Claims for Patent: 12,116,347

Summary for Patent: 12,116,347

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:	US18/414,019
Patent Claims:	1. A pharmaceutical composition comprising (a) a solid form 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 or a salt thereof and (b) a pharmaceutical acceptable carrier, wherein the solid form is Form A characterized by an X-ray powder diffraction pattern having peaks at 8.8±0.2, 9.8±0.2, and 23.3±0.2 degrees 2Θ, when measured by Cu Kα radiation, wherein the solid form is substantially free of other polymorphic 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 or a salt thereof. 2. The pharmaceutical composition of claim 1, wherein the solid form has a D[V,0.90] of about 8 to about 600 μm. 3. The pharmaceutical composition of claim 1, wherein the solid form has a D[V,0.90] of about 8 to less than about 100 μm. 4. The pharmaceutical composition of claim 3, wherein the solid form has a D[V,0.90] particle size of from about 8 to about 75 μm. 5. The pharmaceutical composition of claim 1, wherein the solid form has a D[V,0.50] of about 2 to about 30 μm. 6. The pharmaceutical composition of claim 1, wherein the composition comprises about 50 mg 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 dihydrobromide. 7. The pharmaceutical composition of claim 6, wherein the composition is a tablet. 8. The pharmaceutical composition of claim 1, wherein the composition comprises about 100 mg 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 dihydrobromide. 9. The pharmaceutical composition of claim 8, wherein the composition is a tablet. 10. A pharmaceutical composition comprising (a) a solid form 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 or a salt thereof and (b) a pharmaceutical acceptable carrier, wherein the solid form is Form A characterized by an X-ray powder diffraction pattern having peaks at 8.8±0.2, 9.8±0.2, and 23.3±0.2 degrees 2Θ, when measured by Cu Kα radiation, wherein the solid form has a polymorphic purity of at least 90%. 11. The pharmaceutical composition of claim 10, wherein the solid form has a polymorphic purity of at least 99%. 12. The pharmaceutical composition of claim 10, wherein the solid form has a D[V,0.90] of about 8 to about 600 μm. 13. The pharmaceutical composition of claim 10, wherein the solid form has a D[V,0.90] of about 8 to less than about 100 μm. 14. The pharmaceutical composition of claim 13, wherein the solid form has a D[V,0.90] particle size of from about 8 to about 75 μm. 15. The pharmaceutical composition of claim 10, wherein the solid form has a D[V,0.50] of about 2 to about 30 μm. 16. The pharmaceutical composition of claim 10, wherein the composition comprises about 50 mg 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 dihydrobromide. 17. The pharmaceutical composition of claim 16, wherein the composition is a tablet. 18. The pharmaceutical composition of claim 10, wherein the composition comprises about 100 mg 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 hydrobromide. 19. The pharmaceutical composition of claim 18, wherein the composition is a tablet.