HRP20201848T1 - Bispecifična egfr/c-met antitijela - Google Patents

Bispecifična egfr/c-met antitijela Download PDF

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HRP20201848T1
HRP20201848T1 HRP20201848TT HRP20201848T HRP20201848T1 HR P20201848 T1 HRP20201848 T1 HR P20201848T1 HR P20201848T T HRP20201848T T HR P20201848TT HR P20201848 T HRP20201848 T HR P20201848T HR P20201848 T1 HRP20201848 T1 HR P20201848T1
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cancer
antibody
egfr
met
amino acid
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Mark Chiu
Sheri MOORES
Joost Neijssen
Paul Parren
Janine Schuurman
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Janssen Biotech, Inc.
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Claims (11)

1. Izolirano bispecifično (c-Met) antitijelo specifično za receptor epidermalnog faktora rasta (EGFR)/receptor faktora rasta hepatocita, koje sadrži: a) prvi teški lanac (HC1) koji sadrži HC1 konstantnu domenu 3 (HC1 CH3) i HC1 varijabilnu regiju 1 (VH1); b) drugi teški lanac (HC2) koji sadrži HC2 konstantnu domenu 3 (HC2 CH3) i HC2 varijabilnu regiju 2 (VH2); c) prvi laki lanac (LC1) koji sadrži varijabilnu regiju 1 lakog lanca (VL1); i d) drugi laki lanac (LC2) koji sadrži varijabilnu regiju 2 lakog lanca (VL2), pri čemu se VH1 i VL1 spajaju radi stvaranja prvog mjesta za vezivanje antigena koji specifično veže EGFR, VH2 i VL2 se spajaju radi stvaranja drugog mjesta za vezivanje antigena koji specifično veže c-Met, HC1 sadrži najmanje jednu zamjenu u HC1 CH3 i HC2 sadrži najmanje jednu zamjenu u HC2 CH3, i zamjenu u HC1 CH3 i zamjenu u HC2 CH3 koja se pojavljuje na različitim položajima ostatka aminokiselina, kada je numeriranje ostataka u skladu sa EU indeksom, gdje i) VH1 sadrži regiju određivanja komplementarnosti teškog lanca (HCDR) 1 (HCDR1), HCDR2 i HCDR3 aminokiselinskih sekvenci SEQ ID NOs: 210, 211 i 212, tim redom; i ii) VL1 sadrži regiju određivanja komplementarnosti lakog lanca (LCDR) 1 (LCDR1), LCDR2 i LCDR3 aminokiselinskih sekvenci SEQ ID NOs: 213, 214 i 215, tim redom; i iii) VH2 sadrži HCDR1, HCDR2, i HCDR3 aminokiselinskih sekvenci SEQ ID NOs: 216, 217 i 218, tim redom; i iv) VL2 sadrži LCDR1, LCDR2 i LCDR3 aminokiselinskih sekvenci SEQ ID NOs: 219, 220 i 221, tim redom.
2. Bispecifično antitijelo prema zahtjevu 1, gdje: a) antitijelo je ljudsko antitijelo u kome VH1, VL1, VH2 i VH2 sadrže sekvencu aminokiselina SEQ ID NOs: 189, 190, 193 i 194, tim redom; i/ili b) antitijelo inhibira fosforilaciju kinaza 1 i 2 koje su povezane sa izvanstaničnim signalom (ERK1/2) u NCI-H292, NCI-H1975 ili SKMES-1 staničnoj liniji sa IC50 vrijednosti koja je najmanje 10-puta manja, najmanje 20-puta manja, najmanje 30-puta manja, najmanje 40-puta manja, najmanje 50-puta manja ili najmanje 60-puta manja u usporedbi sa IC50 vrijednosti inhibiranja fosforilacije ERK1/2 u NCI-H292, NCI-H1975 ili SKMES-1 staničnim linijama sa smjesom kontrolnog monovalentnog EGFR antitijela koji sadrži teški lanac 3 (HC3) i laki lanac 3 (LC3) i kontrolno monovalentno c-Met antitijelo koje sadrži teški lanac 4 (HC4) i laki lanac 4 (LC4), pri čemu HC3 i HC1, LC3 i LC1, HC4 i HC2, i LC4 i LC2 imaju redom identične sekvence aminokiselina, i fosforilacija ERK1/2 se mjeri u cijelim staničnim