Claims for Patent: 10,391,055

Summary for Patent: 10,391,055

Title:	Carrier-antibody compositions and methods of making and using the same
Abstract:	Described herein are compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic. Also described are lyophilized compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic.
Inventor(s):	Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN)
Assignee:	Mayo Foundation for Medical Education and Research (Rochester, MN)
Application Number:	15/331,754
Patent Claims:	1. A lyophilized composition comprising nanoparticle complexes having an outside surface, wherein each of the nanoparticle complexes comprises: a) albumin; b) antibodies having a human epidermal growth factor receptor (HER) binding portion; and c) paclitaxel; said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution, the HER binding portion of said antibodies are arranged on the outside surface of the nanoparticle complexes and are capable of binding to HER in vivo. 2. The lyophilized composition of claim 1 that is stable at about 20.degree. C. to about 25.degree. C. for at least 3 months. 3. The lyophilized composition of claim 1, wherein each of the nanoparticle complexes comprises between about 400 and about 800 antibodies. 4. The lyophilized composition of claim 1, wherein less than 0.01% of nanoparticle complexes in the composition have a size greater than 800 nm. 5. The lyophilized composition of claim 1, wherein the average size of the nanoparticle complexes is less than 1 .mu.m. 6. The lyophilized composition of claim 1, wherein the nanoparticle complexes have a dissociation constant between about 1.times.10.sup.-11 M and about 1.times.10.sup.-9 M. 7. The lyophilized composition of claim 1, wherein the albumin is human serum albumin. 8. The lyophilized composition of claim 1, wherein the HER is HER2. 9. The lyophilized composition of claim 1, wherein the antibodies are trastuzumab, ado-trastuzumab emtansine, cetuximab, panitumumab, or pertuzumab. 10. The lyophilized composition of claim 1 which does not contain a bulking agent. 11. The lyophilized composition of claim 1, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 12. The lyophilized composition of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 10:1 and 10:30. 13. The lyophilized composition of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 10:2 and 10:6. 14. The lyophilized composition of claim 9, wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm. 15. The lyophilized composition of claim 9, wherein said complexes have an average size of less than 1 .mu.m. 16. The lyophilized composition of claim 9, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 17. The lyophilized composition of claim 9, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 10:1 and 10:30. 18. The lyophilized composition of claim 9, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 10:2 and 10:6. 19. The lyophilized composition of claim 1, wherein each of the nanoparticle complexes comprises between about 100 and about 1000 antibodies. 20. The lyophilized composition of claim 1, further comprising at least one additional cancer therapeutic agent. 21. The lyophilized composition of claim 1, wherein the antibodies are associated with the albumin through non-covalent bonds. 22. The lyophilized composition of claim 1, wherein the paclitaxel is associated with the albumin through non-covalent bonds. 23. The lyophilized composition of claim 9, wherein the antibodies are associated with the albumin through non-covalent bonds. 24. The lyophilized composition of claim 9, wherein the paclitaxel is associated with the albumin through non-covalent bonds.

Details for Patent 10,391,055

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2034-10-06
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2034-10-06
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2034-10-06
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2034-10-06
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2034-10-06
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2034-10-06