JP2015164920A - FcRnへの変異結合を有するFc変異体 - Google Patents
FcRnへの変異結合を有するFc変異体 Download PDFInfo
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- JP2015164920A JP2015164920A JP2015075006A JP2015075006A JP2015164920A JP 2015164920 A JP2015164920 A JP 2015164920A JP 2015075006 A JP2015075006 A JP 2015075006A JP 2015075006 A JP2015075006 A JP 2015075006A JP 2015164920 A JP2015164920 A JP 2015164920A
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Abstract
Description
その全体が組み込まれる)。
ンデックスまたはKabatのEUインデックスまたはEU付番スキ−ムは、EU抗体の付番を指す(Edelman et al.,1969,Proc Natl Acad Sci USA 63:78−85、参照することによりその全体が本出願に組み込まれる)。修飾は、追加、欠失、または置換であってもよい。置換は、自然発生のアミノ酸、非自然発生のアミノ酸を含むことができる。変異体は、非自然発生のアミノ酸を含んでもよい。例は、米国特許第6,586,207号、国際公開第WO98/48032号、第WO03/073238号、米国特許第2004−0214988A1号、第WO05/35727A2号、第WO05/74524A2号、J.W.Chin et al.,(2002),Journal of the American Chemical Society 124:9026−9027、J.W.Chin,&P.G.Schultz,(2002),ChemBioChem 11:1135−1137、J.W.Chin,et al.,(2002),PICAS United States of America 99:11020−11024、およびL.Wang,&P.G.Schultz,(2002),Chem.1−10を含み、すべて参照することによりその全体が組み込まれる。
抗体
法は、当該技術分野において周知である(Tsurushita&Vasquez,2004,Humanization of Monoclonal Antibodies,Molecular Biology of B Cells,533−545、Elesevier Science(USA)、および本出願に引用した参考文献を参照し、これらすべては、参照することによりその全体が組み込まれる)。ヒト化方法は、Jones et al.,1986,Nature 321:522−525、Riechmann et al.,1988,Nature 332:323−329、Verhoeyen et al.,1988,Science,239:1534−1536、Queen et al.,1989,Proc Natl Acad Sci,USA 86:10029−33、He et al.,1998,J.Immunol.160:1029−1035、Carter et al.,1992,Proc Natl Acad Sci USA 89:4285−9、Presta et al.,1997,Cancer Res.57(20):4593−9、Gorman et al.,1991,Proc.Natl.Acad.Sci.USA 88:4181−4185、O‘Connor et al.,1998,Protein Eng 11:321−8に記載される方法を含むが、これらに限定されず、これらは、参照することによりその全体が組み込まれる。ヒト化または非ヒト抗体可変領域の免疫原性を低下させる他の方法は、例えば、参照することにより組み込まれる、Roguska et al.,1994,Proc.Natl.Acad.Sci.USA 91:969−973に記載されるとおり、最表面化する方法を含んでもよい。一実施形態では、親抗体は、当該技術分野で周知のとおり、親和性が成熟している。構造ベースの方法は、例えば、USSN第11/004,590号に記載するとおり、ヒト化および親和性成熟に使用してもよい。選択ベースの方法は、ヒト化および/または親和性成熟抗体の可変領域に使用してもよく、Wu et al.,1999,J.Mol.Biol.294:151−162、Baca et al.,1997,J.Biol.Chem.272(16):106
