IP Library › Granted Patent US 9,867,803
Granted Patent B2
US 9,867,803 · App. 15/600,473 · Granted Jan 16, 2018

IRE-1α inhibitors

Inventors: Qingping Zeng (Thousand Oaks, CA); Andras Toro (Oxnard, CA); John Bruce Patterson (Ventura, CA); Warren Stanfield Wade (San Diego, CA); Zoltan Zubovics (Budapest, HU); Yun Yang (Tianjin, CN); Zhipeng Wu (Tianjin, CN)
Assignee: SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD.
A61K31/366A61K31/343A61K31/352A61K31/37A61K31/381A61K31/404A61K31/4025A61K31/4045A61K31/415A61K31/4155A61K31/4172A61K31/4184A61K31/423A61K31/427A61K31/4433A61K31/4439A61K31/452A61K31/453A61K31/454A61K31/4545A61K31/496A61K31/5377A61K45/06C07D217/02C07D217/08C07D311/12C07D311/16C07D311/20C07D311/22C07D311/94C07D401/04C07D401/12C07D405/04C07D405/10C07D409/04C07D417/04
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Quick Facts
Patent No.
US 9,867,803
App. No.
15/600,473
Granted
Jan 16, 2018
Kind
B2
Abstract

Compounds which directly inhibit IRE-1α activity in vitro, prodrugs, and pharmaceutically acceptable salts thereof. Such compounds and prodrugs are useful for treating diseases associated with the unfolded protein response or with regulated IRE1-dependent decay (RIDD) and can be used as single agents or in combination therapies.

Claims (90)

1. A method of inhibiting IRE-1a activity, comprising contacting IRE-1a with a compound of formula (A-1k):

or a prodrug or pharmaceutically acceptable salt thereof;

wherein

R3 is hydrogen, optionally substituted alkoxyl, or optionally substituted alkylamino;

R4 is hydrogen or alkoxyl;

R5 is hydrogen, alkyl, alkoxyl, alkylamino, CF 3 , or, together with R6 and the carbon atoms to which they are attached, forms a five-membered cycloalkyl;

R6 is

(a) alkenyl, optionally substituted with 1-3 substituents selected from halogen, —CN, alkyl, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

 or

(b) alkyl, substituted with 1-3 substituents selected from halogen, —CN, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

 or

(c) phenyl, substituted with 1-3 substituents selected from halogen, —CN, alkyl, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

R9 and R10 are independently hydrogen; alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

 wherein n is 0, 1, 2, or 3; or

R9 and R10, together with the nitrogen atom to which they are attached, form a heterocycle containing 1, 2, 3, or 4 heteroatoms selected from N, O, and S, optionally substituted with 1, 2, or 3 substituents selected independently from R11;

R11 is hydrogen; alkyl; aryl; heteroaryl containing 1 or 2 heteroatoms selected from N, O, and S; arylalkyl; heteroarylalkyl in which the heteroaryl contains 1 or 2 heteroatoms selected from N, O, and S;

R12 is amino; alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R11; a 5- or 6-membered heterocycle having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected independently from R11; or a 5- or 6-membered heteroaryl having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected independently from R11;

R13 is alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

 wherein n is 0, 1, 2, or 3; and R14 is hydrogen or R13; or

R13 and R14, together with the nitrogen to which they are attached, form a heterocycle containing 1, 2, or 3 heteroatoms selected independently from N, O, and S, optionally substituted with 1, 2, or 3 substitutents selected independently from R16;

R15 is amino; alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R21; a 5- or 6-membered heterocycle having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected from R21; or a 5- or 6-membered heteroaryl having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected from R21;

R16 is hydrogen; alkyl; aryl; heteroaryl containing 1 or 2 heteroatoms selected from N, O, and S; arylalkyl; heteroarylalkyl in which the heteroaryl contains 1 or 2 heteroatoms selected from N, O, and S;

R17 is alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

 wherein n is 0, 1, 2, or 3; and R18 is hydrogen or R17; or

R17 and R18, together with the nitrogen to which they are attached, form a heterocycle containing 1, 2, 3, or 4 heteroatoms selected independently from N, O, and S, optionally substituted with 1, 2, or 3 substituents selected independently from R20;

R19 is alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21;

R20 is a 5- or 6-membered heterocycle having 1 or 2 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substituents selected independently from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents selected independently from R21; or R21; and

R21 is halogen, perfluoroalkyl, perfluoroalkoxy, —CN, —CONH 2 , —CON(CH 3 ) 2 , alkyl, alkoxy, hydroxylalkyl, or alkoxylalkyl;

wherein the compound directly inhibits IRE-1a activity in vitro.

