HRP20120845T1 - Protutijela za pan-kir2dl nk-receptor i njihova uporaba u dijagnostici i lijeäśenju - Google Patents
Protutijela za pan-kir2dl nk-receptor i njihova uporaba u dijagnostici i lijeäśenju Download PDFInfo
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- HRP20120845T1 HRP20120845T1 HRP20120845TT HRP20120845T HRP20120845T1 HR P20120845 T1 HRP20120845 T1 HR P20120845T1 HR P20120845T T HRP20120845T T HR P20120845TT HR P20120845 T HRP20120845 T HR P20120845T HR P20120845 T1 HRP20120845 T1 HR P20120845T1
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Claims (61)
1. Protutijelo ili fragment protutijela koji se veže za barem dva različita produkta gena za humani inhibitorni receptor sličan imunoglobulinu ubilačkih stanica (eng. Killer Ig-Like Receptor, KIR), gdje to protutijelo može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti prirodnih ubilačkih (NK) stanica u NK stanicama koje eksprimiraju barem jedan od ta dva različita humana inhibitorna KIR receptora, gdje protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3, KIR2DL2 i KIR2DL3 smatraju se jednom inhibitornom KIR molekulom, i gdje je to protutijelo kimerično, humanizirano ili humano protutijelo ili njegov fragment.
2. Protutijelo prema zahtjevu 1, gdje to protutijelo inhibira vezanje HLA-C alel molekule, koja ima Lys ostatak na položaju 80, za humani KIR2DL1 receptor, i vezanje HLA-C alel molekule, koja ima Asn ostatak na položaju 80, za humane KIR2DL2/3 receptore.
3. Protutijelo ili fragment protutijela prema zahtjevu 2, gdje se to protutijelo ili fragment natječe s monoklonskim protutijelom DF200 koje je proizvela stanica deponirana pod pristupnim brojem CNCM I-3224 za vezanje KIR2DL1 i KIR2DL2/3.
4. Protutijelo ili njegov fragment koji se natječe s monoklonskim protutijelom DF200 koje je proizvela stanica deponirana pod pristupnim brojem CNCM I-3224 za vezanje KIR2DL1 i KIR2DL2/3, i gdje je to protutijelo ili njegov fragment kimerično, humanizirano ili humano protutijelo ili njegov fragment i gdje to protutijelom može može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica u NK stanicama koje eksprimiraju barem jedan od ta dva različita humana inhibitorna KIR receptora.
5. Protutijelo prema zahtjevu 3 ili 4, gdje to protutijelo sadrži sve CDR regije od DF200 koje je proizvela stanica deponirana pod pristupnim brojem CNCM I-3224, gdje su CDR teški lanci kako je navedeno u SEQ ID NOS 10, 11 i 12.
6. Protutijelo prema zahtjevu 5, gdje to protutijelo sadrži varijabilnu regiju teškog lanca od DF200 kako je nevadeno u SEQ ID NO 9.
7. Protutijelo prema zahtjevima 1 do 6, gdje je to protutijelo monoklonsko protutijelo ili fragment monoklonskog protutijela.
8. Protutijelo prema zahtjevima 1-7, gdje je to protutijelo fragment protutijela izabran između Fab, Fab’, Fab’-SH, F(ab’)2, Fv, diatijela, jednolančanog fragmenta protutijela, ili multispecifično protutijelo koje sadrži više različitih fragmenata protutijela.
9. Protutijelo prema zahtjevima 1-7, gdje je to protutijelo humanizirano protutijelo ili fragment protutijela.
10. Protutijelo prema zahtjevima 1-7, gdje je to protutijelo humano protutijelo ili fragment protutijela.
11. Protutijelo prema zahtjevima 1-7, gdje je to protutijelo kimerično protutijelo.
12. Hibridom koji proizvodi monoklonsko protutijelo koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora i može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3, KIR2DL2 i KIR2DL3 smatraju se jednom inhibitornom KIR molekulom, i gdje je taj ne-humani domaćin sisavac gentički modificiran ili konstruiran da proizvodi humana protutijela.
