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US 12,760,108 B2Granted
Injectable formulations for treatment of inflammatory bowel disease
AssigneeParagon Therapeutics, Inc.
InventorsPeter Evan Harwin, Tomas Kiselak, Hussam Hisham Shaheen, Eric Franklin Zhu
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Abstract
Provided herein are variant α4β7 integrin antibodies and methods of use.
Claims6
An injectable dosage form comprising a long acting α4β7 targeting antibody, wherein the long acting α4β7 targeting antibody comprises:
- a) a heavy chain amino acid sequence consisting of SEQ ID NO:
- 1;
- and
- b) a light chain amino acid sequence consisting of SEQ ID NO:
- 3,
- wherein the long acting α4β7 targeting antibody has a deglycosylated molecular weight of 146,698.3 daltons as determined by its amino acid sequence;
- and
- wherein the injectable dosage form is an injectable aqueous formulation comprising from about 150 mg/ml to about 200 mg/ml of the long acting α4β7 targeting antibody,
- wherein the injectable aqueous formulation comprises an amount of a polysorbate or poloxamer detergent that reduces aggregation of the long acting α4β7 targeting antibody and minimizes the formation of particulates in the aqueous formulation as compared to a corresponding aqueous formulation that does not have an amount of the polysorbate or poloxamer detergent, and
- wherein the injectable aqueous formulation does not comprise citrate.
7 more elements
An injectable aqueous formulation comprising from about 150 mg/ml to about 200 mg/ml of a long acting α4β7 targeting antibody, wherein the long acting α4β7 targeting antibody comprises:
- a) a heavy chain amino acid sequence consisting of SEQ ID NO:
- 1;
- and
- b) a light chain amino acid sequence consisting of SEQ ID NO:
- 3,
- wherein the long acting α4β7 targeting antibody has a deglycosylated molecular weight of 146,698.3 daltons as determined by its amino acid sequence,
- wherein an average serum half-life of the long acting α4β7 targeting antibody is about 17 days or greater upon administration in cynomolgus monkeys;
- and
- wherein the injectable aqueous formulation comprises an amount of a polysorbate or poloxamer detergent that reduces aggregation of the long acting α4β7 targeting antibody and minimizes the formation of particulates in the aqueous formulation as compared to a corresponding aqueous formulation that does not have an amount of the polysorbate or poloxamer detergent, and wherein the injectable aqueous formulation does not comprise citrate.
6 more elements
Dependencies are inferred from the claim text.