HRP20110171T1 - Postupak za predviđanje reakcije na liječenje inhibitorom her dimerizacije - Google Patents
Postupak za predviđanje reakcije na liječenje inhibitorom her dimerizacije Download PDFInfo
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- HRP20110171T1 HRP20110171T1 HR20110171T HRP20110171T HRP20110171T1 HR P20110171 T1 HRP20110171 T1 HR P20110171T1 HR 20110171 T HR20110171 T HR 20110171T HR P20110171 T HRP20110171 T HR P20110171T HR P20110171 T1 HRP20110171 T1 HR P20110171T1
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- 238000000034 method Methods 0.000 title claims abstract 20
- 239000004010 HER dimerization inhibitor Substances 0.000 title claims abstract 6
- 239000003550 marker Substances 0.000 claims abstract 16
- 108090000623 proteins and genes Proteins 0.000 claims abstract 13
- 102000009024 Epidermal Growth Factor Human genes 0.000 claims abstract 12
- 101800003838 Epidermal growth factor Proteins 0.000 claims abstract 12
- 229940116977 epidermal growth factor Drugs 0.000 claims abstract 12
- 239000012472 biological sample Substances 0.000 claims abstract 10
- VBEQCZHXXJYVRD-GACYYNSASA-N uroanthelone Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CS)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CS)C(=O)N[C@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CS)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(O)=O)C(C)C)[C@@H](C)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H](NC(=O)[C@H](CC=1NC=NC=1)NC(=O)[C@H](CCSC)NC(=O)[C@H](CS)NC(=O)[C@@H](NC(=O)CNC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CS)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H]1N(CCC1)C(=O)[C@H](CS)NC(=O)CNC(=O)[C@H]1N(CCC1)C(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC(N)=O)C(C)C)[C@@H](C)CC)C1=CC=C(O)C=C1 VBEQCZHXXJYVRD-GACYYNSASA-N 0.000 claims abstract 10
- 102000004169 proteins and genes Human genes 0.000 claims abstract 9
- 230000009466 transformation Effects 0.000 claims abstract 8
- IXKSXJFAGXLQOQ-XISFHERQSA-N WHWLQLKPGQPMY Chemical compound C([C@@H](C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)NCC(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(O)=O)NC(=O)[C@@H](N)CC=1C2=CC=CC=C2NC=1)C1=CNC=N1 IXKSXJFAGXLQOQ-XISFHERQSA-N 0.000 claims abstract 6
- 210000002966 serum Anatomy 0.000 claims abstract 6
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims abstract 2
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims abstract 2
- NMWKYTGJWUAZPZ-WWHBDHEGSA-N (4S)-4-[[(4R,7S,10S,16S,19S,25S,28S,31R)-31-[[(2S)-2-[[(1R,6R,9S,12S,18S,21S,24S,27S,30S,33S,36S,39S,42R,47R,53S,56S,59S,62S,65S,68S,71S,76S,79S,85S)-47-[[(2S)-2-[[(2S)-4-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-3-methylbutanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-(1H-imidazol-4-yl)propanoyl]amino]-3-phenylpropanoyl]amino]-4-oxobutanoyl]amino]-3-carboxypropanoyl]amino]-18-(4-aminobutyl)-27,68-bis(3-amino-3-oxopropyl)-36,71,76-tribenzyl-39-(3-carbamimidamidopropyl)-24-(2-carboxyethyl)-21,56-bis(carboxymethyl)-65,85-bis[(1R)-1-hydroxyethyl]-59-(hydroxymethyl)-62,79-bis(1H-imidazol-4-ylmethyl)-9-methyl-33-(2-methylpropyl)-8,11,17,20,23,26,29,32,35,38,41,48,54,57,60,63,66,69,72,74,77,80,83,86-tetracosaoxo-30-propan-2-yl-3,4,44,45-tetrathia-7,10,16,19,22,25,28,31,34,37,40,49,55,58,61,64,67,70,73,75,78,81,84,87-tetracosazatetracyclo[40.31.14.012,16.049,53]heptaoctacontane-6-carbonyl]amino]-3-methylbutanoyl]amino]-7-(3-carbamimidamidopropyl)-25-(hydroxymethyl)-19-[(4-hydroxyphenyl)methyl]-28-(1H-imidazol-4-ylmethyl)-10-methyl-6,9,12,15,18,21,24,27,30-nonaoxo-16-propan-2-yl-1,2-dithia-5,8,11,14,17,20,23,26,29-nonazacyclodotriacontane-4-carbonyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-3-carboxy-1-[[(2S)-1-[[(2S)-1-[[(1S)-1-carboxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-(1H-imidazol-4-yl)-1-oxopropan-2-yl]amino]-5-oxopentanoic acid Chemical compound CC(C)C[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@@H](NC(=O)[C@@H]2CSSC[C@@H]3NC(=O)[C@H](Cc4ccccc4)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](Cc4c[nH]cn4)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@@H]4CCCN4C(=O)[C@H](CSSC[C@H](NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](Cc4c[nH]cn4)NC(=O)[C@H](Cc4ccccc4)NC3=O)[C@@H](C)O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](Cc3ccccc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N3CCC[C@H]3C(=O)N[C@@H](C)C(=O)N2)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2c[nH]cn2)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)C(C)C)C(C)C)[C@@H](C)O)C(C)C)C(=O)N[C@@H](Cc2c[nH]cn2)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1)C(=O)N[C@@H](C)C(O)=O NMWKYTGJWUAZPZ-WWHBDHEGSA-N 0.000 claims 8