78−10684、Rosok et al.,1996,J.Biol.Chem.271(37):22611−22618、Rader et al.,1998,Proc.Natl.Acad.Sci.USA 95:8910−8915、Krauss et al.,2003,Protein Engineering 16(10):753−759に、記載される方法を含むが、それらに限定されない。他のヒト化方法は、CDRの一部のみを移植するステップを伴い、第USSN09/810,510号、Tan et al.,2002,J.Immunol.169:1119−1125、De Pascalis et al.,2002,J.Immunol.169:3076−3084(参照することによりその全体が組み込まれる)に記載される方法を含むが、それらに限定されない。
またはFc融合は、改変糖鎖を含むことができる。あるいは、改変糖鎖は、異なる炭水化物またはオリゴサッカリドを含む、IgG変異体を指し得る。当該技術分野において周知のとおり、グリコシル化のパターンは、タンパク質の配列(例えば、以下に記載する特定のグリコシル化アミノ酸残基の有無)、もしくはタンパク質が産生される宿主細胞または有機体の両方によって異なってもよい。特定の発現系を以下に説明する。
H、カテプシンL、カテプシンO、カテプシンS、カテプシンV、カテプシンX/Z/P、CBL、CCI、CCK2、CCL、CCL1、CCL11、CCL12、CCL13、CCL14、CCL15、CCL16、CCL17、CCL18、CCL19、CCL2、CCL20、CCL21、CCL22、CCL23、CCL24、CCL25、CCL26、CCL27、CCL28、CCL3、CCL4、CCL5、CCL6、CCL7、CCL8、CCL9/10、CCR、CCR1、CCR10、CCR10、CCR2、CCR3、CCR4、CCR5、CCR6、CCR7、CCR8、CCR9、CD1、CD2、CD3、CD3E、CD4、CD5、CD6、CD7、CD8、CD10、CD11a、CD11b、CD11c、CD13、CD14、CD15、CD16、CD18、CD19、CD20、CD21、CD22、CD23、CD25、CD27L、CD28、CD29、CD30、CD30L、CD32、CD33(p67タンパク質)、CD34、CD38、CD40、CD40L、CD44、CD45、CD46、CD49a、CD52、CD54、CD55、CD56、CD61、CD64、CD66e、CD74、CD80(B7−1)、CD89、CD95、CD123、CD137、CD138、CD140a、CD146、CD147、CD148、CD152、CD164、CEACAM5、CFTR、cGMP、CINC、ボツリヌス菌毒素、ウェフシュキン毒素、CKb8−1、CLC、CMV、CMVUL、CNTF、CNTN−1、COX、C−Ret、CRG−2、CT−1、CTACK、CTGF、CTLA−4、CX3CL1、CX3CR1、CXCL、CXCL1、CXCL2、CXCL3、CXCL4、CXCL5、CXCL6、CXCL7、CXCL8、CXCL9、CXCL10、CXCL11、CXCL12、CXCL13、CXCL14、CXCL15、CXCL16、CXCR、CXCR1、CXCR2、CXCR3、CXCR4、CXCR5、CXCR6、サイトケラチン腫瘍関連抗原、DAN、DCCDcR3、DC−SIGN、分解促進因子、デス(1−3)−IGF−I(脳IGF−1)、Dhh、ジゴキシン、DNAM−1、Dナーゼ、Dpp、DPPIV/CD26、Dtk、ECAD、EDA、EDA−A1、EDA−A2、
EDAR、EGF、EGFR(ErbB−1)、EMA、EMMPRIN、ENA、エンドセリン受容体、エンケファリナーゼ、eNOS、Eot、エオタキシン1、EpCAM、エフリンB2/EphB4、EPO、ERCC、E−セレクチン、ET−1、因子IIa、因子VII、因子VIIc、因子IX、線維芽細胞活性化タンパク質(FAP)、Fas、FcR1、FEN−1、フェリチン、FGF、FGF−19、FGF−2、FGF3、FGF−8、FGFR、FGFR−3、フィブリン、FL、FLIP、Flt−3、Flt−4、卵胞刺激ホルモン、フラクタルカイン、FZD1、FZD2、FZD3、FZD4、FZD5、FZD6、FZD7、FZD8、FZD9、FZD10、G250、Gas6、GCP−2、GCSF、GD2、GD3、GDF、GDF−1、GDF−3(Vgr−2)、GDF−5(BMP−14、CDMP−1)、GDF−6(BMP−13、 