HRP20221530T1 - Kombinirana terapija uporabom inhibitora ljudskog rasta i faktora diferencijacije 15 (gdf-15) te blokatora imunološke kontrolne točke - Google Patents
Kombinirana terapija uporabom inhibitora ljudskog rasta i faktora diferencijacije 15 (gdf-15) te blokatora imunološke kontrolne točke Download PDFInfo
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- 239000003112 inhibitor Substances 0.000 title claims 27
- 229940126533 immune checkpoint blocker Drugs 0.000 title claims 9
- 102000000597 Growth Differentiation Factor 15 Human genes 0.000 title 1
- 108010041834 Growth Differentiation Factor 15 Proteins 0.000 title 1
- 238000002648 combination therapy Methods 0.000 title 1
- 230000004069 differentiation Effects 0.000 title 1
- 206010028980 Neoplasm Diseases 0.000 claims 13
- 201000011510 cancer Diseases 0.000 claims 13
- 101001117317 Homo sapiens Programmed cell death 1 ligand 1 Proteins 0.000 claims 9
- 101000611936 Homo sapiens Programmed cell death protein 1 Proteins 0.000 claims 9
- 102000048776 human CD274 Human genes 0.000 claims 9
- 102000048362 human PDCD1 Human genes 0.000 claims 9
- 238000000034 method Methods 0.000 claims 9
- 125000003275 alpha amino acid group Chemical group 0.000 claims 7
- 206010009944 Colon cancer Diseases 0.000 claims 4
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 4
- 108091036414 Polyinosinic:polycytidylic acid Proteins 0.000 claims 4
- 206010060862 Prostate cancer Diseases 0.000 claims 4
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 4
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 4
- 206010017758 gastric cancer Diseases 0.000 claims 4
- 201000001441 melanoma Diseases 0.000 claims 4
- 229940115272 polyinosinic:polycytidylic acid Drugs 0.000 claims 4
- 201000011549 stomach cancer Diseases 0.000 claims 4
- 239000012270 PD-1 inhibitor Substances 0.000 claims 3
- 239000012668 PD-1-inhibitor Substances 0.000 claims 3
- 239000012271 PD-L1 inhibitor Substances 0.000 claims 3
- 210000001744 T-lymphocyte Anatomy 0.000 claims 3
- 201000010536 head and neck cancer Diseases 0.000 claims 3
- 208000014829 head and neck neoplasm Diseases 0.000 claims 3
- 230000003308 immunostimulating effect Effects 0.000 claims 3
- 230000000977 initiatory effect Effects 0.000 claims 3
- 229940121655 pd-1 inhibitor Drugs 0.000 claims 3
- 229940121656 pd-l1 inhibitor Drugs 0.000 claims 3
- 210000002966 serum Anatomy 0.000 claims 3
- 239000007787 solid Substances 0.000 claims 3
- 206010044412 transitional cell carcinoma Diseases 0.000 claims 3
- 101150013553 CD40 gene Proteins 0.000 claims 2
- 206010008342 Cervix carcinoma Diseases 0.000 claims 2
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- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 2
- 208000024313 Testicular Neoplasms Diseases 0.000 claims 2
- 206010057644 Testis cancer Diseases 0.000 claims 2
- 102100040245 Tumor necrosis factor receptor superfamily member 5 Human genes 0.000 claims 2
- 208000006105 Uterine Cervical Neoplasms Diseases 0.000 claims 2
- 201000010881 cervical cancer Diseases 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 201000007270 liver cancer Diseases 0.000 claims 2
- 208000014018 liver neoplasm Diseases 0.000 claims 2
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 2
- 201000002528 pancreatic cancer Diseases 0.000 claims 2
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- 201000003120 testicular cancer Diseases 0.000 claims 2
- 206010006187 Breast cancer Diseases 0.000 claims 1
