Anti-FGFR2 Antibody Formulations
AssigneeFive Prime Therapeutics, Inc.
InventorsIsaias Prado, Chin-Yi Huang
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Abstract
This disclosure relates to a formulation of an anti-fibroblast growth factor receptor 2 (FGFR2) antibody that, in some embodiments, is capable of being stored as a liquid, for example in a ready-to-use form, and that, in some embodiments, may be administered intravenously such as by intravenous (IV) infusion.
Claims36
A pharmaceutical formulation, comprising:
- i) 10-30 mg/mL of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody;
- ii) 5-40 mM of a buffer selected from one or more of histidine, citrate, or phosphate;
- iii) 130 to 170 mM arginine or 250-290 mM sucrose;
- and
- iv) 0.002% to 0.1% polysorbate 20 or polysorbate 80;
- wherein the formulation has a pH of 5.0 to 6.5, and wherein the anti-FGFR2 antibody is selected from:
- a) an antibody comprising a heavy chain comprising the sequence of SEQ ID NO:
- 2 and a light chain comprising the sequence of SEQ ID NO:
- 3;
- b) an antibody comprising a heavy chain comprising a heavy chain (HC) hypervariable region 1 (HVR1) comprising the sequence of SEQ ID NO:
- 6, an HC HVR2 comprising the sequence of SEQ ID NO:
- 7, and an HC HVR3 comprising the sequence of SEQ ID NO:
- 8, and a light chain comprising a light chain (LC) HVR1 comprising the sequence of SEQ ID NO:
- 9, a LC HVR2 comprising the sequence of SEQ ID NO:
- 10, and a LC HVR3 comprising the sequence of SEQ ID NO:
- 11;
- and
- c) an antibody comprising a heavy chain comprising a variable region sequence comprising the sequence of SEQ ID NO:
- 4 and a light chain comprising a light chain variable region sequence comprising the sequence of SEQ ID NO:
- 5.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, wherein the formulation is a liquid formulation that has not been lyophilized prior to use, comprising:
- i) 10-25 mg/mL of the anti-FGFR2 antibody;
- ii) 10-30 mM histidine buffer;
- iii) 140-160 mM arginine;
- and
- iv) 0.005% to 0.05% polysorbate 20;
- wherein the formulation has a pH of 5.6 to 5.8.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, wherein the formulation is a liquid formulation that has not been lyophilized prior to use, comprising:
- i) 10-25 mg/mL of the anti-FGFR2 antibody;
- ii) 20 mM histidine buffer;
- iii) 150 mM arginine;
- and
- iv) 0.01% polysorbate 20;
- wherein the formulation has a pH of 5.7.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, comprising:
- i) 20 mg/mL of the anti-FGFR2 antibody;
- ii) 20 mM L-histidine buffer;
- iii) 150 mM L-arginine;
- iv) 0.01% polysorbate 20,
- wherein the formulation has a pH of 5.7 and is a liquid formulation that has not been lyophilized prior to use.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, wherein the formulation is a liquid formulation that has not been lyophilized prior to use, comprising:
- i) 10-25 mg/mL of the anti-FGFR2 antibody;
- ii) 10-30 mM histidine buffer;
- iii) 260-280 mM sucrose;
- and
- iv) 0.005% to 0.05% polysorbate 20;
- wherein the formulation has a pH of 5.8 to 6.2.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, wherein the formulation is a liquid formulation that has not been lyophilized prior to use, comprising:
- i) 10-25 mg/mL of the anti-FGFR2 antibody;
- ii) 20 mM histidine buffer;
- iii) 270 mM sucrose;
- and
- iv) 0.01% polysorbate 20;
- wherein the formulation has a pH of 6.0.
A pharmaceutical formulation of an anti-Fibroblast Growth Factor Receptor 2 (FGFR2) antibody, comprising:
- i) 20 mg/mL of the anti-FGFR2 antibody;
- ii) 20 mM L-histidine buffer;
- iii) 270 mM sucrose;
- and
- iv) 0.01% polysorbate 20,
- wherein the formulation has a pH of 6.0 and is a liquid formulation that has not been lyophilized prior to use.
Dependencies are inferred from the claim text.