CDMP−2)、GDF−7(BMP−12、CDMP−3)、GDF−8(ミオスタチン)、GDF−9、GDF−15(MIC−1)、GDNF、GDNF、GFAP、GFRa−1、GFR−α1、GFR−α2、GFR−α3、GITR、グルカゴン、Glut 4、グリコタンパク質IIb/IIIa(GPIIb/IIIa)、GM−CSF、gp130、gp72、GRO、成長ホルモン放出因子、ハパテン(NP−capまたはNIP−cap)、HB−EGF、HCC、HCMVgBエンベロープ糖タンパク質、HCMVgHエンベロープ糖タンパク質、HCMV UL、造血成長因子(HGF)、HepB gp120、ヘパラナーゼ、Her2、Her2/neu(ErbB−2)、Her3(ErbB−3)、Her4(ErbB−4)、単純ヘルペスウイルス(HSV)gBグリコタンパク質、HSVgDグリコタンパク質、HGFA、高分子量メラノーマ関連抗原(HMW−MAA)、HIVgp120、HIV IIIBgp120V3ループ、HLA、HLA−DR、HM1.24、HMFG PEM、HRG、Hrk、ヒト心臓ミオシン、ヒトサイトロメガロウイルス(HCMV)、ヒト成長ホルモン(HGH)、HVEM、I−309、IAP、ICAM、ICAM−1、ICAM−3、ICE、ICOS、IFNg、Ig、IgA受容体、IgE、IGF、IGF結合タンパク質、IGF
−1R、IGFBP、IGF−I、IGF−II、IL、IL−1、IL−1R、IL−2、IL−2R、IL−4、IL−4R、IL−5、IL−5R、IL−6、IL−6R、IL−8、IL−9、IL−10、IL−12、IL−13、IL−15、IL−18、IL−18R、IL−23、インターフェロン(INF)−α、INF−β、INF−γ、インヒビン、iNOS、インスリンA−鎖、インスリンB−鎖、インスリン様成長因子1、インテグリンα2、インテグリンα3、インテグリンα4、インテグリンα4/β1、インテグリンα4/β7、インテグリンα5(αV)、インテグリンα5/β1、インテグリンα5/β3、インテグリンα6、インテグリンβ1、インテグリンβ2、インターフェロンγ、IP−10、I−TAC、JE、カリクレイン2、カリクレイン5、カリクレイン6、カリクレイン11、カリクレイン12、カリクレイン14、カリクレイン15、カリクレインL1、カリクレインL2、カリクレインL3、カリクレインL4、KC、KDR、ケラチノサイト成長因子(KGF)、ラミニン5、LAMP、LAP、LAP(TGF−1)、潜在性TGF−1、潜在性TGF−1bp1、LBP、LDGF、LECT2、レフティー、ルイス−Y抗原、ルイス−Y関連抗原、LFA−1、LFA−3、Lfo、LIF、LIGHT、リポタンパク質、LIX、LKN、Lptn、L−セレクチン、LT−a、LT−b、LTB4、LTBP−1、肺表面活性剤、黄体形成ホルモン、リンホトキシンβ受容体、Mac−1、MAdCAM、MAG、MAP2、MARC、MCAM、MCAM,MCK−2、MCP、M−CSF、MDC、Mer、金属、LOPROTEASES、MGDF受容体、MGMT、MHC(HLA−DR)、MIF、MIGMIP、MIP−1−α、MK、MMAC1、MMP、MMP−1、MMP−10、MMP−11、MMP−12、MMP−13、MMP−14、MMP−15、MMP−2、MMP−24、MMP−3、MMP−7、MMP−8、MMP−9、MPIF、Mpo、MSK、MSP、ムチン(Muc1)、MUC18、ミュラー管抑制物質、Mug、MuSK、NAIP、NAP、NCAD、N−カドヘリン、NCA90、NCAM、NCAM、ネプリリシン、ニューロトロフィン−3,−4,または−6、ニュートリン、神経細
胞成長因子(NGF)、NGFR、NGF−β、nNOS、NO、NOS、Npn、NRG−3、NT、NTN、OB、OGG1、OPG、OPN、OSM、OX40L、OX40R、p150、p95、PADPr、副甲状腺ホルモン、PARC、PARP、PBR、PBSF、PCAD、P−カドヘリン、PCNA、PDGF、PDGF、PDK−1、PECAM、PEM、PF4、PGE、PGF、PGI2、PGJ2、PIN、PLA2、胎盤アルカリホスファターゼ(PLAP)、PlGF、PLP、PP14、プロインスリン、プロレラキシン、タンパク質C、PS、PSA、PSCA、前立腺特異的膜抗原(PSMA)、PTEN、PTHrp、Ptk、PTN、R51、RANK、RANKL、RANTES、RANTES、レラキシンA−鎖、レラキシンB−鎖、レニン、呼吸器合胞体ウイルス(RSV)F、RSV