Claims for Patent: 10,780,049

Summary for Patent: 10,780,049

Title:	Lyophilized compositions comprising albumin-rankl or albumin-GD2 paclitaxel nanoparticle complexes
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:	15/460,699
Patent Claims:	1. A lyophilized composition comprising nanoparticle complexes comprising: albumin; antibodies, each having an antigen-binding portion, wherein the antigen is receptor activator of nuclear factor kappa-B ligand (RANKL) or GD2; and paclitaxel; said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution the nanoparticle complexes have binding specificity for the antigen expressed by a cancer cell in vivo, wherein said complexes have an average size of less than 1 .mu.m, and wherein the antibodies are associated with the albumin through non-covalent bonds. 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 the albumin is human serum albumin. 5. 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. 6. The lyophilized composition of claim 1 which does not contain a bulking agent. 7. The lyophilized composition of claim 1, wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm. 8. The lyophilized composition of claim 1, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 9. The lyophilized composition of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30. 10. The lyophilized composition of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6. 11. The lyophilized composition of claim 1, wherein the antibodies are denosumab or dinutuximab. 12. The lyophilized composition of claim 1, wherein the antibodies are denosumab. 13. The lyophilized composition of claim 1, wherein the antibodies are dinutuximab. 14. The lyophilized composition of claim 11, wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm. 15. The lyophilized composition of claim 11, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 16. The lyophilized composition of claim 11, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30. 17. The lyophilized composition of claim 11, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6. 18. The lyophilized composition of claim 1, wherein each of the nanoparticle complexes comprises between about 100 and about 1000 antibodies. 19. The lyophilized composition of claim 1, further comprising at least one additional cancer therapeutic agent. 20. The lyophilized composition of claim 1, wherein the paclitaxel is associated with the albumin through non-covalent bonds. 21. The lyophilized composition of claim 11, wherein the paclitaxel is associated with the albumin through non-covalent bonds.

Details for Patent 10,780,049

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
Central Laboratory Of The Netherlands Red Cross Blood Transfusion Service	N/A	albumin (human)	Injection	101993	09/07/1979		2034-10-06