina koji sadrži SEQ ID NO: 1 i laki lanac koji sadrži SEQ ID NO: 2.
8. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen upotrebi u liječenju multiplog mijeloma kod subjekta.
9. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen upotrebi u liječenju karcinoma prijelaznih stanica mokraćnog mjehura kod subjekta.
10. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen upotrebi kao medikament.
11. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen upotrebi kod inhibiranja, odgađanja i/ili sprječavanja rasta tumora koji sadrži tumorske stanice CD138 i/ili širenja tumorskih stanica takvog tumora kod pacijenta.
12. Imunokonjugat namjienjen upotrebi u skladu s patentnim zahtjevom 11, naznačen time što: – navedeni pacijent boluje od hematološke zloćudne novotvorine i/ili čvrstog tumora koji sadrži stanice koje eksprimiraju CD138, gdje po mogućnosti navedeni pacijent boluje od jednog od sljedećeg: multiplog mijeloma, karcinoma jajnika, karcinoma bubrega, karcinoma žučnog mjehura, karcinoma dojke, raka prostate, raka pluća, karcinoma debelog crijeva, Hodgkinovog i nehodgkinovskog limfoma, kronične limfocitne leukemije (CLL), akutne limfoblastične leukemije (ALL), akutne mijeloblastične leukemije (AML), sarkoma čvrstog tkiva ili karcinoma debelog crijeva, gdje pacijent najpoželjnije boluje od multiplog mijeloma; – navedena efektorska molekula u navedenom imunokonjugatu je toksin, citotoksični enzim, niskomolekulski citotoksični lijek, porirajuće sredstvo, modifikator biološkog odgovora, enzim koji aktivira predlijek, protutijelo, citokin ili radionuklid; – navedeni imunokonjugat treba primijeniti u jednoj dozi od 5 mg/m2 do otprilike 300 mg/m2; ili – navedeni imunokonjugat treba primijeniti u najmanje dvije doze od otprilike 5 mg/m2 do otprilike 300 mg/m2, izborno u intervalima reda veličine sata, dana, tjedna ili njihovih kombinacija.
13. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen inhibiranju, odgađanju i/ili sprječavanju rasta tumora i/ili širenju zloćudnih tumorskih stanica koje uključuju stanice koje eksprimiraju CD138 kod pacijenta, gdje se pacijenta liječi jednim ili više citotoksičnih sredstava i/ili zračenjem, u količini koja može smanjiti tumorsko opterećenje.
14. Imunokonjugat namijenjen upotrebi u skladu s patentnim zahtjevom 13, naznačen time što je citotoksično sredstvo mefalan, vinkristin, doksorubicin, deksametazoin, ciklofosfamid, etopozid, citarabin, cisplatin, talidomid, prednizon, bortezomib, lenalidomid, sorafenib, romidpsin, ili njihove kombinacije, ili je na bazi protutijela.
15. Imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je namijenjen upotrebi u liječenju subjekta sa stanjem koje bi se poboljšalo suprimiranjem preživljenja stanica mijeloma, gdje imunokonjugat može selektivno smanjivati preživljenje ili rast navedenih stanica mijeloma kod navedenog subjekta.
16. Farmaceutski pripravak, naznačen time što sadrži imunokonjugat u skladu s bilo kojim od patentnih zahtjeva 1 do 7 i jednu ili više farmaceutski prihvatljivih pomoćnih tvari, gdje je pripravak pogodan za inhibiranje, odgađanje i/ili sprječavanje rasta tumora i/ili širenja tumorskih stanica.
17. Komplet, naznačen time što, u odvojenim spremnicima, sadrži farmaceutske pripravke namijenjene upotrebi u kombinaciji radi inhibiranja, odgađanja i/ili sprječavanja rasta tumora i/ili širenja tumorskih stanica, gdje jedan spremnik sadrži djelotvornu količinu farmaceutskog pripravka u skladu s patentnim zahtjevom 16, te gdje zaseban spremnik sadrži drugi farmaceutski pripravak, koji sadrži djelotvornu količinu dodatnog sredstva, po mogućnosti citotoksičnog sredstva, za inhibiranje, odgađanje i/ili sprječavanje rasta tumora i/ili širenje tumorskih stanica, i jednu ili više farmaceutski prihvatljivih pomoćnih tvari, gdje se po mogućnosti navedeno sredstvo u navedenom drugom farmaceutskom pripravku bira iz skupine koju čine mefalan, vinkristin, doksorubicin, deksametazoin, ciklofosfamid, etopozid, citarabin, cisplatin, talidomid, prednizon, bortezomib, lenalidomid sorafenib, romidpsin i njihove kombinacije, ili je na bazi protutijela.
18. Upotreba imunokonjugata u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što je imunokonjugat namijenjen proizvodnji medikamenta za inhibiranje, odgađanje i/ili sprječavanje rasta tumora koji sadrži tumorske stanice CD138 i/ili širenje tumorskih stanica takvog tumora kod pacijenta.
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RU2561041C2 (ru) 2009-05-06 2015-08-20 Биотест Аг Применения иммуноконъюгатов, мишенью которых является cd138

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