Fgp、Ret、リウマチ因子、RLIP76、RPA2、RSK、S100、SCF/KL、SDF−1、SERINE、血清アルブミン、sFRP−3、Shh、SIGIRR、SK−1、SLAM、SLPI、SMAC、SMDF、SMOH、SOD、SPARC、Stat、STEAP、STEAP−II、TACE、TACI,TAG−72(腫瘍関連グリコタンパク質−72)、TARC、TCA−3、T−細胞受容体(例えば、T−細胞受容体α/β)、TdT、TECK、TEM1、TEM5、TEM7、TEM8、TERT、精巣PLAP様アルカリホスファターゼ、TfR、TGF、TGF−α、TGF−β、TGF−βパン特異性、TGF−βRI(ALK−5)、TGF−βRII、TGF−βRIIb、TGF−βRIII、TGF−β1、TGF−β2、TGF−β3、TGF−β4、TGF−β5、トロンビン、胸腺Ck−1、甲状腺刺激ホルモン、Tie、TIMP、TIQ、組織因子、TMEFF2、Tmpo、TMPRESS2、TNF、TNF−α、TNF−αβ、TNF−β2、TNFc、TNF−RI、TNF−RII、TNFRSF10A(TRAIL R1Apo−2、DR4)、TNFRSF10B(TRAIL R2DR5、KILLER、TRICK−2A、TRICK−B)、TNFRSF10C(TRAIL R3DcR1、LIT、TRID)、TNFRSF10D(TRAIL R4DcR2、TRUNDD)、TNF
RSF11A(RANK ODF R、TRANCE R)、TNFRSF11B(OPG OCIF、TR1)、TNFRSF12(TWEAK R FN14)、TNFRSF13B(TACI)、TNFRSF13D(BAFF R)、TNFRSF14(HVEM ATAR、HveA、LIGHT R、TR2)、TNFRSF16(NGFR p75NTR)、TNFRSF17(BCMA)、TNFRSF18(GITR AITR)、TNFRSF19(TROY TAJ、TRADE)、TNFRSF19L(RELT)、TNFRSF1A(TNF RI CD120a、p55−60)、TNFRSF1B(TNF RII CD120b、p75−80)、TNFRSF26(TNFRH3)、TNFRSF3(LTbR TNF RIII、TNFC R)、TNFRSF4(OX40 ACT35、TXGP1 R)、TNFRSF5(CD40 p50)、TNFRSF6(Fas Apo−1、APT1、CD95)、TNFRSF6B(DcR3M68、TR6)、TNFRSF7(CD27)、TNFRSF8(CD30)、TNFRSF9(4−1BB CD137、ILA)、TNFRSF21(DR6)、TNFRSF22(DcTRAIL R2 TNFRH2)、TNFRSF23(DcTRAIL R1TNFRH1)、TNFRSF25(DR3 Apo−3、LARD、TR−3、TRAMP、WSL−1)、TNFSF10(TRAIL Apo−2リガンド、TL2)、TNFSF11(TRANCE/RANKリガンド ODF、OPGリガンド)、TNFSF12(TWEAK Apo−3リガンド、DR3リガンド)、TNFSF13(APRIL TALL2)、TNFSF13B(BAFF BLYS、TALL1、THANK、TNFSF20)、TNFSF14(LIGHT HVEMリガンド、LTg)、TNFSF15(TL1A/VEGI)、TNFSF18(GITRリガンド AITRリガンド、TL6)、TNFSF1A(TNF−コネクチン、DIF、TNFSF2)、TNFSF1B(TNF−b LTa、TNFSF1)、TNFSF3(LTb TNFC、p33)、TNFSF4(OX40リガンドgp34、TXGP1)、TNFSF5(CD40リガンドCD154、gp39、HIGM1、IMD3、TRAP)、
TNFSF6(FasリガンドApo−1リガンド、APT1リガンド)、TNFSF7(CD27リガンドCD70)、TNFSF8(CD30リガンドCD153)、TNFSF9(4−1BBリガンドCD137リガンド)、TP−1、t−PA、Tpo、TRAIL、TRAIL R、TRAIL−R1、TRAIL−R2、TRANCE、伝達受容体、TRF、Trk、TROP−2、TSG、TSLP、腫瘍関連抗原CA125、腫瘍関連抗原発現ルイスY関連炭水化物、TWEAK、TXB2、Ung、uPAR、uPAR−1、ウロキナーゼ、VCAM、VCAM−1、VECAD、VE−カドヘリン、VE−カドヘリン−2、VEFGR−1(flt−1)、VEGF、VEGFR、VEGFR−3(flt−4)、VEGI、VIM、ウイルス抗原、VLA、VLA、VLA−1、VLA−4、VLRインテグリン、フォン・ヴィレブランド因子、WIF−1、WNT1、WNT2、WNT2B/13、WNT3、WNT3A、WNT4、WNT5A、WNT5B、WNT6、WNT7A、WNT7B、WNT8A、WNT8B、WNT9A、WNT9A、WNT9B、WNT10A、WNT10B、WNT11、WNT16、XCL1、XCL2、XCR1、XCR1、XEDAR、XIAP、XPD、ならびにホルモンおよび成長因子の受容体。
