IP Library › Granted Patent US 11,666,594
Granted Patent B2
US 11,666,594 · App. 17/065,242 · Granted Jun 6, 2023

Antibody-drug conjugates comprising a cyclic dinucleotide

Inventors: Masato Yoshikawa (Fujisawa Kanagawa, JP); Morihisa Saitoh (Fujisawa Kanagawa, JP); Taisuke Kato (Fujisawa Kanagawa, JP); Yayoi Nakayama (Fujisawa Kanagawa, JP); Tomohiro Seki (Fujisawa Kanagawa, JP); Yasuo Nakagawa (Fujisawa Kanagawa, JP); Yusuke Tominari (Fujisawa Kanagawa, JP); Masaki Seto (Fujisawa Kanagawa, JP); Yusuke Sasaki (Fujisawa Kanagawa, JP); Masanori Okaniwa (Fujisawa Kanagawa, JP); Tsuneo Oda (Fujisawa Kanagawa, JP); Akito Shibuya (Fujisawa Kanagawa, JP); Kosuke Hidaka (Fujisawa Kanagawa, JP); Zenyu Shiokawa (Fujisawa Kanagawa, JP); Shumpei Murata (Fujisawa Kanagawa, JP); Atsutoshi Okabe (Fujisawa Kanagawa, JP); Yoshihisa Nakada (Fujisawa Kanagawa, JP); Michiyo Mochizuki (Fujisawa Kanagawa, JP); Brian Scott Freeze (Boston, MA); Taisuke Tawaraishi (Fujisawa Kanagawa, JP); Yasufumi Wada (Fujisawa Kanagawa, JP); Paul D. Greenspan (Acton, MA)
Assignee: Takeda Pharmaceutical Company Limited
A61K31/7084A61K31/7076A61K47/6807A61P35/00C07H21/00C07H21/02
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Quick Facts
Patent No.
US 11,666,594
App. No.
17/065,242
Granted
Jun 6, 2023
Kind
B2
Abstract

The present disclosure provides a compound having a STING agonistic activity, which may be expected to be useful as an agent for the prophylaxis or treatment of STING-related diseases. The present disclosure relates to a compound represented by the formula (I): wherein each symbol is as defined in the description, or a salt thereof.

Claims (59)

1. A compound having Formula (XIV):

(CD-L) n -A  (XIV)

or a pharmaceutically acceptable salt thereof, wherein:

CD is a group selected from any one of Formulae (XX), (XXIV), (XXVIII), or (XXIX):

R 1 and R 2 are each independently a hydroxy group, hydrogen, amino group, or a halogen atom;

B 3 and B 4 are independently an optionally substituted 5- to 14-membered aromatic heterocyclic group;

X 1 and X 2 are each an oxygen atom;

Q 1 , Q 2 , Q 3 , and Q 4 are each independently an oxygen atom or a sulfur atom;

L is a linker;

A is an antibody or antibody fragment; and

n is 1-10.

2. The compound of claim 1 , wherein R 1 and R 2 are each independently a hydroxy group or a halogen atom.

3. The compound of claim 1 , wherein CD is a group selected from:

4. The compound of claim 1 , wherein:

L is —X 3 -T-Z-Q-;

X 3 is —(CH 2 ) o —,

o is 1, 2, or 3; or

X 3 is absent;

T is a peptide, or is absent;

Z is a peptide, —NH—, —S—, —O—, NHC(═O)CH 2 CH 2 —, —S(═O) 2 —CH 2 CH 2 —, —C(═O)NHNH—, —C(═O)O—, —C(═O)NH—, —CH 2 —, —CH 2 CH 2 —, —CH 2 CH 2 CH 2 —, —CH 2 ═CH 2 —, polyethylene glycol (PEG),

Q is:

wherein the “*” indicates the attachment point to any available carbon atom, nitrogen atom, oxygen atom, or sulfur atom attached to the antibody or antibody fragment.

5. The compound of claim 4 , wherein the compound has formula (XXX):

6. The compound of claim 5 , wherein the compound has formula (XXXII):

wherein:

R 10a and R 10b are independently C 1-3 alkyl; and

m is 2, 3, 4, or 5.

7. The compound of claim 5 , wherein the compound has formula (XXXIII):

wherein p is 4, 5, or 6.

8. The compound of claim 5 , wherein the compound has formula (XXXIV):

wherein:

q is 1, 2, or 3; and

r is 1, 2, or 3.

