JP2012522512A5 - - Google Patents
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- JP2012522512A5 JP2012522512A5 JP2012503679A JP2012503679A JP2012522512A5 JP 2012522512 A5 JP2012522512 A5 JP 2012522512A5 JP 2012503679 A JP2012503679 A JP 2012503679A JP 2012503679 A JP2012503679 A JP 2012503679A JP 2012522512 A5 JP2012522512 A5 JP 2012522512A5
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- JP
- Japan
- Prior art keywords
- antibody
- seq
- immunoconjugate
- sequence
- amino acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 102000004965 antibodies Human genes 0.000 claims description 83
- 108090001123 antibodies Proteins 0.000 claims description 83
- 125000003275 alpha amino acid group Chemical group 0.000 claims description 24
- 102100008382 FCRL5 Human genes 0.000 claims description 10
- 101700031417 FCRL5 Proteins 0.000 claims description 10
- 235000018417 cysteine Nutrition 0.000 claims description 9
- -1 cysteine amino acids Chemical class 0.000 claims description 8
- 235000001014 amino acid Nutrition 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 2
- 108010027440 Immunoconjugates Proteins 0.000 claims 27
- 102000018748 Immunoconjugates Human genes 0.000 claims 27
- 239000003814 drug Substances 0.000 claims 13
- 229940079593 drugs Drugs 0.000 claims 11
- 206010029592 Non-Hodgkin's lymphomas Diseases 0.000 claims 7
- 230000001472 cytotoxic Effects 0.000 claims 5
- 231100000433 cytotoxic Toxicity 0.000 claims 5
- 125000005647 linker group Chemical group 0.000 claims 5
- 230000035693 Fab Effects 0.000 claims 4
- 239000008177 pharmaceutical agent Substances 0.000 claims 4
- 239000000523 sample Substances 0.000 claims 4
- 239000000126 substance Substances 0.000 claims 4
- 239000000611 antibody drug conjugate Substances 0.000 claims 3
- 108091008116 antibody drug conjugates Proteins 0.000 claims 3
- 210000004027 cells Anatomy 0.000 claims 3
- 108010045030 monoclonal antibodies Proteins 0.000 claims 3
- 102000005614 monoclonal antibodies Human genes 0.000 claims 3
- GXJABQQUPOEUTA-RDJZCZTQSA-N Bortezomib Chemical compound C([C@@H](C(=O)N[C@@H](CC(C)C)B(O)O)NC(=O)C=1N=CC=NC=1)C1=CC=CC=C1 GXJABQQUPOEUTA-RDJZCZTQSA-N 0.000 claims 2
- 206010008958 Chronic lymphocytic leukaemia Diseases 0.000 claims 2
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims 2
- 206010024324 Leukaemias Diseases 0.000 claims 2
- 208000000429 Leukemia, Lymphocytic, Chronic, B-Cell Diseases 0.000 claims 2