サイトカインの用語は、天然の供給源由来または組み換え細胞培養由来のタンパク質、および天然配列のサイトカインの生物学的に活性な等価物が含まれる。
)、Genmabによって現在開発されているHuMax−EGFr(第USSN10/172,317号)、425、EMD55900、EMD62000、およびEMD72000(Merck KGaA)(US第5,558,864号、Murthy et al.,1987,Arch Biochem Biophys.252(2):549−60、Rodeck et al.,1987,J Cell Biochem.35(4):315−20、Kettleborough et al.,1991,Protein Eng.4(7):773−83)、ICR62(Institute of Cancer Research)(PCT第WO95/20045号、Modjtahedi et al.,1993,J.Cell Biophys.1993,22(1−3):129−46、Modjtahedi et al.,1993,Br J Cancer.1993,67(2):247−53、Modjtahedi et al.,1996,Br J Cancer,73(2):228−35、Modjtahedi et al.,2003,Int J Cancer,105(2):273−80)、TheraCIM hR3(YM Biosciences,Canada and Centro de Immunologia Molecular,Cuba(US第5,891,996号、US第6,506,883号、Mateo et al.,1997,Immunotechnology,3(1):71−81)、mAb−806(Ludwig Institue for Cancer Research,Memorial Sloan−Kettering)(Jungbluth et al.,2003,Proc Natl Acad Sci USA.100(2):639−44)、KSB−102(KS Biomedix)、MR1−1(IVAX,National Cancer Institute)(PCT第WO0162931A2号)、およびSC100(Scancell)(PCT第WO01/88138号)と実質的に同様である抗体において用途を見出し得る。別の好適な実施形態では、本発明のFcポリペプチドは、アレムツズマブ(Campath(登録商標),Millenium)
、B細胞慢性リンパ球性白血病の治療に現在承認されているヒト化モノクローナル抗体において用途を見出し得る。本発明のFcポリペプチドは、他の臨床産物および候補と実質的に同様であるさまざまな抗体またはFc融合において用途を見出し得、それらは、ムロモナブ−CD3(Orthoclone OKT3(登録商標))、Ortho Biotech/Johnson&Johnsonによって開発された抗CD3抗体、イブリツモマブ・チウキセタン(Zevalin(登録商標))、IDEC/Schering AGによって開発された抗CD20抗体、ゲムツズマブオゾガマイシン(Mylotarg(登録商標))、Celltech/Wyethによって開発された抗CD33(p67タンパク質)抗体、アレファセプト(Amevive(登録商標))、Biogenによって開発された抗LFA−3Fc融合、Centocor/Lillyによって開発されたアビシキシマブ(ReoPro(登録商標))、Novartisによって開発されたバシリキシマブ(Simulect(登録商標))、MedImmuneによって開発されたパリビズマブ(Synagis(登録商標))、インフリキシマブ(Remicade(登録商標))、Centocorによって開発された抗TNFアルファ抗体、アダリムマブ(Humira(登録商標))、Abbottによって開発された抗TNFアルファ抗体、Humicade(登録商標)、Celltechによって開発された抗TNFアルファ抗体、エタナーセプト(Enbrel(登録商標))、Immunex/Amgenによって開発された抗TNFアルファFc融合、ABX−CBL、Abgenixによって開発されている抗CD147抗体、ABX−IL8、Abgenixによって開発されている抗IL8抗体、ABX−MA1、Abgenixによって開発されている抗MUC18抗体、ペムツモマブ(R1549、90Y−muHMFG1)、Antisomaによって開発されている抗MUC1、Therex(R1550)、Antisomaによって開発されている抗MUC1抗体、Antisomaによって開発されているAngioMab(AS1405)、Antisomaによって開発されているHuBC−1、Antisomaによって開発されているチオプラチン(AS1407)、Ante