- 102000006747 Transforming Growth Factor alpha Human genes 0.000 claims 8
- 101800004564 Transforming growth factor alpha Proteins 0.000 claims 8
- 150000001413 amino acids Chemical group 0.000 claims 8
- 239000012634 fragment Substances 0.000 claims 7
- 238000006471 dimerization reaction Methods 0.000 claims 3
- 239000003112 inhibitor Substances 0.000 claims 3
- 238000006243 chemical reaction Methods 0.000 claims 2
- 239000003153 chemical reaction reagent Substances 0.000 claims 2
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 238000002965 ELISA Methods 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims 1
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 102100029986 Receptor tyrosine-protein kinase erbB-3 Human genes 0.000 claims 1
- 101710100969 Receptor tyrosine-protein kinase erbB-3 Proteins 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 239000008280 blood Substances 0.000 claims 1
- 102000052116 epidermal growth factor receptor activity proteins Human genes 0.000 claims 1
- 108700015053 epidermal growth factor receptor activity proteins Proteins 0.000 claims 1
- 238000000684 flow cytometry Methods 0.000 claims 1
- 238000005734 heterodimerization reaction Methods 0.000 claims 1
- 238000003365 immunocytochemistry Methods 0.000 claims 1
- 238000003364 immunohistochemistry Methods 0.000 claims 1
- 239000003547 immunosorbent Substances 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- YOHYSYJDKVYCJI-UHFFFAOYSA-N n-[3-[[6-[3-(trifluoromethyl)anilino]pyrimidin-4-yl]amino]phenyl]cyclopropanecarboxamide Chemical compound FC(F)(F)C1=CC=CC(NC=2N=CN=C(NC=3C=C(NC(=O)C4CC4)C=CC=3)C=2)=C1 YOHYSYJDKVYCJI-UHFFFAOYSA-N 0.000 claims 1
- 239000000523 sample Substances 0.000 claims 1
- 230000001131 transforming effect Effects 0.000 claims 1
- 239000003102 growth factor Substances 0.000 abstract 3
- 238000000844 transformation Methods 0.000 abstract 1
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Abstract
Postupak za predviđanje reakcije na liječenje pacijenata inhibitorom HER dimerizacije, naznačen time, da se sastoji od sljedećih korakaa) određivanje biološkog uzorka iz pacijenta, pri čemu biološki uzorak je krvni serum, razine ekspresije od- marker-proteina kodiranog alfa faktorom transformacije rasta marker-gena ili- kombinacije marker-proteina kodiranih marker-genima, gdje se kombinacija marker-proteina kodiranih marker-genima sastoji od marker-proteina kodiranih sa: - marker-genom alfa faktora transformacije rasta i HER2-marker-genom, - marker-genom alfa faktora transformacije rasta i marker-genom faktora epidermalnog rasta, - amfiregulin-marker-genom i marker-genom alfa faktora transformacije rasta, - marker-genom alfa faktora transformacije rasta, marker-genom faktora epidermalnog rasta i HER2-marker-genom, - amfiregulin-marker-genom, marker-genom faktora epidermalnog rasta i marker-genom alfa faktora transformacije rasta, - amfiregulin-marker-genom, marker-genom alfa faktora transformacije rasta i HER2-marker-genom, - marker-genom faktora epidermalnog rasta, marker-genom alfa faktora transformacije rasta i HER2-marker-genom, - amfiregulin-marker-genom, marker-genom faktora epidermalnog rasta, marker-genom alfa faktora transformacije rasta i HER2-marker-genom, u biološkom uzorku od pacijenta, pri čemu je biološki uzorak krvni serum, ipredviđanje reakcije na liječenje inhibitorom HER dimerizacije kod pacijenta pomoću procjene rezultata iz koraka a). Patent sadrži još 15 patentnih zahtjeva.
