US2020306243A1PendingUtilityA1

Compounds and conjugates thereof

Assignee: MEDIMMUNE LTDPriority: Mar 29, 2019Filed: Mar 23, 2020Published: Oct 1, 2020
Est. expiryMar 29, 2039(~12.7 yrs left)· nominal 20-yr term from priority
Y02P20/55A61K 47/65A61K 47/6803C07K 5/06052A61K 47/545A61K 47/68037A61K 31/4745C07D 491/22A61P 35/00A61K 47/6855A61K 47/6889
63
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Claims

Abstract

with a linker for connecting to a Ligand Unit, wherein the linker is attached in a cleavable manner to the amino residue. The Ligand Unit is preferably an antibody. Also provided is A* with the linking unit attached, and intermediates for their synthesis, as well as the released warhead.

Claims

exact text as granted — not AI-modified
1 . A compound with the formula I: 
       
         
           
           
               
               
           
         
       
       and salts and solvates thereof, wherein R L  is a linker for connection to a Ligand Unit, which is selected from:
 (Ia): 
 
       
         
           
           
               
               
           
         
         wherein 
         Q is: 
       
       
         
           
           
               
               
           
         
       
       where Q X  is such that Q is an amino-acid residue, a dipeptide residue, a tripeptide residue or a tetrapeptide residue;
 X is: 
 
       
         
           
           
               
               
           
         
         where a=0 to 5, b1=0 to 16, b2=0 to 16, c1=0 or 1, c2=0 or 1, d=0 to 5, wherein at least b1 or b2=0 and at least c1 or c2=0; 
         G L  is a linker for connecting to a Ligand Unit; 
         (Ib): 
       
       
         
           
           
               
               
           
         
         where R L1  and R L2  are independently selected from H and methyl, or together with the carbon atom to which they are bound form a cyclopropylene or cyclobutylene group; and 
         e is 0 or 1. 
       
     
     
         2 . The compound according to  claim 1 , wherein R L  is of formula Ia 
       
         
           
           
               
               
           
         
       
       wherein
 Q is: 
 
       
         
           
           
               
               
           
         
       
       where Q X  is such that Q is an amino-acid residue, a dipeptide residue, a tripeptide residue or a tetrapeptide residue;
 X is: 
 
       
         
           
           
               
               
           
         
         where a=0 to 5, b1=0 to 16, b2=0 to 16, c1=0 or 1, c2=0 or 1, d=0 to 5, wherein at least b1 or b2=0 and at least c1 or c2=0; 
       
       G L  is a linker for connecting to a Ligand Unit. 
     
     
         3 . The compound according to  claim 2 , wherein Q is:
 (a) an amino acid residue selected from: Phe, Lys, Val, Ala, Cit, Leu, Ile, Arg, and Trp; or   (b) a dipeptide residue selected from:
   NH -Phe-Lys- C═O , 
   NH -Val-Ala- C═O , 
   NH -Val-Lys- C═O , 
   NH -Ala-Lys- C═O , 
   NH -Val-Cit- C═O , 
   NH -Phe-Cit- C═O , 
   NH -Leu-Cit- C═O , 
   NH -Ile-Cit- C═O , 
   NH -Phe-Arg- C═O , 
   NH -Trp-Cit- C═O , and 
   NH -Gly-Val- C═O ; or 
   (c) a tripeptide residue selected from:
   NH -Glu-Val-Ala- C═O , 
   NH -Glu-Val-Cit- C═O , 
   NH -αGlu-Val-Ala- C═O , and 
   NH -αGlu-Val-Cit- C═O ; or 
   (d) a tetrapeptide residue selected from:
   NH -Gly-Gly-Phe-Gly C═O ; and 
   NH -Gly-Phe-Gly-GLY C═O . 
   
     
     
         4 . The compound according to either  claim 2  or  claim 3 , wherein a is:
 (a) 0 to 3; or 
 (b) 0 or 1; or 
 (c) 0. 
 
     
     
         5 . The compound according to  claim 2 , wherein b1 is:
 (a) 0 to 8; or   (b) 0; or   (c) 2; or   (d) 3; or   (e) 4; or   (f) 5; or   (g) 8.   
     
     
         6 . The compound according to  claim 2 , wherein b2 is:
 (a) 0 to 8; or   (b) 0; or   (c) 2; or   (d) 3; or   (e) 4; or   (f) 5; or   (g) 8.   
     
     
         7 . The compound according to  claim 2 , wherein
 (i) c1 is:   (a) 0; or   (b) 1; and   (ii) c2 is:   (a) 0; or   (b) 1;   wherein at least one of c1 and c2 is 0.   
     