2. The method of claim 1 , wherein the IRE-1a activity is selected from the group consisting of cleavage of RNA, cleavage of mRNA, RNA splicing, and mRNA splicing.

3. The method of claim 2 , wherein the IRE-1a activity is cleavage of mRNA and wherein the mRNA is selected from the group consisting of Blos1 mRNA, DGAT2 mRNA, CD59 mRNA, and IRE-1α mRNA.

4. The method of claim 2 , which comprises administering the compound or the prodrug or pharmaceutically acceptable salt thereof to a patient in need thereof to treat a disorder associated with the unfolded protein response or a disorder associated with a target of regulated IRE1-dependent decay (RIDD).

5. The method of claim 4 , wherein the disorder is associated with the unfolded protein response, further comprising administering to the patient a therapeutic agent that induces or up-regulates IRE-1α expression.

6. The method of claim 4 , wherein the disorder is associated with the unfolded protein response, further comprising administering to the patient a therapeutic agent which is less effective when IRE-1a is expressed.

7. The method of claim 4 , wherein the disorder is associated with the unfolded protein response, further comprising administering a proteasome inhibitor.

8. The method of claim 4 , wherein the disorder is associated with a target of RIDD.

9. The method of claim 1 , wherein R3 is optionally substituted alkoxyl.

10. The method of claim 1 , wherein R4 is hydrogen.

11. The method of claim 1 , wherein R5 is alkyl.

12. The method of claim 1 , wherein R6 is alkyl, substituted with 1-3 substituents selected from halogen, —CN, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

13. The method of claim 1 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

14. The method of claim 1 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

15. A method of inhibiting IRE-1a activity, comprising contacting IRE-1a with a pharmaceutical composition comprising:

1) a compound of formula (A-1k):

or a prodrug or pharmaceutically acceptable salt thereof;

wherein

R3 is hydrogen, optionally substituted alkoxyl, or optionally substituted alkylamino;

R4 is hydrogen or alkoxyl;

R5 is hydrogen, alkyl, alkoxyl, alkylamino, CF 3 , or, together with R6 and the carbon atoms to which they are attached, forms a five-membered cycloalkyl;

R6 is

(a) alkenyl, optionally substituted with 1-3 substituents selected from halogen, —CN, alkyl, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

 or

(b) alkyl, substituted with 1-3 substituents selected from halogen, —CN, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

 or

(c) phenyl, substituted with 1-3 substituents selected from halogen, —CN, alkyl, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

R9 and R10 are independently hydrogen; alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

wherein n is 0, 1, 2, or 3; or

R9 and R10, together with the nitrogen atom to which they are attached, form a heterocycle containing 1, 2, 3, or 4 heteroatoms selected from N, O, and S, optionally substituted with 1, 2, or 3 substituents selected independently from R11;

R11 is hydrogen; alkyl; aryl; heteroaryl containing 1 or 2 heteroatoms selected from N, O, and S; arylalkyl; heteroarylalkyl in which the heteroaryl contains 1 or 2 heteroatoms selected from N, O, and S;

R12 is amino; alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R11; a 5- or 6-membered heterocycle having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected independently from R11; or a 5- or 6-membered heteroaryl having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected independently from R11;

R13 is alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

wherein n is 0, 1, 2, or 3; and R14 is hydrogen or R13; or

R13 and R14, together with the nitrogen to which they are attached, form a heterocycle containing 1, 2, or 3 heteroatoms selected independently from N, O, and S, optionally substituted with 1, 2, or 3 substitutents selected independently from R16;

R15 is amino; alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R21; a 5- or 6-membered heterocycle having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected from R21; or a 5- or 6-membered heteroaryl having 1, 2, or 3 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substitutents selected from R21;

R16 is hydrogen; alkyl; aryl; heteroaryl containing 1 or 2 heteroatoms selected from N, O, and S; arylalkyl; heteroarylalkyl in which the heteroaryl contains 1 or 2 heteroatoms selected from N, O, and S;

