Claims for Patent: 10,710,966

Summary for Patent: 10,710,966

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):	Greer Elaine, Anderson Stephen, Maloney Mark, Yu Shu, Albert Ekaterina, Rigsbee Emily
Assignee:	Pfizer Inc.
Application Number:	US16818863
Patent Claims:	2. The method of claim 1 , wherein the subject is administered 50 mg to 500 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 1 ,8-difluoro-1 claim 1 ,2 claim 1 ,3 claim 1 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily.3. The method of claim 1 , wherein the subject is administered 100 mg to 400 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 1 ,8-difluoro-1 claim 1 ,2 claim 1 ,3 claim 1 ,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino) propan-2-yl)-1H-imidazol-4-yl)pentanamide daily.4. The method of claim 1 , wherein the subject is administered about 300 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 1 ,8-difluoro-1 claim 1 ,2 claim 1 ,3 claim 1 ,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 200 mg of the hydrobromide salt of (S)-2-(((S)-6 claim 1 ,8-difluoro-1 claim 1 ,2 claim 1 ,3 claim 1 ,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 a total daily dose provided as two separate doses.7. The method of claim 6 , wherein the total daily dose is provided as two separate doses of 150 mg.8. The method of claim 6 , wherein the total daily dose is provided as two separate doses of 100 mg.9. The method of claim 1 , wherein crystalline Form A is anhydrous.10. The method of claim 1 , wherein the melting point of crystalline Form A is about 254° C.11. The method of claim 1 , wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2 claim 1 , 9.8±0.2 claim 1 , 23.3±0.2 claim 1 , 25.4±0.2 claim 1 , 28.0±0.2 claim 1 , and 29.3±0.2 degrees two theta.12. The method of claim 1 , wherein Form A is characterized by an XRPD pattern having peaks at 8.8±0.2 claim 1 , 9.8±0.2 claim 1 , 20.0±0.2 claim 1 , 23.3±0.2 claim 1 , 25.4±0.2 claim 1 , 28.0±0.2 claim 1 , 29.3±0.2 claim 1 , and 32.5±0.2 degrees two theta.13. The method of claim 1 , wherein Form A is characterized by an XRPD pattern substantially as shown in .14. The method of claim 1 , wherein Form A is characterized by a TGA profile substantially as shown in .15. The method of claim 1 , wherein Form A is characterized by a DSC profile substantially as shown in .16. The method of claim 1 , wherein Form A has a unit cell that indexes as primitive monoclinic.17. The method of claim 1 , wherein Form A has a unit cell with an a value of 10.035 Å claim 1 , a b value of 7.532 Å claim 1 , and a c value of 20.092 Å.18. The method of claim 1 , wherein Form A has a unit cell with a volume of 1518.1 Å.19. The method of claim 1 , wherein Form A is s free of other polymorphic forms.20. The method of claim 1 , wherein Form A has a polymorphic purity of at least 90%.21. The method of claim 1 , wherein Form A has a polymorphic purity of at least 99%.22. The method of claim 1 , wherein Form A has one or more of a D[V claim 1 ,0.10] particle size between 0.5 μm and 15 μm claim 1 , a D[V claim 1 ,0.50] particle size between 2 μm and 30 μm claim 1 , a D[V claim 1 ,0.90] particle size between 8 μm and 600 μm claim 1 , or a D[4 claim 1 ,3] particle size of 5 μm to 200 μm.23. The method of claim 1 , wherein Form A has a D[V claim 1 ,0.10] particle size between 0.5 μm and 15 μm.24. The method of claim 1 , wherein the pharmaceutical composition is a tablet.