JP2023179713A5 - - Google Patents
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- JP2023179713A5 JP2023179713A5 JP2023178591A JP2023178591A JP2023179713A5 JP 2023179713 A5 JP2023179713 A5 JP 2023179713A5 JP 2023178591 A JP2023178591 A JP 2023178591A JP 2023178591 A JP2023178591 A JP 2023178591A JP 2023179713 A5 JP2023179713 A5 JP 2023179713A5
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- 125000003275 alpha amino acid group Chemical group 0.000 claims 47
- 239000008194 pharmaceutical composition Substances 0.000 claims 16
- 239000000611 antibody drug conjugate Substances 0.000 claims 14
- 229940049595 antibody-drug conjugate Drugs 0.000 claims 14
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 12
- 239000012634 fragment Substances 0.000 claims 12
- 206010028980 Neoplasm Diseases 0.000 claims 11
- 239000000427 antigen Substances 0.000 claims 11
- 102000036639 antigens Human genes 0.000 claims 11
- 108091007433 antigens Proteins 0.000 claims 11
- 201000011510 cancer Diseases 0.000 claims 11
- 125000000539 amino acid group Chemical group 0.000 claims 8
- IEDXPSOJFSVCKU-HOKPPMCLSA-N [4-[[(2S)-5-(carbamoylamino)-2-[[(2S)-2-[6-(2,5-dioxopyrrolidin-1-yl)hexanoylamino]-3-methylbutanoyl]amino]pentanoyl]amino]phenyl]methyl N-[(2S)-1-[[(2S)-1-[[(3R,4S,5S)-1-[(2S)-2-[(1R,2R)-3-[[(1S,2R)-1-hydroxy-1-phenylpropan-2-yl]amino]-1-methoxy-2-methyl-3-oxopropyl]pyrrolidin-1-yl]-3-methoxy-5-methyl-1-oxoheptan-4-yl]-methylamino]-3-methyl-1-oxobutan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]-N-methylcarbamate Chemical compound CC[C@H](C)[C@@H]([C@@H](CC(=O)N1CCC[C@H]1[C@H](OC)[C@@H](C)C(=O)N[C@H](C)[C@@H](O)c1ccccc1)OC)N(C)C(=O)[C@@H](NC(=O)[C@H](C(C)C)N(C)C(=O)OCc1ccc(NC(=O)[C@H](CCCNC(N)=O)NC(=O)[C@@H](NC(=O)CCCCCN2C(=O)CCC2=O)C(C)C)cc1)C(C)C IEDXPSOJFSVCKU-HOKPPMCLSA-N 0.000 claims 7
- 108010093470 monomethyl auristatin E Proteins 0.000 claims 7
- 206010005003 Bladder cancer Diseases 0.000 claims 6
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 6
- 201000005112 urinary bladder cancer Diseases 0.000 claims 6
- 210000004408 hybridoma Anatomy 0.000 claims 4
- 125000006850 spacer group Chemical group 0.000 claims 3
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 208000026310 Breast neoplasm Diseases 0.000 claims 2
- 206010009944 Colon cancer Diseases 0.000 claims 2
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 2
- 206010030155 Oesophageal carcinoma Diseases 0.000 claims 2
- 206010033128 Ovarian cancer Diseases 0.000 claims 2
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 2
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 2
- 229960002173 citrulline Drugs 0.000 claims 2
- 208000029742 colonic neoplasm Diseases 0.000 claims 2
- 201000004101 esophageal cancer Diseases 0.000 claims 2
- 201000010536 head and neck cancer Diseases 0.000 claims 2
- 208000014829 head and neck neoplasm Diseases 0.000 claims 2
- 201000005202 lung cancer Diseases 0.000 claims 2
- 208000020816 lung neoplasm Diseases 0.000 claims 2
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 2
- 201000002528 pancreatic cancer Diseases 0.000 claims 2
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 2
- 229910052717 sulfur Inorganic materials 0.000 claims 2
- 125000004434 sulfur atom Chemical group 0.000 claims 2
- KXDHJXZQYSOELW-UHFFFAOYSA-N Carbamic acid Chemical group NC(O)=O KXDHJXZQYSOELW-UHFFFAOYSA-N 0.000 claims 1
- RHGKLRLOHDJJDR-BYPYZUCNSA-N L-citrulline Chemical compound NC(=O)NCCC[C@H]([NH3+])C([O-])=O RHGKLRLOHDJJDR-BYPYZUCNSA-N 0.000 claims 1