lizatima pomoću sendvič imunotesta upotrebom antifosfo ERK1/2 antitijela kao antitijela za hvatanje i antitijela koja se vežu za nefosforilni i fosforilni ERK1/2 koji je konjugiran sa elektrohemiluminscentnim spojem kao antitijelom za detekciju, opcionalno gdje: i) antitijelo inhibira fosforilaciju ERK1/2 sa IC50 vrijednosti 2x10-9 M ili manje, 1x10-9 M ili manje, ili 1x10-10 M ili manje; i/ili ii) ERK1 je fosforilan na položajima Thr202 i Tyr204, i ERK2 je fosforilan na ostacima Thr185 i Tyr197; i/ili i/ili; c) antitijelo koje inhibira fosforilaciju proteina kinaze B (AKT) na Ser473 u NCI-H1975 staničnoj liniji sa IC50 vrijednosti koja je najmanje 70-puta manja kada se usporedi sa IC50 vrijednosti inhibiranja fosforilacije AKT na Ser473 u NCI-H1975 staničnoj liniji s smjesom kontrolnog monovalentnog EGFR antitijela koje sadrži HC3 i LC3 i kontrolnog monovalentnog c-Met antitijela koje sadrži HC4 i LC4, gdje HC3 i HC1, LC3 i LC1, HC4 i HC2, i LC4 i LC2 imaju redom identične sekvence aminokiselina, i fosforilacija AKT na Ser473 se mjeri u cijelim staničnim lizatima sendvič imunotestom upotrebom antitijela koje se veže za nefosforilni i fosforilni AKT kao antitijelo za hvatanje i anti-fosfoAKT Ser473 antitijelom konjugiranim s elektrohemiluminiscentnim spojem kao antitijelo za detekciju, opcionalno gdje antitijelo inhibira fosforilaciju AKT na Ser473 s IC50 vrijednosti 1x10-9 M ili manje; i/ili d) antitijelo koje inhibira fosforilaciju AKT na Thr308 u NCI-H1975 staničnoj liniji s IC50 vrijednosti koja je najmanje 100-puta manja u usporedbi s IC50 vrijednosti inhibiranja fosforilacije AKT na Thr308 u NCIH1975 staničnoj liniji s smjesnom kontrolnog monovalentnog EGFR antitijela koje sadrži HC3 i LC3 kontrolno monovalentno c-Met antitijelo koje sadrži HC4 i LC4, gdje HC3 i HC1, LC3 i LC1, HC4 i HC2, i LC4 i LC2 imaju redom identične sekvence aminokiselina, i fosforilacija AKT na Thr308 se mjeri u cijelim staničnim lizatima sendvič imunotestom upotrebom antitijela koje se vezuje za nefosforilni i fosforilni AKT kao antitijelo za hvatanje i antifosfo AKT Thr308 antitijelom konjugiranim s elektrohemiluminiscentnim spojem kao antitijelo za detekciju, opcionalno gdje antitijelo inhibira fosforilaciju AKT na Thr308 s IC50 vrijednosti od 1x10-9 M ili manje; i/ili; e) bispecifično antitijelo veže EGFR koje ima sekvencu aminokiselina prikazanu u SEQ ID NO: 73 na EGFR ostacima K489, 1491, K467 i S492 i c-Met na ostacima PEFRDSYPIKYVHAF (SEQ ID NO: 238) i FAQSKPDSAEPMDRSA (SEQ ID NO: 239); i/ili f) antitijelo inhibira rast NCI-H292 ili NCI-H1975 stanica s IC50 vrijednosti koja je najmanje 300-puta manja, najmanje 400-puta manja, najmanje 500-puta manja, najmanje 600-puta manja, najmanje 700-puta manja ili najmanje 800-puta manja u usporedbi s IC50 vrijednosti inhibiranja rasta NCI-H292 ili NCI-H1975 stanica sa cetuksimabom kada se NCI-H292 ili NCI-H1975 stanice uzgajaju u uvjetima koji osiguravaju nisko vezivanje; i/ili g) antitijelo inhibira rast SKMES-1 tumorskih stanica koje eksprimiraju HGF u SCID Beige miševima s postotkom (%) T/C vrijednosti od najmanje 500-puta manje u danu 36 u usporedbi scetuksimabom, kada se bispecifično antitijelo i cetuksimab daju u dozi od 20 mg/kg ; i/ili; h) antitijelo neutralizira EGFR i c-Met signalne puteve.