Claims (16)
1. Postupak za predviđanje reakcije na liječenje pacijenata inhibitorom HER dimerizacije, naznačen time, da se sastoji od sljedećih koraka
a) određivanje biološkog uzorka iz pacijenta, pri čemu biološki uzorak je krvni serum, razine ekspresije od
- marker-proteina kodiranog alfa faktorom transformacije rasta marker-gena ili
- kombinacije marker-proteina kodiranih marker-genima, gdje se kombinacija marker-proteina kodiranih marker-genima sastoji od marker-proteina kodiranih sa:
- marker-genom alfa faktora transformacije rasta i HER2-marker-genom,
- marker-genom alfa faktora transformacije rasta i marker-genom faktora epidermalnog rasta,
- amfiregulin-marker-genom i marker-genom alfa faktora transformacije rasta,
- marker-genom alfa faktora transformacije rasta, marker-genom faktora epidermalnog rasta i HER2-marker-genom,
- amfiregulin-marker-genom, marker-genom faktora epidermalnog rasta i marker-genom alfa faktora transformacije rasta,
- amfiregulin-marker-genom, marker-genom alfa faktora transformacije rasta i HER2-marker-genom,
- marker-genom faktora epidermalnog rasta, marker-genom alfa faktora transformacije rasta i HER2-marker-genom,
- amfiregulin-marker-genom, marker-genom faktora epidermalnog rasta, marker-genom alfa faktora transformacije rasta i HER2-marker-genom,
u biološkom uzorku od pacijenta, pri čemu je biološki uzorak krvni serum,
i
b) predviđanje reakcije na liječenje inhibitorom HER dimerizacije kod pacijenta pomoću procjene rezultata iz koraka a).
2. Postupak prema zahtjevu 1, naznačen time, da korak a) određivanje marker-proteina kodiranog marker-genom ili kombinacijom marker-proteina kodiranih marker-genima, sadrži
a1) određivanje razine ekspresije marker-proteina kodiranog marker-genom ili kombinacijom marker-proteina kodiranih marker-genima,
a2) utvrđivanje da li je razina ekspresije određena u koraku a1) iznad ili ispod granične vrijednosti.
3. Postupak prema zahtjevu 2, naznačen time, da je granična vrijednost utvrđena prije koraka a1) u postupku prema zahtjevu 2, pomoću
1) određivanja razine ekspresije marker-proteina kodiranog marker-genom ili kombinacijom marker-proteina kodiranih marker-genima u većem broju bioloških uzoraka, pri čemu su biološki uzorci krvni serumi, od pacijenata prije liječenja inhibitorom HER dimerizacije,
2) uspoređivanja uzajamne veze reakcije pacijenata liječenih inhibitorom HER dimerizacije s razinom ekspresije marker-proteina kodiranog marker-genom ili kombinacijom marker-proteina kodiranih marker-genima određenima u koraku a),
te time utvrđivanja granične vrijednosti.
4. Postupak prema bilo kojem zahtjevu 1 do 3, naznačen time, da inhibitor HER dimerizacije inhibira HER2 heterodimerizaciju s EGFR ili HER3.