gren(登録商標)(ナタリズマブ)、Biogenによって開発されている抗アルファ−4−ベータ−1(VLA−4)およびアルファ−4−ベータ−7抗体、VLA−1mAb、Biogenによって開発されている抗VLA−1インテグリン抗体、LTBRmAb、Biogenによって開発されている抗リンホトキシンβ受容体(LTBR)抗体、CAT−152、Cambridge Antibody Technologyによって開発されている抗TGF−β2抗体、J695、Cambridge Antibody TechnologyおよびAbbottによって開発されている抗IL−12抗体、CAT−192、Cambridge Antibody TechnologyおよびGenzymeによって開発されている抗TGFβ1抗体、CAT−213、Cambridge Antibody Technologyによって開発されている抗エオタキシン1抗体、Lympho Stat−B(登録商標)、Cambridge Antibody TechnologyおよびHuman Genome Sciences Inc.によって開発されている抗Blys抗体、TRAIL−R1mAb、Cambridge Antibody TechnologyおよびHuman Genome Sciences Inc.によって開発されている抗TRAIL−R1抗体、Avastin(登録商標)(ベバシズマブ、rhuMAb−VEGF)、Genentechによって開発されている抗VEGF抗体、Genentechによって開発されている抗HER受容体群抗体、抗組織因子(ATF)、Genentechによって開発されている抗組織因子抗体、Xolair(登録商標)(オマリズマブ)、Genentechによって開発されている抗IgE抗体、Raptiva(登録商標)(エファリズマブ)、GenentechおよびXomaによって開発されている抗CD11a抗体、GenentechおよびMillenium Pharmaceuticalsによって開発されているMLN−02抗体(以前のLDP−02)、HuMaxCD4、Genmabによって開発されている抗−CD4抗体、HuMax−IL15、GenmabおよびAmgenによって開発されている抗IL15抗体、GenmabおよびMedarexに
よって開発されているHuMax−炎症、HuMax−癌、GenmabおよびMedarex、ならびにOxford GcoSciencesによって開発されている抗ヘパラナーゼI抗体、GenmabおよびAmgenによって開発されているHuMax−リンパ腫、Genmabによって開発されているHuMax−TAC、IDEC−131,IDEC Pharmaceuticalsによって開発されている抗−CD40L抗体、IDEC−151(クレノリキシマブ)、IDEC Pharmaceuticalsによって開発されている抗CD4抗体、IDEC−114、IDEC Pharmaceuticalsによって開発されている抗CD80抗体、IDEC−152、IDEC Pharmaceuticalsによって開発されている抗CD23、IDEC Pharmaceuticalsによって開発されている抗マクロファージ遊走因子(MIF)抗体、BEC2、Imcloneによって開発されている抗イディオタイプ抗体、IMC−1C11、Imcloneによって開発されている抗KDR抗体、DC101、Imcloneによって開発されている抗flk−1抗体、Imcloneによって開発されている抗VEカドヘリン抗体、CEA−Cide(登録商標)(ラベツズマブ)、Immunomedicsによって開発されている抗癌胎児性抗原(CEA)抗体、LymphoCide(登録商標)(エプラツズマブ)、Immunomedicsによって開発されている抗CD22抗体、Immunomedicsによって開発されているAFP−Cide、Immunomedicsによって開発されているMyelomaCide、Immunomedicsによって開発されているLkoCide、Immunomedicsによって開発されているProstaCide、MDX−010、Medarexによって開発されている抗CTLA4抗体、MDX−060、Medarexによって開発されている抗CD30抗体、Medarexによって開発されているMDX−070、Medarexによって開発されているMDX−018、Osidem(登録商標)(IDM−1)、および、MedarexおよびImmuno−Designed