Claims for Patent: 10,596,112

Summary for Patent: 10,596,112

Title:	Methods of using albumin-antibody nanoparticle complex compositions for treating cancer
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:	15/460,552
Patent Claims:	1. A method for treating cancer in a subject in need thereof, the method comprising reconstituting a lyophilized nanoparticle composition in a pharmaceutically acceptable excipient to form a reconstituted nanoparticle composition and administering a therapeutically effective amount of the reconstituted nanoparticle composition to the subject, wherein the lyophilized composition comprises lyophilized nanoparticle complexes comprising albumin, antibodies having an epitope-binding portion, and paclitaxel, wherein the cancer expresses the epitope and upon reconstitution with the pharmaceutically acceptable excipient the nanoparticle complexes have binding specificity for the epitope expressed by the cancer, 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 method of claim 1, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 3. The method of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30. 4. The method of claim 1, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6. 5. The method of claim 1, wherein the epitope is vascular endothelial growth factor (VEGF), epidermal growth factor receptor (EGFR), human epidermal growth factor 2 (HER2), CD20, or PD-1. 6. The method of claim 5, wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm. 7. The method of claim 5, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:1 and 10:30. 8. The method of claim 5, wherein the ratio of albumin-paclitaxel nanoparticle to antibodies is between 10:2 and 10:6. 9. The method of claim 1, wherein the reconstituted nanoparticle composition is administered intravenously. 10. The method of claim 1, wherein the reconstituted nanoparticle composition is administered directly to the tumor. 11. The method of claim 1, comprising (a) administering the reconstituted nanoparticle composition once a week for three weeks. 12. The method of claim 11, comprising (b) ceasing administration of the reconstituted nanoparticle composition for one week. 13. The method of claim 12, comprising (c) repeating steps (a) and (b) as necessary to treat the cancer. 14. The method of claim 1, wherein the therapeutically effective amount comprises about 20 mg/m.sup.2 to about 90 mg/m.sup.2 of antibodies. 15. The method of claim 1, wherein the therapeutically effective amount comprises about 50 mg/m.sup.2 to about 200 mg/m.sup.2 of albumin and paclitaxel. 16. The method of claim 5, wherein the therapeutically effective amount comprises about 20 mg/m.sup.2 to about 90 mg/m.sup.2 of antibodies. 17. The method of claim 5, wherein the therapeutically effective amount comprises about 50 mg/m.sup.2 to about 200 mg/m.sup.2 of albumin and paclitaxel. 18. The method of claim 1, wherein the subject is a human. 19. The method of claim 1, wherein the cancer is lymphoma, leukemia, melanoma, colorectal cancer, lung cancer, head and neck cancer, cervical cancer, glioblastoma, ovarian cancer, renal cell cancer, breast cancer, neuroblastoma, peritoneal cancer, fallopian tube cancer, or bone cancer. 20. The method of claim 1, wherein the paclitaxel is associated with the albumin through non-covalent bonds. 21. The method of claim 5, wherein the paclitaxel is associated with the albumin through non-covalent bonds. 22. The method of claim 1, wherein the antibodies are adotrastuzumab emtansine, alemtuzumab, bevacizumab, cetuximab, denosumab, dinutuximab, ipilimumab, nivolumab, obinutuzumab, ofatumumab, panitumumab, pembrolizumab, pertuzumab, rituximab, trastuzumab, ibritumomab, brentuximab, blinatumomab, ramucirumab, or gemtuzumab antibodies.

Details for Patent 10,596,112

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2034-10-06
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2034-10-06
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2034-10-06
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	05/07/2001		2034-10-06