HRP20190898T1 - Postupci konjugacije - Google Patents

Postupci konjugacije Download PDF

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Publication number
HRP20190898T1
HRP20190898T1 HRP20190898TT HRP20190898T HRP20190898T1 HR P20190898 T1 HRP20190898 T1 HR P20190898T1 HR P20190898T T HRP20190898T T HR P20190898TT HR P20190898 T HRP20190898 T HR P20190898T HR P20190898 T1 HRP20190898 T1 HR P20190898T1
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HR
Croatia
Prior art keywords
succinimidyl
antibody
maytansinoid
mixture
acid
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HRP20190898TT
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English (en)
Inventor
Brenda A. Kellogg
Rajeeva Singh
Ravi V. J. Chari
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Immunogen, Inc.
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Publication date
Application filed by Immunogen, Inc. filed Critical Immunogen, Inc.
Publication of HRP20190898T1 publication Critical patent/HRP20190898T1/hr

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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • 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
    • 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
    • A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
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    • 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
    • A61K47/6835—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
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    • 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
    • A61K47/6835—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
    • 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
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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
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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
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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
    • A61K47/6891—Pre-targeting systems involving an antibody for targeting specific cells
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    • A61K47/69—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6901—Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D213/00—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/60—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
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    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

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Claims (16)

1. Postupak za pripravu pročišćenog konjugata u otopini, naznačen time što konjugat sadrži majtanzinoid koji sadrži tiolnu skupinu vezanu na protutijelo, te postupak obuhvaća korake: (a) dovođenje u kontakt majtanzinoida s bifunkcionalnim veznim reagensom za kovalentno vezanje poveznice na majtanzinoid i na taj način pripravljanje nepročišćene prve smjese koja sadrži majtanzinoid s vezanim poveznicama, (b) konjugiranje protutijela na majtanzinoid s vezanim poveznicama reakcijom nepročišćene prve smjese s protutijelom da se dobije druga smjesa, te (c) podvrgavanje druge smjese tangencijalnoj protočnoj filtraciji, dijalizi, gel filtraciji, adsorpcijskoj kromatografiji, selektivnom taloženju ili njihovoj kombinaciji, te se na taj način pripravlja pročišćeni konjugat.
2. Postupak prema zahtjevu 1, naznačen time što se korak (b) provodi u otopini uz pH od oko 4 do oko 9.
3. Postupak prema zahtjevu 1, naznačen time što je druga smjesa u koraku (b) uglavnom bez neželjenih umreženih, hidroliziranih vrsta nastalih uslijed unutar-molekularnih ili među-molekularnih reakcija.
4. Postupak prema bilo kojem od zahtjeva 1-3, naznačen time što je majtanzinoid DM1.
5. Postupak prema bilo kojem od zahtjeva 1-3, naznačen time što je majtanzinoid DM4.
6. Postupak prema bilo kojem od zahtjeva 1-5, naznačen time što je protutijelo monoklonsko protutijelo.
7. Postupak prema zahtjevu 6, naznačen time što je protutijelo humano ili humanizirano monoklonsko protutijelo.
8. Postupak prema zahtjevu 1, naznačen time što je protutijelo MY9, anti-B4, C242 ili protutijelo koje se veže na antigen odabran iz skupine koja se sastoji od EpCAM, CD2, CD3, CD4, CD5, CD6, CD11, CD19, CD20, CD22, CD26, CD30, CD33, CD37, CD38, CD40, CD44, CD56, CD79, CD105, CD138, receptora EphA, receptora EphB, EGFR, EGFRvIII, HER2, HER3, mezotelin, kripto, alfavbeta3, alfavbeta5 i alfavbeta6 integrina.
9. Postupak prema zahtjevu 7, naznačen time što je humano ili humanizirano protutijelo huMy9-6, huB4, huC242, huN901, DS6, CNTO 95, B-B4, trastuzumab, pertuzumab, bivatuzumab, sibrotuzumab, rituksimab ili humano ili humanizirano protutijelo koje se veže na antigen odabran iz skupine koja se sastoji od receptora EphA2, CD38 i IGF-IR.
10. Postupak prema bilo kojem od zahtjeva 1-9, naznačen time što se poveznica odnosi na poveznicu koja se može cijepati.
11. Postupak prema bilo kojem od zahtjeva 1-9, naznačen time što se poveznica odnosi na poveznicu koja se ne može cijepati.
12. Postupak prema bilo kojem od zahtjeva 1-11, naznačen time što je pH otopine u koraku (b) od 5 do 8,7.
13. Postupak prema zahtjevu 12, naznačen time što je pH otopine u koraku (b) od 6,5 do 8,5.
14. Postupak prema bilo kojem od zahtjeva 1-13, naznačen time što postupak nadalje između koraka (a) i (b) sadrži korak gašenja majtanzinoida u nepročišćenoj prvoj smjesi s reagensom za gašenje.
15. Postupak prema zahtjevu 14, naznačen time što je reagens za gašenje odabran iz skupine koja sadrži 4-maleimidomaslačnu kiselinu, 3-maleimidopropionsku kiselinu, N-etilmaleimid, jodoacetamid i jodacetamidopropionsku kiselinu.
16. Postupak prema zahtjevu 1, naznačen time što je bifunkcionalnim vezni reagens odabran iz skupine koja sadrži N-sukcinimidil 4-(maleimidometil) cikloheksankarboksilat (SMCC), N-sukcinimidil-4-(N-maleimidometil)-cikloheksan-1-karboksi-(6-amidokaproat) (LC-SMCC), N-sukcinimidil ester K-maleimidoundekanske kiseline (KMUA), N-sukcinimidil ester γ-maleimidomaslačne kiseline (GMBS), N-hidroksisukcinimidni ester ε-maleimidokapronske kiseline (EMCS), m-maleimidobenzoil-N-hidroksisukcinimidni ester (MBS), N-(α-maleimidoacetoksi)-sukcinimid ester (AMAS), sukcinimidil-6-(β-maleimidopropionamido)heksanoat (SMPH), N-sukcinimidil 4-(p-maleimidofenil)-butirat (SMPB), N-(p-maleimidofenil)izocijanat (PMPI), N-sukcinimidil-4-(jodoacetil)-aminobenzoat (SIAB), N-sukcinimidil jodoacetat (SIA), N-sukcinimidil bromoacetat (SBA), N-sukcinimidil 3-(bromoacetamido)propionat (SBAP), N-sukcinimidil 3-(2-piridilditio)propionat (SPDP), N-sukcinimidil 4-(2-piridilditio)butanoat (SPDB) i N-sukcinimidil 4-(2-piridilditio)pentanoat (SPP).
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