13. Hibridom prema zahtjevu 12, gdje taj hibridom proizvodi protutijelo koje inhibira vezanje HLA-c alel molekule, koja ima Lys ostatak na položaju 80, za humani KIR2DL1 receptor, i vezanje HLA-C alel molekule, koja ima Asn ostatak na položaju 80, za humane KIR2DL2/3 receptore.
14. Hibridom prema zahtjevu 12, gdje taj hibridom proizvodi protutijelo koje se veže za u biti jednaki epitop kao monoklonsko protutijelo DF200 koje je proizveo hibridom DF200 deponiran pod pristupnim brojem CNCM I-3224.
15. Postupak proizvodnje protutijela ili fragmenta protutijela koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje to protutijelo može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora, taj postupak obuhvaća korake:
a) imunizacija ne-humanog sisavca imunogenom koji sadrži inhibitorni KIR polipetid;
b) priprema protutijela ili fragmenata protutijela iz imunizirane životinje, gdje se ta protutijela vežu za KIR polipetid,
c) odabir protutijela ili fragmenata protutijela iz (b) koji križno reagiraju barem s KIR2DL1, KIR2DL2 i KIR2DL3 , i
d) odabir protutijela ili fragmenata protutijela iz (c) koji mogu neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora,
gdje se redoslijed koraka (c) i (d) po izboru može zamijeniti i gdje protutijelo ili fragment protutijela veže KIR2DL1, KIR2DL2 i KIR2DL3 i gdje KIR2DL2 i KIR2DL3 smatraju se jednom inhibitornom KIR molekulom.
16. Postupak prema zahtjevu 15, gdje je protutijelo ili fragment protutijela pripremljen u koraku (b) monoklonsko protutijelo ili njegov fragment.
17. Postupak prema zahtjevu 15, gdje je inhibitorni KIR polipetid, koji se koristi za imunizaciju, KIR2DL polipeptid i protutijela izabrana u koraku (c) križno reagiraju barem s KIR2DL1 i KIR2DL2/3.
18. Postupak prema zahtjevu 17, gdje to protutijelo ili fragmenti protutijela izabranog u koraku (c) inhibira vezanje HLA-c alel molekule koja ima Lys ostatak na položaju 80, za humani KIR2DL1 receptor, i vezanje HLA-C alel molekule, koja ima Asn ostatak na položaju 80, za humane KIR2DL2/3 receptore.
19. Postupak prema zahtjevu 15, gdje to protutijelo ili fragmenti protutijela izabrani u koraku (d), uzrokuju barem 50% lize ciljnih stanica zabilježene s NK stanicama ili linijama NK stanica koje nisu blokirane svojim KIR-om, mjereno testom citotoksičnosti oslobađanjem kroma, u populaciji NK stanica koje eksprimiraju dani KIR u kontaktu s ciljnim stanicama koje eksprimiraju srodnu molekulu MHC klase I.
20. Postupak prema zahtjevu 15, gdje se ta protutijela ili fragmenti protutijela vežu u biti za isti epitop kao monoklonsko protutijelo DF200 koje je proizvela stanica deponira pod pristupnim brojem CNCM I-3224.
21. Postupak prema zahtjevu 15, koji obuhvaća dodatni korak stvaranja fragmenata izabranih monoklonskih protutijela.
22. Postupak proizvodnje protutijela koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje to protutijelo može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora, taj postupak obuhvaća korake:
a) odabir, iz knjižnice ili repertoara, monoklonskog protutijela ili fragmenta protutijela koje križno reagira s barem dva različita genska produkta humanog inhibitornog KIR2DL, i
b) odabir protutijela iz (a) koje može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR2DL receptora,
gdje protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3 i gdje KIR2DL2 i KIR2DL3 smatraju se jednom inhibitornom KIR molekulom.
23. Postupak prema zahtjevu 22, gdje protutijelo izabrano u koraku (b) inhibira vezanje HLA-c alel molekule koja ima Lys ostatak na položaju 80, za humani KIR2DL1 receptor, i vezanje HLA-C alel molekule, koja ima Asn ostatak na položaju 80, za humane KIR2DL2/3 receptore.
