HRP20230504T1 - Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma - Google Patents
Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma Download PDFInfo
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- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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Claims (18)
1. Inhibitor signalizacije receptora aktivina tipa II (ActRII) za upotrebu u postupku liječenja mijelodisplastičnih sindroma (MDS) kod subjekta, pri čemu postupak obuhvaća:
(a) određivanje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti; i
(b) davanje subjektu farmaceutski učinkovite doze inhibitora signalizacije ActRII između 0,1 mg/kg i 2,0 mg/kg, ako je najmanje 15%, 16%, 17%, 18%, 19% ili 20% od eritroblasta kod subjekta prstenasti sideroblasti,
pri čemu je navedeni inhibitor signalizacije ActRII polipeptid koji sadrži:
(i) aminokiselinsku sekvencu koja je najmanje 90% identična sa SEQ ID NO:7;
(ii) aminokiselinsku sekvencu koja je najmanje 95% identična sa SEQ ID NO:7;
(iii) aminokiselinsku sekvencu koja je najmanje 98% identična sa SEQ ID NO:7;
(iv) aminokiselinsku sekvencu SEQ ID NO:7;
(v) aminokiselinsku sekvencu koja je najmanje 90% identična sa SEQ ID NO:25;
(vi) aminokiselinsku sekvencu koja je najmanje 95% identična sa SEQ ID NO:25;
(vii) aminokiselinsku sekvencu koja je najmanje 98% identična sa SEQ ID NO:25;
(viii) aminokiselinsku sekvencu SEQ ID NO:25; ili
(ix) fragment izvanstanične domene ActRIIB, pri čemu se fragment sastoji od aminokiselinske sekvence SEQ ID NO:23; poveznice; i Fc od IgG.
2. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1, naznačen time što se postupkom postiže:
(a) dugoročno smanjenje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti u usporedbi s početnim postotkom eritroblasta kod subjekta koji su prstenasti sideroblasti, pri čemu dugoročno smanjenje je smanjenje postotka eritroblasta koje se održava najmanje 1, 2, 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII; i/ili
(b) dugotrajno povećanje razine hemoglobina kod subjekta u usporedbi s početnom razinom hemoglobina kod subjekta, pri čemu je početna razina hemoglobina kod subjekta razina hemoglobina kod subjekta u vremenskom razdoblju prije davanja subjektu početne dozu inhibitora signalizacije ActRII; pri čemu dugoročno povećanje je povećanje razine hemoglobina koje se održava najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon vremenskog razdoblja primjene inhibitora signalizacije ActRII.
3. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što se inhibitor signalizacije ActRII primjenjuje u kratkom vremenskom periodu, i pri čemu je kratki vremenski period 1, 2, 3, 4 ili 5 mjeseci.
4. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što postupak nadalje obuhvaća:
(c) određivanje drugog postotka eritroblasta kod subjekta koji su prstenasti sideroblasti nakon određenog vremenskog razdoblja, izborno pri čemu je vremenski period 1, 2, 3, 4, 5 ili 6 mjeseci; i
(d) izborno davanje subjektu prilagođene doze inhibitora signalizacije ActRII.
5. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1 ili 2, naznačen time što postupak nadalje obuhvaća:
(c) određivanje razine hemoglobina kod subjekta nakon što je subjektu primijenjen inhibitor signalizacije ActRII, izborno pri čemu se razina hemoglobina određuje unutar 6, 12, 18 i/ili 24 mjeseca nakon što je primijenjen inhibitor signalizacije ActRII; i
(d) prekid primjene inhibitora signalizacije ActRII subjektu, ako je razina hemoglobina kod subjekta najmanje 11 g/dL.
6. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 1, naznačen time što se postotak eritroblasta kod subjekta koji su prstenasti sideroblasti određuje unutar 1 dana, 2 dana, 3 dana, 4 dana, 5 dana, 6 dana, 1 tjedna, 2 tjedana, 3 tjedna, 4 tjedna, 5 tjedana, 6 tjedana, 7 tjedana, 8 tjedana, 3 mjeseca, 4 mjeseca, 5 mjeseci ili 6 mjeseci davanja subjektu farmaceutski učinkovite doze inhibitora signalizacije ActRII.
7. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 2, naznačen time što je dugoročno smanjenje postotka eritroblasta kod subjekta koji su prstenasti sideroblasti najmanje 1,5, 2,5, 5,0, 7,5 ili 10,0 puta ispod početnog postotka eritroblasta kod subjekta koji su prstenasti sideroblasti najmanje 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
8. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 2, naznačen time što je dugotrajno povećanje razine hemoglobina kod subjekta razina hemoglobina između oko 11 g/dL i 18 g/dL kod subjekta tijekom najmanje 3, 4 , 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
9. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 3, naznačen time što
(i) prvi postotak eritroblasta koji su prstenasti sideroblasti kod subjekta kojemu je primijenjen inhibitor signalizacije ActRII tijekom kratkog vremenskog razdoblja smanjen je na manje od 10%, 9%, 8%, 7%, 6%, 5%, 4 %, 3%, 2% ili manje od 1% tijekom najmanje 6, 12, 18 ili 24 mjeseca nakon kratkog vremenskog razdoblja primjene inhibitora signalizacije ActRII; i/ili
(ii) razina hemoglobina kod subjekta kojem je primijenjen inhibitor signalizacije ActRII u kratkom vremenskom razdoblju je između oko 11 g/dL i 18 g/dL tijekom najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon razdoblja primjene inhibitora signalizacije ActRII.
10. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 9, naznačen time što subjekt ima povećanu vjerojatnost postizanja normalizacije jednog ili više hematoloških parametara, ako je najmanje 15%, 16%, 17%, 18%, 19 % ili 20% eritroblasta kod subjekta, prstenasti sideroblasti u usporedbi sa subjektom koji ima najviše 15% eritroblasta koji su prstenasti sideroblasti.
11. Inhibitor signalizacije ActRII za upotrebu prema zahtjevu 10, naznačen time što je hematološki parametar razina hemoglobina, hematokrit, broj crvenih krvnih stanica ili postotak eritroblasta kod subjekta koji su prstenasti sideroblasti.
12. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 11, naznačen time što kod subjekta nije potrebna transfuzija crvenih krvnih stanica najmanje 3, 4, 5, 6, 12, 18 ili 24 mjeseca nakon vremenskog razdoblja primjene inhibitora signalizacije ActRII.
13. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 12, naznačen time što se inhibitor signalizacije ActRII primjenjuje:
(i) jednom svaka tri tjedna;
(ii) jednom svakih 28 dana; ili
(iii) jednom svaka 42 dana.
14. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 13, naznačen time što se inhibitor signalizacije ActRII primjenjuje putem injekcije, po izboru pri čemu je injekcija potkožna.
15. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži aminokiselinsku sekvencu SEQ ID NO:25.
16. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži aminokiselinsku sekvencu SEQ ID NO:7.
17. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 14, naznačen time što je inhibitor signalizacije ActRII polipeptid koji sadrži fragment izvanstanične domene od ActRIIB, pri čemu se fragment sadrži aminokiselinsku sekvencu SEQ ID NO:23; poveznicu; i Fc od IgG.
18. Inhibitor signalizacije ActRII za upotrebu prema bilo kojem od zahtjeva 1 do 17, pri čemu je subjekt čovjek.
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462086977P | 2014-12-03 | 2014-12-03 | |
| US201462088478P | 2014-12-05 | 2014-12-05 | |
| US201562153872P | 2015-04-28 | 2015-04-28 | |
| US201562173782P | 2015-06-10 | 2015-06-10 | |
| US201562218728P | 2015-09-15 | 2015-09-15 | |
| PCT/US2015/063595 WO2016090077A1 (en) | 2014-12-03 | 2015-12-03 | Activin-actrii antagonists and uses for treating anemia |
| EP15865213.1A EP3227675B1 (en) | 2014-12-03 | 2015-12-03 | Activin-actrii antagonists and uses for treating myelodysplastic syndrome |
Publications (1)
| Publication Number | Publication Date |
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| HRP20230504T1 true HRP20230504T1 (hr) | 2023-09-15 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230504TT HRP20230504T1 (hr) | 2014-12-03 | 2015-12-03 | Antagonisti aktivin-actrii i upotreba u liječenju mijelodisplastičnog sindroma |