- DASWEROEPLKSEI-UIJRFTGLSA-N Monomethyl auristatin E Chemical compound CN[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H]([C@@H](C)CC)[C@H](OC)CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@H](C)[C@@H](O)C1=CC=CC=C1 DASWEROEPLKSEI-UIJRFTGLSA-N 0.000 claims 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
- 201000005510 acute lymphocytic leukemia Diseases 0.000 claims 2
- 239000002246 antineoplastic agent Substances 0.000 claims 2
- 229960001467 bortezomib Drugs 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 239000003153 chemical reaction reagent Substances 0.000 claims 2
- 125000000151 cysteine group Chemical group N[C@@H](CS)C(=O)* 0.000 claims 2
- 238000001514 detection method Methods 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 239000007850 fluorescent dye Substances 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 229920000023 polynucleotide Polymers 0.000 claims 2
- 239000002157 polynucleotide Substances 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 230000002062 proliferating Effects 0.000 claims 2
- JJAHTWIKCUJRDK-UHFFFAOYSA-N succinimidyl 4-(N-maleimidomethyl)cyclohexane-1-carboxylate Chemical compound C1CC(CN2C(C=CC2=O)=O)CCC1C(=O)ON1C(=O)CCC1=O JJAHTWIKCUJRDK-UHFFFAOYSA-N 0.000 claims 2
- 230000001225 therapeutic Effects 0.000 claims 2
- NFGXHKASABOEEW-UHFFFAOYSA-N (+)-methoprene Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 1
- VQZYZXLBKBUOHE-UHFFFAOYSA-N (2,5-dioxopyrrolidin-1-yl) 3-(pyridin-2-yldisulfanyl)butanoate Chemical compound C=1C=CC=NC=1SSC(C)CC(=O)ON1C(=O)CCC1=O VQZYZXLBKBUOHE-UHFFFAOYSA-N 0.000 claims 1
- MFRNYXJJRJQHNW-DEMKXPNLSA-N (2S)-2-[[(2R,3R)-3-methoxy-3-[(2S)-1-[(3R,4S,5S)-3-methoxy-5-methyl-4-[methyl-[(2S)-3-methyl-2-[[(2S)-3-methyl-2-(methylamino)butanoyl]amino]butanoyl]amino]heptanoyl]pyrrolidin-2-yl]-2-methylpropanoyl]amino]-3-phenylpropanoic acid Chemical compound CN[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H]([C@@H](C)CC)[C@H](OC)CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@H](C(O)=O)CC1=CC=CC=C1 MFRNYXJJRJQHNW-DEMKXPNLSA-N 0.000 claims 1
- VWUXBMIQPBEWFH-WCCTWKNTSA-N (7R,8R,9S,13S,14S,17S)-13-methyl-7-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)nonyl]-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,17-diol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3[C@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)CC2=C1 VWUXBMIQPBEWFH-WCCTWKNTSA-N 0.000 claims 1
