Claims for Patent: 11,845,732

Summary for Patent: 11,845,732

Title:	Solid state forms of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide and uses thereof
Abstract:	The present disclosure relates to: a) solid state forms of hydrobromide salts of Compound 1; b) pharmaceutical compositions comprising one or more solid state forms of hydrobromide salts of Compound 1, and, optionally, a pharmaceutically acceptable carrier; c) methods of treating tumors or cancers by administering one or more solid state forms of hydrobromide salts of Compound 1 to a subject in need thereof; and d) methods for the preparation of solid state forms of Compound 1.
Inventor(s):	Elaine Greer, Stephen Anderson, Mark Maloney, Shu Yu, Ekaterina Albert, Emily Rigsbee
Assignee:	Pfizer Corp SRL
Application Number:	US18/170,884
Patent Claims:	1. A method of treating tumors or cancer comprising administering to a subject in need of such treatment a pharmaceutical composition comprising (i) a crystalline form of a dihydrobromide salt of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide of Formula (I) selected from the group consisting of: a) crystalline Form A, wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2, 9.8±0.2, and 23.3±0.2 degrees two theta; b) crystalline Form B, wherein Form B is characterized by an XRPD pattern substantially as shown in FIG. 4 ; c) crystalline Form D, wherein Form D is characterized by an XRPD pattern substantially as shown in FIG. 11 ; d) crystalline Form E, wherein Form E is characterized by an XRPD pattern substantially as shown in FIG. 14 ; e) crystalline Form F, wherein Form F is characterized by an XRPD pattern substantially as shown in FIG. 17 ; f) crystalline Form F′, wherein Form F′ is characterized by an XRPD pattern substantially as shown in FIG. 18 ; g) crystalline Form G, wherein Form G is characterized by an XRPD pattern substantially as shown in FIG. 21 ; h) crystalline Form H, wherein Form H is characterized by an XRPD pattern substantially as shown in FIG. 22 ; i) crystalline Form H′, wherein Form H′ is characterized by an XRPD pattern substantially as shown in FIG. 23 ; j) crystalline Form J, wherein Form J is characterized by an XRPD pattern substantially as shown in FIG. 24 ; k) crystalline Form K, wherein Form K is characterized by an XRPD pattern substantially as shown in FIG. 25 ; l) crystalline Form L, wherein Form L is characterized by an XRPD pattern substantially as shown in FIG. 26 ; m) crystalline Form M, wherein Form M is characterized by an XRPD pattern substantially as shown in FIG. 29 ; and n) crystalline Form N, wherein Form N is characterized by an XRPD pattern substantially as shown in FIG. 30 ; and (ii) a pharmaceutically acceptable carrier. 2. The method of claim 1, wherein the tumors are desmoid tumors. 3. The method of claim 1, wherein the cancer is selected from the group consisting of multiple myeloma, a cancer having a mutation in a Notch pathway gene, adenoid cystic carcinoma, and T-cell acute lymphoblastic leukemia. 4. The method of claim 1, wherein the subject is administered about 50 μmg to about 500 μmg of the dihydrobromide salt of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily. 5. The method of claim 1, wherein the subject is administered about 100 μmg to about 400 μmg of the dihydrobromide salt of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily. 6. The method of claim 1, wherein the subject is administered about 300 μmg of the dihydrobromide salt of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily. 7. The method of claim 1, wherein the subject is administered about 200 μmg of the dihydrobromide salt of (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily. 8. The method of claim 1, wherein the total daily dose is provided as two separate doses. 9. The method of claim 8, wherein the total daily dose is provided as two separate doses of 150 μmg. 10. The method of claim 8, wherein the total daily dose is provided as two separate doses of 100 μmg. 11. The method of claim 1, wherein the crystalline Form A is anhydrous. 12. The method of claim 1, wherein the melting point of crystalline Form A is about 254° C. 13. The method of claim 1, wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2, 9.8±0.2, 23.3±0.2, 25.4±0.2, 28.0±0.2, and 29.3±0.2 degrees two theta. 14. The method of claim 1, wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2, 9.8±0.2, 20.0±0.2, 23.3±0.2, 25.4±0.2, 28.0±0.2, 29.3±0.2, and 32.5±0.2 degrees two theta. 15. The method of claim 1, wherein Form A is characterized by an XRPD pattern substantially as shown in FIG. 1 . 16. The method of claim 1, wherein Form A is characterized by a TGA profile substantially as shown in FIG. 2 . 17. The method of claim 1, wherein Form A is characterized by a DSC profile substantially as shown in FIG. 3 . 18. The method of claim 1, wherein Form A has a unit cell that indexes as primitive monoclinic. 19. The method of claim 1, wherein Form A has a unit cell with an a value of about 10.035 Å, a b value of about 7.532 Å, and a c value of about 20.092 Å. 20. The method of claim 1, wherein Form A has a unit cell with a volume of about 1518.1 Å3.