- RHGKLRLOHDJJDR-UHFFFAOYSA-N Ndelta-carbamoyl-DL-ornithine Natural products OC(=O)C(N)CCCNC(N)=O RHGKLRLOHDJJDR-UHFFFAOYSA-N 0.000 claims 1
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Natural products CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims 1
- 235000013477 citrulline Nutrition 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 230000001394 metastastic effect Effects 0.000 claims 1
- 206010061289 metastatic neoplasm Diseases 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 210000004881 tumor cell Anatomy 0.000 claims 1
- 239000004474 valine Substances 0.000 claims 1
- 125000002987 valine group Chemical group [H]N([H])C([H])(C(*)=O)C([H])(C([H])([H])[H])C([H])([H])[H] 0.000 claims 1
Claims (29)
- モノメチルアウリスタチンE（MMAE）に結合された抗191P4D12抗体またはその抗原結合フラグメントを含む、抗体薬物結合体であって、該抗体またはその抗原結合フラグメントが以下を含む、抗体薬物結合体：
(i) SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、およびSEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3を含む軽鎖可変領域であって、該軽鎖可変領域が、SEQ ID NO:8に示された軽鎖可変領域アミノ酸配列と少なくとも85％、86％、87％、88％、89％、90％、91％、92％、93％、94％、95％、96％、97％、98％または99％同一のアミノ酸配列を含む、軽鎖可変領域、
(ii) SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、SEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3、およびSEQ ID NO:8のアミノ酸残基23～アミノ酸残基130を含む軽鎖可変領域、
(iii)SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、SEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3、およびSEQ ID NO:8のアミノ酸残基23～アミノ酸残基236を含む軽鎖、
(iv) SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、SEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3、およびAmerican Type Culture Collection(ATCC)アクセッション番号PTA-11267で寄託されたハイブリドーマによって産生された抗体の軽鎖可変領域のアミノ酸配列を含む軽鎖可変領域、
(v) SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、SEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3、およびATCCアクセッション番号PTA-11267で寄託されたハイブリドーマによって産生された抗体の軽鎖のアミノ酸配列を含む軽鎖、
(vi) SEQ ID NO:7の45～52の範囲のアミノ酸配列を含む重鎖可変領域相補性決定領域1(CDRH1)、SEQ ID NO:7の70～77の範囲のアミノ酸配列を含むCDRH2、およびSEQ ID NO:7の116～125の範囲のアミノ酸配列を含むCDRH3を含む重鎖可変領域であって、該重鎖可変領域が、SEQ ID NO:7に示された重鎖可変領域アミノ酸配列と少なくとも85％、86％、87％、88％、89％、90％、91％、92％、93％、94％、95％、96％、97％、98％または99％同一のアミノ酸配列を含む、重鎖可変領域、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3、
(vii) SEQ ID NO:7のアミノ酸残基20～アミノ酸残基136を含む重鎖可変領域、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3、
(viii) SEQ ID NO:7のアミノ酸残基20～アミノ酸残基466を含む重鎖、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3、
(ix) ATCCアクセッション番号PTA-11267で寄託されたハイブリドーマによって産生された抗体の重鎖可変領域のアミノ酸配列を含む重鎖可変領域、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3、または
(x) ATCCアクセッション番号PTA-11267で寄託されたハイブリドーマによって産生された抗体の重鎖のアミノ酸配列を含む重鎖、ならびにSEQ ID NO:8の49～54の範囲のアミノ酸配列を含む軽鎖可変領域相補性決定領域1(CDRL1)、SEQ ID NO:8の72～74の範囲のアミノ酸配列を含むCDRL2、およびSEQ ID NO:8の111～119の範囲のアミノ酸配列を含むCDRL3。 - 抗原結合フラグメントが、Fab、F(ab') 2 、Fv、またはscFvフラグメントである、請求項1記載の抗体薬物結合体。
- 抗体が完全ヒト抗体である、請求項1記載の抗体薬物結合体。
- 抗体またはその抗原結合フラグメントが、組換えにより産生された、請求項1～3のいずれか一項記載の抗体薬物結合体。
- 抗体またはその抗原結合フラグメントが、リンカーを介してMMAEに結合された、請求項1～4のいずれか一項記載の抗体薬物結合体。
- リンカーがバリン-シトルリンを含む、請求項5記載の抗体薬物結合体。
- リンカーが、酵素切断可能リンカーであり、該リンカーユニットが、抗体またはその抗原結合フラグメントの硫黄原子との結合を形成する、請求項5または6記載の抗体薬物結合体。
- リンカーが、式-A a -W w -Y y -を有し；
-A-がストレッチャーユニットであり、aが0または1であり；-W-がアミノ酸ユニットであり、wが0～12の範囲の整数であり；且つ-Y-がスペーサーユニットであり、yが0、1、または2であり；
該ストレッチャーユニットが、以下の式（1）の構造：
を有し；該アミノ酸ユニットが、バリン シトルリンであり；且つ該スペーサーユニットが、以下の式（2）の構造：
を有するPAB基であり；
該ストレッチャーユニットが、抗体またはその抗原結合フラグメントの硫黄原子との結合を形成し；且つ
該スペーサーユニットが、カルバメート基を介してMMAEに結合された、
請求項5～7のいずれか一項記載の抗体薬物結合体。 - 前記抗体またはその抗原結合フラグメント当たり1ユニット～10ユニットのMMAEを含む、請求項1～8のいずれか一項記載の抗体薬物結合体。
- 前記抗体またはその抗原結合フラグメント当たり2ユニット～5ユニットのMMAEを含む、請求項1～9のいずれか一項記載の抗体薬物結合体。
- 前記抗体またはその抗原結合フラグメント当たり3ユニット～5ユニットのMMAEを含む、請求項1～10のいずれか一項記載の抗体薬物結合体。
- 以下の構造：
を有し、
