HRP20200720T1 - Anti-gitr antitijela - Google Patents

Anti-gitr antitijela Download PDF

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Publication number
HRP20200720T1
HRP20200720T1 HRP20200720TT HRP20200720T HRP20200720T1 HR P20200720 T1 HRP20200720 T1 HR P20200720T1 HR P20200720T T HRP20200720T T HR P20200720TT HR P20200720 T HRP20200720 T HR P20200720T HR P20200720 T1 HRP20200720 T1 HR P20200720T1
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Croatia
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antibody
antigen
cancer
bound fragment
fragment
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HRP20200720TT
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Xiao Min Schebye
Grigori P. Ermakov
Douglas J. Hodges
Leonard G. Presta
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Merck Sharp & Dohme Corp.
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Publication of HRP20200720T1 publication Critical patent/HRP20200720T1/hr

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Claims (28)

1. Monoklonsko antitijelo ili njegov fragment vezan za antigen koji se veže na ljudski GITR sadrži: humaniziranu varijabilnu domenu lakog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 105; i humaniziranu varijabilnu domenu teškog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 104.
2. Antitijelo ili njegov fragment vezan za antigen prema zahtjevu 1, naznačeno time što antitijelo ili njegov fragment vezan za antigen sadrži varijabilnu domenu lakog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 105, pri čemu aminokiselina na položaju 31 je Q i aminokiselina na položaju 57 je Q; i varijabilnu domenu teškog lanca koja sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 104.
3. Antitijelo ili fragment vezan za antigen prema bilo kojem od zahtjeva 1 ili 2, koji je fragment vezan za antigen odabran iz skupine koja se sastoji od Fab, Fab', Fab'-SH, Fv, scFv, F(ab')2, i diatijela.
4. Antitijelo ili fragment vezan za antigen prema zahtjevu 1 ili 2, proizveden hibridomom PTA-9890 deponiranim u Američkoj zbirci tipskih kultura (ATCC).
5. Antitijelo ili fragment vezan za antigen prema bilo kojem od zahtjeva 1, 2 ili 4 koji je antitijelo.
6. Antitijelo ili fragment vezan za antigen prema zahtjevu 1 naznačeno time što je teški lanac spojen na γ1 konstantnu regiju ljudskog teškog lanca.
7. Antitijelo ili fragment vezan za antigen prema zahtjevu 1, koji sadrži γ1 konstantnu regiju ljudskog teškog lanca ili njegovu varijantu, naznačeno time što varijanta konstantne regije sadrži do 20 konzervativno modificiranih aminokiselinskih supstitucija.
8. Antitijelo ili fragment vezan za antigen prema zahtjevu 1, naznačeno time što sadrži γ4 konstantnu regiju ljudskog teškog lanca ili njegovu varijantu, pri čemu varijanta konstantne regije sadrži do 20 konzervativno modificiranih aminokiselinskih supstitucija.
9. Farmaceutski pripravak koji sadrži antitijelo ili fragment vezan za antigen prema zahtjevu 1 i farmaceutski prihvatljiv nosač.
10. Nukleinska kiselina koja kodira varijabilnu domenu lakog lanca i varijabilnu domenu teškog lanca antitijela ili fragmenta vezanog za antigen prema bilo kojem od zahtjeva 1-8.
11. Ekspresijski vektor koji sadrži nukleinsku kiselinu prema zahtjevu 10 operativno povezan na ekspresijske kontrolne sekvence koje stanica domaćina prepoznaje kada je stanica domaćina transficirana vektorom.
12. Stanica domaćina sadrži ekspresijski vektor prema zahtjevu 11.
13. Stanica domaćina prema zahtjevu 12 koja je stanica jajnika kineskog hrčka ili stanica Pichia pastoris.
14. Postupak za proizvodnju antitijela ili njegovog fragmenta vezanog za antigen koji se veže na ljudski GITR sadrži: kultiviranje stanice domaćina prema zahtjevu 12 ili 13 u mediju kulture pod uvjetima u kojima je sekvenca nukleinske kiseline izražena, stvarajući tako antitijelo ili njegov fragment vezan za antigen koji sadrži kodirane varijabilne domene lakog i teškog lanca; i obnavljanje antitijela ili njegovog fragmenta vezanog za antigen iz stanice domaćina ili medija kulture.
15. Antitijelo ili njegov fragment vezan za antigen koji se veže na ljudski GITR, koje se može dobiti postupkom prema zahtjevu 14.
16. Antitijelo ili njegov fragment vezan za antigen prema bilo kojem od zahtjeva 1-8 ili 15 za uporabu u postupku liječenja ljudskog subjekta terapijom.
17. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 16, naznačeno time što je terapija povećanjem imunološke reakcije kod ljudskog subjekta.
18. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 16 ili 17, naznačeno time što se antitijelo ili njegov fragment vezan za antigen primjenjuje istodobno s drugim terapijskim sredstvom.
19. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 18, naznačeno time što je drugo terapijsko sredstvo antitijelo.
20. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 18, naznačeno time što je drugo terapijsko sredstvo anti-TGFß antitijelo.
21. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 16 ili 17, naznačeno time što se antitijelo ili fragment vezan za antigen primjenjuje istodobno s lokalnim zračenjem.
22. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 18, naznačeno time što je drugo terapijsko sredstvo odabrano iz skupine koja se sastoji od tiotepe, busulfana, improsulfana, piposulfana, benzodope, karbokuona, meturedopa, uredopa, altretamina, trietilenmelamina, trietilenfosforamida, trietilentiotiofosforamida trimetilolomelamina, bulatacina, bulatacinona, kamptotecina, topotekana, briostatina, kalistatina, CC-1065, kriptoficina 1, kriptoficina 8, dolastatina, duokarmicina, KW-2189, CB 1-TM1, eleuterobina, pankratistatina, sarkodictina, spongistatina, klorambucila, klomafazina, kolofosfamida, estramustina, ifosfamida, mekloretamina, mekloretamin oksid hidroklorida, melfalana, novembikina, fenesterina, prednimustina, trofosfamida, uracil gorušice, ranimnustina, kalikeamicina, kaliheamicina omega II, dinamicina, dinamicina A, klodronata, neokarzinostatin kromofora, aklacionomizina, aktinomicina, autramicina, azaserina, bleomicina, kaktinomicina, karabicina, kaminomicina, karzinofilina, kromomicina, dactinomicina, daunorubicina, detorubicina, 6-diazo-5-okso-L-norleucina, doksorubicina, morfolino-doksorubicina, cijanomorfolino-doksorubicina, 2-pirolinodoksorubicina, deoksidoksorubicina, epirubicina, ezorubicina, idarubicina, marcelomicina, mitomicina C, mikofenolne kiseline, nogalamicina, olivomicina, peplomicina, porfiromicina, puromicina, kuelamicina, rodorubicina, streptonigrina, streptozocina, tubercidina, ubenimeksa, zinostatina, zorubicina, 5-fluorouracila (5-FU), denopterina, metotreksata, pteropterina, trimetreksata, fludarabina, 6-merkaptopurina, tiamiprina, tioguanina, ancitabina, azacidina, 6-azauridina, karmofura, citarabina, dideoksiuridina, doksifluridina, enocitabina, floksuridina, kalusterona, dromostanolon propionata, epitiostanola, mepitiostana, testolaktona, aminoglutetimida, mitotana, trilostana, frolinske kiseline, aceglatona, aldofosfamid glikozida, aminolevulinske kiseline, eniluracila, amsakrina, bestrabucila, bizantrena, edatraksata, defofamina, demecolcina, diazikuona, elformithina, eliptinium acetata, epotilona, etoglucida, galij nitrata, hidroksiuree, lentinana, lonidainina, majtanzina, ansamitocina, mitoguazona, mitoksantrona, mopidanmola, nitraerina, pentostatina, fenameta, pirarubicina, losoksantrona, podofilinske kiseline, 2-etilhidrazida, prokarbazina, razoksana, rizoksina, sizofurana, spirogermanijuma, tenuazonske kiseline, triazikuona, 2,2', 2"-triklorotrietilamina, T-2 toksina, verakurina A, roridina A, anguidina, uretana, vindesina, dakarbazina, manomustina, mitobronitola, mitolaktola, pipobromana, gacitozina, arabinozida, ciklofosfamida, paklitaksela, bez kremofora, izgrađene albumin formulacije nanočestica od paklitaksela, docetaksela, kloranbucila, gemcitabina, 6-tioguanina, merkaptopurina, metotreksata, cisplatina, karboplatina, vinblastina, platine, etoposida, ifosfamida, mitoksantrona, vinkristina, vinorelbina, novantrona, tenipozida, edatreksata, daunomicina, aminopterina, kapecitabina, ibandronata, CPT-11, RFS2000, difluorometilomitina (DMFO), retinoične kiseline, tamoksifena, raloksifena, droloksifena, 4-hidroksitamoksifena, trioksifena, keoksifena, LY117018, onapristona, toremifena, 4(5)-imidazola, aminoglutetimida, megestrol acetata, eksemestana, formestanija, fadrozoal, vorozola, letrozola, anastrozola, flutamida, nilutamida, bikalutamida, leuprolida, gaserelina, alovektina, leuvektina. Vaksida, rekombinantnog IL-2, lurtotekana i abareliksa.
23. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 18, naznačeno time što je drugo terapijsko sredstvo izabrano iz skupine koja se sastoji od alkilacijskog sredstva, etilenimina, metilamelamina, acetogenina, kamptotekina, kriptofikina, sarkodicitina, antibiotika, bisfosfonata, mitomicina, anti-metabolita, analoga folne kiseline, analoga purina, androgena, anti-adrenala, dodatka folne kiseline, epotilona, trikotecena, taksoida, retinoida, antihormonalnog sredstva, inhibitora aromataze, anti-androgena, antisens oligonukleotida, ribozima, ekspresijskog inhibitora HER2 i cjepiva.
24. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 17, naznačeno time što je imunološka reakcija protiv proliferativnog poremećaja.
25. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 17, naznačeno time što je imunološka reakcija protiv raka.
26. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 25, naznačeno time što je rak odabran iz skupine koja se sastoji od adenokarcinoma, limfoma, blastoma, sarkoma, leukemije, raka pločastih stanica, malo-staničnog raka pluća, ne-staničnog raka pluća, raka gastrointestinalnog sustava, Hodgkinsovog limfoma, ne-Hodgkinsovog limfoma, raka gušterače, glioblastoma, glioma, raka grlića maternice, raka jajnika, raka jetre, raka mokraćnog mjehura, raka dojke, raka debelog crijeva, kolorektalnog raka, raka endometrije, mijeloma, raka pljuvačne žlijezde, bubrežnog raka, raka bazalnih stanica, melanoma, raka prostate, raka vulve, raka štitnjače, raka testisa, raka jednjaka i raka glave i vrata.
27. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 17, naznačeno time što je imunološka reakcija protiv virusne infekcije.
28. Antitijelo ili njegov fragment vezan za antigen za uporabu prema zahtjevu 27, naznačeno time što virusnu infekciju uzrokuje virus koji je odabran iz skupine koja se sastoji od ljudskog virusa papiloma (HPV), virusa herpes simpleks, virusa hepatitis B, virusa hepatitis C, virusa ospica, virusa ljudske imunodeficijencije (HIV) i Epstein Barr virusa (EBV).
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