Dosing and administration of recombinant L-asparaginase

Patent metadata

Field	Value
Publication number	US-12551540-B2
Application number	US-202217709166-A
Country	US
Kind code	B2
Filing date	Mar 30, 2022
Priority date	Mar 30, 2021
Publication date	Feb 17, 2026
Grant date	Feb 17, 2026

Abstract

The present invention provides compositions and methods for treating a disease treatable by asparagine depletion in a human subject comprising dosing a human subject with L-asparaginase.

First claim

The invention claimed is:

1 . A method of treating cancer in a human subject in need thereof, said method comprising administering to the human subject L-asparaginase, other than an Escherichia coli derived asparaginase, as a set of time-ordered doses;
wherein the set of time-ordered doses comprises two series of three doses, wherein a first dose and a second dose are each 25 mg/m 2 and a third dose is 50 mg/m 2 , wherein the first, the second and the third dose are administered on a Monday, Wednesday and Friday, respectively, and wherein the L-asparaginase is a tetramer wherein each monomer of the tetramer comprises SEO ID NO:1, wherein the doses at 25 mg/m 2 are administered intravascularly and the doses at 50 mg/m 2 are administered intramuscularly, and wherein the cancer is a blood cell cancer treatable by asparagine depletion, thereby treating cancer in the subject.

2 . The method of claim 1 , wherein the human subject exhibited hypersensitivity to the Escherichia coli derived asparaginase.

3 . The method of claim 1 , wherein the human subject is an adult.

4 . The method of claim 1 , wherein the human subject is pediatric.

5 . The method of claim 1 , wherein the L-asparaginase demonstrates less than 6% aggregation.

6 . The method according to claim 1 , wherein the L-asparaginase is co-administered with one or more other chemotherapeutic agents as part of a multi-agent chemotherapeutic regimen.

7 . A method of substituting a treatment of a human subject for cancer, wherein the human subject is in need thereof, said method comprising administering to the human subject, as a substitute for an Escherichia coli derived asparaginase, a series of six doses of an L-asparaginase,
wherein a first dose and a second dose are each 25 mg/m 2 and a third dose is 50 mg/m 2 , wherein the first, the second and the third dose are administered on a Monday, Wednesday and Friday, respectively, and wherein the L-asparaginase is a tetramer wherein each monomer of the tetramer comprises SEO ID NO: 1 wherein the doses at 25 mg/m 2 are administered intravascularly and the doses at 50 mg/m 2 are administered intramuscularly, wherein the L-asparaginase is not an Escherichia coli derived asparaginase, and wherein the cancer is a blood cell cancer treatable by asparagine depletion, thereby substituting a treatment of the human subject for cancer.

8 . The method of claim 7 , wherein each respective dose of the Escherichia coli derived asparaginase in a plurality of doses of the Escherichia coli derived asparaginase is separately substituted with an instance of the series of six doses of the L-asparaginase.

9 . The method of claim 7 , wherein the human subject exhibited hypersensitivity to the Escherichia coli derived asparaginase.

10 . The method of claim 7 , wherein the human subject is an adult.

11 . The method of claim 7 , wherein the human subject is pediatric.

12 . The method of claim 7 , wherein the L-asparaginase demonstrates less than 6% aggregation.

13 . The method according to claim 7 , wherein the L-asparaginase is co-administered with one or more other chemotherapeutic agents as part of a multi-agent chemotherapeutic regimen.

14 . The method according to claim 1 , wherein the cancer is acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL).

15 . The method according to claim 1 , wherein the cancer is acute myeloid leukemia (AML).

16 . The method according to claim 1 , wherein the cancer is diffuse large B-cell lymphoma (DLBCL).

17 . The method according to claim 7 , wherein the cancer is acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL).

18 . The method according to claim 7 , wherein the cancer is acute myeloid leukemia (AML).

19 . The method according to claim 7 , wherein the cancer is diffuse large B-cell lymphoma (DLBCL).

20 . The method of claim 1 , wherein the first dose is administered on a Monday, the second dose is administered on a Wednesday, and the third dose is administered on a Friday.

Assignees

• Jazz Pharmaceuticals Ireland Ltd

Inventors

• Choi Mi Rim
• Lin Tong
• Silverman Jeffrey

Classifications

• C12Y305/01001

  Asparaginase (3.5.1.1) · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61P35/02

  specific for leukemia · CPC title