Pharmaceutical formulations containing CD80 extracellular domain-Fc fusion proteins
The present disclosure provides pharmaceutical compositions comprising CD80 extracellular domain (ECD)-fragment crystallizable (Fc) fusion molecules. The present disclosure also provides methods for treating solid tumors by administering such pharmaceutical compositions.
1 . A pharmaceutical composition consisting of (i) sialylated CD80 ECD-Fc fusion molecules, (ii) about 20 mM L-histidine, (iii) about 270 mM sucrose, and (iv) about 0.05% weight/volume polysorbate 20, wherein the pH of the composition is about 6.7.
2 . A pharmaceutical composition consisting of (i) sialylated CD80 ECD-Fc fusion molecules, (ii) about 20 mM L-histidine, (iii) about 270 mM sorbitol, and (iv) about 0.05% weight/volume polysorbate 20, wherein the pH of the composition is about 6.7.
3 . A syringe or vial comprising the pharmaceutical composition of claim 1 .
4 . The pharmaceutical composition of claim 1 , wherein the concentration of CD80 ECD-Fc fusion molecules is about 5 mg/ml to about 15 mg/ml.
5 . The pharmaceutical composition of claim 4 , wherein the concentration of the CD80 ECD-Fc fusion molecules is about 10 mg/ml.
6 . The pharmaceutical composition of claim 1 , wherein the composition is a liquid.
7 . The pharmaceutical composition of claim 1 , wherein the composition is for intravenous administration.
8 . The pharmaceutical composition of claim 1 , wherein the CD80 ECD-Fc fusion molecules comprise a human CD80 ECD and a human IgG1 Fc domain.
9 . The pharmaceutical composition of claim 1 , wherein the CD80 ECD-Fc fusion molecules comprise 15-60 moles sialic acid (SA) per mole of fusion protein.
10 . The pharmaceutical composition of claim 2 , wherein the concentration of CD80 ECD-Fc fusion molecules is about 5 mg/ml to about 15 mg/ml.
11 . The pharmaceutical composition of claim 10 , wherein the concentration of the CD80 ECD-Fc fusion molecules is about 10 mg/ml.
12 . The pharmaceutical composition of claim 2 , wherein the composition is a liquid.
13 . The pharmaceutical composition of claim 2 , wherein the composition is for intravenous administration.
14 . The pharmaceutical composition of claim 2 , wherein the CD80 ECD-Fc fusion molecules comprise a human CD80 ECD and a human IgG1 Fc domain.
15 . The pharmaceutical composition of claim 2 , wherein the CD80 ECD-Fc fusion molecules comprise 15-60 moles sialic acid (SA) per mole of fusion protein.
16 . A syringe or vial comprising the pharmaceutical composition of claim 2 .