24. Postupak prema zahtjevu 22, gdje protutijelo izabrano u koraku (b), uzrokuju barem 50% lize ciljnih stanica zabilježene s NK stanicama ili linijama NK stanica koje nisu blokirane svojim KIR-om, mjereno testom citotoksičnosti oslobađanjem kroma, u populaciji NK stanica koje eksprimiraju dani KIR u kontaktu s ciljnim stanicama koje eksprimiraju srodnu molekulu MHC klase I.
25. Postupak prema zahtjevu 22, gdje se to protutijelo veže u biti za isti epitop kao monoklonsko protutijelo DF200 koje je proizvela stanica deponira pod pristupnim brojem CNCM I-3224.
26. Postupak prema zahtjevu 22, koji obuhvaća dodatni korak stvaranja fragmenata izabranih monoklonskih protutijela.
27. Postupak proizvodnje protutijela koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje to protutijelo može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora, taj postupak obuhvaća korake:
a) uzgoj kulture hibridoma prema bilo kojem od zahtjeva 12 do 14, u uvjetima koji uzorkuju ekspresiju tog monoklonskog protutijela; i
b) odvajanje tog monoklonskog protutijela od hibridoma.
28. Postupak prema zahtjevu 27, koji obuhvaća dodatni korak stvaranja fragmenata tog monoklonskog protutijela.
29. Postupak proizvodnje protutijela ili fragmenta protutijela koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje to protutijelo može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora, taj postupak obuhvaća korake:
a) izolacija iz hibridoma, DNA kodiranje tog monoklonskog protutijela, gdje hibridom sadrži a) B stanicu iz ne-humanog domaćina sisavca koji je imuniziran antigenom koji sadrži epitop prisutan na inhibitornom KIR polipetidu, fuzioniranu za b) besmrtnu stanicu, gdje taj hibridom proizvodi monoklonsko protutijelo koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora i može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na populaciji NK stanica koje eksprimiraju ta barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje the protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3, KIR2DL2 i KIR2DL3 se smatraju jednom inhibitornom KIR molekulom.;
b) po izboru modificiranje DNA da kodira modificirano ili derivirano protutijelo izabrano između humaniziranog protutijela, kimeričnog protutijela, jednolančanog protutijela ili imunoreaktivnog fragmenta protutijela;
c) umetanje DNA ili modificirane DNA u vektor ekspresije, gdje to protutijelo ili fragment protutijela može biti eksprimirano kada je taj vektor ekspresije prisutan u domaćinu koji se uzgaja u odgovarajućim uvjetima;
d) transfekcija stanice domaćina tim vektorom ekspresije, gdje ta stanica domaćin ne proizvodi na drugi način imunoglobulin protein;
e) uzgoj kulture transfecirane stanice domaćina u uvjetima koji uzrokuju ekspresiju tog protutijela ili fragmenta protutijela; i
f) izolacija protutijela ili fragmenta protutijela koje je proizvela ta transfecirana stanice domaćin.
30. Protutijelo ili fragment protutijela proizveden prema bilo kojem od zahtjeva 15 do 29, gdje je protutijelo ili fragment protutijela humano protutijelo ili fragment protutijela.
31. Farmaceutski oblik koji sadrži protutijelo koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora, gdje to protutijelo ili fragment protutijela može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na NK stanicama koje eksprimiraju barem jedan od ta dva različita humana inhibitorna KIR receptora, to protutijelo ili fragment protutijela prisutno je u količini koja je učinkovita da na uočljiv način potencira citotoksičnost NK stanica u bolesnika ili u biološkom uzorku koji sadrži NK stanice; i farmaceutski prihvatljiv nosač ili pomoćnu tvar, gdje protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3, KIR2DL2 i KIR2DL3 se smatraju jednom inhibitornom KIR molekulom..
