IP Library Granted Patent US 12,251,385
Granted Patent B2
US 12,251,385 · App. 17/885,493 · Granted Mar 18, 2025

Covalent inhibitors of menin-MLL interaction for diabetes mellitus

Inventors: Thomas Butler (Redwood City, CA); James T. Palmer (Warrandyte, AU)
Assignee: BIOMEA FUSION, INC.
A61K31/5377A61P3/10
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Quick Facts
Patent No.
US 12,251,385
App. No.
17/885,493
Granted
Mar 18, 2025
Kind
B2
Abstract

Disclosed herein are heterocyclic compounds that inhibit the binding of menin and MLL or MLL fusion proteins for the treatment of diabetes mellitus. Also described are specific covalent inhibitors of menin-MLL interaction. Also disclosed are pharmaceutical compositions that include the described compounds. Methods of using the menin-MLL covalent inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of diabetes mellitus.

Claims (101)

1. A method for reducing HbA1c in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound according to Formula (I)

or a pharmaceutically acceptable salt thereof, wherein

A is carbon or nitrogen;

Cy is substituted or unsubstituted

Q is —N(H)—;

Z is —CR 5a ═ or —N═;

X is —NR 3a — or —C(R 3b ) 2 —;

Y is a single bond, —NR 3a —, or —C(R 3b ) 2 —;

W is —C(O)— or —S(O) 2 —;

one of R 1 and R 2 is Cy 2 -N(H)C(O)—C(R 6a )═C(R 6b )(R 6c ) or CH 2 -Cy 2 -N(H)C(O)—C(R 6a )═C(R 6b )(R 6c ); and the other is hydrogen;

Cy 2 is an optionally substituted group selected from phenyl, pyridyl, or a 4- to 7-membered heterocycloalkyl ring having one nitrogen;

each R 3a and R 3b is hydrogen;

each R 4a and R 4b is independently hydrogen, fluoro, or methyl;

R 5a is hydrogen;

each R 6a and R 6b is independently hydrogen or C 1-6 alkyl; or

R 6a and R 6b are joined together to form a bond;

R 6c is hydrogen or substituted or unsubstituted C 1-6 alkyl;

m is one, two, or three; and

n is one, two, three, or four.

2. The method according to claim 1 , wherein —X—W—Y— is —N(H)—C(O)—N(H)—, —N(H)—C(O)—CH 2 —, —CH 2 —C(O)—N(H)—, —N(H)—S(O) 2 —N(H)—, —N(H)—S(O) 2 —CH 2 —, —CH 2 —S(O) 2 —N(H)—, or —N(H)—C(O)—.

3. The method according to claim 1 , wherein the compound is according to Formula (XXIIIa), (XXIIIb), (IVa), or (IVb)

or a pharmaceutically acceptable salt thereof; and wherein p is zero, one, two, or three.

4. The method according to claim 1 , wherein Cy is

wherein R 7 is

5. The method according to claim 1 , wherein the compound is according to Formula (XXIVa) or (XXIVb)

or a pharmaceutically acceptable salt thereof; wherein

p is zero, one, two, or three; and

R 7 is

6. The method according to claim 1 , wherein the compound is according to Formula (VIIa), (VIIb), (VIIc), (VIIIa), (VIIIb), (VIIIc), (XXVIa), (XXVIb), or (XXVIc)

or a pharmaceutically acceptable salt thereof.

7. The method of claim 1 , wherein

i) R 6a is hydrogen;

R 6b is hydrogen; and

R 6c is hydrogen; or

ii) R 6a is hydrogen;

R 6b is hydrogen; and

R 6c is CH 3 or CH 2 CH 3 ; or

iii) R 6a is hydrogen;

R 6b is hydrogen; and

R 6c is CH 2 N(CH 3 ) 2 ; or

iv) R 6a and R 6b , joined together, form a single bond; and R 6c is CH 3 .

8. The method of claim 1 , wherein each of R 6a and R 6b is hydrogen; and R 6c is substituted or unsubstituted alkyl.

9. The method according to claim 1 , wherein the compound is according to Formula (IXa), (IXb), (IXc), (Xa), (Xb), (Xc), (XIa), (XIb), (XIc), (XIIa), (XIIb), (XIIc), (XIIIa), (XIIIb), (XIIIc), or (XIVa)

or a pharmaceutically acceptable salt thereof.

10. The method according to claim 1 , wherein the compound is according to Formula (XVI) or (XVII)

or a pharmaceutically acceptable salt thereof.

11. The method according to claim 1 , wherein the compound is according to Formula (XXVIIa), (XXVIIb), (XXVIIc), (XXVIIIa), (XXVIIIb), (XXVIIIc), (XXIXa), (XXIXb), or (XXIXc)

or a pharmaceutically acceptable salt thereof.

12. The method according to claim 1 , wherein the compound is

or a pharmaceutically acceptable salt thereof.

13. The method according to claim 1 , wherein the compound is Compound 10

or a pharmaceutically acceptable salt thereof.

14. The method of claim 1 , wherein the compound is any one of the compounds selected from

Compound

ID

Structure

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

or

Compound

ID

Structure

101

102

103

104

105

106

107

108

109

110

111

112

15. The method of claim 1 , wherein the HbA1c is lowered by at least 0.5% within one month of dosing.

16. The method of claim 1 , wherein the HbA1c is lowered by 1%-3.5% between day 21 and day 29 of dosing.

17. The method of claim 1 , wherein reducing HbA1c occurs within four weeks of dosing.

Assignments (3)
CHANGE OF NAME Recorded Dec 1, 2022
From: BIOMEA FUSION, LLC
To: BIOMEA FUSION, INC.
Reel/Frame 061945/0958 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2022
From: PALMER, JAMES T.; BUTLER, THOMAS
To: BIOMEA FUSION, INC.
Reel/Frame 061908/0157 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2022
From: PALMER, JAMES T.; BUTLER, THOMAS
To: BIOMEA FUSION, INC
Reel/Frame 061703/0787 →
Continuity (4)
Provisional Application 63317518 · Mar 7, 2022
Provisional Application 63249568 · Sep 28, 2021
Provisional Application 63232154 · Aug 11, 2021
Related Publication 20230120115A1 · Apr 20, 2023
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