- GHASVSINZRGABV-UHFFFAOYSA-N 5-flurouricil Chemical compound FC1=CNC(=O)NC1=O GHASVSINZRGABV-UHFFFAOYSA-N 0.000 claims 1
- AOJJSUZBOXZQNB-TZSSRYMLSA-N ADRIAMYCIN Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 1
- OMNVYXHOSHNURL-WPRPVWTQSA-N Ala-Phe Chemical compound C[C@H](N)C(=O)N[C@H](C(O)=O)CC1=CC=CC=C1 OMNVYXHOSHNURL-WPRPVWTQSA-N 0.000 claims 1
- 229940064734 Aminobenzoate Drugs 0.000 claims 1
- YBBLVLTVTVSKRW-UHFFFAOYSA-N Anastrozole Chemical compound N#CC(C)(C)C1=CC(C(C)(C#N)C)=CC(CN2N=CN=C2)=C1 YBBLVLTVTVSKRW-UHFFFAOYSA-N 0.000 claims 1
- 229940064005 Antibiotic throat preparations Drugs 0.000 claims 1
- 229940083879 Antibiotics FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE Drugs 0.000 claims 1
- 229940042052 Antibiotics for systemic use Drugs 0.000 claims 1
- 229940042786 Antitubercular Antibiotics Drugs 0.000 claims 1
- BFYIZQONLCFLEV-DAELLWKTSA-N Aromasine Chemical compound O=C1C=C[C@]2(C)[C@H]3CC[C@](C)(C(CC4)=O)[C@@H]4[C@@H]3CC(=C)C2=C1 BFYIZQONLCFLEV-DAELLWKTSA-N 0.000 claims 1
- MLDQJTXFUGDVEO-UHFFFAOYSA-N BAY-43-9006 Chemical compound C1=NC(C(=O)NC)=CC(OC=2C=CC(NC(=O)NC=3C=C(C(Cl)=CC=3)C(F)(F)F)=CC=2)=C1 MLDQJTXFUGDVEO-UHFFFAOYSA-N 0.000 claims 1
- 108010005144 Bevacizumab Proteins 0.000 claims 1
- 108010071919 Bispecific Antibodies Proteins 0.000 claims 1
- ANRHNWWPFJCPAZ-UHFFFAOYSA-M CHEMBL593252 Chemical compound [Cl-].C1=CC(N)=CC2=[S+]C3=CC(N)=CC=C3N=C21 ANRHNWWPFJCPAZ-UHFFFAOYSA-M 0.000 claims 1
- 229960004562 Carboplatin Drugs 0.000 claims 1
- OLESAACUTLOWQZ-UHFFFAOYSA-L Carboplatin Chemical compound O=C1O[Pt]([N]([H])([H])[H])([N]([H])([H])[H])OC(=O)C11CCC1 OLESAACUTLOWQZ-UHFFFAOYSA-L 0.000 claims 1
- 108010022830 Cetuximab Proteins 0.000 claims 1
- 229940064701 Corticosteroid nasal preparations for topical use Drugs 0.000 claims 1
- 229960001334 Corticosteroids Drugs 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 claims 1
- 108090000695 Cytokines Proteins 0.000 claims 1
- 229960003957 Dexamethasone Drugs 0.000 claims 1
- UREBDLICKHMUKA-CXSFZGCWSA-N Dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 1
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N Docetaxel Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims 1
- 229960004679 Doxorubicin Drugs 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- AAKJLRGGTJKAMG-UHFFFAOYSA-N Erlotinib Chemical compound C=12C=C(OCCOC)C(OCCOC)=CC2=NC=NC=1NC1=CC=CC(C#C)=C1 AAKJLRGGTJKAMG-UHFFFAOYSA-N 0.000 claims 1