Moleculesによって開発されている抗Her2抗体、HuMax(登録商標)−CD4、Me
darexおよびGenmabによって開発されている抗CD4抗体、HuMax−IL15、MedarexおよびGenmabによって開発されている抗IL15抗体、CNTO148、MedarexおよびCentocor/J&Jによって開発されている抗TNFα抗体、CNTO1275、Centocor/J&Jによって開発されている抗サイトカイン抗体、MOR101およびMOR102、MorphoSysによって開発されている抗細胞内接着分子−1(ICAM−1)(CD54)抗体、MorphoSysによって開発されている抗線維芽細胞増殖因子受容体3(FGFR−3)抗体、Nuvion(登録商標)(ビジリズマブ)、Protein Design Labsによって開発されている抗CD3抗体、HuZAF(登録商標)、Protein Design Labsによって開発されている抗γインターフェロン抗体、Protein Design Labsによって開発されている抗α5β1インテグリン、Protein Design Labsによって開発されている抗IL−12、ING−1、Xomaによって開発されている抗Ep−CAM抗体、およびMLN01、Xomaによって開発されている抗ベータ2インテグリン抗体を含むが、それらに限定されず、本項において上述に引用した参考文献のすべては、参照することにより本出願に明確に組み込まれる。
原虫に関連する標的抗原に対する抗体は、トリパノソーマ、ドノバン・リーシュマニアを含むリーシュマニア種、プラスモジウムspp.、ニューモシスティス・カリニ、クリプトスポリジウム・パルウム、ランブル鞭毛虫、赤痢アメーバ、およびサイクロスーポラ・カネタネンシスに関連した抗体を含むが、それらに限定されない。
原核抗原に対する抗体も有用であり、菌(炭疽菌、ビブリオ属(例えば、コレラ菌)、エシェリキア属(例えば、腸管毒素原性大腸菌)、シゲラ菌(例えば、S・ディゼンテリエ)、サルモネラ菌(例えば、チフス菌)、マイコバクテリウム(例えば、結核菌、ハンセン菌)、クロストリジウム属(例えば、ボツリヌス菌、破傷風菌、C・ディフィシレ、ウェルシュ菌)、コリネバクテリウム(例えば、Cジフテリア菌)、連鎖球菌(例えば、化膿連鎖球菌、肺炎連鎖球菌)、ブドウ球菌(例えば、黄色ブドウ球菌)、ヘモフィルス属(例えば、インフルエンザ菌)、ナイセリア(例えば、髄膜炎菌、淋菌)、エルシニア属(例えば、Y・ランブル鞭毛虫、Y・ペスト菌)、シュードモナス菌(例えば、緑膿菌、P・プチダ)、クラミジア(例えば、クラミジア・トラコマチス)、ボルデテラ属(例えば、百日咳菌)、トレポネーマ属(例えば、梅毒トレポネーマ)、炭疽菌、ペスト菌、ブルセラ菌種、野兎病菌、鼻疽菌、類鼻疽菌、鼻疽菌、類鼻疽菌、ボツリヌス菌、サルモネラ種、SEBコレラ毒素B、大腸菌O157:H7、リステリア菌種、トリコスポロン・ベイゲリ、ロドトルラ種、ハンセヌラ・アノマーラ、エンテロバクター種、クレブシエラ種、リステリア菌種、マイコプラズマ種等)を含むが、それらに限定されない、病原性および非病原性の原核生物等の適切な細菌に対する抗体を含む。
、FcγRIIc、FcγRIIIa、およびFcγRIIIbを含むが、それらに限定されない)の増加または減少した親和性を有するように最適化される。これらの実施形態は、ヒトの向上した治療特性、例えば、増加した血清半減期および減少したエフェクター機能を有する、IgGポリペプチドを提供することが見込まれる。別の実施形態では、IgG変異体は、FcRnの強化された親和性、および1つ以上のFcγRの強化された親和性、さらに、1つ以上の他のFcγRの減少した親和性を提供する。例えば、IgG変異体は、FcRnおよびFcγRIIIaへの強化された結合、さらに、FcγRIIbへの減少された結合を有してもよい。あるいは、IgG変異体は、FcRnおよびFcγRへの減少した結合を有してもよい。別の実施形態では、IgG変異体は、FcRnの減少した親和性、およびFcγRIIbの強化した親和性、さらに、1つ以上の活性FcγRへの減少した親和性を有してもよい。さらに別の実施形態では、IgG変異体は、増加した血清半減期および減少したエフェクター機能を有してもよい。