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- 206010014733 Endometrial cancer Diseases 0.000 claims 1
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- 208000006168 Ewing Sarcoma Diseases 0.000 claims 1
- 206010027476 Metastases Diseases 0.000 claims 1
- 208000006265 Renal cell carcinoma Diseases 0.000 claims 1
- YQHZVYJAGWMHES-ZLUOBGJFSA-N Ser-Ala-Ser Chemical group OC[C@H](N)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(O)=O YQHZVYJAGWMHES-ZLUOBGJFSA-N 0.000 claims 1
- 206010041067 Small cell lung cancer Diseases 0.000 claims 1
- 208000000102 Squamous Cell Carcinoma of Head and Neck Diseases 0.000 claims 1
- 210000004556 brain Anatomy 0.000 claims 1
- 238000002619 cancer immunotherapy Methods 0.000 claims 1
- 239000013066 combination product Substances 0.000 claims 1
- 229940127555 combination product Drugs 0.000 claims 1
- 210000002889 endothelial cell Anatomy 0.000 claims 1
- 238000009169 immunotherapy Methods 0.000 claims 1
- 208000002154 non-small cell lung carcinoma Diseases 0.000 claims 1
- 201000002740 oral squamous cell carcinoma Diseases 0.000 claims 1
- 201000004228 ovarian endometrial cancer Diseases 0.000 claims 1
- 208000000587 small cell lung carcinoma Diseases 0.000 claims 1
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 claims 1
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Claims (12)
1. Inhibitor hGDF-15 za uporabu u postupku za imunoterapiju raka, postupak je postupak liječenja solidnog raka u kombinaciji s blokatorom imunoloških kontrolnih točaka kod ljudskog pacijenata, naznačen time što se inhibitor hGDF-15 treba primijeniti na ljudskog pacijenata, pri čemu je inhibitor hGDF-15 monoklonsko antitijelo sposobno vezati se na hGDF-15, ili njegov dio koji se veže na hGDF-15, i pri čemu je blokator imunološke kontrolne točke odabran iz jedne ili više sljedećih skupina koje se sastoje od:
i) inhibitora humanog PD-1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-1, ili njegov dio koji se veže na humani PD-1; i
ii) inhibitora humanog PD-L1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-L1, ili njegov dio koji se veže na humani PD-L1.
2. Inhibitor hGDF-15 za uporabu prema zahtjevu 1, naznačen time što pacijent je pacijent koji ima razinu hGDF-15 u serumu od najmanje 1.2 ng/ml prije početka primjene inhibitora hGDF-15, pri čemu je pacijent poželjno pacijent koji ima razinu hGDF-15 u serumu od najmanje 1.5 ng/ml prije početka primjene inhibitora hGDF-15, i pri čemu je poželjnije pacijent je pacijent koji ima razinu hGDF-15 u serumu od najmanje 1.8 ng/ml prije početka primjene inhibitora hGDF-15;
i/ili gdje je rak odabran iz skupine koju čine melanom, kolorektalni rak, rak prostate, rak glave i vrata, urotelni rak, rak želuca, rak gušterače, rak jetre, rak testisa, rak jajnika, rak endometrija, rak grlića maternice, rak mozga, rak dojke, rak želuca, karcinom bubrežnih stanica, Ewingov sarkom, rak pluća nemalih stanica i rak pluća malih stanica, pri čemu je rak poželjno odabran iz skupine koju čine melanom, kolorektalni rak, rak prostate, rak glave i rak vrata, urotelni rak, rak želuca, rak gušterače, rak jetre, rak testisa, rak jajnika, rak endometrija i rak grlića maternice, i gdje je rak poželjnije odabran iz skupine koju čine melanom, kolorektalni rak, rak prostate, rak glave i vrata, urotelni rak i rak želuca;
i/ili pri čemu je rak odabran iz skupine koja se sastoji od melanoma, oralnog karcinoma skvamoznih stanica, kolorektalnog raka i raka prostate.