3. Bispecifično antitijelo prema zahtjevu 1 ili zahtjevu 2, pri čemu HC1 i HC2 su od IgG1, IgG2, IgG3 ili IgG4 izotipa, na primjer gdje HC1 i HC2 su od IgG1 izotipa; opcionalno gdje HC1 CH3 sadrži najmanje jedan, dva, tri, četiri, pet, šest, sedam ili osam zamjena i HC2 CH3 sadrži najmanje jednu, dvije, tri, četiri, pet, šest, sedam ili osam zamjena na položajima ostatka 350, 366, 368, 370, 399, 405, 407 ili 409, pri čemu je numeriranje ostataka u skladu sa EU indeksom, što je a) gdje HC1 CH3 sadrži najmanje jednu, dvije, tri ili četiri zamjene i HC2 CH3 sadrži najmanje jednu, dvije, tri ili četiri zamjene na položajima ostataka 350, 370, 405 ili 409; b) gdje HC1 CH3 sadrži najmanje jednu zamjenu i HC2 CH3 sadrži najmanje jednu zamjenu na položajima ostataka 405 ili 409; c) gdje HC1 CH3 sadrži K409R ili F405L zamjenu i HC2 CH3 sadrži K409R ili F405L zamjenu; ili d) gdje HC1 CH3 sadrži F405L zamjenu i HC2 CH3 sadrži K409R zamjenu.
4. Bispecifično antitijelo prema bilo kojem od zahtjeva 1 do 3, (a) koje dalje sadrži 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 ili 15 konzervativnih zamjena aminokiselina u HC1, LC1, HC2 ili LC2, koji opcionalno sadrži zamjenu M252Y/S254T/T256E u HC1 i/ili HC2, pri čemu je numeriranje ostataka u skladu sa EU indeksom; i/ili (b) gdje antitijelo ima biantenarnu strukturu glikana sa sadržajem fukoze između 1 do 15%.
5. Farmaceutski sastav koji sadrži bispecifično antitijelo prema bilo kojem od zahtjeva 1 do 4 i farmaceutsko prihvatljivi nosač.
6. Bispecifično antitijelo prema bilo kojem od zahtjeva 1 do 4 za upotrebu u postupku liječenja raka, koji obuhvaća davanje terapeutski efikasne količine bispecifičnog EGFR/c-Met antitijela pacijentu kojem je potrebno u vremenskom periodu koji je dovoljan za liječenje raka, opciono gdje: a) rak je povezan sa mutacijom koja aktivira EGFR, umnožavanjem gena za EGFR, povećanim nivoima kruženja HGF, mutacijom koja aktivira c-Met, umnožavanjem gena za c-Met ili mutiranim KRAS, kao što je: (i) mutacija koja aktivira EGFR je G719A, G719X (pri čemu je X bilo koja aminokiselina), L861X (pri čemu je X bilo koja aminokiselina), L858R, E746K, L747S, E749Q, A750P, A755V, V765M, L858P ili T790M zamjena, brisanje E746-A750, brisanje R748-P753, unos Ala (A) između M766 i A767, unos Ser, Val i Ala (SVA) između S768 i V769, i unos Asn i Ser (NS) između P772 i H773, opcionalno gdje mutacija koja aktivira EGFR je L858R, del(E476, A750) i/ili T790M zamjena; ili (ii) mutirani KRAS ima G12V ili G12C zamjenu; ili (iii) subjekt je otporan ili je stekao otpornost na liječenje s erlotinibom, gefitinibom, afatinibom, CO-1686, AZD9192 ili cetuksimabom; ili (iv) rak je rak epitelnih stanica, rak grudi, rak jajnika, rak pluća, ne-sitnostanični rak pluća (NSCLC), adenokarcinom pluća, rak malih stanica pluća, kolorektalni rak, analni rak, rak prostate, rak bubrega, rak mjehura, rak glave i vrata, rak ždrijela, rak nosa, rak gušterače, rak kože, oralni rak, rak jezika, rak jednjaka, vaginalni rak, i rak vrata maternice, rak slezena, rak testisa, rak želuca, rak prsne žlijezde, rak debelog crijeva, rak štitne žlijezde, rak jetre, hepatocelularni rak (HCC) ili sporedni ili sporadični rak papilarnih bubrežnih stanica(PRCC); ili b) subjekt je homozigot za fenilalanin na položaju 158 od CD16 ili heterozigot za valin i fenilalanin na položaju 158 od CD16.