32. Oblik prema zahtjevu 31, gdje protutijelo je protutijelo prema zahtjevima 1 do 11 ili 30.
33. Farmaceutski oblik koji sadrži protutijelo ili fragment protutijela koje veže barem dva različita genska produkta humanog inhibitornog KIR receptora gdje protutijelo veže KIR2DL1, KIR2DL2 i KIR2DL3, KIR2DL2 i KIR2DL3 se smatraju jednom inhibitornom KIR molekulom, i gdje to protutijelo ili fragment protutijela može neutralizirati KIR-om posredovanu inhibiciju citotoksičnosti NK stanica na NK stanicama koje eksprimiraju barem jedan od dva različita humana inhibitorna KIR receptora, to protutijelo ili fragment protutijela prisutno je u količini koja je učinkovita da na uočljiv način potencira citotoksičnost NK stanica u bolesnika ili u biološkom uzorku koji sadrži NK stanice; i farmaceutski prihvatljiv nosač ili pomoćnu tvar, dalje sadrži terapijsko sredstvo izabrano između imunomodulatornog sredstva, hormona, kemoterapijskog sredstva, anti-angiogeničnog sredstva, apoptotičnog sredstva, drugog protutijela koje veže i inhibira taj inhibitorni KIR receptor, anti-infektivnog sredstva, ciljnog sredstva ili dodatnog spoja.
34. Oblik prema zahtjevu 31, koji dalje sadrži terapijsko sredstvo izabrano između imunomodulatornog sredstva, hormona, kemoterapijskog sredstva, anti-angiogeničnog sredstva, apoptotičnog sredstva, drugog protutijela koje veže i inhibira taj inhibitorni KIR receptor, anti-infektivnog sredstva, ciljnog sredstva ili dodatnog spoja.
35. Oblik prema zahtjevu 33 ili 34, gdje se to imunomodulatorno sredstvo izabire između IL-1alfa, IL-1beta, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-11, I-12, IL-13, IL-15, IL-21, TGF-beta, GM-CSF, M-CSF, G-CSF, TNF-alfa, TNF-beta, LAF, TCGF, BCGF, TRF, BAF, BDG, MP, LIF, OSM, TMF, PDGF, IFN-alfa, IFN-beta, ili IFN-gama.
36. Oblik prema zahtjevu 33 ili 34, gdje se to kemoterapijsko sredstvo izabire između alkilirajućih sredstava, antimetabolita, citotoksičnih antibiotika, adriamicina, daktinomicina, mitomicina, karminomicina, daunomicina, doksorubicina, tamoksifena, taksola, taksoter, vinkristina, vinblastina, vinorelbina, etopozida (VP-16), 5-fluorouracila (5FU), citozin arabinozida, ciklofosfamida, tiotepa, metotreksata, kamptotecina, aktinomicina-D, mitomicina C, cisplatina (CDDP), aminopterina, kombretastatina, drugih vinka alkaloida, i njihovih derivata ili pro-lijekova.
37. Oblik prema zahtjevu 33 ili 34, gdje se taj hormon izabire između leuprorelina, goserelina, triptorelina, buserelina, tamoksifena, toremifena, flutamida, nilutamida, ciproterona, bikalutamida, anastrozola, eksemestana, letrozola, fadrozola, medroksi, klormadinona, megestrola, drugih LHRH agonista, drugih anti-estrogena, drugih anti-androgena, drugih inhibitora aromataze i drugih progestagena.
38. Oblik prema zahtjevu 33 ili 34, gdje se dodatni spoj izabire između fenotiazina, supstituiranih benzamida, antihistamina, butirofenona, kortikosteroida, benzodiazepina, kanabinoida, zoledronične kiseline, pamidronične kiseline, eritropoetina, G-CSF, filgrastima, lenograstima, darbepoetina, drugih anti-emetika, drugih antagonista serotonina, drugih bisfosfonata ili drugih hematopoetskih faktora rasta.
39. Oblik prema zahtjevu 33 ili 34, gdje se anti-apoptotična sredstva izabiru između nekodirajućih (antisense) sekvenci nukleotida, RNAi, siRNA ili male molekule kemijskog spoja koji inhibira ekspresiju gena izabranog između bcr-abl, bcl-2, Bcl-x1, Mcl-1, Bak, A1, ili A20.