- 229960001433 Erlotinib Drugs 0.000 claims 1
- 229960002949 Fluorouracil Drugs 0.000 claims 1
- 229960002258 Fulvestrant Drugs 0.000 claims 1
- 229940093922 Gynecological Antibiotics Drugs 0.000 claims 1
- 229960003444 IMMUNOSUPPRESSANTS Drugs 0.000 claims 1
- KTUFNOKKBVMGRW-UHFFFAOYSA-N Imatinib Chemical compound C1CN(C)CCN1CC1=CC=C(C(=O)NC=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)C=C1 KTUFNOKKBVMGRW-UHFFFAOYSA-N 0.000 claims 1
- RCINICONZNJXQF-MZXODVADSA-N Intaxel Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims 1
- UWKQSNNFCGGAFS-XIFFEERXSA-N Irinotecan Chemical compound C1=C2C(CC)=C3CN(C(C4=C([C@@](C(=O)OC4)(O)CC)C=4)=O)C=4C3=NC2=CC=C1OC(=O)N(CC1)CCC1N1CCCCC1 UWKQSNNFCGGAFS-XIFFEERXSA-N 0.000 claims 1
- RHGKLRLOHDJJDR-BYPYZUCNSA-N L-citrulline zwitterion Chemical compound NC(=O)NCCC[C@H]([NH3+])C([O-])=O RHGKLRLOHDJJDR-BYPYZUCNSA-N 0.000 claims 1
- 239000005517 L01XE01 - Imatinib Substances 0.000 claims 1
- 239000005551 L01XE03 - Erlotinib Substances 0.000 claims 1
- 239000005511 L01XE05 - Sorafenib Substances 0.000 claims 1
- 239000002136 L01XE07 - Lapatinib Substances 0.000 claims 1
- BCFGMOOMADDAQU-UHFFFAOYSA-N Lapatinib Chemical compound O1C(CNCCS(=O)(=O)C)=CC=C1C1=CC=C(N=CN=C2NC=3C=C(Cl)C(OCC=4C=C(F)C=CC=4)=CC=3)C2=C1 BCFGMOOMADDAQU-UHFFFAOYSA-N 0.000 claims 1
- GOTYRUGSSMKFNF-UHFFFAOYSA-N Lenalidomide Chemical compound C1C=2C(N)=CC=CC=2C(=O)N1C1CCC(=O)NC1=O GOTYRUGSSMKFNF-UHFFFAOYSA-N 0.000 claims 1
- HPJKCIUCZWXJDR-UHFFFAOYSA-N Letrozole Chemical compound C1=CC(C#N)=CC=C1C(N1N=CN=C1)C1=CC=C(C#N)C=C1 HPJKCIUCZWXJDR-UHFFFAOYSA-N 0.000 claims 1
- 206010024325 Leukaemic lymphoma Diseases 0.000 claims 1
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- 206010025323 Lymphomas Diseases 0.000 claims 1
- 206010026798 Mantle cell lymphomas Diseases 0.000 claims 1
- SGDBTWWWUNNDEQ-LBPRGKRZSA-N Melphalan Chemical compound OC(=O)[C@@H](N)CC1=CC=C(N(CCCl)CCCl)C=C1 SGDBTWWWUNNDEQ-LBPRGKRZSA-N 0.000 claims 1
- WMZYAQQKYLKWGI-UHFFFAOYSA-N ON1C(=O)CCC1=O.OC(=O)CCCSSC1=CC=CC=N1 Chemical compound ON1C(=O)CCC1=O.OC(=O)CCCSSC1=CC=CC=N1 WMZYAQQKYLKWGI-UHFFFAOYSA-N 0.000 claims 1
- 206010025310 Other lymphomas Diseases 0.000 claims 1
- 229960001592 Paclitaxel Drugs 0.000 claims 1
- 108010004729 Phycoerythrin Proteins 0.000 claims 1
