Claims for Patent: 10,441,656

Summary for Patent: 10,441,656

Title:	Nanoparticle complexes of paclitaxel, cetuximab, and albumin, and methods of making the same
Abstract:	This invention relates to methods of making antibody-albumin nanoparticle complexes and pharmaceutical compositions thereof, comprising albumin, an antibody with binding specificity for a EGFR cetuximab), and paclitaxel, the methods comprising mixing in vitro an aqueous albumin-paclitaxel nanoparticle with an antibody with binding specificity for EGFR cetuximab) under conditions to form the nanoparticle complexes.
Inventor(s):	Markovic; Svetomir N. (Rochester, MN), Nevala; Wendy K. (Rochester, MN)
Assignee:	MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH (Rochester, MN)
Application Number:	15/412,596
Patent Claims:	1. A method of making an antibody-albumin nanoparticle complex, the method comprising mixing in vitro an aqueous albumin-paclitaxel nanoparticle with an antibody with binding specificity for epidermal growth factor receptor (EGFR) under conditions to form the nanoparticle complex, wherein the antibody is cetuximab, and wherein said nanoparticle complexes have an average diameter of between 0.1 .mu.m and 1 .mu.m. 2. The method of claim 1, wherein the average diameter of said complexes is between about 0.1 .mu.m and 0.9 .mu.m. 3. The method of claim 1, wherein the ratio of albumm-paelitaxel nanoparticle to antibody is between 5:1 and 1:2.5. 4. The method of claim 3, wherein the ratio is about 5:1. 5. The method of claim 1, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody at an incubation temperature of between 15.degree. C. and 30.degree. C. 6. The method of claim 1, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody for between about 5 minutes and about 60 minutes. 7. The method of claim 1, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody for between about 20 minutes and about 400 minutes. 8. A method of making a pharmaceutical composition comprising a pharmaceutically acceptable carrier and antibody-albumin nanoparticle complexes, the method comprising mixing aqueous albumin-paclitaxel nanoparticles with an antibody with binding specificity for epidermal growth factor receptor (EGFR) in vitro under conditions to firm the nanoparticle complexes, and adding the pharmaceutically acceptable carrier to the nanoparticle complexes, wherein the antibody is cetuximab, and wherein said nanoparticle complexes have an average diameter of between 0.1 .mu.m and 1 .mu.m. 9. The method of claim 8, wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 5:1 and 1:2.5. 10. The method of claim 9, wherein the ratio is about 5:1. 11. The method of claim 8, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody at an incubation temperature of between 15 CC and 30.degree. C. 12. The method of claim 8, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody for between about 5 minutes and about 60 minutes. 13. The method of claim 8, wherein the aqueous albumin-paclitaxel nanoparticle is incubated with the antibody for between about 20 minutes and about 400 minutes. 14. The method of claim 8, wherein the pharmaceutically acceptable carrier is saline, water, lactic acid, mannitol, or a combination thereof. 15. The method of claim 8, wherein the pharmaceutical composition is formulated for injection into a patient.

Details for Patent 10,441,656

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	02/12/2004		2032-10-01
Eli Lilly And Company	ERBITUX	cetuximab	Injection	125084	03/28/2007		2032-10-01