40. Oblik prema zahtjevu 33 ili 34, gdje se anti-angiogenično sredstvo izabire između neutralizirajućih protutijela, nekodirajuće RNA, siRNA, RNAi, RNA aptamera ili ribozima usmjerenih protiv gena koji kodira VEGF, gena koji kodira VEGF receptore, VEGF, ili VEGF receptor; ili varijante VEGF koja ima antagonistička svojstva protiv VEGF.
41. Oblik prema zahtjevu 33 ili 34, gdje je to drugo protutijelo, koje veže i inhibira taj inhibitorni KIR receptor, protutijelo ili derivat ili njegov fragment koje se veže za epitop inhibitornog KIR receptora koji se razlikuje od epitopa koje to protutijelo veže i koje veže zajedničku determinantu prisutnu na barem dva različita genska produkta humanog inhibitornog KIR receptora.
42. Oblik prema bilo kojem od zahtjeva 31-41 za uporabu za potenciranje aktivnosti NK stanica u bolesnika kojem je to potrebno.
43. Oblik prema zahtjevu 42, gdje taj bolesnik boluje od raka, drugog proliferativnog poremećaja, infektivne bolesti ili imunog poremećaja.
44. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od karcinoma skvamoznih stanica, leukemije, akutne limfoticne leukemije, akutne limfoblastične leukemije, limfoma B-stanica, limfoma T-stanica, Hodgkinovog limfoma, ne-Hodgkinovog limfoma, limfoma dlakavih stanica, Burkettovog limfoma, akutnih ili kroničnih mijeloičnih leukemija, promijelocitne leukemije, fibrosarkoma, rabdomiosarkoma; melanoma, seminoma, teratokarcinoma, neuroblastoma, glioma, astrocitoma, schwannoma, osteosarkoma, kseroderme pigmentosum, keratoakantoma, raka folikula štitnjače, drugog karcinoma mjehura, dojke, kolona, bubrega, jetre, pluča, jajnika, prostate, gušterače, želuca, cerviksa, štitnjače ili kože, drugih hematopoetskih tumora limfoidne linije, drugih hematopoetskih tumira mijeloične linije, drugih tumora mezenhimskog porijekla, drugih tumora središnjeg ili perifernog živčanog sustava.
45. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od akutne mijeloblastične leukemije (AML).
46. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od ne-Hodgkinovog limfoma.
47. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od karcinoma dojke.
48. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od karcinoma jajnika.
49. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od hematopoetskog tumora limfoidne linije.
50. Oblik prema zahtjevu 49, gdje je taj tumor izabran između T-prolimfocitične leukemije (T-PLL) uključujući tip malih stanica i cerebriformih stanica; velike granularne limfocitne leukemije (LGL) tipa T-stanica; Sezary sindroma (SS); limfom leukemije odraslih T-stanica (ATLL); a/d T-NHL hepatospleničnog limfoma; perifernog/post-timusnog limfoma T-stanica pleomorfnog ili imunoblastičnog podtipa; angio imunoblastičnog limfoma T-stanica; angiocentričnog (nazalnog) limfoma T-stanica; anaplastičnog (Ki 1+) limfoma velikih stanica; intestinalnog limfoma T-stanica; T-limfoblastične leukemije ili limfom/leukemije (T-Lbly/TALL).
51. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od proliferativnog poremećaja izabranog između hiperplazija, fibroze, angiogeneze, psorijaze, ateroskleroze, stenoze ili restenoze nakon angioplastike, i drugih bolesti naznačenih proliferacijom glatkih mišića u krvnim žilama.
52. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od infektivne bolesti uzrokovane virusom izabranim između hepatitia tipa A, hepatitisa tipa B, hepatitisa tipa C, influence, varicella, adenovirusa, herpesa simpleksa tipa I (HSV-1), herpesa simpleksa tipa 2 (HSV-2), rinderpesta, rinovirusa, echovirusa, rotavirusa, respiratornog sincicijskog virusa, papilloma virusa, citomegaloviruas, arbovirusa, huntavirusa, coxsackie virusa, virusa zaušnjaka, virusa ospica, rubella viruas, polio virusa ili virusa humane imunodeficijencije tipa tipa I ili tipa 2 (HIV-1, HIV-2).