親抗体がヒトIgG1である変異抗体が、等価残基を決定するための上述の方法または他の方法を使用して生成される場合は、変異抗体は、異なる抗原、ヒトIgG2親抗体、ヒトIgA親抗体、マウスIgG2a、またはIgG2b親抗体等を結合する、別のIgG1親抗体内で操作されてもよい。上述のとおり、ここでもまた、親IgG変異体の関連は、IgG変異体を他の親IgGへ輸送する能力に影響を及ぼさない。
数/予測倍数)−1]]。この分析を、変異体をそれらの複合単一変異体によって分類して、図11bにプロットする。本グラフは、再度、一部の変異体、特に259I/308Fおよび428L/434Sの相乗作用を強調している。また、図11bおよび11cは、スクリーニングから、いくつもの最良の単一置換の組み合わせの、予測不可能な性質を強調している。例えば、428Lの、434Sおよび259Iとの組み合わせが相乗的な結合の改善を提供するのに対して、252Yまたは434Mは、428Lと組み合わされると否定的な影響がある。428Lの434Sとの組み合わせと、434Mとの組み合わせとの間の著しい差異は、所与の位置での置換の特定のアミノ酸同一性の重要性をさらに強調している。
Claims (17)
- 野生型ヒトFc領域と比べて少なくとも1つの修飾を含む変異Fc領域であって、前記修飾は、252Y/428L、252Y/434S、および428L/434Sから成る群から選択され、付番はEUインデックスによる、変異体。
- 前記修飾は、428L/434Sである、請求項1に記載の変異体。
- 前記修飾は、252Y/428Lである、請求項1に記載の変異体。
- 前記修飾は、252Y/434Sである、請求項1に記載の変異体。
- 前記変異体は、抗体またはイムノアドヘシンを含み、前記Fc領域は、IgG1、IgG2、IgG3、およびIgG4から成る群から選択される、請求項1に記載の変異体。
- 前記変異体は、IgG1 Fc領域を含む、請求項5に記載の変異体。
- 前記変異体は、IgG2 Fc領域を含む、請求項5に記載の変異体。
- 前記変異体は、哺乳動物において、前記野生型Fc領域を持つ前記抗体またはイムノアドヘシンと比べて、より長い血清半減期を有する、請求項5に記載の変異体。
- 前記哺乳動物は、ヒトFcRnを発現するマウスまたは非ヒト霊長動物である、請求項8に記載の変異体。
- 前記哺乳動物は、ヒトである、請求項8に記載の変異体。
- 前記抗体またはイムノアドヘシンは、血管内皮成長因子(VEGF)、腫瘍壊死因子α(TNF−α)、CD25、上皮成長因子受容体(EGFR)、およびIgEから成る群から選択される抗原に対する特異性を有する、請求項5に記載の変異体。
- IgG2 Fc領域の変異体を含む変異抗体または変異イムノアドヘシン、であって、前記変異抗体または免疫グロブリンは、野生型IgG2 Fc領域と比べて1〜5つの修飾を含み、前記修飾のうちの少なくとも1つは、434位においてであり、付番はEUインデックスにより、哺乳動物において、前記野生型IgG2 Fc領域を持つ前記抗体またはイムノアドヘシンと比べて、より長い血清半減期を有する、変異抗体または変異イムノアドヘシン。
- 前記変異体は、434Sにおける少なくとも1つの修飾と、252位および428位から成る群から選択される位置に1つの修飾とを含む、請求項12に記載の変異体。
- 前記哺乳動物は、ヒトFcRnを発現するマウスまたは非ヒト霊長動物である、請求項12に記載の変異体。
- 前記哺乳動物は、ヒトである、請求項12に記載の変異体。
- 野生型ヒトFc領域と比べて少なくとも2つの修飾を含む変異Fc領域であって、少なくとも1つの修飾は428Lであり、少なくとも1つの修飾は、252位または434位においてであり、付番はEUインデックスによる、変異体。
- 前記Fc領域は、抗体またはイムノアドヘシンを含み、前記抗体またはイムノアドヘシンは、IgG1またはIgG2 Fc領域を含み、前記変異体は、哺乳動物において、前記野生型ヒトFc領域を持つ前記抗体またはイムノアドヘシンと比べて、より長い血清半減期を有し、前記哺乳動物は、ヒトFcRnを発現するマウス、非ヒト霊長動物、またはヒトである、請求項16に記載の変異体。
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