3. Inhibitor hGDF-15 za uporabu prema bilo kojem od prethodnih zahtjeva,
naznačen time što je inhibitor monoklonsko antitijelo koje se može vezati na hGDF-15, ili njegov dio koji se veže na hGDF-15, pri čemu
(i) vezanje je vezanje na konformacijski ili diskontinuirani epitop na hGDF-15, i pri čemu se konformacijski ili diskontinuirani epitop sastoji od aminokiselinskih sekvenci SEQ ID br.: 25 i SEQ ID br.: 26, i/ili pri čemu
(ii) antitijelo ili njegov dio koji se veže na hGDF-15 sadrži varijabilnu domenu teškog lanca koja sadrži regiju CDR1 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 3, regiju CDR2 koja sadrži aminokiselinsku sekvencu SEQ ID NO: 4 i CDR3 regiju koja sadrži aminokiselinsku sekvencu SEQ ID NO: 5,
i pri čemu antitijelo ili njegov dio koji se veže na hGDF-15 sadrži varijabilnu domenu lakog lanca koja sadrži CDR1 regiju koja sadrži aminokiselinsku sekvencu SEQ ID NO: 6, CDR2 regiju koja sadrži aminokiselinsku sekvencu ser-ala-ser i CDR3 regiju koja sadrži aminokiselinsku sekvencu SEQ ID NO: 7.
4. Inhibitor hGDF-15 za uporabu prema bilo kojem od prethodnih zahtjeva,
naznačen time što postupak je postupak za liječenje metastaza raka, i/ili
pri čemu inhibitor hGDF-15 povećava postotak CD8+T-stanica u raku povećanjem adhezije CD8+T-stanica na endotelne stanice i time povećanje ulaska CD8+T-stanica iz krvotoka u rak.
5. Pripravak koji sadrži inhibitor hGDF-15 i blokator imunološke kontrolne točke, naznačen time što je inhibitor hGDF-15 monoklonsko antitijelo koje se može vezati za hGDF-15 ili njegov dio koji se veže na hGDF-15, i pri čemu je blokator imunološke kontrolne točke odabran iz jedne ili više sljedećih skupina koje se sastoje od:
i) inhibitora humanog PD-1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-1, ili njegov dio koji se veže na humani PD-1; i
ii) inhibitor humanog PD-L1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-L1, ili njegov dio koji se veže na humani PD-L1.
6. Pripravak prema zahtjevu 5, za uporabu u medicini.
7. Komplet koji sadrži inhibitor hGDF-15 i najmanje jedan blokator imunološke kontrolne točke, naznačen time što je inhibitor hGDF-15 monoklonsko antitijelo koje se može vezati za hGDF-15, ili njegov dio koji se veže na hGDF-15, i pri čemu je blokator imunološke kontrolne točke odabran je iz jedne ili više sljedećih skupina koje se sastoje od:
i) inhibitora humanog PD-1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-1, ili njegov dio koji se veže na humani PD-1; i
ii) inhibitor humanog PD-L1, inhibitor je monoklonsko antitijelo koje se može vezati na humani PD-L1, ili njegov dio koji se veže na humani PD-L1.
8. Komplet prema zahtjevu 7, naznačen time što se inhibitor hGDF-15 i jedan ili više ili svi blokatori imunoloških kontrolnih točaka nalaze u odvojenim spremnicima ili u jednom spremniku.
9. Pripravak za uporabu u medicini prema zahtjevu 6, ili komplet prema zahtjevu 7 ili 8,
za uporabu u postupku za liječenje solidnog raka, naznačen time što je postupak poželjno postupak za imunoterapiju raka i pri čemu je poželjno da je rak definiran kao u zahtjevu 2.
10. Inhibitor hGDF-15 za uporabu prema bilo kojem od zahtjeva 1-4, naznačen time što uporaba je uporaba u kombinaciji s poliinozinskom:policitidilnom kiselinom, pri čemu kombinacija je kombinacija s poliinozinskom:policitidilnom kiselinom.
