HRP20210593T1 - Anti-her3 antitijelo-lijek konjugat - Google Patents
Anti-her3 antitijelo-lijek konjugat Download PDFInfo
- Publication number
- HRP20210593T1 HRP20210593T1 HRP20210593TT HRP20210593T HRP20210593T1 HR P20210593 T1 HRP20210593 T1 HR P20210593T1 HR P20210593T T HRP20210593T T HR P20210593TT HR P20210593 T HRP20210593 T HR P20210593T HR P20210593 T1 HRP20210593 T1 HR P20210593T1
- Authority
- HR
- Croatia
- Prior art keywords
- cancer
- ch2ch2
- succinimid
- antibody
- ggfg
- Prior art date
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- 239000000611 antibody drug conjugate Substances 0.000 title claims 18
- 229940049595 antibody-drug conjugate Drugs 0.000 title claims 18
- 206010009944 Colon cancer Diseases 0.000 claims 7
- 208000014018 liver neoplasm Diseases 0.000 claims 7
- 208000029742 colonic neoplasm Diseases 0.000 claims 5
- 201000007270 liver cancer Diseases 0.000 claims 5
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 4
- 206010028980 Neoplasm Diseases 0.000 claims 4
- 208000015634 Rectal Neoplasms Diseases 0.000 claims 4
- 206010038389 Renal cancer Diseases 0.000 claims 4
- 239000002246 antineoplastic agent Substances 0.000 claims 4
- 229940041181 antineoplastic drug Drugs 0.000 claims 4
- 201000011510 cancer Diseases 0.000 claims 4
- 208000005017 glioblastoma Diseases 0.000 claims 4
- 201000010982 kidney cancer Diseases 0.000 claims 4
- 229910052757 nitrogen Inorganic materials 0.000 claims 4
- 125000004433 nitrogen atom Chemical group N* 0.000 claims 4
- 206010038038 rectal cancer Diseases 0.000 claims 4
- 201000001275 rectum cancer Diseases 0.000 claims 4
- 206010073069 Hepatic cancer Diseases 0.000 claims 3
- 125000005647 linker group Chemical group 0.000 claims 3
- 125000001570 methylene group Chemical group [H]C([H])([*:1])[*:2] 0.000 claims 3
- 206010061424 Anal cancer Diseases 0.000 claims 2
- 208000007860 Anus Neoplasms Diseases 0.000 claims 2
- 206010005003 Bladder cancer Diseases 0.000 claims 2
- 206010006187 Breast cancer Diseases 0.000 claims 2
- 208000026310 Breast neoplasm Diseases 0.000 claims 2
- 206010008342 Cervix carcinoma Diseases 0.000 claims 2
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 2
- 206010014733 Endometrial cancer Diseases 0.000 claims 2
- 206010014759 Endometrial neoplasm Diseases 0.000 claims 2
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 2
- 206010051066 Gastrointestinal stromal tumour Diseases 0.000 claims 2
- 201000010915 Glioblastoma multiforme Diseases 0.000 claims 2
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 2
- 208000032271 Malignant tumor of penis 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
- 208000002471 Penile Neoplasms Diseases 0.000 claims 2
- 206010034299 Penile cancer Diseases 0.000 claims 2
- 206010060862 Prostate cancer Diseases 0.000 claims 2
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 2
- 208000004337 Salivary Gland Neoplasms Diseases 0.000 claims 2
- 206010061934 Salivary gland cancer Diseases 0.000 claims 2
- 208000024770 Thyroid neoplasm Diseases 0.000 claims 2
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 claims 2
- 208000002495 Uterine Neoplasms Diseases 0.000 claims 2
- 206010047741 Vulval cancer Diseases 0.000 claims 2
- 208000004354 Vulvar Neoplasms Diseases 0.000 claims 2
- 208000030002 adult glioblastoma Diseases 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 125000003277 amino group Chemical group 0.000 claims 2
- 230000000259 anti-tumor effect Effects 0.000 claims 2
- 201000011165 anus cancer Diseases 0.000 claims 2
- 201000010881 cervical cancer Diseases 0.000 claims 2
- 210000001072 colon Anatomy 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 201000004101 esophageal cancer Diseases 0.000 claims 2
- 201000011243 gastrointestinal stromal tumor 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
- 206010073071 hepatocellular carcinoma 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
- 201000001441 melanoma Diseases 0.000 claims 2
- 201000002528 pancreatic cancer Diseases 0.000 claims 2
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 2
- 201000002628 peritoneum cancer Diseases 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 201000002510 thyroid cancer Diseases 0.000 claims 2
- 206010044412 transitional cell carcinoma Diseases 0.000 claims 2
