IP Library Granted Patent US 10,300,016
Granted Patent B2
US 10,300,016 · App. 15/286,006 · Granted May 28, 2019

Carrier-antibody compositions and methods of making and using the same

Inventors: Svetomir N. Markovic (Rochester, MN); Wendy K. Nevala (Rochester, MN)
Assignee: Mayo Foundation for Medical Education and Research
A61K9/0095A61K9/08A61K9/146A61K9/1658A61K9/19A61K31/337A61K33/24A61K39/3955A61K47/643A61K47/6803A61K47/6845A61K47/6849A61K47/6851A61K47/6871A61K47/6929A61K47/6931A61K51/1021C07K16/22C07K16/2863C07K16/2887C07K16/30C07K16/32C07K16/40A61K2039/505C07K2317/24C07K2317/52C07K2317/76C07K2317/92
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Quick Facts
Patent No.
US 10,300,016
App. No.
15/286,006
Granted
May 28, 2019
Kind
B2
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.

Claims (31)

1. A lyophilized composition comprising nanoparticle complexes, wherein the nanoparticle complexes have an outside surface and comprise:

albumin;

cetuximab antibodies, each having an epidermal growth factor receptor (EGFR)-binding portion; and

paclitaxel;

said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution an amount of the antibodies are arranged on the outside surface of the nanoparticle complexes and the nanoparticle complexes are capable of binding to EGFR in vivo.

2. The lyophilized composition of claim 1 that is stable at about 20° C. to about 25° C. for at least 3 months.

3. The lyophilized composition of claim 1 , wherein each of the nanoparticle complexes comprises between about 400 to about 800 antibodies.

4. The lyophilized composition of claim 3 , wherein less than 0.01% of nanoparticle complexes have a size greater than 800 nm.

5. The lyophilized composition of claim 1 wherein said nanoparticle complexes have an average size of about 160 nm.

6. The lyophilized composition of claim 1 , wherein the albumin is human serum albumin.

7. The lyophilized composition of claim 1 , wherein the nanoparticle complexes have a dissociation constant between about 1×10 −11 M and about 1×10 −9 M.

8. A lyophilized composition comprising nanoparticle complexes, wherein the nanoparticle complexes have an outside surface and comprise:

albumin;

cetuximab antibodies, each having an epidermal growth factor receptor (EGFR)-binding portion; and

paclitaxel;

said nanoparticle complexes being lyophilized, and wherein upon reconstitution with an aqueous solution an amount of the antibodies are arranged on the outside surface of the nanoparticle complexes and the nanoparticle complexes are capable of binding to EGFR in vivo;

wherein the lyophilized composition does not contain a bulking agent.

9. The lyophilized composition of claim 8 that is stable at about 20° C. to about 25° C. for at least 3 months.

10. The lyophilized composition of claim 8 , wherein the nanoparticle complexes comprise an average of about 100 to about 1000 antibodies.

11. The lyophilized composition of claim 10 , wherein less than 0.01% of the nanoparticle complexes have a size greater than 800 nm.

12. The lyophilized composition of claim 8 wherein said nanoparticle complexes have an average size of about 160 nm.

13. The lyophilized composition of claim 8 , wherein the albumin is human serum albumin.

14. The lyophilized composition of claim 8 , wherein the nanoparticle complexes have a dissociation constant between about 1×10 −11 M and about 1×10 −9 M.

15. The lyophilized composition of claim 1 , wherein said complexes have an average size of less than 1 μm.

16. The lyophilized composition of claim 1 , wherein said nanoparticle complexes have an average size between about 130 nm and about 800 nm.

17. The lyophilized composition of claim 1 , wherein the ratio of albumin-paclitaxel nanoparticle to antibody is between 10:1 and 10:30.

18. The lyophilized composition of claim 1 , 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 4, 2017
From: MARKOVIC, SVETOMIR N.; NEVALA, WENDY K.
To: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
Reel/Frame 040846/0880 →
Continuity (8)
Continuation 15064396 · Mar 8, 2016
Continuation 14882327 · Oct 13, 2015
Continuation PCTUS2015054295 · Oct 6, 2015
Provisional Application 62206770 · Aug 18, 2015
Provisional Application 62206771 · Aug 18, 2015
Provisional Application 62206772 · Aug 18, 2015
Provisional Application 62060484 · Oct 6, 2014
Related Publication 20170021032A1 · Jan 26, 2017
Cited By (3)
US 12,364,754 US 12,365,714 US 12,403,119