11. Inhibitor hGDF-15 za uporabu prema bilo kojem od zahtjeva 1-4 i 10, naznačen time što uporaba je uporaba u kombinaciji s imuno-stimulirajućim anti-humanimCD40 antitijelom, poželjno imuno-stimulirajućim monoklonskim anti-humanimCD40 antitijelom.
12. Kombinirani proizvod koji sadrži inhibitor hGDF-15 i bilo što od sljedećeg:
a) poliinozinska:policitidilna kiselina;
b) imuno-stimulirajuće anti-humanoCD40 antitijelo, poželjno imuno-stimulirajuće monoklonsko anti-humanoCD40 antitijelo; ili
c) poliinozinska:policitidilna kiselina i imuno-stimulirajuće anti-humanoCD40 antitijelo, poželjno imuno-stimulirajuće monoklonsko anti-humanoCD40 antitijelo,
za uporabu u postupku liječenja solidnog raka u ljudskom pacijentu, pri čemu kombinacija izborno sadrži blokator imunološke kontrolne točke, i pri čemu je inhibitor monoklonsko antitijelo sposobno vezati se na hGDF-15, ili njegov dio koji se veže na hGDF-15.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB1517531.8A GB201517531D0 (en) | 2015-10-02 | 2015-10-02 | Combination therapy using inhibitors of human growth and differentiation factor 15 (GDF-15) and immune checkpoint blockers |
GBGB1607801.6A GB201607801D0 (en) | 2016-04-29 | 2016-04-29 | Combination therapy using inhibitors of human Growth and Differentiation Factor 15 (GDF-15) and immune checkpoint blockers |
PCT/EP2016/073520 WO2017055613A2 (en) | 2015-10-02 | 2016-09-30 | Combination therapy using inhibitors of human growth and differentiation factor 15 (gdf-15) and immune checkpoint blockers |
EP16778750.6A EP3355919B1 (en) | 2015-10-02 | 2016-09-30 | Combination therapy using inhibitors of human growth and differentiation factor 15 (gdf-15) and immune checkpoint blockers |
Publications (1)
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Families Citing this family (11)
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TR201910744T4 (tr) * | 2012-09-26 | 2019-08-21 | Univ Wuerzburg J Maximilians | Büyüme ve farklılaşma faktörü 15 e (gdf-15) yönelik monoklonal antikorlar. |
WO2017202936A1 (en) | 2016-05-24 | 2017-11-30 | Novo Nordisk A/S | Mic-1 compounds and use thereof |
TWI710377B (zh) | 2017-05-23 | 2020-11-21 | 丹麥商諾佛 儂迪克股份有限公司 | Mic-1化合物及其用途 |
WO2021111636A1 (ja) * | 2019-12-06 | 2021-06-10 | 大塚製薬株式会社 | 抗gdf15抗体 |
CN112162097B (zh) * | 2020-07-24 | 2022-04-01 | 广州医科大学 | Gdf1作为评估pd-1单抗治疗效果的生物标志物 |
WO2022101263A1 (en) * | 2020-11-10 | 2022-05-19 | Catalym Gmbh | Anti-gdf15 antibody and a dosage regimen for the treatment of cancer |
CN112778419A (zh) * | 2021-02-01 | 2021-05-11 | 重庆中元汇吉生物技术有限公司 | 抗ck-mb的抗体或其抗原结合部分及其应用 |
MX2023011655A (es) | 2021-03-31 | 2023-10-11 | Cambridge Entpr Ltd | Inhibidores terapeuticos de la se?alizacion de gdf15. |
AU2022328390A1 (en) | 2021-08-10 | 2024-03-21 | Adimab, Llc | Anti-gdf15 antibodies, compositions and uses thereof |
WO2023122213A1 (en) | 2021-12-22 | 2023-06-29 | Byomass Inc. | Targeting gdf15-gfral pathway cross-reference to related applications |
