Lyophilized formulations of engineered anti-IL-23p19 antibodies

1. A lyophilized formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, comprising:

a) said anti-human IL-23p19 antibody, or antigen binding fragment thereof;

b) sodium citrate;

c) polysorbate 80; and

d) sucrose

wherein the antibody, or antigen binding fragment thereof, comprises:

i) a light chain comprising CDRL1, CDRL2 and CDRL3, wherein:

CDRL1 comprises the sequence of SEQ ID NO:36;

CDRL2 comprises the sequence of SEQ ID NO:41; and

CDRL3 comprises the sequence of SEQ ID NO:46;

and

ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:

CDRH1 comprises the sequence of SEQ ID NO:19;

CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26; and

CDRH3 comprises the sequence of SEQ ID NO:31.

2. The lyophilized formulation of claim 1 , wherein the formulation has a pH between 4.4 and 5.2 when reconstituted.

3. The lyophilized formulation of claim 1 that enables reconstitution of the antibody, or antigen binding fragment thereof, at a concentration of 100 mg/mL.

4. The lyophilized formulation of claim 1 , wherein polysorbate 80 is present at a weight ratio of approximately 0.2% compared to the antibody or antigen binding fragment thereof.

5. The lyophilized formulation of claim 1 , wherein sucrose is present at a weight ratio of approximately 70% compared to the antibody, or antigen binding fragment thereof.

6. A lyophilized pharmaceutical formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, made by lyophilizing an aqueous solution comprising:

a) 5-25 mg/mL anti-human IL-23p19 antibody, or antigen binding fragment thereof;

b) about 50 mM sucrose;

c) about 0.05 mg/mL polysorbate 80; and

d) about 2.5 mM citrate buffer at pH 4.4-5.2,

wherein the antibody, or antigen binding fragment thereof, comprises:

i) a light chain comprising CDRL1, CDRL2 and CDRL3, wherein:

CDRL1 comprises the sequence of SEQ ID NO:36;

CDRL2 comprises the sequence of SEQ ID NO:41; and

CDRL3 comprises the sequence of SEQ ID NO:46;

and

ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:

CDRH1 comprises the sequence of SEQ ID NO:19;

CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26; and

CDRH3 comprises the sequence of SEQ ID NO:31.

7. The lyophilized pharmaceutical formulation of claim 6 , wherein the anti-human IL-23p19 antibody, or antigen binding fragment thereof, is present at about 25 mg/mL in the aqueous solution.

8. The lyophilized pharmaceutical formulation of claim 6 , wherein the aqueous solution has a pH of about 4.8.

9. A lyophilized pharmaceutical formulation of an anti-human IL-23p19 antibody, or antigen binding fragment thereof, that when reconstituted comprises:

a) 25-100 mg/mL anti-human IL-23p19 antibody, or antigen binding fragment thereof;

b) about 200 mM sucrose;

c) about 0.2 mg/mL polysorbate 80; and

d) about 10 mM citrate buffer at pH 4.4 to 5.2,

wherein the antibody, or antigen binding fragment thereof, comprises:

i) a light chain comprising comprising CDRL1, CDRL2 and CDRL3, wherein:

CDRL1 comprises the sequence of SEQ ID NO:36;

CDRL2 comprises the sequence of SEQ ID NO:41; and

CDRL3 comprises the sequence of SEQ ID NO:46;

and

ii) a heavy chain comprising CDRH1, CDRH2 and CDRH3, wherein:

CDRH1 comprises the sequence of SEQ ID NO:19;

CDRH2 comprises a sequence selected from the group consisting of SEQ ID NOs:24-26; and

CDRH3 comprises the sequence of SEQ ID NO:31.

10. The lyophilized pharmaceutical formulation of claim 9 , wherein the anti-human IL-23p19 antibody, or antigen binding fragment thereof, is present at about 100 mg/mL in the reconstituted solution.

11. The lyophilized pharmaceutical formulation of claim 9 , wherein the reconstituted solution has a pH of about 4.8.

12. The lyophilized formulation of any one of claim 1 , 6 or 9 , wherein the antibody, or antigen binding fragment thereof, comprises a light chain variable domain comprising residues 1-108 of SEQ ID NO: 14.

13. The lyophilized formulation of any one of claim 1 , 6 or 9 , wherein the antibody, or antigen binding fragment thereof, comprises a heavy chain variable domain comprising a sequence selected from the group consisting of residues 1-116 of SEQ ID NOs: 6-8.

14. The lyophilized formulation of any one of claim 1 , 6 or 9 , wherein the antibody, or antigen binding fragment thereof, comprises:

i) a light chain comprising SEQ ID NO: 14; and

ii) a heavy chain comprising a sequence selected from the group consisting of SEQ ID NOs: 6-8.