7. Bispecifično antitijelo za upotrebu prema zahtjevu 6 (a)(iv), koja obuhvaća davanje drugog terapeutskog sredstva, opcionalno gdje: a) drugo terapeutsko sredstvo je hemoterapeutsko sredstvo ili ciljana protiv raka terapija, kao što je: i) hemioterapeutsko sredstvo je cisplatin ili vinblastin; ili ii) hemioterapeutsko sredstvo ili ciljana protiv raka terapija je tirozin kinazni inhibitor EGFR, c-Met, HER2, HER3, HER4 ili VEGFR, opcionalno gdje je tirozin kinazni inhibitor erlotinib, gefitinib ili afatinib; ili b) drugo terapeutsko sredstvo se daje istovremeno, stupnjevito ili odvojeno.
8. Postupak in vitro inhibiranja rasta ili proliferacije stanica koje eksprimiraju EGFR i/ili c-Met, koji obuhvaća kontakt stanica sa bispecifičnim antitijelom prema bilo kojem od zahtjeva 1-4.
9. Bispecifično antitijelo prema bilo kojem od zahtjeva 1 do 4 za upotrebu u postupku inhibiranja rasta ili metastaza tumora ili stanica raka koje eksprimiraju EGFR i/ili c-Met kod subjekta koji obuhvaća davanje subjektu efikasne količine bispecifičnog antitijela za inhibiranje rasta ili metastaza tumora ili raka stanica koje eksprimiraju EGFR i/ili c-Met, opcionalno gdje je tumor koji eksprimira EGFR i/ili c-Met rak epitelnih stanica, rak grudi, rak jajnika, rak pluća, ne-sitnostanični rak pluća (NSCLC), adenokarcinom pluća, rak malih stanica pluća, kolorektalni rak, analni rak, rak prostate, rak bubrega, rak mjehura, rak glave i vrata, rak ždrijela, rak nosa, rak gušterače, rak kože, oralni rak, rak jezika, rak jednjaka, vaginalni rak, rak vrata maternice, rak slezena, rak testisa, rak želuca, rak prsne žlijezde, rak debelog crijeva, rak štitne žlijezde, rak jetre, hepatocelularni karcinom (HCC) ili sporedni ili nasljedni rak papilarnih stanica (PRCC), kao što gdje je tumor koji eksprimira EGFR i/ili c-Met povezan sa mutacijom koja aktivira EGFR, umnožavanjem gena za EGFR, povećanim nivoima kruženja HGF, mutacijom koja aktivira c-Met, umnožavanjem gena za c-Met ili mutiranog KRAS, opcionalno gdje: a) mutacija koja aktivira EGFR je G719A, G719X (pri čemu je X bilo koja aminokiselina), L861X (pri čemu je X bilo koja aminokiselina), L858R, E746K, L747S, E749Q, A750P, A755V, V765M, L858P ili T790M zamjena, brisanje E746-A750, brisanje R748-P753, unos Ala (A) između M766 i A767, i unos Ser, Val i Ala (SVA) između S768 i V769, i unos Asn i Ser (NS) između P772 i H773; ili b) mutirani KRAS ima G12V ili G12C zamjenu.
10. Bispecifično antitijelo prema bilo kojem od zahtjeva 1 do 4 za upotrebu u terapiji, kao što je za upotrebu u liječenju raka, opcionalno kada je rak rak epitelnih stanica, rak grudi, rak jajnika, rak pluća, ne-sitnostanični rak pluća (NSCLC), adenokarcinom pluća, rak malih stanica pluća, kolorektalni rak, analni rak, rak prostate, rak bubrega, rak mjehura, rak glave i vrata, rak ždrijela, rak nosa, rak gušterače, rak kože, oralni rak, rak jezika, rak jednjaka, vaginalni rak, rak vrata maternice, rak slezena, rak testisa, rak želuca, rak prsne žlijezde, rak debelog crijeva, rak štitne žlijezde, rak jetre, hepatocelularni karcinom (HCC) ili sporedni ili nasljedni karcinom papilarnih stanica bubrega (PRCC).
