Claims for Patent: 10,590,087

Summary for Patent: 10,590,087

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:	US16/537,394
Patent Claims:	1. A crystalline form of a hydrobromide 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) wherein the crystalline form is Form A characterized by an XRPD pattern having peaks at 8.8±0.2, 9.8±0.2, and 23.3±0.2 degrees two theta. 2. The crystalline form of claim 1, wherein the crystalline Form A is anhydrous. 3. The crystalline form of claim 1, wherein the melting point of crystalline Form A is about 254° C. 4. The crystalline form 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. 5. The crystalline form 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. 6. The crystalline form of claim 1, wherein Form A is characterized by an XRPD pattern substantially as shown in FIG. 1. 7. The crystalline form of claim 1, wherein Form A is characterized by a TGA profile substantially as shown in FIG. 2. 8. The crystalline form of claim 1, wherein Form A is characterized by a DSC profile substantially as shown in FIG. 3. 9. The crystalline form of claim 1, wherein Form A has a unit cell that indexes as primitive monoclinic. 10. The crystalline form of claim 1, wherein Form A has a unit cell with an a value of 10.035 Å, a b value of 7.532 Å, and a c value of 20.092 Å. 11. The crystalline form of claim 1, wherein Form A has a unit A cell with a volume of 1518.1 Å3. 12. The crystalline form of claim 1, wherein the Form A has one or more of a D[V,0.10] particle size between 0.5 μm and about 15 μm, a D[V,0.50] particle size between 2 μm and 30 μm, a D[V,0.90] particle size between 8 μam and 600 μm, or a D[4,3] particle size of 5 μm to 200 μm. 13. A pharmaceutical composition comprising the crystalline form of claim 1 and a pharmaceutically acceptable carrier. 14. The pharmaceutical composition of claim 13, wherein the pharmaceutical composition is a tablet. 15. The pharmaceutical composition of claim 1, wherein the A pharmaceutical composition comprises 25 mg to 400 mg of the hydrobromide 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. 16. The pharmaceutical composition of claim 13, wherein the A pharmaceutical composition comprises 50 mg of the hydrobromide 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. 17. The pharmaceutical composition of claim 13, wherein the A pharmaceutical composition comprises 100 mg of the hydrobromide 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. 18. The pharmaceutical composition of claim 13, wherein the A pharmaceutical composition comprises 150 mg of the hydrobromide 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.