53. Oblik prema zahtjevu 43, gdje taj bolesnik boluje od infektivne bolesti uzrokovane bakterijama, protozoama ili parazitima izabranim između Staphylococcus, S. pyogenes, Enterococci, Bacillus anthracis, Lactobacillus, Listeria, Corynebacterium diphtheriae, G. vaginalis; Nocardia; Streptomyces; Thermoactinomyces vulgaris; Treponima; Camplyobacter, P aeruginosa; Legionella; N.gonorrhoeae; N.meningitides; F. meningosepticum; F. odoratum; Brucella; B. pertussis; B. bronchiseptica; E. coli; Klebsiella; Enterobacter; S. marcescens; S. liquefaciens; Edwardsiella; P. mirabilis; P. vulgaris; Streptobacillus; R. fickettsii; C. psittaci; C. trachomatis; M. tuberculosis, M. intracellulare, M. fortuitum, M. leprae, M. avium, M. bovis, M. africanum, M. kansasii, M. lepraemurium; Nocardia, drugog Streptococcus, drugog Bacillus, druge Gardnerella, drugog Pseudomonas, druge Neisseria, drugog Flavobacterium, druge Bordetella, druge Escherichia, druge Serratia, drugog Proteus, druge Rickettsiaceae, druge Chlamydia, druge Mycobacterium, leishmania, ili tripanosome.
54. Oblik prema zahtjevu 43, sadrži lijek koji se koristi u kombinaciji s odgovarajućim dodatnim terapijskim sredstvom izabranim između imunomodulatornog sredstva, hormona, kemoterapijskog sredstva, anti-angiogeničnog sredstva, apoptotičnog sredstva, drugog protutijela koje veže i inhibira inhibitorni KIR receptor, anti-infektivnog sredstva, ciljnog sredstva ili dodatnog spoja gdje se to dodatno terapijsko sredstvo primjenjuje bolesniku kao jedan dozirni oblik zajedno s protutijelom, ili kao posebni dozirni oblik.
55. Oblik prema zahtjevu 54, gdje taj bolesnik boluje od hematopoetskog tumora limfoidne linije, akutne mijeloblastične leukemije (AML) ili ne-Hodgkinovog limfoma.
56. Oblik prema zahtjevu 54, gdje taj bolesnik boluje od karcinoma dojke ili jajnika.
57. Protutijelo prema zahtjevu 1, gdje je to protutijelo ili fragment protutijela konjugirano ili kovalento vezano za toksin, spoj koji se može detektirati ili čvrstu podlogu.
58. In vitro postupak otkrivanja prisutnosti NK stanica koje nose inhibitorni KIR na svojoj staničnoj površini u biološkom uzorku, taj postupak obuhvaća korake:
a) kontakt biološkog uzorka s protutijelom ili fragmentom protutijela prema zahtjevu 57, gdje je to protutijelo ili fragment protutijela konjugirano ili kovalento vezano za spoj koji se može detektirati; i
b) otkrivanje prisutnosti tog protutijela u biološkom uzorku.
59. Postupak pročišćavanja NK stanica iz uzorka, koje nose inhibitorni KIR na svojoj staničnoj površini, postupak obuhvaća korake:
a) kontakt uzorka s protutijelom ili fragmentom protutijela prema zahtjevu 57 u uvjetima koji omogućuju da se NK stanice, koje nose inhibitorni KIR na svojoj staničnoj površini, vežu za to protutijelo ili fragment protutijela, gdje je to protutijelo ili fragment protutijela konjugirano ili kovalento vezano za čvrstu podlogu; i
b) ispiranje tih vezanih NK stanica s protutijela ili fragmenta protutijela koje je konjugirano ili kovalento vezano za čvrstu podlogu.
60. Oblik koji sadrži protutijelo ili fragment protutijela prema zahtjevu 1, gdje je to protutijelo inkorporirano u liposom.
61. Oblik prema zahtjevu 60, gdje je u liposom dodatno inkorporirana dodatna tvar izabrana između molekule nukleinske kiseline za dopremu gena za gensku terapiju; molekule nukleinske kisline za dopremu nekodirajuće RNA, RNAi ili siRNA za supresiju gena u NK stanici.
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