JPWO2021231319A5 - - Google Patents

Claims (23)

a) about 1 mg to about 50 mg of a polypeptide comprising a circularly permuted IL-2 fused to the extracellular portion of the IL-2Rα chain;
b) sucrose,
c) mannitol,
c) a citrate buffer; and d) a surfactant. The composition of claim 1, wherein the polypeptide comprises an amino acid sequence having at least 95% identity to SEQ ID NO:1. The composition of claim 1, wherein the polypeptide comprises the amino acid sequence of SEQ ID NO:1. The composition of claim 1, wherein the polypeptide consists of the amino acid sequence of SEQ ID NO:1. The composition according to any one of claims 1 to 4, wherein the composition comprises about 1 mg to about 15 mg of the polypeptide. The composition of claim 5, wherein the composition comprises about 1 mg of the polypeptide. The composition according to any one of claims 1 to 6, wherein the composition comprises about 30 mg to about 90 mg of sucrose. The composition according to any one of claims 1 to 7, wherein the composition comprises about 30 mg to about 90 mg of mannitol. The composition according to any one of claims 1 to 8, wherein the citrate buffer contains citric acid monohydrate and trisodium citrate dihydrate. The composition of claim 9, wherein the composition comprises citric acid monohydrate and trisodium citrate dihydrate in a mass ratio of about 1:10 to about 1:2 citric acid monohydrate:trisodium citrate dihydrate. 11. The composition of claim 10, wherein the composition comprises citric acid monohydrate and trisodium citrate dihydrate in a weight ratio of about 1:9 citric acid monohydrate:trisodium citrate dihydrate. The composition according to any one of claims 1 to 11, wherein the surfactant comprises polysorbate 20. The composition of claim 12, wherein the composition comprises about 0.10 mg to about 0.12 mg of polysorbate 20. The composition according to any one of claims 1 to 13, wherein the composition is a freeze-dried composition. 15. A kit comprising: a first container comprising the composition of claim 14; and a second container comprising an aqueous solution comprising water for injection, a citrate buffer, and a surfactant. The kit of claim 15, wherein the citrate buffer in the aqueous solution comprises citric acid monohydrate and trisodium citrate dihydrate. The kit of claim 16, wherein the surfactant in the aqueous solution comprises polysorbate 20. The kit according to any one of claims 15 to 17, further comprising instructions for reconstituting a lyophilized composition using the aqueous solution. The kit of claim 18, further comprising instructions for treating a subject with cancer using the reconstituted composition. The kit of claim 19, wherein the cancer is a solid tumor. The kit of claim 19, wherein the cancer is mucosal melanoma or advanced cutaneous melanoma. The kit according to any one of claims 15 to 21, wherein the second container contains 1.1 mL of liquid. The kit according to any one of claims 15 to 22, wherein the first container is a glass vial and the second container is a glass vial.