Claims for Patent: 12,115,156

Summary for Patent: 12,115,156

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:	US18/312,484
Patent Claims:	1. An X4P-001 composition comprising a compound of formula I: or a pharmaceutically acceptable salt thereof; and a compound of formula I-6: or a pharmaceutically acceptable salt thereof; and wherein the compound of formula I-6 is present in an amount less than about 0.3% w/w of the X4P-001 composition. 2. The X4P-001 composition of claim 1, wherein the compound of formula I-6 is present in an amount less than about 0.2% w/w of the X4P-001 composition. 3. The X4P-001 composition of claim 1, wherein the compound of formula I-6 is present in an amount less than about 0.1% w/w of the X4P-001 composition. 4. The X4P-001 composition of claim 1, wherein the X4P-001 composition further comprises one or more of the following compounds: 5. The X4P-001 composition of claim 4, wherein the X4P-001 composition comprises less than 0.7% w/w total of I-1, I-2, I-3, I-5, I-6, and I-7. 6. 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; and wherein the X4P-001 composition comprises no more than 3.0% total impurities. 7. The X4P-001 composition of claim 1, wherein the amount of I-6, or a pharmaceutically acceptable salt thereof, is from 0.01 to 0.3% w/w of the X4P-001 composition; and wherein the total the total weight of I-6 and any additional impurities that are present comprise no more than 0.8% w/w of the X4P-composition. 8. The X4P-001 composition of claim 7, wherein the compound of formula I is present in the X4P-001 composition as a free base. 9. The X4P-001 composition of claim 8, wherein the X4P-001 composition comprises no more than 0.7% w/w total impurities. 10. The X4P-001 composition of claim 9, wherein the R-enantiomeric excess (% ee) of the compound of formula I is no less than 97.0%. 11. The X4P-001 composition of claim 10, wherein the X4P-001 composition comprises no more than 0.2% total organic impurities as an area percent (measured by HPLC) relative to the total area of an HPLC chromatogram. 12. A pharmaceutical composition comprising the X4P-001 composition of claim 1, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 13. A unit dosage form comprising the pharmaceutical composition of claim 12, wherein the X4P-001 composition is present in an amount of about 100 mg. 14. A pharmaceutical composition comprising the X4P-001 composition of claim 3, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 15. A unit dosage form comprising the pharmaceutical composition of claim 14, wherein the X4P-001 composition is present in an amount of about 100 mg. 16. A pharmaceutical composition comprising the X4P-001 composition of claim 5, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 17. A pharmaceutical composition comprising the X4P-001 composition of claim 10, and a pharmaceutically acceptable adjuvant, carrier, or vehicle. 18. A unit dosage form comprising the pharmaceutical composition of claim 16, wherein the X4P-001 composition is present in an amount of about 100 mg.