式中、L-が抗191P4D12抗体またはその抗原結合フラグメントを示し、pが1～10の範囲である、請求項1～11のいずれか一項記載の抗体薬物結合体。 - pが3～5である、請求項12記載の抗体薬物結合体。
- ヒト用単位剤形で、治療的有効量の請求項1～13のいずれか一項記載の抗体薬物結合体および薬学的に許容される賦形剤を含む、薬学的組成物。
- pが約3.8である、請求項14記載の薬学的組成物。
- 対象の癌を予防または治療するための、請求項14または15記載の薬学的組成物。
- 癌が191P4D12を発現する腫瘍細胞を含む、請求項16記載の薬学的組成物。
- 対象がヒト対象である、請求項16または17記載の薬学的組成物。
- 癌が、結腸癌、卵巣癌、食道癌、頭頚部癌、膵臓癌、肺癌、膀胱癌、または乳癌である、請求項16～18のいずれか一項記載の薬学的組成物。
- 癌が膵臓癌である、請求項19記載の薬学的組成物。
- 癌が肺癌である、請求項19記載の薬学的組成物。
- 癌が膀胱癌である、請求項19記載の薬学的組成物。
- 癌が乳癌である、請求項19記載の薬学的組成物。
- 癌が結腸癌である、請求項19記載の薬学的組成物。
- 癌が卵巣癌である、請求項19記載の薬学的組成物。
- 癌が食道癌である、請求項19記載の薬学的組成物。
- 癌が頭頚部癌である、請求項19記載の薬学的組成物。
- 膀胱癌が進行した膀胱癌である、請求項22記載の薬学的組成物。
- 膀胱癌が転移性の膀胱癌である、請求項22または28記載の薬学的組成物。
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US38793310P | 2010-09-29 | 2010-09-29 | |
| US61/387,933 | 2010-09-29 | ||
| JP2020110083A JP7042872B2 (ja) | 2010-09-29 | 2020-06-26 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2022039841A JP7370405B2 (ja) | 2010-09-29 | 2022-03-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022039841A Division JP7370405B2 (ja) | 2010-09-29 | 2022-03-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023179713A JP2023179713A (ja) | 2023-12-19 |
| JP2023179713A5 true JP2023179713A5 (ja) | 2024-04-05 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2013531875A Active JP6083871B2 (ja) | 2010-09-29 | 2011-09-29 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2016243252A Withdrawn JP2017110002A (ja) | 2010-09-29 | 2016-12-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207295A Pending JP2019031563A (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207044A Pending JP2019055958A (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207426A Active JP6726258B2 (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2020110083A Active JP7042872B2 (ja) | 2010-09-29 | 2020-06-26 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2022039841A Active JP7370405B2 (ja) | 2010-09-29 | 2022-03-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2023178591A Pending JP2023179713A (ja) | 2010-09-29 | 2023-10-17 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
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| JP2013531875A Active JP6083871B2 (ja) | 2010-09-29 | 2011-09-29 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2016243252A Withdrawn JP2017110002A (ja) | 2010-09-29 | 2016-12-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207295A Pending JP2019031563A (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207044A Pending JP2019055958A (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2018207426A Active JP6726258B2 (ja) | 2010-09-29 | 2018-11-02 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2020110083A Active JP7042872B2 (ja) | 2010-09-29 | 2020-06-26 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
| JP2022039841A Active JP7370405B2 (ja) | 2010-09-29 | 2022-03-15 | １９１ｐ４ｄ１２タンパク質に結合する抗体薬物結合体（ａｄｃ） |
Country Status (29)
| Country | Link |
|---|---|
| US (8) | US8637642B2 (ja) |
| EP (3) | EP3903812A1 (ja) |
| JP (8) | JP6083871B2 (ja) |
| KR (9) | KR20130130709A (ja) |
| CN (2) | CN103402538B (ja) |
| AU (1) | AU2011312417B2 (ja) |
| BR (1) | BR112013007309B1 (ja) |
| CA (1) | CA2811644C (ja) |
| CY (2) | CY1121023T1 (ja) |
| DK (2) | DK3409287T5 (ja) |
| EA (2) | EA027887B1 (ja) |
| ES (2) | ES2680624T3 (ja) |
| FR (1) | FR22C1050I2 (ja) |
| HK (1) | HK1256964A1 (ja) |
| HR (1) | HRP20181154T8 (ja) |
| HU (3) | HUE054855T2 (ja) |
| IL (5) | IL311145A (ja) |
| LT (2) | LT2621526T (ja) |
| MX (4) | MX337873B (ja) |
| NL (1) | NL301198I2 (ja) |
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