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N Prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 1
- PYWVYCXTNDRMGF-UHFFFAOYSA-N Rhodamine B Chemical compound [Cl-].C=12C=CC(=[N+](CC)CC)C=C2OC2=CC(N(CC)CC)=CC=C2C=1C1=CC=CC=C1C(O)=O PYWVYCXTNDRMGF-UHFFFAOYSA-N 0.000 claims 1
- 229960001603 Tamoxifen Drugs 0.000 claims 1
- NKANXQFJJICGDU-QPLCGJKRSA-N Tamoxifen Chemical compound C=1C=CC=CC=1C(/CC)=C(C=1C=CC(OCCN(C)C)=CC=1)/C1=CC=CC=C1 NKANXQFJJICGDU-QPLCGJKRSA-N 0.000 claims 1
- MPLHNVLQVRSVEE-UHFFFAOYSA-N Texas Red Chemical compound [O-]S(=O)(=O)C1=CC(S(Cl)(=O)=O)=CC=C1C(C1=CC=2CCCN3CCCC(C=23)=C1O1)=C2C1=C(CCC1)C3=[N+]1CCCC3=C2 MPLHNVLQVRSVEE-UHFFFAOYSA-N 0.000 claims 1
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- 108010011559 alanylphenylalanine Proteins 0.000 claims 1
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- XXXHSQBVHSJQKS-UHFFFAOYSA-N amino benzoate Chemical compound NOC(=O)C1=CC=CC=C1 XXXHSQBVHSJQKS-UHFFFAOYSA-N 0.000 claims 1
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- 239000004037 angiogenesis inhibitor Substances 0.000 claims 1
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- YBJHBAHKTGYVGT-ZKWXMUAHSA-N biotin Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)O)SC[C@@H]21 YBJHBAHKTGYVGT-ZKWXMUAHSA-N 0.000 claims 1
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- 125000001295 dansyl group Chemical group [H]C1=C([H])C(N(C([H])([H])[H])C([H])([H])[H])=C2C([H])=C([H])C([H])=C(C2=C1[H])S(*)(=O)=O 0.000 claims 1
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- GNBHRKFJIUUOQI-UHFFFAOYSA-N fluorescein Chemical group O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C=C1OC1=CC(O)=CC=C21 GNBHRKFJIUUOQI-UHFFFAOYSA-N 0.000 claims 1
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Images
Description
一態様では、FcRH5と結合する抗体であって、以下からなる群から選択される少なくとも1、2、3、4、5または6つのHVRを含む抗体を提供する:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3。
他の一実施形態では、HVR−H2は、配列番号36の配列を有する。別の実施形態では、抗体は、ヒトκ亜群1共通フレームワーク配列を含む。他の一実施形態では、抗体は、重鎖ヒト亜群III共通フレームワーク配列を含む。別の実施形態では、抗体は、配列番号19から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する軽鎖可変ドメインを含む。一実施形態では、抗体は、配列番号21から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する重鎖可変ドメインを含む。別の実施形態では、抗体は、配列番号19から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する軽鎖可変ドメインを含む。
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3。