     
         8 . The compound according to  claim 2 , wherein d is:
 (a) 0 to 3; or   (b) 1 or 2; or   (c) 2; or   (d) 5.   
     
     
         9 . The compound according to  claim 2 , wherein:
 (a) a is 0, b1 is 0, c1 is 1, c2 is 0 and d is 2, and b2 is 0, 2, 3, 4, 5 or 8; or   (b) a is 1, b2 is 0, c1 is 0, c2 is 0 and d is 0, and b1 is 0, 2, 3, 4, 5 or 8; or   (c) a is 0, b1 is 0, c1 is 0, c2 is 0 and d is 1, and b2 is 0, 2, 3, 4, 5 or 8; or   (d) b1 is 0, b2 is 0, c1 is 0, c2 is 0, one of a and d is 0, and the other of a and d is 1 or 5; or   (e) a is 1, b2 is 0, c1 is 0, c2 is 1, d is 2, and b1 is 0, 2, 3, 4, 5 or 8.   
     
     
         10 . The compound according to  claim 2 , wherein G L  is selected from 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       where Ar represents a C 5-6  arylene group, and X represents C 1-4  alkyl. 
     
     
         11 . A compound according to  claim 10 , wherein G L  is selected from G L1-1  and G L1-2 . 
     
     
         12 . The compound according to  claim 1 , wherein R L  is of formula Ib, 
       
         
           
           
               
               
           
         
       
       and: 
       (a) both R L1  and R L2  are H; or 
       (b) R L1  is H and R L2  is methyl; or 
       (c) both R L1  and R L2  are methyl; or 
       (d) wherein R L1  and R L2  together with the carbon atom to which they are bound form a cyclopropylene group; or 
       (e) wherein R L1  and R L2  together with the carbon atom to which they are bound form a cyclobutylene group. 
     
     
         13 . A conjugate of formula IV:
   L-(D L ) p   (IV)
   
       or a pharmaceutically acceptable salt or solvate thereof, wherein L is a Ligand unit, D L  is a Drug Linker unit that is of formula III: 
       
         
           
           
               
               
           
         
       
       R LL  is a linker connected to the Ligand unit selected from 
       (Ia′) 
       
         
           
           
               
               
           
         
       
       where
 Q is: 
 
       
         
           
           
               
               
           
         
       
       where Q X  is such that Q is an amino-acid residue, a dipeptide residue, a tripeptide residue or a tetrapeptide residue;
 X is: 
 
       
         
           
           
               
               
           
         
         where a=0 to 5, b1=0 to 16, b2=0 to 16, c1=0 or 1, c2=0 or 1, d=0 to 5, wherein at least b1 or b2=0 and at least c1 or c2=0; 
       
       and G LL  is a linker connected to a Ligand Unit; and
 (Ib′) 
 
       
         
           
           
               
               
           
         
       
       where R L1  and R L2  are independently selected from H and methyl, or together with the carbon atom to which they are bound form a cyclopropylene or cyclobutylene group; and 
       p is an integer of from 1 to 20. 
     
     
         14 . The conjugate according to  claim 13 , wherein G LL  is selected from: 
       
         
           
           
               
               
           
         
         
           
           
               
               
           
         
       
       where Ar represents a C 5-6  arylene group and X represents C 1-4  alkyl. 
     
     
         15 . The conjugate according to  claim 14 , wherein G LL  is selected from G LL1-1  and G LL1-2 . 
     
     
         16 . The conjugate according to  claim 13 , wherein the Ligand Unit is an antibody or an active fragment thereof. 
     
     
         17 . The conjugate according to  claim 16 , wherein the drug loading (p) of drugs (D) to antibody (Ab) is an integer from 1 to about 10. 
     
     
         18 . A mixture of conjugates according to  claim 17 , wherein the average drug loading per antibody in the mixture of antibody-drug conjugates is about 1 to about 10. 
     
     
         19 . A pharmaceutical composition comprising the conjugate or mixture of any one of  claims 13  to  18  and a pharmaceutically acceptable diluent, carrier or excipient. 
     
     
         20 - 22 . (canceled) 
     
     
         23 . A method for the treatment of cancer in a patient in need thereof, comprising administering to the patient the pharmaceutical composition of  claim 19 . 
     
     
         24 . (canceled) 
     
     
         25 . The compound A: 
       
         
           
           
               
               
           
         
       
       as a single enantiomer or in an enantiomerically enriched form. 
     
     
         26 . A compound with the formula VI: 
       
         
           
           
               
               
           
         
       
       where Q is as in either  claim 1  or  3 .

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