Claims for Patent: 11,045,461

Summary for Patent: 11,045,461

Title:	Compositions of CXCR4 inhibitors and methods of preparation and use
Abstract:	The present invention provides compositions and methods of use for treating, preventing, or ameliorating a disease, disorder, or condition associated with a chemokine receptor such as CXCR4.
Inventor(s):	Karel Marie Joseph Brands
Assignee:	X4 Pharmaceuticals Inc
Application Number:	US16/704,302
Patent Claims:	1. An X4P-001 composition comprising a compound of formula I: or a pharmaceutically acceptable salt thereof; and the following compound: or a pharmaceutically acceptable salt thereof, in an amount from about 0.001 to about 0.5% w/w of the X4P-001 composition. 2. The X4P-001 composition of claim 1, wherein the amount of I-6, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.4% w/w of the X4P-001 composition. 3. The X4P-001 composition of claim 1, wherein the amount of I-6, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.3% w/w of the X4P-001 composition. 4. The X4P-001 composition of claim 1, wherein the amount of I-6 is from 0.01 to 0.2% w/w of the X4P-001 composition. 5. The X4P-001 composition of claim 2, wherein the composition comprises at least a detectable amount of the following compound: or a pharmaceutically acceptable salt thereof. 6. The X4P-001 composition of claim 2, wherein the composition comprises at least a detectable amount of the following compound: or a pharmaceutically acceptable salt thereof. 7. The X4P-001 composition of claim 6, wherein the composition comprises at least a detectable amount of the following compound: or a pharmaceutically acceptable salt thereof. 8. The X4P-001 composition of claim 6, wherein the composition comprises at least a detectable amount of the following compound: or a pharmaceutically acceptable salt thereof. 9. The X4P-001 composition of claim 8, wherein the X4P-001 composition does not comprise I-2 or I-5, or a pharmaceutically acceptable salt thereof, in a detectable amount. 10. The X4P-001 composition of claim 5, wherein the amount of I-2, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.3% w/w of the X4P-001 composition. 11. The X4P-001 composition of claim 6, wherein the amount of I-3, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.4% w/w of the X4P-001 composition. 12. The X4P-001 composition of claim 8, wherein the amount of I-3, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.4% w/w of the X4P-001 composition. 13. The X4P-001 composition of claim 7, wherein the amount of I-5, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.4% w/w of the X4P-001 composition. 14. The X4P-001 composition of claim 12, wherein the amount of I-7, or a pharmaceutically acceptable salt thereof, is from about 0.01 to about 0.25% w/w of the X4P-001 composition. 15. The X4P-001 composition of claim 14, wherein the compound of formula I is present in the X4P-001 composition as a free base. 16. The X4P-001 composition of claim 15, wherein the composition comprises no more than 3.0% of total impurities. 17. The X4P-001 composition of claim 16, wherein the R-enantiomeric excess (% ee) of the compound of formula I is no less than 97.0%. 18. The X4P-001 composition of claim 16, wherein the total weight of I-6 and any additional impurities that are present comprise no more than about 0.8% w/w of the X4P-001 composition. 19. A pharmaceutical composition comprising the X4P-001 composition according to claim 1, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 20. A pharmaceutical composition comprising the X4P-001 composition according to claim 15, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 21. A compound of the following formula: or a pharmaceutically acceptable salt thereof.