5. Postupak prema zahtjevu 4, naznačen time, da inhibitor HER dimerizacije je protutijelo, najbolje protutijelo 2C4.
6. Postupak prema bilo kojem zahtjevu 1 do 5, naznačen time, da pacijent je tumorski pacijent, posebno pacijent od raka dojke, raka jajnika, raka pluća ili od raka prostate.
7. Postupak prema bilo kojem zahtjevu 2 do 6, naznačen time, da je razina ekspresije marker-proteina kodiranog marker-genom ili kombinacijom marker-proteina kodiranih marker-genima u uzorku koji je određen otkrivanjem razine ekspresije fragmenta marker-proteina ili fragmenata kombinacije marker-proteina kodiranih marker-genima.
8. Postupak prema bilo kojem zahtjevu 2 do 7, naznačen time, da se razina ekspresije marker-proteina ili njegovog fragmenta ili kombinacije marker-proteina ili njihovih fragmenata otkriva uporabom reagensa koji se specifično veže na marker-protein ili na njegov fragment ili na kombinaciju marker-proteina ili njihovih fragmenata.
9. Postupak prema zahtjevu 8, naznačen time, da je reagens odabran iz skupine koja se sastoji od protutijela, fragmenta protutijela ili derivata protutijela.
10. Postupak prema bilo kojem zahtjevu 2 do 9, naznačen time, da je razina ekspresije utvrđena uporabom postupka odabranog iz skupine koja se sastoji od proteomiksa, protoka citometrije, imunocitokemije, imunohistokemije, ispitivanja imunosorbenta povezanih s enzimima, ispitivanja više-kanalskog imunosorbenta povezanih s enzimima, te od varijacija ovih postupaka.
11. Postupak prema bilo kojem zahtjevu 7 do 10, naznačen time, da je fragment marker-proteina izvanstanična domena HER2-marker-proteina.
12. Postupak prema zahtjevu 11, naznačen time, da izvanstanična domena HER2-marker-proteina ima molekularnu masu od oko 105.000 Dalton-a.
13. Postupak prema bilo kojem zahtjevu 1 do 12, naznačen time, da
sekvenca amino kiseline amfiregulin-marker-proteina je sekvenca amino kiseline SEQ ID NO:1,
da sekvenca amino kiseline marker-proteina faktora epidermalnog rasta je sekvenca amino kiseline SEQ ID NO:2,
da sekvenca amino kiseline marker-proteina alfa faktora transformacije rasta je sekvenca amino kiseline SEQ ID NO: 3, ili
da sekvenca amino kiseline HER2-marker-proteina je sekvenca amino kiseline SEQ ID NO:4.
14. Postupak prema bilo kojem zahtjevu 2 do 13, naznačen time, da je granična vrijednost u krvnom serumu za
marker-protein alfa faktora transformacije rasta je između 2,0 i 5,0 pg/ml, najbolje oko 3,5 pg/ml;
marker-protein faktora epidermalnog rasta je između 100 do 250 pg/ml, najbolje oko 150 pg/ml; ili
amfiregulin-marker-protein je između 6 do 15 pg/ml, najbolje oko 12 pg/ml.
15. Postupak prema bilo kojem zahtjevu 11 do 13, naznačen time, da granična vrijednost u krvnom serumu za izvanstaničnu domenu od HER2-marker-proteina je između 12 do 22 ng/ml, najbolje oko 18 ng/ml.
16. Uporaba protutijela koje se specifično veže na marker-protein alfa faktora transformacije rasta, naznačena time, da je za predviđanje reakcije na liječenje pacijenta protutijelom 2C4.
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|---|---|---|---|
| EP05017663 | 2005-08-12 | ||
| PCT/EP2006/004950 WO2007019899A2 (en) | 2005-08-12 | 2006-05-24 | Method for predicting the response to a treatment with a her dimerization inhibitor |
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|---|---|
| HRP20110171T1 true HRP20110171T1 (hr) | 2011-04-30 |
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ID=35511140
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20110171T HRP20110171T1 (hr) | 2005-08-12 | 2011-03-09 | Postupak za predviđanje reakcije na liječenje inhibitorom her dimerizacije |
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| EP (2) | EP1915460B1 (hr) |
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| KR (2) | KR20110074921A (hr) |
| CN (2) | CN101705287A (hr) |
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| DE (1) | DE602006019265D1 (hr) |
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