Glycoengineered binding protein compositions

Patent metadata

Field	Value
Publication number	US-2016319010-A1
Application number	US-201615198696-A
Country	US
Kind code	A1
Filing date	Jun 30, 2016
Priority date	Nov 15, 2013
Publication date	Nov 3, 2016
Grant date	—

Abstract

Provided are glycoengineered populations of Fc domain-containing binding proteins with a reduced anti-drug immune response (ADA). Also provided are methods of treating disease using such compositions, and methods and host for making such compositions.

First claim

We claim:

1 . A composition comprising a population of Fc domain-containing binding proteins wherein less than 3% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms and wherein the Fc domain-containing binding proteins comprise the polypeptide sequence of adalimumab.

2 . The composition of claim 1 , wherein less than 2% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms.

3 . The composition of claim 1 , wherein less than 1% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms.

4 . The composition of claim 1 , wherein less than 0.1% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms.

5 . The composition of claim 1 , wherein 0.1-3% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms.

6 . The composition of claim 1 , wherein 0.1-2% of the Fc domain-containing binding proteins in the population comprise M3-M9 glycoforms.

7 . The composition of claim 1 , wherein the Fc domain-containing binding proteins in the population comprise M5-M7 glycoforms.

8 . The composition of claim 1 , wherein the level of M3-M9 glycoforms is determined using the 2-AB labeling method.

9 . The composition of claim 8 , wherein the 2-AB labeling method employs a fluorophore selected from the group consisting of a 2-AB (2-aminobenzamide) and a 2-AA (anthranilic acid or 2-aminobenzoic acid).

10 . The composition of claim 1 , wherein the composition is produced in a cultured mammalian host cell line.

11 . The composition of claim 10 , wherein the cultured mammalian host cell line is selected from the group consisting of a CHO cell line, a HEK 293 cell line, a NS0 myeloma cell line, a COS cell line and a SP2 cell line.

12 . The composition of claim 10 , wherein the cultured mammalian host cell line is a CHO cell line.

13 . A pharmaceutical composition comprising the population of Fc domain-containing binding proteins of claim 1 , and a pharmaceutically acceptable carrier.

14 . The pharmaceutical composition of claim 13 , wherein the population of Fc domain-containing binding proteins is present in the pharmaceutical composition at a concentration of about 0.1-20 mg/kg.

15 . The pharmaceutical composition of claim 13 , wherein the pharmaceutically acceptable carrier comprises one or more excipient selected from the group consisting of a buffering agent, a surfactant and a polyol, or a combination thereof.

16 . The pharmaceutical composition of claim 15 , wherein the buffering agent is an amino acid.

17 . The pharmaceutical composition of claim 16 , wherein the amino acid is histidine.

18 . The pharmaceutical composition of claim 15 , wherein the surfactant is polysorbate 80.

19 . The pharmaceutical composition of claim 15 , wherein the polyol is mannitol.

20 . The pharmaceutical composition of claim 13 , wherein the pharmaceutical composition is in a syringe.

21 . A composition comprising a population of Fc domain-containing binding proteins wherein less than 3% of the Fc domain-containing binding proteins in the population comprise M5-M9 glycoforms and wherein the Fc domain-containing binding proteins comprise the polypeptide sequence of adalimumab.

22 . The composition of claim 21 , wherein less than 2% of the Fc domain-containing binding proteins in the population comprise M5-M9 glycoforms.

23 . The composition of claim 21 , wherein 0.1-2% of the Fc domain-containing binding proteins in the population comprise M5-M9 glycoforms.

24 . A pharmaceutical composition comprising the population of Fc domain-containing binding proteins of claim 21 , and a pharmaceutically acceptable carrier.

25 . The pharmaceutical composition of claim 24 , wherein the population of Fc domain-containing binding proteins is present in the pharmaceutical composition at a concentration of about 0.1-20 mg/kg.

26 . The pharmaceutical composition of claim 24 , wherein the pharmaceutically acceptable carrier comprises one or more excipient selected from the group consisting of a buffering agent, a surfactant and a polyol, or a combination thereof.

27 . The pharmaceutical composition of claim 26 , wherein the buffering agent is an amino acid.

28 . The pharmaceutical composition of claim 27 , wherein the amino acid is histidine.

29 . The pharmaceutical composition of claim 26 , wherein the surfactant is polysorbate 80.

30 . The pharmaceutical composition of claim 26 , wherein the polyol is mannitol.

Assignees

• Abbvie Inc

Inventors

• Labkovsky Boris
• Ghayur Tariq
• Gaza-Bulseco Georgeen
• Mishra Pratibha
• Hegde Subramanya
• Krishnan Sudha

Classifications

• C07K2317/52

  Constant or Fc region; Isotype · CPC title

• C07K2317/21

  from primates, e.g. man · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• C07K2317/14

  Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title

• C07K16/241 Primary

  Tumor Necrosis Factors · CPC title