US2023257388A1PendingUtilityA1

Granzyme b directed imaging and therapy

Assignee: CYTOSITE BIOPHARMA INCPriority: Feb 13, 2018Filed: Apr 25, 2023Published: Aug 17, 2023
Est. expiryFeb 13, 2038(~11.6 yrs left)· nominal 20-yr term from priority
C07D 487/06A61K 51/0468C07D 498/06A61B 6/037A61P 37/00C07K 5/0808A61K 38/06A61P 37/02A61K 49/04
66
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Claims

Abstract

Provided herein are heterocyclic compounds useful for imaging Granzyme B. Methods of imaging Granzyme B, combination therapies, and kits comprising the Granzyme B imaging agents are also provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A compound of Formula I: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1, 2, or 3; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4  haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 , with the proviso that, when X is CH 2 , at least one of R 1  and R 2  is —NR 10 R 12 , and at least one of R 10  and R 12  is —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl or —C(O)HET; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4  haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13 ″) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         2 . The compound of  claim 1 , wherein X is CH 2 . 
     
     
         3 . The compound of  claim 2 , wherein R 1  is —NR 10  R 12 . 
     
     
         4 . The compound of  claim 2 , wherein R 2  is C 1-6  alkyl. 
     
     
         5 . The compound of  claim 2 , wherein each of R 3 , R 6 , R 7 , R 8 , and R 8′  is H. 
     
     
         6 . The compound of  claim 2 , wherein R 9  is HET. 
     
     
         7 . The compound of  claim 2 , wherein R 1  is —NR 10  R 12 ; R 2  is C 1-6  alkyl; each of R 3 , R 6 , R 7 , R 8 , and R 8′  is H; and R 9  is HET. 
     
     
         8 . The compound of  claim 7 , wherein R 1  is —NR 10 R 12 , in which R 10  is H and R 12  is —C(O)C 1-4  alkyl. 
     
     
         9 . The compound of  claim 7 , wherein R 1  is —NR 10 R 12 , in which R 10  is H and R 12  is —C(O)C 6-10  aryl or —C(O)HET. 
     
     
         10 . The compound of  claim 7 , wherein R 2  is butyl. 
     
     
         11 . The compound of  claim 7 , wherein R 9  is monocyclic heteroaryl. 
     
     
         12 . The compound of  claim 7 , wherein R 1  is —NR 10 R 12 , in which R 10  is H and R 12  is —C(O)C 1-4  alkyl, —C(O)C 6-10  aryl, or —C(O)HET; R 2  is butyl; and R 9  is monocyclic heteroaryl. 
     
     
         13 . The compound of  claim 12 , wherein R 2  is 
       
         
           
           
               
               
           
         
       
       and R 9  is 
       
         
           
           
               
               
           
         
       
     
     
         14 . The compound of  claim 2 , wherein the compound is one of the following: 
       
         
           
           
               
               
           
         
       
     
     
         15 . The compound of  claim 1 , wherein X is O. 
     
     
         16 . The compound of  claim 15 , wherein R 1  is —NR 10 R 12 ; R 2  is C 1-6  alkyl; each of R 3 , R 6 , R 7 , R 8 , and R 8′  is H; and R 9  is HET. 
     
     
         17 . The compound of  claim 16 , wherein R 1  is —NR 10 R 12 , in which R 10  is H and R 12  is —C(O)C 1-4  alkyl, —C(O)C 6-10  aryl, or —C(O)HET; R 2  is butyl; and R 9  is monocyclic heteroaryl. 
     
     
         18 . The compound of  claim 17 , wherein R 2  is 
       
         
           
           
               
               
           
         
       
       and R 9  is 
       
         
           
           
               
               
           
         
       
     
     
         19 . The compound of  claim 15 , wherein the compound is one of the following: 
       
         
           
           
               
               
           
         
       
     
     
         20 . The compound of  claim 1 , wherein X is NR 4 , in which R 4  is H or C 1-4  alkyl. 
     
     
         21 . The compound of  claim 20 , wherein R 1  is —NR 10 R 12 ; R 2  is C 1-6  alkyl; each of R 3 , R 6 , R 7 , R 8 , and R 8′  is H; and R 9  is HET. 
     
     
         22 . The compound of  claim 21 , wherein R 1  is —NR 10 R 12 , in which R 10  is H and R 12  is —C(O)C 1-4  alkyl, —C(O)C 6-10  aryl, or —C(O)HET; R 2  is butyl; and R 9  is monocyclic heteroaryl. 
     