- 201000005112 urinary bladder cancer Diseases 0.000 claims 2
- 206010046766 uterine cancer Diseases 0.000 claims 2
- 201000005102 vulva cancer Diseases 0.000 claims 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 210000004899 c-terminal region Anatomy 0.000 claims 1
- 125000002915 carbonyl group Chemical group [*:2]C([*:1])=O 0.000 claims 1
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 206010017758 gastric cancer Diseases 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 210000004185 liver Anatomy 0.000 claims 1
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 210000002784 stomach Anatomy 0.000 claims 1
- 201000011549 stomach cancer Diseases 0.000 claims 1
Classifications
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- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
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Claims (19)
1. Antitijelo-lijek konjugat pri čemu je spoj protiv tumora predstavljen sljedećom formulom
[image]
je konjugirano sa anti-HER3 antitijelom pomoću tioetarske veze koja se formira na segmentu disulfidne veze prisutnom u zglobnom dijelu anti-HER3 antitijela preko veznika koji ima strukturu predstavljenu sljedećom formulom:
-L1-L2-LP-NH- (CH2)n1-La-(CH2)n2-C(=O)- ili -L1-L2-LP-
pri čemu, anti-HER3 antitijelo je povezano za terminal od L1,
spoj protiv tumora je povezan za karbonil grupu -(CH2)n2-C(=O)- segmenta ili C terminal od LP, atomom dušika amino grupe na položaju 1 kao položaju vezivanja, pri čemu, n1 predstavlja cijeli broj 0 do 6,
n2 predstavlja cijeli broj 0 do 5,
L1 predstavlja -(Sukcinimid-3-il-N)-(CH2)n3-C(=O)-,
pri čemu n3 predstavlja cijeli broj 2 do 8,
L2 predstavlja -NH-(CH2CH2-O)n4-CH2CH2-C(=O)- ili jednostruku vezu, pri čemu n4 predstavlja cijeli broj 1 do 6,
LP predstavlja tetrapeptidni ostatak -GGFG- ili pentapeptidni ostatak -DGGFG-,
La predstavlja -O- ili jednostruku vezu,
-(Sukcinimid-3-il-N)- ima strukturu predstavljenu sljedećom formulom:
[image]
koja je povezana sa anti-HER3 antitijelom na svom položaju 3 i povezana je sa metilenskom grupom u strukturi veznika koja sadrži ovu strukturu na atomu dušika na položaju 1.
2. Antitijelo-lijek konjugat prema patentnom zahtjevu 1, pri čemu lijek-veznik strukturni segment u kojem je lijek povezan sa -L1-L2-LP-NH-(CH2)n1-La-(CH2)n2-C(=O)- ili -L1-L2-LP- je jedna lijek-veznik struktura odabrana iz sljedeće grupe:
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-D X),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(N H-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(= O)-(NH-DX),
-(Sukcinimid-3-il-N) -CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2C H2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-NH-CH2CH2-C( =O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-NH-CH2CH2CH2 -C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-NH-CH2CH2CH2 CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-C H2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2 -C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2 -C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2 -O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2 -O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-GGFG-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-DGGFG-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-(NH-DX);
pri čemu, -(Sukcinimid-3-il-N)- ima strukturu predstavljenu sljedećom formulom:
[image]
koja je povezana sa anti-HER3 antitijelom na svom položaju 3 i povezana je sa metilenskom grupom u strukturi veznika koja sadrži ovu strukturu na atomu dušika na položaju 1,
-(NH-DX) predstavlja grupu predstavljenu sljedećom formulom, sa atomom dušika amino grupe na položaju 1 koji je položaj vezivanja,
[image]
-GGFG- predstavlja tetrapeptidni ostatak od -Gly-Gly-Phe-Gly-i -DGGFG- predstavlja pentapeptidni ostatak od -Asp-Gly-Gly-Phe-Gly-.
3. Antitijelo-lijek konjugat prema patentnom zahtjevu 2, pri čemu segment lijek-veznik strukture je jedna lijek-veznik struktura odabrana iz sljedeće grupe:
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-NH-CH2CH2CH2 -C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2O-CH2CH2O-CH2CH2-C (=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX),
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-(NH-DX).