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| Country | Link |
|---|---|
| US (1) | US11471510B2 (hr) |
| EP (2) | EP3227675B1 (hr) |
| JP (2) | JP2018501307A (hr) |
| KR (1) | KR102556991B1 (hr) |
| CN (1) | CN107533040B (hr) |
| AU (2) | AU2015358469B2 (hr) |
| BR (1) | BR112017011722A2 (hr) |
| CA (1) | CA2969572A1 (hr) |
| CY (1) | CY1126033T1 (hr) |
| DK (1) | DK3227675T3 (hr) |
| ES (1) | ES2946160T3 (hr) |
| FI (1) | FI3227675T3 (hr) |
| HK (1) | HK1248807A1 (hr) |
| HR (1) | HRP20230504T1 (hr) |
| HU (1) | HUE062189T2 (hr) |
| IL (1) | IL252631B2 (hr) |
| LT (1) | LT3227675T (hr) |
| MD (1) | MD4801C1 (hr) |
| NZ (1) | NZ770419A (hr) |
| PL (1) | PL3227675T3 (hr) |
| PT (1) | PT3227675T (hr) |
| RS (1) | RS64214B1 (hr) |
| SI (1) | SI3227675T1 (hr) |
| SM (1) | SMT202300166T1 (hr) |
| TW (2) | TWI773117B (hr) |
| WO (1) | WO2016090077A1 (hr) |
Families Citing this family (26)
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| US8216997B2 (en) | 2008-08-14 | 2012-07-10 | Acceleron Pharma, Inc. | Methods for increasing red blood cell levels and treating anemia using a combination of GDF traps and erythropoietin receptor activators |
| KR20220156979A (ko) | 2012-11-02 | 2022-11-28 | 셀진 코포레이션 | 골 및 다른 장애를 치료하기 위한 액티빈-actrii 길항제 및 용도 |
| MA41052A (fr) | 2014-10-09 | 2017-08-15 | Celgene Corp | Traitement d'une maladie cardiovasculaire à l'aide de pièges de ligands d'actrii |
| MA41119A (fr) | 2014-12-03 | 2017-10-10 | Acceleron Pharma Inc | Méthodes de traitement de syndromes myélodysplasiques et d'anémie sidéroblastique |
| SMT202300166T1 (it) | 2014-12-03 | 2023-07-20 | Celgene Corp | Antagonisti di attivina- actrii e usi per il trattamento di sindrome mielodisplastica |
| MX2017013520A (es) | 2015-04-22 | 2018-05-22 | Alivegen Usa Inc | Nuevas proteinas hibridas de bloqueo del ligando actriib para tratar enfermedades de atrofia muscular. |
| EP3298034A4 (en) | 2015-05-20 | 2019-02-13 | Celgene Corporation | IN VITRO CELL CULTURE PROCEDURE FOR BETA THALASSEMIA BY MEANS OF ACTIVIN TYPE II RECEPTOR LIGANDS |
| US11123430B2 (en) | 2015-11-04 | 2021-09-21 | Acceleron Pharma Inc. | Methods for increasing red blood cell levels and treating ineffective erythropoiesis |
| KR20180096645A (ko) | 2015-11-23 | 2018-08-29 | 악셀레론 파마 인코포레이티드 | 눈 질환의 치료 방법 |
| EA201990226A1 (ru) | 2016-07-27 | 2019-08-30 | Акселерон Фарма Инк. | Способы и композиции для лечения миелофиброза |
| WO2018022982A1 (en) * | 2016-07-29 | 2018-02-01 | Trustees Of Boston University | Age-associated clonal hematopoiesis accelerates cardio-metabolic disease development |
| CN110036025B (zh) | 2016-10-05 | 2024-03-22 | 阿塞勒隆制药公司 | 变体ActRIIB蛋白及其用途 |
| JOP20190085A1 (ar) | 2016-10-20 | 2019-04-17 | Biogen Ma Inc | طرق علاج الضمور العضلي ومرض العظام باستخدام بروتينات احتجاز مركب ترابطي actriib هجين حديثة |
| CN119591692A (zh) | 2016-11-10 | 2025-03-11 | 科乐斯疗法公司 | 激活素受体iia型变体及其使用方法 |
| HRP20241477T1 (hr) | 2017-06-14 | 2025-01-03 | Celgene Corporation | Postupci liječenja mijeloproliferativne neoplazme povezane s mijelofibrozom i anemijom |
| AU2018364668B2 (en) | 2017-11-09 | 2024-05-30 | Keros Therapeutics, Inc. | Activin receptor type lla variants and methods of use thereof |
| KR20200109330A (ko) | 2018-01-12 | 2020-09-22 | 케로스 테라퓨틱스, 인크. | 액티빈 수용체 유형 iib 변이체 및 그의 사용 방법 |
| WO2019213016A1 (en) * | 2018-04-30 | 2019-11-07 | The Children's Hospital Of Philadelphia | Methods of improving anemias by combining agents |
| WO2020092523A1 (en) * | 2018-10-31 | 2020-05-07 | Celgene Corporation | TREATMENT OF ANEMIA DUE TO VERY LOW, LOW, OR INTERMEDIATE RISK MYELODYSPLASTIC SYNDROMES IN SUBJECTS WITH RING SIDEROBLASTS USING ACTIVIN-ACTRll LIGAND TRAPS |
| KR20210113314A (ko) * | 2019-01-10 | 2021-09-15 | 스미토모 다이니폰 파마 온콜로지, 인크. | 골수이형성 증후군을 치료하기 위한 alk5 억제제 |
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