9. The compound of claim 1 , wherein:

B 3 is a group selected from formula (B 3 -A) or formula (B 3 -B):

R 13 , R 14 , R 15 , R 16 and R 17 are each independently a hydrogen atom, a halogen atom, a cyano group, a nitro group, an optionally substituted hydrocarbon group, an optionally substituted heterocyclic group, an acyl group, an optionally substituted amino group, an optionally substituted carbamoyl group, an optionally substituted thiocarbamoyl group, an optionally substituted sulfamoyl group, an optionally substituted hydroxy group, an optionally substituted sulfanyl (SH) group or an optionally substituted silyl group;

Y 11 , Y 12 , Y 13 , Y 14 , Y 15 and Y 16 are each independently N or CR 1a ;

Z 11 , Z 12 , Z 13 , Z 14 , Z 15 and Z 16 are each independently N or C;

R 1a is a hydrogen atom, a halogen atom, a cyano group, a nitro group, an optionally substituted hydrocarbon group, an optionally substituted heterocyclic group, an acyl group, an optionally substituted amino group, an optionally substituted carbamoyl group, an optionally substituted thiocarbamoyl group, an optionally substituted sulfamoyl group, an optionally substituted hydroxy group, an optionally substituted sulfanyl (SH) group or an optionally substituted silyl group;

B 4 is a group selected from formula (B 4 -A) or formula (B 4 —B):

R 23 , R 24 , R 25 , R 26 and R 27 are each independently a hydrogen atom, a halogen atom, a cyano group, a nitro group, an optionally substituted hydrocarbon group, an optionally substituted heterocyclic group, an acyl group, an optionally substituted amino group, an optionally substituted carbamoyl group, an optionally substituted thiocarbamoyl group, an optionally substituted sulfamoyl group, an optionally substituted hydroxy group, an optionally substituted sulfanyl (SH) group or an optionally substituted silyl group;

Y 21 , Y 22 , Y 23 , Y 24 , Y 25 and Y 26 are each independently N or CR 2a ;

Z 21 , Z 22 , Z 23 , Z 24 , Z 25 and Z 26 are each independently N or C;

R 2a is a hydrogen atom, a halogen atom, a cyano group, a nitro group, an optionally substituted hydrocarbon group, an optionally substituted heterocyclic group, an acyl group, an optionally substituted amino group, an optionally substituted carbamoyl group, an optionally substituted thiocarbamoyl group, an optionally substituted sulfamoyl group, an optionally substituted hydroxy group, an optionally substituted sulfanyl (SH) group or an optionally substituted silyl group.

10. The compound of claim 9 , wherein at least one of B 3 or B 4 is:

R 18 is hydrogen or C 1-6 alkyl; and

R 19 is a halogen atom.

11. The compound of claim 10 , wherein B 3 is:

12. The compound of claim 11 , wherein R 19 is a fluoro atom.

13. The compound of claim 11 , wherein R 18 is hydrogen or methyl.

14. The compound of claim 12 , wherein B 4 is selected from the group consisting of:

each of which is optionally and independently substituted at:

(i) any available carbon atom with a halo, C 1-6 alkyl, C 1-6 alkoxy, C 1-6 alkylthio, or amino group; and/or

(ii) any available nitrogen atom with a C 1-6 alkyl group.

15. The compound of claim 9 , wherein B 4 is selected from the group consisting of:

16. The compound of claim 1 , wherein the antibody is an anti-guanylyl cyclase C (GCC) antibody.

17. The compound of claim 16 , wherein the antibody is an anti-guanylyl cyclase C (GCC) antibody comprising a heavy chain region comprising amino acid sequence SEQ. ID. No. 1 or SEQ. ID. No. 2.

18. A pharmaceutical composition comprising the Formula (XIV) of claim 1 , and a pharmaceutically acceptable excipient.

19. A method of treating a patient comprising administering to the patient a therapeutically effective amount of the compound of claim 1 , wherein the patient has cancer and responds to the treatment.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: TAWARAISHI, TAISUKE; WADA, YASUFUMI
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 063700/0701 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: GREENSPAN, PAUL D.
To: MILLENNIUM PHARMACEUTICALS, INC.
Reel/Frame 063700/0745 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: FREEZE, BRIAN SCOTT
To: MILLENNIUM PHARMACEUTICALS, INC.
Reel/Frame 063700/0769 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: MILLENNIUM PHARMACEUTICALS, INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 063701/0538 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 19, 2023
From: YOSHIKAWA, MASATO; SAITOH, MORIHISA; KATO, TAISUKE; YOSHITOMI, YAYOI; SEKI, TOMOHIRO; NAKAGAWA, YASUO; TOMINARI, YUSUKE; SETO, MASAKI; SASAKI, YUSUKE; OKANIWA, MASANORI; ODA, TSUNEO; SHIBUYA, AKITO; HIDAKA, KOSUKE; SHIOKAWA, ZENYU; MURATA, SHUMPEI; OKABE, ATSUTOSHI; NAKADA, YOSHIHISA; MOCHIZUKI, MICHIYO
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 063704/0878 →
Priority Claims (2)
JP 2016-234553 · Dec 1, 2016 · national
JP 2017-107216 · May 30, 2017 · national
Continuity (4)
Division 16185258 · Nov 9, 2018
Continuation PCTIB2017057588 · Dec 1, 2017
Provisional Application 62589300 · Nov 21, 2017
Related Publication 20210106607A1 · Apr 15, 2021