他の一実施形態では、HVR−H2は、配列番号36の配列を有する。別の実施形態では、抗体は、ヒトκ亜群1共通フレームワーク配列を含む。他の一実施形態では、抗体は、重鎖ヒト亜群III共通フレームワーク配列を含む。別の実施形態では、抗体は、配列番号19から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する軽鎖可変ドメインを含む。一実施形態では、抗体は、配列番号21から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する重鎖可変ドメインを含む。別の実施形態では、抗体は、配列番号19から選択されるアミノ酸配列と少なくとも90%のアミノ酸配列同一性を有する軽鎖可変ドメインを含む。
一態様では、本発明は、1つ以上の遊離システインアミノ酸を含むシステイン操作された抗FcRH5抗体であって、FcRH5ポリペプチドと結合し、親抗FcRH5抗体の1つ以上のアミノ酸残基をシステインに置き換えることを包含するプロセスにより調製されるシステイン操作された抗FcRH5抗体を包含するが、ここで、親抗体は、以下から選択される少なくとも1つのHVR配列を含む:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3。
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3。
一態様では、FcRH5と結合する抗体であって、以下のものを含む抗体が提供される:
(a)以下の:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3
からなる群から選択される少なくとも1、2、3、4、5または6つのHVR。
一実施形態では、本発明の抗体のHVR−L1は、配列番号26の配列を含む。一実施形態では、本発明の抗体のHVR−L2は、配列番号27の配列を含む。一実施形態では、本発明の抗体のHVR−L3は、配列番号28の配列を含む。一実施形態では、本発明の抗体のHVR−H1は、配列番号35の配列を含む。一実施形態では、本発明の抗体のHVR−H2は、配列番号36の配列を含む。一実施形態では、本発明の抗体のHVR−H3は、配列番号37の配列を含む。一実施形態では、(本明細書中に記載されるような組合せで)これらの配列を含む本発明の抗体は、ヒト化またはヒト抗体である。
(a)以下の:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3
からなる群から選択される少なくとも1、2、3、4、5または6つのHVR。
一実施形態では、本発明の抗体のHVR−L1は、配列番号26の配列を含む。一実施形態では、本発明の抗体のHVR−L2は、配列番号27の配列を含む。一実施形態では、本発明の抗体のHVR−L3は、配列番号28の配列を含む。一実施形態では、本発明の抗体のHVR−H1は、配列番号35の配列を含む。一実施形態では、本発明の抗体のHVR−H2は、配列番号36の配列を含む。一実施形態では、本発明の抗体のHVR−H3は、配列番号37の配列を含む。一実施形態では、(本明細書中に記載されるような組合せで)これらの配列を含む本発明の抗体は、ヒト化またはヒト抗体である。
一態様では、FcRH5と結合する抗体であって、以下のものを含む抗体が提供される:
(a)以下の:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3
からなる群から選択される少なくとも1、2、3、4、5または6つのHVR;ならびに
(b)変異体HVR配列は、配列番号26、27、28、69、70または71で示される配列の少なくとも1つの残基の修飾を含む、少なくとも1つの変異体HVR。一実施形態では、本発明の抗体のHVR−L1は、配列番号26の配列を含む。一実施形態では、本発明の抗体のHVR−L2は、配列番号27の配列を含む。一実施形態では、本発明の抗体のHVR−L3は、配列番号28の配列を含む。一実施形態では、本発明の抗体のHVR−H1は、配列番号35の配列を含む。一実施形態では、本発明の抗体のHVR−H2は、配列番号36の配列を含む。一実施形態では、本発明の抗体のHVR−H3は、配列番号37の配列を含む。一実施形態では、(本明細書中に記載されるような組合せで)これらの配列を含む本発明の抗体は、ヒト化またはヒト抗体である。
(a)以下の:
(i)配列KASQDVSTAVA(配列番号26)を含むHVR−L1
(ii)配列SASYRYT(配列番号27)を含むHVR−L2
(iii)配列QQHFSSPRT(配列番号28)を含むHVR−L3
(iv)配列GFTFSSYAVS(配列番号69)を含むHVR−H1
(v)配列ATISSGGSLTFYLDSVR(配列番号70)を含むHVR−H2
(vi)配列PIPDYYALDY(配列番号71)を含むHVR−H3
からなる群から選択される少なくとも1、2、3、4、5または6つのHVR;ならびに
(b)変異体HVR配列は、配列番号26、27、28、69、70または71で示される配列の少なくとも1つの残基の修飾を含む、少なくとも1つの変異体HVR。一実施形態では、本発明の抗体のHVR−L1は、配列番号26の配列を含む。一実施形態では、本発明の抗体のHVR−L2は、配列番号27の配列を含む。一実施形態では、本発明の抗体のHVR−L3は、配列番号28の配列を含む。一実施形態では、本発明の抗体のHVR−H1は、配列番号35の配列を含む。一実施形態では、本発明の抗体のHVR−H2は、配列番号36の配列を含む。一実施形態では、本発明の抗体のHVR−H3は、配列番号37の配列を含む。一実施形態では、(本明細書中に記載されるような組合せで)これらの配列を含む本発明の抗体は、ヒト化またはヒト抗体である。