     
         23 . The compound of  claim 22 , wherein R 2  is 
       
         
           
           
               
               
           
         
       
       and R 9  is 
       
         
           
           
               
               
           
         
       
     
     
         24 . The compound of  claim 20 , wherein the compound is one of the following: 
       
         
           
           
               
               
           
         
       
     
     
         25 . A compound of Formula II: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1, 2, or 3; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 , with the proviso that, when X is CH 2 , at least one of R 1  and R 2  is —NR 10 R 12 , and at least one of R 10  and R 12  is —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl or —C(O)HET; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13″ ) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1 -4 alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         26 . A compound of Formula III: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13 ″) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         27 . A compound of Formula IV: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13 ″) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1 -4 alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         28 . A compound of Formula V: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13 ″) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl, wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         29 . A compound of Formula VI: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 1 ″ groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 
       each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl;
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13″ ) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1 -4 alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13″ , independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         30 . A compound of Formula VII: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13 ″) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1 -4 alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13 ″, independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         31 . A compound of Formula VIII: 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt thereof, or a stereoisomer or tautomer thereof, wherein:
 m is 0, 1, or 2; 
 n is 1 or 2; 
 R 1  and R 2  are each independently selected from the group consisting of: hydrogen, C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, C 6-10  aryl, HET and —NR 10 R 12 , wherein each C 1-6  alkyl, C 1-6  alkoxy, C 3-6  cycloalkyl, are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo and hydroxy, and each C 6-10  aryl and HET are optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4 haloalkyl; 
 or R 1  and R 2  may come together, with the carbon atom to which they are attached, to form a 5-6 membered cycloalkyl or 5-6 heterocycloalkyl group, each of which may be optionally substituted with 1, 2, or 3 R 10  groups; 
 each R 3  and R 7  is independently selected from the group consisting of hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 X is selected from the group consisting of CH 2 , O, S, SO 2 , and NR 4 ; 
 R 4  is selected from the group H, C 1-4  alkyl and C 1-4 haloalkyl; 
 each R 5 , R 6 , R 8′  and R 8  is independently selected from the group consisting of hydrogen, halo, COOH, hydroxy, OC 1-4  alkyl, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 9  is COOR 13 , —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, —B(OR 13′ ) 2 , —PO(OR 13″ ) 2 , or HET, wherein the HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of oxo, halo, hydroxy, C 1-4  alkyl and C 1-4  haloalkyl; 
 R 10  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl and halo groups; 
 each HET is an independently selected mono- or bicyclic 5-10-membered heteroaryl or a mono- or bicyclic 5-10 membered heterocycloalkyl group, wherein each HET comprises 1, 2, 3, or 4 heteroatoms selected from O, S and N and is optionally substituted with 1 or 2 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —O—C 1-4  haloalkyl, halo, hydroxy and oxo groups; 
 R 11  is selected from hydrogen, C 1-4  alkyl and C 1-4 haloalkyl; 
 R 12  is selected from the group consisting of hydrogen, C 1-4  alkyl, —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl, —C(O)HET and —C(O)C 1-4  alkyl; wherein the C 1-4  alkyl is optionally substituted with 1, 2, or 3 halo groups; wherein the —C(O)C 1-4  alkyl is optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2 , HET, —O—C 1-4  alkyl and C 6-10  aryl; wherein the —O—C 1-4  alkyl may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of halo, oxo, —N(R 11 ) 2  and C 6-10  aryl; wherein the C 6-10  aryl may be optionally substituted with 1, 2, or 3 halo groups and wherein the —C(O)C 6-10  aryl, —C(O)C 6-10  cycloalkyl and —C(O)HET may be optionally substituted with 1, 2, or 3 substituents independently selected from the group consisting of C 1-4  alkyl, C 1-4  haloalkyl, —O—C 1-4  alkyl, —OC 1-4  haloalkyl and halo groups; and 
 each of R 13 , R 13′ , and R 13″ , independently, is selected from the group consisting of hydrogen, C 1-6  alkyl, C 1-6  cycloalkyl and HET, 
 wherein at least one of R 1 , R 2 , R 5  and R 9  optionally comprises an imaging agent. 
 
     
     
         32 . The compound according to  claims 1 - 31 , wherein at least one of R 1 , R 2 , R 5  and R 9  comprises an imaging agent. 
     
     
         33 . The compound according to  claim 32 , wherein the said imaging agent is selected from a group consisting of a PET imaging agent, a SPECT imaging agent, and a computed tomography imaging agent. 
     
     
         34 . The compound according to  claim 32 , wherein the said imaging agent is selected from a group consisting of a paramagnetic ion, an x-ray imaging agent, a fluorophore and a radioisotope. 
     
     
         35 . The compound according to  claims 1 - 31 , wherein at least one of R 1 , R 2 , R 5  and R 9  contains a radioisotope. 
     
     
         36 . The compound according to  claim 35 , wherein the said radioisotope is  18 F. 
     
     
         37 . The compound according to  claims 1 - 31 , wherein at least one of R 1 , R 2 , R 5  and R 9  contains a PET imaging agent. 
     
     
         38 . The compound according to  claim 37 , wherein the said PET imaging agent comprises  18 F. 
     
     
         39 . A pharmaceutical composition comprising a compound according to  claims 1 - 38  and a pharmaceutically acceptable carrier. 
     
     
         40 . A method of treating an immunoregulatory abnormality in a subject in need thereof, the method comprising administering to said patient a compound according to  claims 1 - 38  in an amount effective for treating said immunoregulatory abnormality.

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