4. Antitijelo-lijek konjugat prema patentnom zahtjevu 3, gdje je lijek-veznik struktura:
-(Sukcinimid-3-il-N) -CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
5. Antitijelo-lijek konjugat prema patentnom zahtjevu 3, gdje je lijek-veznik struktura:
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-NH-CH2CH2CH2 -C(=O)-(NH-DX).
6. Antitijelo-lijek konjugat prema patentnom zahtjevu 3, gdje je lijek-veznik struktura:
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX).
7. Antitijelo-lijek konjugat prema patentnom zahtjevu 3, gdje je lijek-veznik struktura:
-(Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2O-CH2CH2O-CH2CH2-C (=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
8. Antitijelo-lijek konjugat prema patentnom zahtjevu 3, gdje je lijek-veznik struktura:
-(Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-DGGFG-(NH-DX).
9. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 8, gdje anti-HER3 antitijelo sadrži CDRH1 do CDRH3 i CDRL1 do CDRL3 od U1-49, U1-53, U1-59, U1-7 ili U1-9 u teškim i lakim lancima, redom.
10. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 8, gdje anti-HER3 antitijelo sadrži varijabilnu regiju teškog lanca i varijabilni lanac lakog lanca od U1-49, U1-53, U1-59, U1-7 ili U1-9 na teškim i lakim lancima, redom.
11. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 8, gdje anti-HER3 antitijelo sadrži aminokiselinske sekvence predstavljene pomoću SEQ ID No: 42 i 44, SEQ ID No: 54 i 56, SEQ ID No: 70 i 72, SEQ ID No: 92 i 94, ili, SEQ ID No: 96 i 98, u teškim i lakim lancima, redom.
12. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 8, gdje anti-HER3 antitijelo sadrži aminokiselinske sekvence predstavljene pomoću SEQ ID No: 583 i 584 u teškim i lakim lancima, redom.
13. Antitijelo-lijek konjugat prema patentnom zahtjevu 12, gdje anti-HER3 antitijelu nedostaje lizin ostatak na karboksilnom terminusu teškog lanca.
14. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 13, gdje prosječan broj jedinica odabrane lijek-veznik strukture konjugirane po antitijelu je u opsegu od 2 do 8.
15. Antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 13, gdje prosječan broj jedinica odabrane lijek-veznik strukture konjugirane po antitijelu je u opsegu od 3 do 8.
16. Lijek protiv tumora i/ili lijek protiv raka koji sadrži antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 15, sol istog ili hidrat istog.
17. Lijek protiv tumora i/ili lijek protiv raka prema patentnom zahtjevu 16, za primjenu u liječenju raka pluća, raka bubrega, urotelijalnog raka, kolorektalnog raka, raka prostate, glioblastoma multiforme, raka jajnika, raka gušterače, raka dojke, melanoma, raka jetre, raka mokraćnog mjehura, raka želuca, gastrointestinalnog stromalnog tumora, raka grlića materice, raka glave i vrata, raka jednjaka, epidermoidnog raka, peritonealnog raka, adultnog glioblastoma multiforme, raka jetre, hepatocelularnog raka, raka debelog crijeva, rektalnog raka, raka debelog crijeva i rektuma, raka endometrija, raka materice, raka žlijezda slinovnica, renalnog raka, raka vulve, tiroidnog raka, hepatičnog raka, raka anusa, ili raka penisa.
18. Farmaceutska kompozicija koja sadrži antitijelo-lijek konjugat prema bilo kojem od patentnih zahtjeva 1 do 15, sol istog ili hidrat istog kao aktivni sastojak, i farmaceutski prihvatljiv sastojak formulacije.
19. Farmaceutska kompozicija prema patentnom zahtjevu 18, za primjenu u liječenju raka pluća, raka bubrega, urotelijalnog raka, kolorektalnog raka, raka prostate, glioblastoma multiforme, raka jajnika, raka gušterače, raka dojke, melanoma, raka jetre, raka mokraćnog mjehura, raka želuca, gastrointestinalnog stromalnog tumora, raka grlića materice, raka glave i vrata, raka jednjaka, epidermoidnog raka, peritonealnog raka, adultnog glioblastoma multiforme, hepatičnog raka, hepatocelularnog raka, raka debelog crijeva, rektalnog raka, raka debelog crijeva i rektuma, raka endometrija, raka materice, raka žlijezda slinovnica, renalnog raka, raka vulve, tiroidnog raka, hepatičnog raka, raka anusa, ili raka penisa.
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EP15719011.7A EP3129063B1 (en) | 2014-04-10 | 2015-04-10 | Anti-her3 antibody-drug conjugate |
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