WO2024052532A1 (en) | 2022-09-08 | 2024-03-14 | Catalym Gmbh | Anti-gdf15 antibody used in a combination treatment of specific patient groups and a dosage regimen for the treatment of cancer |
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JP2002543841A (ja) | 1999-05-17 | 2002-12-24 | バイオファーム ゲゼルシャフト ツア バイオテクノロジシェン エントヴィックルング ウント ツム フェルトリーブ フォン ファルマカ エムベーハー | TGF−βスーパーファミリーの新規のメンバーであるGDF―15の神経保護特性 |
WO2005099746A1 (en) | 2004-04-13 | 2005-10-27 | St Vincent's Hospital Sydney Limited | Method for modulating appetite |
WO2007067500A2 (en) * | 2005-12-05 | 2007-06-14 | Genomic Health, Inc. | Predictors of patient response to treatment with egfr inhibitors |
US20100278843A1 (en) | 2007-08-16 | 2010-11-04 | St. Vincent's Hospital Sydney Limited | Agents and methods for modulating macrophage inhibitory cytokine (mic-1) activity |
CN102164959A (zh) | 2008-09-29 | 2011-08-24 | 罗氏格黎卡特股份公司 | 针对人il17的抗体及其应用 |
US9212221B2 (en) | 2010-03-03 | 2015-12-15 | Detroit R & D, Inc. | Form-specific antibodies for NAG-1 (MIC-1, GDF-15), H6D and other TGF-β subfamily and heart disease and cancer diagnoses |
US9469876B2 (en) * | 2010-04-06 | 2016-10-18 | Caris Life Sciences Switzerland Holdings Gmbh | Circulating biomarkers for metastatic prostate cancer |
WO2012162561A2 (en) * | 2011-05-24 | 2012-11-29 | Zyngenia, Inc. | Multivalent and monovalent multispecific complexes and their uses |
WO2013012648A1 (en) | 2011-07-15 | 2013-01-24 | Emory University | Gdf15 in diagnostic and therapeutic applications |
EP2807266B1 (en) * | 2012-01-26 | 2020-01-15 | Amgen Inc. | Growth differentiation factor 15 (gdf-15) polypeptides |
TR201910744T4 (tr) | 2012-09-26 | 2019-08-21 | Univ Wuerzburg J Maximilians | Büyüme ve farklılaşma faktörü 15 e (gdf-15) yönelik monoklonal antikorlar. |
DK2934584T3 (da) | 2012-12-21 | 2020-05-18 | Aveo Pharmaceuticals Inc | Anti-gdf15-antistoffer |
EP4043580A1 (en) * | 2013-03-15 | 2022-08-17 | Myriad myPath, LLC | Genes and gene signatures for diagnosis and treatment of melanoma |
US20150104470A1 (en) * | 2013-10-11 | 2015-04-16 | Neil H. Riordan | Immune modulation by peri-lymphatic or intra-lymphatic cell therapy |
WO2015108907A2 (en) | 2014-01-14 | 2015-07-23 | Dana-Farber Cancer Institute, Inc. | Compositions and methods for identification, assessment, prevention, and treatment of melanoma using pd-l1 isoforms |
HUE047398T2 (hu) * | 2014-03-26 | 2020-04-28 | Univ Wuerzburg J Maximilians | Növekedési és differenciálódási faktor 15 (GDF-15) elleni monoklonális antitestek és azok alkalmazásai rákos sorvadás és rák kezelésére |
WO2016049470A1 (en) | 2014-09-25 | 2016-03-31 | Aveo Pharmaceuticals, Inc. | Methods of reversing cachexia and prolonging survival comprising administering a gdf15 modulator and an anti-cancer agent |
TWI803682B (zh) | 2018-08-20 | 2023-06-01 | 美商輝瑞股份有限公司 | 抗-gdf15抗體、組成物及使用方法 |
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