11. Bispecifično antitijelo za upotrebu prema zahtjevu 10, gdje je bispecifično antitijelo davano u kombinaciji s drugim terapeutskim agensom, istovremeno, stupnjevito ili odvojeno, opcionalno gdje drugi terapeutski agens je hemoterapeutski agens, kao što su: a) alkilirajuće sredstvo kao što su tiotepa i ciklosfosfamid; b) alkil sulfonat kao što su busulfan, improsulfan i piposulfan; c) aziridini kao što su benzodopa, karbohion, meturedopa, i uredopa; d) etilenimin i metilamelamin uključujući altretamin, trietilenmelamin, trietilenfosforamid, trietilentiofosfaoramid i trimetilolomelamin; e) azotni iperit kao što su hlorambucil, hlornafazin, holofosfamid, estramustin, ifosfamid, mehloretamin, mehloretamin oksid hidrohlorid, melfalan, novembihin, fenesterin, prednimustin, trofosfamid, uracil iperit; f) nitrozurea kao što su karmustin, hlorozotocin, fotemustin, lomustin, nimustin, ranimustin; g) antibiotik kao što je aklacinomisini, aktinomicin, autramicin, azaserin, bleomicini, kaktinomicin, kaliheamicin, karabicin, karminomicin, karzinofilin, hromomicini, daktinomicin, daunorubicin, detorubicin, 6-diazo-5-okso-L-norleucin, doksorubicin, epirubicin, ezorubicin, idarubicin, marcelomicin, mitomicini, mikofenolna kiselina, nogalamicin, olivomicini, peplomicin, potfiromicin, puromicin, hielamicin, rodorubicin, streptonigrin, streptozocin, tubercidin, ubenimeks, zinostatin, zorubicin; h) anti-metabolit kao što je metotreksat i 5-FU; i) analog folne kiseline kao što su denopterin, metotreksat, pteropterin, trimetreksat; j) purinski analog kao što su fludarabin, 6-merkaptopurin, tiamiprin, tioguanin; k) analog pirimidina kao što su ancitabin, azacitidin, 6-azauridin, karmofur, citarabin, dideoksiuridin, doksifluridin, enocitabin, floksuridin; l) androgen kao što su kalusteron, dromostanolon propionat, epitiostanol, mepitiostan, testolakton; m) anti-andrenalni kao što su aminoglutetimid, mitotan, trilostan; n) dopuna folne kiseline kao što je frolinska kiselina; o) aceglaton; aldofosfamid glikozid; aminolevulinska kiselina; amsakrin; bestrabucil; bisantren; edatraksat; defofamin; demekolcin; diazihion; elfornitin; eliptinium acetat; etoglucid; galijum nitrat; hidroksiurea; lentinan; jonidamin; mitoguazon; mitoksantron; mopidamol; nitracrin; pentostatin; fenamet; pirarubicin; podofilin kiselina; 2-etilhidrazid; prokarbazin; PSK®; razoksan; sizofiran; spirogermanijum; tenuazonska kiselina; triazihion; 2,2’,2"-trihlorotrietilamin; uretan; vindezin; dakarbazin; manomustin; mitobronitol; mitolaktol; pipobroman; gakitozin; arabinozid; ciklofosfamid; ili tiotepa; p) član taksoida ili obitelji taksana, kao što su paklitaksel i njihovi analozi; hlorambucil; gemcitabin; 6-tioguanin; merkaptopurin; metotreksat; q) analog platine kao što su cisplatin i karboplatin; r) vinblastin; platina; etopozid (VP-16); ifosfamid; mitomicin C; mitoksantron; vinkristin; vinorelbin; navelbin; novantron; tenipozid; daunomicin; aminopterin; kseloda; ibandronat; CPT-11; inhibitor topoizomeraze RFS 2000; difluorometilornitin (DMFO); retinoinska kiselina; esperamicini; ili kapecitabin; s) inhibitor receptorskih tirozin kinaza i/ili angiogeneze, uključujući sorafenib, sunitinib pazopanib, toceranib, vandetanib, cediranib, regorafenib, aksitinib (AG013736), lestaurtinib, erlotinib, gefitinib, BIBW 2992, lapatinib, neratinib t) anti-hormonalno sredstvo koje djeluje tako što regulira ili inhibira djelovanje hormona na tumore kao što su anti-estrogeni uključujući na primjer tamoksifen, raloksifen, aromataza inhibirajuće 4(5)-imidazole, 4-hidroksitamoksifen, trioksifen, keoksifen, LI 117018, onapriston, i toremifen; ili u) anti-androgen kao što su flutamid, nilutamid, bikalutamid, leuprolid, i goserelin; i farmaceutski prihvatljive soli, kiseline ili derivate od bilo koga gore navedenog.
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