Claims (61)
- 以下の(a)及び(b)を含む単離された抗FcRH5モノクローナル抗体:
(a)(i)、(ii)及び(iii)を含む軽鎖可変領域:
(i)配列番号26の配列を含むHVR−L1;
(ii)配列番号27の配列を含むHVR−L2;
(iii)配列番号28の配列を含むHVR−L3;
(b)(vi)、(v)及び(vi)を含む重鎖可変領域:
(iv)配列番号35の配列を含むHVR−H1;
(v)配列番号36の配列を含むHVR−H2;
(vi)配列番号37の配列を含むHVR−H3。 - Fab、Fab’−SH、Fv、scFvまたは(Fab’)2断片である請求項1記載の抗体。
- ヒト化されている請求項1記載の抗体。
- キメラ抗体である請求項1記載の抗体。
- 抗体がフレームワーク配列を含み、前記フレームワーク配列の少なくとも一部がヒト共通フレームワーク配列である請求項1記載の抗体。
- ヒトκ亜群1共通フレームワーク配列を含む請求項1記載の抗体。
- 重鎖ヒト亜群III共通フレームワーク配列を含む請求項1記載の抗体。
- 重鎖可変領域が配列番号40のアミノ酸配列を含む請求項1記載の抗体。
- 軽鎖可変領域が配列番号30のアミノ酸配列を含む請求項1記載の抗体。
- 軽鎖可変領域が配列番号30のアミノ酸配列を含む請求項8記載の抗体。
- Fc領域に連結される単一Fab領域を含む請求項1記載の抗体。
- 抗体が配列番号38のアミノ酸配列を含むCH1、および/または配列番号39のアミノ酸配列を含むFc配列を含む請求項10記載の抗体。
- 抗体が配列番号29のアミノ酸配列を含むCL1配列を含む請求項12記載の抗体。
- (a)抗体の重鎖可変ドメインおよび請求項1の抗体の軽鎖可変ドメインを含む抗体を発現する細胞を培養するプロセス;ならびに
(b)前記培養細胞から抗体を単離するプロセス
により製造される、抗FcRH5モノクローナル抗体。 - 1つ以上の遊離システインアミノ酸を含む請求項1記載の抗体。
- 1つ以上の遊離システインアミノ酸が、0.6〜1.0の範囲のチオ反応性値を有する請求項15記載の抗体。
- 1つ以上の遊離システインアミノ酸残基が軽鎖中に位置する請求項15記載の抗体。
- 重鎖配列が配列番号42のアミノ酸配列を含む請求項15記載の抗体。
- 軽鎖配列が配列番号41のアミノ酸配列を含む請求項18記載の抗体。
- 重鎖配列が配列番号44のアミノ酸配列を含む請求項15記載の抗体。
- 軽鎖配列が配列番号43のアミノ酸配列を含む請求項20記載の抗体。
- 遊離システインアミノ酸が、カバット番号付け規約による軽鎖の位置205、114、および/または400にある請求項15記載の抗体。
- 請求項1記載の抗体と同一のエピトープに結合する単離された抗体。
- 抗体が一価であり、Fc領域を含む請求項1記載の抗体。
- 二重特異性抗体である請求項1記載の抗体。
- CD3に特異的に結合する請求項25記載の抗体。
- 請求項1−26のいずれかに記載の抗体をコードするポリヌクレオチド。
- 請求項27記載のポリヌクレオチドを含むベクター。
- 請求項28記載のベクターを含む宿主細胞。
- 細胞傷害性物質と共有結合される請求項1−26のいずれかに記載の抗体を含む免疫接合体。
- 細胞傷害性物質が、毒素、化学療法薬、薬剤部分、抗生物質、放射性同位体および核酸分解酵素から選択される請求項30記載の免疫接合体。
- 捕捉標識、検出標識または固体支持体に共有結合される請求項1−26のいずれかに記載の抗体を含む免疫接合体。
- 抗体がビオチン捕捉標識に共有結合される請求項32記載の免疫接合体。
- 抗体が蛍光染料検出標識に共有結合される請求項32記載の免疫接合体。
- 蛍光染料が、フルオレセイン型、ローダミン型、ダンシル、リサミン、シアニン、フィコエリトリン、テキサスレッドおよびその類似体から選択される請求項34記載の免疫接合体。
- 抗体が、3H、11C、14C、18F、32P、35S、64Cu、68Ga、86Y、99Tc、111In、123I、124I、125I、131I、133Xe、177Lu、211Atおよび213Biから選択される放射性核種検出標識に共有結合される請求項32記載の免疫接合体。
- 式Ab−(L−D)p を有する免疫接合体であって:
(a)Abは請求項1記載の抗体であり;
(b)Lはリンカーであり;
(c)Dは薬剤部分であり;及び
(d)pは1から8である、
免疫接合体。 - Lが、6−マレイミドカプロイル(MC)、マレイミドプロパノイル(MP)、バリン−シトルリン(val−cit)、アラニン−フェニルアラニン(ala−phe)、p−アミノベンジルオキシカルボニル(PAB)、N−スクシンイミジル4−(2−ピリジルチオ)ペンタノエート(SPP)、N−スクシンイミジル4−(N−マレイミドメチル)シクロヘキサン−1カルボキシレート(SMCC)、4−(2−ピリジルジチオ)酪酸−N−ヒドロキシスクシンイミドエステル(SPDB)およびN−スクシンイミジル(4−ヨード−アセチル)アミノベンゾエート(SIAB)から選択される請求項37記載の免疫接合体。
- Dが、アウリスタチンまたはドロスタチンであり、Dは以下の式D E またはD F の薬剤部分である請求項37記載の免疫接合体:
(式中、R 2 およびR 6 は、各々、メチルであり、R 3 およびR 4 は、各々、イソプロピルであり、R 7 は、sec−ブチルであり、R 8 の各存在は、−CH 3 、−O−CH 3 、−OHおよびHであり、R 9 は、Hであり、R 10 は、アリールであり、Zは、−O−または−NH−であり、R 11 は、H、C 1 −C 8 アルキルまたは−(CH 2 ) 2 −O−(CH 2 ) 2 −O−(CH 2 ) 2 −O−CH 3 であり、R 18 は、−C(R 8 ) 2 −C(R 8 ) 2 −アリールである。) - DがMMAEおよびMMAFから選択される請求項37記載の免疫接合体。
- 免疫接合体が式Ab−(L−MMAE) p を有する請求項37記載の免疫接合体(式中、pは2から5である)。
- 免疫接合体が式Ab−(L−MMAF) p を有する請求項37記載の免疫接合体(式中、pは2から5である)。
- Lがval−cit、MC、PABおよび/またはMC−PABを含む請求項41記載の免疫接合体。
- Lがval−cit、MC、PABおよび/またはMC−PABを含む請求項42記載の免疫接合体。
- Dがメイタンシノイドであり、メイタンシノイドがDM1、DM3およびDM4から選択される請求項37記載の免疫接合体。
- 請求項1−26のいずれかに記載の抗体または請求項37−46のいずれかに記載の免疫接合体、および製薬上許容可能な担体を含む薬学的組成物。
- FcRH5を発現する細胞の増殖の抑制するための医薬剤の調整における請求項1−26のいずれかに記載の抗体または請求項37−46のいずれかに記載の免疫接合体の使用。
- 抗体が細胞障害性物質に接合している請求項48記載の使用。
- 医薬剤がさらに有効量の別の治療薬を含む請求項48記載の使用。
- 増殖性障害を治療するための医薬剤の調整における請求項1−26のいずれかに記載の抗体または請求項37−46のいずれかに記載の免疫接合体の使用。
- 前記増殖性障害が癌である請求項51記載の使用。
- 前記癌が、リンパ腫、非ホジキンリンパ腫(NHL)、攻撃性NHL、再発性攻撃性NHL、再発性無痛性NHL、難治性NHL、難治性無痛性NHL、慢性リンパ性白血病(CLL)、小リンパ球性リンパ腫、白血病、有毛細胞白血病(HCL)、急性リンパ性白血病(ALL)およびマントル細胞リンパ腫から選択される請求項52記載の使用。
- 抗体が細胞障害性物質に接合している請求項51記載の使用。
- 医薬剤がさらに有効量の別の治療薬を含む請求項51記載の使用。
- 治療薬が、抗体、化学療法薬、細胞傷害性物質、抗血管新生剤、免疫抑制剤、プロドラッグ、サイトカイン、サイトカインアンタゴニスト、細胞傷害性放射線療法、コルチコステロイド、抗嘔吐薬、癌ワクチン、鎮痛薬または増殖阻害剤からなる群から選択される請求項55記載の使用。
- 治療薬が、ベルケード、レブリミド、タモキシフェン、レトロゾール、エキセメスタン、アナストロゾール、イリノテカン、セツキシマブ、フルベストラント、ビノレルビン、エルロチニブ、ベカシズマブ、ビンクリスチン、イマチニブ、ソラフェニブ、ラパチニブまたはトラスツズマブ、シスプラチン、ゲムシタビン、メトトレキセート、ビンブラスチン、カルボプラチン、パクリタキセル、ペメトレキセド、5−フルオロウラシル、ドキソルビシン、ボルテゾミブ、レナリドミド、メルファラン、プレドニソン、デキサメタゾンまたはドセタキセルからなる群から選択される請求項55記載の使用。
- FcRH5を含有することが推測される生物学的試料中のFcRH5の存在の確定するためのin vitroでの方法であって、前記試料を請求項1−26のいずれかに記載の抗体にin vitroで曝露すること、ならびに前記抗体と前記試料中のFcRH5との結合を確定することを包含し、ここで、前記抗体の前記試料中のFcRH5への結合が前記試料中の前記タンパク質の存在を示す方法。
- 請求項1−26のいずれかに記載の抗FcRH5抗体(Ab)、およびアウリスタチンまたはマイタンシノイド薬剤部分(D)を含む抗体−薬剤接合体であって、抗体が1つ以上のシステインアミノ酸を介して、リンカー部分(L)によりDに結合され;当該化合物が式I:
Ab−(L−D)p I
(式中、pは1、2、3または4である)
を有する抗体−薬剤接合体の製造方法であって、
(a)抗体の操作されたシステイン基をリンカー試薬と反応させて抗体−リンカー中間体Ab−Lを形成することと;
(b)Ab−Lを活性化薬剤部分Dと反応させて、それにより抗体−薬剤接合体が形成されるステップ
を包含するか、あるいは
(c)薬剤部分の求核性基をリンカー試薬と反応させて、薬剤−リンカー中間体D−Lを形成することと;
(d)D−Lを抗体の操作されたシステイン基と反応させて、それにより抗体−薬剤接合体を形成するステップ
を包含する方法。 - 式Ab−(L−D) p を有する免疫接合体であって、
(a)Abは以下を含む単離された抗FcRH5モノクローナル抗体である抗体であり:
i.aないしcを含む軽鎖可変領域:
a.配列番号26のアミノ酸配列を含むHVR−L1;
b.配列番号27のアミノ酸配列を含むHVR−L2;
c.配列番号28のアミノ酸配列を含むHVR−L3;
ii.aないしcを含む重鎖可変領域:
a.配列番号35のアミノ酸配列を含むHVR−H1;
b.配列番号36のアミノ酸配列を含むHVR−H2;
c.配列番号37のアミノ酸配列を含むHVR−H3;
(b)LはMC−VC−PABであるリンカーであり;
(c)DはMMAEである薬剤部分であり;および
(d)pは1から8である
免疫接合体。 - 重鎖可変領域が配列番号40のアミノ酸配列を含み、軽鎖可変領域が配列番号30のアミノ酸配列を含む請求項60記載の免疫接合体。
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