Anti-c-met-antibody formulations

Patent metadata

Field	Value
Publication number	US-9487589-B2
Application number	US-201414534085-A
Country	US
Kind code	B2
Filing date	Nov 5, 2014
Priority date	Jun 30, 2011
Publication date	Nov 8, 2016
Grant date	Nov 8, 2016

Abstract

Provided herein are pharmaceutical formulations comprising a one-armed, anti-c-met antibody and uses of the same.

First claim

The invention claimed is:

1. A pharmaceutical formulation comprising:
(a) an anti-c-met antibody, wherein the anti-c-met antibody is onartuzumab present at a concentration between about 10 mg/mL and about 100 mg/mL;
(b) a histidine buffer at pH 5.0-5.4;
(c) a saccharide; and
(d) polysorbate 20, wherein the polysorbate 20 is present at a concentration of about 0.04% w/v.

2. The pharmaceutical formulation of claim 1 , wherein the saccharide is present at a concentration of about 75 mM to about 200 mM.

3. The pharmaceutical formulation of claim 1 , wherein the saccharide is a disaccharide.

4. The pharmaceutical formulation of claim 3 , wherein the disaccharide is trehalose.

5. The pharmaceutical formulation of claim 3 , wherein the disaccharide is sucrose.

6. The pharmaceutical formulation of claim 1 , wherein the histidine buffer is at a concentration of about 1 mM to about 50 mM.

7. The pharmaceutical formulation of claim 1 , wherein the formulation is diluted with a diluent.

8. A method of treating a subject having a proliferative disorder, said method comprising administering to the subject an effective amount of the pharmaceutical formulation of claim 1 .

9. The method of claim 8 , wherein the proliferative disorder is cancer.

10. The method of claim 9 , wherein the cancer is lung cancer, glioblastoma, pancreatic cancer, sarcoma, renal cell carcinoma, hepatocellular carcinoma, gastric cancer, colorectal cancer, and/or breast cancer.

11. The method of claim 8 , further comprising a second therapeutic agent.

12. A method of making a pharmaceutical formulation of claim 1 comprising combining:
(a) the anti-c-met antibody;
(b) the histidine buffer;
(c) the saccharide; and
(d) the polysorbate 20.

13. The pharmaceutical formulation of claim 6 , wherein the histidine buffer is at a concentration of about 1 mM to about 20 mM.

14. The pharmaceutical formulation of claim 6 , wherein the histidine buffer is at a concentration of about 5 mM to about 15 mM.

15. The pharmaceutical formulation of claim 6 , wherein the histidine buffer is at a concentration of about 5 mM.

16. The pharmaceutical formulation of claim 6 , wherein the histidine buffer is at a concentration of about 7.5 mM.

17. The pharmaceutical formulation of claim 6 , wherein the histidine buffer is at a concentration of about 10 mM.

18. A pharmaceutical formulation comprising:
(a) an anti-c-met antibody, wherein the anti-c-met antibody is present at a concentration of about 60 mg/ml, wherein the anti-c-met antibody is onartuzumab;
(b) a histidine buffer at pH 5.4, wherein the histidine buffer is at a concentration of about 5 mM to about 15 mM, wherein the histidine buffer is histidine acetate;
(c) a saccharide, wherein the saccharide is present at a concentration of about 120 mM, wherein the saccharide is sucrose; and
(d) polysorbate 20, wherein the polysorbate 20 is present at a concentration of about 0.04%.

19. A pharmaceutical formulation comprising:
(a) an anti-c-met antibody, wherein the anti-c-met antibody is present at a concentration of about 60 mg/ml, wherein the anti-c-met antibody is onartuzumab;
(b) a histidine buffer at pH 5.4, wherein the histidine buffer is at a concentration of about 7.5 mM, wherein the histidine buffer is histidine acetate;
(c) a saccharide, wherein the saccharide is present at a concentration of about 120 mM, wherein the saccharide is sucrose; and
(d) polysorbate 20, wherein the polysorbate 20 is present at a concentration of about 0.04%.

20. The pharmaceutical formulation of any one of claim 1 , 6 , or 13 - 17 , wherein the histidine buffer is histidine acetate.

Assignees

• Genentech Inc

Inventors

• Demeule Barthelemy
• Kabakoff Bruce
• Liu Jun
• Piros Nicole
• Zhu Qing

Classifications

• A61P35/00

  Antineoplastic agents · CPC title

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K2317/522

  CH1 domain · CPC title

• C07K16/2863 Primary

  against receptors for growth factors, growth regulators · CPC title