	US 12,121,571 B2
	Recombinant L-asparaginase
Mi Rim Choi, Encino, CA (US); Tong Lin, Palo Alto, CA (US); and Jeffrey Silverman, Burlingame, CA (US)
Assigned to Jazz Pharmaceuticals Ireland Ltd., Dublin (IE)
Filed by Jazz Pharmaceuticals Ireland Ltd., Dublin (IE)
Filed on Oct. 23, 2020, as Appl. No. 17/078,376.
Claims priority of provisional application 63/047,222, filed on Jul. 1, 2020.
Claims priority of provisional application 62/926,201, filed on Oct. 25, 2019.
Prior Publication US 2021/0308237 A1, Oct. 7, 2021
Int. Cl. A61K 38/50 (2006.01); A61K 9/00 (2006.01); A61P 1/00 (2006.01)

CPC A61K 38/50 (2013.01) [A61K 9/0019 (2013.01); A61P 1/00 (2018.01); C12Y 305/01001 (2013.01)]

32 Claims

1. A method of treating a disease characterized by benefiting from asparagine depletion in a human subject, the method comprising intramuscularly administering to the human subject a pharmaceutical composition having a pH of about 7.0 and comprising:

(i) a recombinant L-asparaginase; and

(ii) trehalose,

wherein the recombinant L-asparaginase is a tetramer,

wherein the tetramer comprises four monomers,

wherein each monomer has an amino acid sequence comprising SEQ ID NO: 1,

wherein the recombinant L-asparaginase in the pharmaceutical composition demonstrates less than 5% aggregation, and

wherein the treatment results in asparagine depletion in the subject, thereby treating the disease.