HRP20191872T1 - Sirp-alfa imunoglobulin fuzijski proteini - Google Patents

Sirp-alfa imunoglobulin fuzijski proteini Download PDF

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HRP20191872T1
HRP20191872T1 HRP20191872TT HRP20191872T HRP20191872T1 HR P20191872 T1 HRP20191872 T1 HR P20191872T1 HR P20191872T T HRP20191872T T HR P20191872TT HR P20191872 T HRP20191872 T HR P20191872T HR P20191872 T1 HRP20191872 T1 HR P20191872T1
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seq
residues
fusion protein
sirpα
antibody
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HRP20191872TT
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Kin-Ming Lo
Nora ZIZLSPERGER
Aroop SIRCAR
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Merck Patent Gmbh
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Publication of HRP20191872T1 publication Critical patent/HRP20191872T1/hr

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    • C07K16/2827—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against B7 molecules, e.g. CD80, CD86
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Claims (23)

1. SIRPα imunoglobulin fuzijski protein koji sadrži: (i) izvanstaničnu domenu IgV signalnog regulatornog proteina alfa (SIRPα) ili varijantu SIRPα koja sadrži sekvencu aminokiselina najmanje 80% identičnu (a) ostacima 3-115 SEQ ID NO:6, (b) ostacima 3-114 SEQ ID NO:8 ili (c) ostacima 1-115 SEQ ID NO:190, pri čemu varijanta SIRPα sadrži modifikaciju aminokiseline na jednom ili više položaja koja odgovaraju 6, 27, 31, 37, 54, 56, 66 ili 72 SEQ ID NO:6, SEQ ID NO: 8 ili SEQ ID NO:190, pri čemu je modifikacija supstitucija izabrana iz skupine koja se sastoji od: V6I; V27I; A27I; 131R; I31T; Q37W; Q37H; E54P; H56P; S66Q; L66Q; i M72R; i (ii) molekulu imunoglobulina ili njegov dio koji se veže na površinski antigen na stanici koja potiče bolest.
2. SIRPα imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 1, pri čemu (i) na stanici koja potiče bolest je tumorska stanica i površinski antigen je tumorski antigen; (ii) varijanta SIRPα sadrži sekvencu aminokiselina najmanje 85%, najmanje 90% ili najmanje 95% identičnu ostacima 3-115 SEQ ID NO:6, ostacima 3-114 SEQ ID NO:8 ili ostacima 1-115 SEQ ID NO:190; i/ili (iii) varijanta SIRPα sadrži sekvencu aminokiselina najmanje 80%, najmanje 85%, najmanje 90% ili najmanje 95% identičnu ostacima 1-115 SEQ ID NO:6 ili ostacima 1-114 SEQ ID NO:8.
3. Imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 1, pri čemu (i) varijanta SIRPα sadrži sekvencu aminokiselina najmanje 80%, najmanje 85%, najmanje 90% ili najmanje 95% identičnu sekvenci izabranoj iz skupine koja se sastoji od: ostataka 1-114 SEQ ID NO:193, ostataka 1-115 SEQ ID NO:194, ostataka 1-115 SEQ ID NO:195, ostataka 1-115 SEQ ID NO:196, ostataka 1-114 SEQ ID NO:197, ostataka 1-114 SEQ ID NO:198, ostataka 1-115 SEQ ID NO:199, ostataka 1-114 SEQ ID NO: 200 i ostataka 1-115 SEQ ID NO: 190; ili (ii) izvanstanična domena IgV sadrži sekvencu izabranu iz skupine koja se sastoji od ostataka 1-115 SEQ ID NO:6, ostataka 1-114 SEQ ID NO:8, 1-114 SEQ ID NO:193, ostataka 1-115 SEQ ID NO:194, ostataka 1-115 SEQ ID NO:195, ostataka 1-115 SEQ ID NO:196, ostataka 1-114 SEQ ID NO:197, ostataka 1-114 SEQ ID NO:198, ostataka 1-115 SEQ ID NO:199, ostataka 1-114 SEQ ID NO:200 i ostataka 1-115 SEQ ID NO:190 ili pri čemu varijanta SIRPα sadrži sekvencu aminokiselina najmanje 80%, najmanje 85%, najmanje 90% ili najmanje 95% identičnu ostacima 1-343 SEQ ID NO:6.
4. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu molekula imunoglobulina ili njegov dio sadrži varijabilnu domenu antitijela ili je regija Fc konstruirana tako da sadrži mjesto vezanja antigena, opcionalno pri čemu je regija Fc konstruirana tako da sadrži mjesto vezanja antigena koji sadrži dio Fcab.
5. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu molekula imunoglobulina sadrži netaknuto antitijelo ili dio antitijela koji veže antigen.
6. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-5, pri čemu je SIRPα ili varijanta SIRPα vezana za laki lanac antitijela ili njegov dio ili za teški lanac antitijela ili njegov dio.
7. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu fuzijski protein sadrži dio molekule imunoglobulina koji sadrži fragment Fab antitijela, fragment F(ab’)2 antitijela ili jednolančano antitijelo ili pri čemu je molekula imunoglobulina ili njegov dio vezan za SIRPα ili varijantu SIRPα preko povezivačkog dijela.
8. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-7, pri čemu SIRPα ili varijanta SIRPα (i) povezana je na svom N-kraju s molekulom imunoglobulina ili njegovim dijelom; (ii) povezana je na svom C-kraju s molekulom imunoglobulina ili njegovim dijelom; (iii) povezana je na svom N-kraju s molekulom imunoglobulina ili njegovim dijelom; ili (iv) povezana je na svom C-kraju s molekulom imunoglobulina ili njegovim dijelom.
9. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-8, pri čemu je tumorski antigen izabran iz skupine koja se sastoji od HER2, HER3, EGFR, CD20, GD2, PD-L1 i CD19.
10. Imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 5, pri čemu je antitijelo anti-EGFR antitijelo, opcionalno pri čemu je anti-EGFR antitijelo cetuksimab ili pri čemu anti-EGFR antitijelo sadrži regije cetuksimaba koje određuju komplementarnost.
11. SIRPα imunoglobulin fuzijski protein koji sadrži: anti-EGFR antitijelo ili njegov dio koji veže antigen; i izvanstaničnu domenu IgV ili varijante SIRPα koja sadrži sekvencu aminokiselina najmanje 80% identičnu ostacima 1-115 SEQ ID NO:6 ili ostacima 1-114 SEQ ID NO:8, pri čemu (i) varijanta SIRPα sadrži modifikaciju aminokiseline na jednom ili više položaja koja odgovaraju 6, 27, 31, 37, 54, 56, 66 ili 72 SEQ ID NO:6, SEQ ID NO: 8, pri čemu je modifikacija supstitucija izabrana iz skupine koja se sastoji od: V6I; V27I; A27I; I31R; I31T; Q37W; Q37H; E54P; H56P; S66Q; L66Q; i M72R, i/ili (ii) varijanta SIRPα sadrži modifikaciju aminokiseline na položaju koji odgovara položaju 37 SEQ ID NO:6 ili SEQ ID NO:8 gdje je supstitucija Q37W.
12. SIRPα imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 11, pri čemu (i) anti-EGFR antitijelo sadrži varijabilnu regiju teškog lanca ili varijabilnu regiju lakog lanca cetuksimaba; (ii) anti-EGFR antitijelo sadrži regije cetuksimaba koje određuju komplementarnost; (iii) anti-EGFR antitijelo cetuksimaba; ili (iv) anti-EGFR antitijelo izabrano je iz skupine koja se sastoji od cetuksimaba, panitumumaba, nimotuzumaba, matuzumaba, futuksimaba, imgatuzumaba, necitumumaba, opcionalno pri čemu anti-EGFR antitijelo sadrži regije koje određuju komplementarnost antitijela izabranog između cetuksimaba, panitumumaba, nimotuzumaba, matuzumaba, futuksimaba, imgatuzumaba i necitumumaba.
13. Imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 1, pri čemu je površina antigena antigen tumorskih stanica; pri čemu fuzijski protein ima prosječni intenzitet fluorescencije (MFI) u vezivanju crvenih krvnih stanica (RBC) 10% ili manje kad se % RBC vezivanja MFI na anti-CD47 antitijelo kalibrira na 100%, pri čemu je anti-CD47 antitijelo B6H12/hulgG1; i pri čemu se fuzijski protein veže i na CD47 antigen na krvnoj stanici koja nije crvena.
14. Imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 13, pri čemu IgV izvanstanična domena od SIRPα ili varijanta SIRPα sadrži sekvencu aminokiselina najmanje 85% identičnu, najmanje 90% identičnu ili najmanje 95% identičnu ostacima 3-115 SEQ ID NO:6 ili 3-114 SEQ ID NO:8 i/ili pri čemu IgV izvanstanična domena od SIRPα ili varijanta SIRPα sadrži sekvencu aminokiselina najmanje 85% identičnu, najmanje 90% identičnu ili najmanje 95% identičnu ostacima 1-115 SEQ ID NO:6 ili 1-114 SEQ ID NO:8.
15. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 13 ili 14, pri čemu je antigen tumorskih stanica EGFR i/ili pri čemu je molekula imunoglobulina netaknuto antitijelo.
16. Imunoglobulin fuzijski protein u skladu s patentnim zahtjevom 15, pri čemu je antitijelo anti-EGFR antitijelo, opcionalno pri čemu je anti-EGFR antitijelo cetuksimab.
17. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 14-16, pri čemu fuzijski protein ima % RBC vezivanja MFI (i) manji od 10%, manji od 5%, manji od 4%, manji od 3%, manji od 2% ili manji od 1%; (ii) između 0-1%, 0-2%, 0-3%, 0-4%, 1-2%, 1-3%, 1-4%, 2-3%, 2-4%, 3-4%, 5-10%, 3-7% ili 3-10%; ili (iii) 5% ili manji, 4% ili manji, 3% ili manji, 2% ili manji, 1% ili manji.
18. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 14-16, pri čemu je krvna stanica koja nije crvena tumorska stanica.
19. Nukleinska kiselina ili nukleinske kiseline koje kodiraju imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-19.
20. Stanica koja sadrži nukleinsku kiselinu ili nukleinske kiseline u skladu s patentnim zahtjevom 19.
21. Postupak za proizvodnju imunoglobulina fuzijskog proteina održavanjem stanice u skladu s patentnim zahtjevom 20 pod uvjetima koji omogućuju ekspresiju nukleinske kiseline ili nukleinskih kiselina u skladu s patentnim zahtjevom 19.
22. Farmaceutski pripravak koji sadrži farmaceutski učinkovitu količinu imunoglobulina fuzijskog proteina u skladu s bilo kojim od patentnih zahtjeva 1-18 i farmaceutski prihvatljiv nosač.
23. Imunoglobulin fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-18 za uporabu u liječenju karcinoma kod sisavca, opcionalno pri čemu je karcinom karcinom dojke, kolorektalni, karcinom pluća, gušterače, endometrija, jajnika, želuca, prostate, bubrega, vrata maternice, mijelom, limfom, leukemija, karcinom štitnjače, maternice, mjehura, neuroendokrini karcinom, karcinom glave i vrata, jetre, nazofaringeusa, karcinom testisa, karcinom pluća malih stanica, karcinom pluća ne-malih stanica, melanom, karcinom bazalnih stanica, karcinom skvamoznih stanica kože, dermatofibrosarkom protuberans, karcinom Merkelovih stanica, glioblastom, gliom, sarkom, mezoteliom ili mijelodisplastični sindromi.
HRP20191872TT 2014-08-15 2019-10-15 Sirp-alfa imunoglobulin fuzijski proteini HRP20191872T1 (hr)

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Application Number Priority Date Filing Date Title
US201462038196P 2014-08-15 2014-08-15
EP15750744.3A EP3180363B2 (en) 2014-08-15 2015-08-14 Sirp-alpha immunoglobulin fusion proteins
PCT/EP2015/068798 WO2016024021A1 (en) 2014-08-15 2015-08-14 Sirp-alpha immunoglobulin fusion proteins

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