Granted Patent B2

US 9,340,613 · App. 14/096,596 · Granted May 17, 2016

Inventors: Yan Chen (Malvern, PA); Debra Gardner (Bear, DE); David M. Knight (Berwyn, PA); Michael W. Lark (Devon, PA); Bailin Liang (Jacksonville, FL); David M. Marquis (Encinitas, CA); David J. Shealy (Downingtown, PA); Eric Michael Smith (San Diego, CA); Xiao-yu R. Song (Bridgewater, NJ); Vedrana Stojanovic-Susulic (Princeton Junction, NJ); Raymond W. Sweet (Bryn Mawr, PA); Susan Tam (Boothwyn, PA); Alain P. Vasserot (Carlsbad, CA); Sheng-Jiun Wu (Broomall, PA); Jing Yang (Ambler, PA)

Assignees: Janssen Biotech, Inc.; Applied Molecular Evolution

C07K16/248A61K2039/505C07K2316/96C07K2317/21C07K2317/24C07K2317/34C07K2317/565C07K2317/73C07K2317/76C07K2317/92

Abstract

Claims (15)

1. A lyophilized pharmaceutical formulation of an isolated IL-6 antibody, comprising at least one light chain variable region and one heavy chain variable region, said light chain variable region comprising:

a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:132 comprising the sequence S-X 1 -X 2 -X 3 -X 4 -V-X 5 -Y-M-Y, wherein X 1 is A or G, X 2 is S or R, X 3 is H, I, S, or Y, X 4 is S or Y, and X 5 is S or F;

a CDRL2 amino acid sequence of SEQ ID NO:133 comprising the sequence D-X 6 -S-X 7 -L-X 8 -S, wherein X 6 is F, L, M, or T, X 7 is N or E, and X 8 is A or T; and

a CDRL3 amino acid sequence of SEQ ID NO:134 comprising the sequence X 9 -X 10 -W-S-G-Y-P-Y-T, wherein X 9 is M, C, or S, and X 10 is Q or C; said heavy chain variable region comprising:

a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:135 comprising the sequence G-F-X 11 -X 12 -S-X 13 -F-A-X 14 -S, wherein X 11 is T or Q, X 12 is F, S, or T, X 13 is S or P, and X 14 is L or M;

a CDRH2 amino acid sequence of SEQ ID NO:136 comprising the sequence K-X 15 -S-X 16 -G-G-S-X 17 -X 18 -Y-X 19 -X 20 -D-T-X 21 -X 22 -X 23 , wherein X 15 is A or I, X 16 is S or P, X 17 is Y or W, X 18 is T, E, or Y, X 19 is Y or F, X 20 is P, S, D, or F, X 21 is V or D, X 22 is T or A, and X 23 is G or P; and

a CDRH3 amino acid sequence of SEQ ID NO:137 comprising the sequence Q-L-W-G-X 24 -Y-A-L-D-X 25 , wherein X 24 is S, Y, T, or N, and X 25 is Y, T, F, or I.

2. The lyophilized pharmaceutical formulation of claim 1 , comprising histidine buffer, sucrose, and polysorbate 80.

3. The lyophilized pharmaceutical formulation of claim 2 , wherein the pH is about 5.5.

4. The lyophilized pharmaceutical formulation of claim 1 , wherein the isolated IL-6 antibody comprises a light chain variable region amino acid sequence of SEQ ID NO:97 and a heavy chain variable region amino acid sequence of SEQ ID NO:99.

5. The lyophilized pharmaceutical formulation of claim 4 , comprising histidine buffer, sucrose, and polysorbate 80.

6. The lyophilized pharmaceutical formulation of claim 5 , wherein the pH is about 5.5.

7. The lyophilized pharmaceutical formulation of claim 1 , wherein the isolated IL-6 antibody comprises a complementarity determining region light chain 1 (CDRL1) amino acid sequence of SEQ ID NO:3, a CDRL2 amino acid sequence of SEQ ID NO:21, a CDRL3 amino acid sequence of SEQ ID NO:29, a complementarity determining region heavy chain 1 (CDRH1) amino acid sequence of SEQ ID NO:39, a CDRH2 amino acid sequence of SEQ ID NO:59, and a CDRH3 amino acid sequence of SEQ ID NO:89.

8. The lyophilized pharmaceutical formulation of claim 7 , comprising histidine buffer, sucrose, and polysorbate 80.

9. The lyophilized pharmaceutical formulation of claim 8 , wherein the pH is about 5.5.

Assignments (1)

Continuity (8)