R17 is alkyl; alkoxylalkyl; perfluoroalkoxylalkyl; aryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or

wherein n is 0, 1, 2, or 3; and R18 is hydrogen or R17; or

R17 and R18, together with the nitrogen to which they are attached, form a heterocycle containing 1, 2, 3, or 4 heteroatoms selected independently from N, O, and S, optionally substituted with 1, 2, or 3 substituents selected independently from R20;

R19 is alkoxy; aryl, optionally substituted with 1, 2, or 3 substitutents selected independently from R21; a 5- or 6-membered heterocycle, optionally substituted with 1, 2, or 3 substituents independently selected from R21; or a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents independently selected from R21;

R20 is a 5- or 6-membered heterocycle having 1 or 2 heteroatoms selected from N, O, and S and optionally substituted with 1, 2, or 3 substituents selected independently from R21; a 5- or 6-membered heteroaryl, optionally substituted with 1, 2, or 3 substituents selected independently from R21; or R21; and

R21 is halogen, perfluoroalkyl, perfluoroalkoxy, —CN, —CONH 2 , —CON(CH 3 ) 2 , alkyl, alkoxy, hydroxylalkyl, or alkoxylalkyl;

wherein the compound directly inhibits IRE-1a activity in vitro; and

2) a pharmaceutically acceptable vehicle.

16. The method of claim 15 , wherein the IRE-1a activity is selected from the group consisting of cleavage of RNA, cleavage of mRNA, RNA splicing, and mRNA splicing.

17. The method of claim 16 , wherein the IRE-1a activity is cleavage of mRNA and wherein the mRNA is selected from the group consisting of Blos1 mRNA, DGAT2 mRNA, CD59 mRNA, and IRE-1α mRNA.

18. The method of claim 16 , which comprises administering the compound or the prodrug or pharmaceutically acceptable salt thereof to a patient in need thereof to treat a disorder associated with the unfolded protein response or a disorder associated with a target of regulated IRE1-dependent decay (RIDD).

19. The method of claim 18 , wherein the disorder is associated with the unfolded protein response, further comprising administering to the patient a therapeutic agent that induces or up-regulates IRE-1α expression.

20. The method of claim 18 , wherein the disorder is associated with the unfolded protein response, further comprising administering to the patient a therapeutic agent which is less effective when IRE-1α is expressed.

21. The method of claim 18 , wherein the disorder is associated with the unfolded protein response, further comprising administering a proteasome inhibitor.

22. The method of claim 18 , wherein the disorder is associated with a target of RIDD.

23. The method of claim 15 , wherein R3 is optionally substituted alkoxyl.

24. The method of claim 15 , wherein R4 is hydrogen.

25. The method of claim 15 , wherein R5 is alkyl.

26. The method of claim 15 , wherein R6 is alkyl, substituted with 1-3 substituents selected from halogen, —CN, perfluoroalkyl, alkoxy, hydroxylalkyl, alkoxylalkyl, perfluoroalkoxy,

27. The method of claim 15 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

28. The method of claim 15 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 22, 2018
From: SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD.
To: FOSUN ORINOVE PHARMATECH, INC.
Reel/Frame 045320/0357 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2017
From: ZENG, QINGPING; TORO, ANDRAS; PATTERSON, JOHN BRUCE; WADE, WARREN S.; ZUBOVICS, ZOLTAN; YANG, YUN; WU, ZHIPENG
To: MANNKIND CORPORATION
Reel/Frame 043541/0027 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 4, 2017
From: ZENG, QINGPING; TORO, ANDRAS; PATTERSON, JOHN BRUCE; WADE, WARREN S.; ZUBOVICS, ZOLTAN; YANG, YUN; WU, ZHIPENG
To: MANNKIND CORPORATION
Reel/Frame 043446/0409 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2017
From: MANNKIND CORPORATION
To: SHANGHAI FOSUN PHARMACEUTICAL INDUSTRIAL DEVELOPMENT CO. LTD.
Reel/Frame 042483/0622 →
Continuity (4)
Division 14594400 · Jan 12, 2015
Division 13639734
Provisional Application 61320975 · Apr 5, 2010
Related Publication 20170326104A1 · Nov 16, 2017