Compositions comprising il-15n72d-based molecules and bacillus calmette-guerin (bcg)

Patent metadata

Field	Value
Publication number	US-2024252591-A1
Application number	US-202418639678-A
Country	US
Kind code	A1
Filing date	Apr 18, 2024
Priority date	Jun 30, 2014
Publication date	Aug 1, 2024
Grant date	—

Abstract

The invention features combination therapies using an IL-15-based superagonist complex and an antibody to effectively treat subjects with cancer and infectious diseases.

First claim

1 .- 30 . (canceled)

31 . A pharmaceutical composition comprising:
i) an effective amount of Bacillus Calmette-Guerin (BCG); and ii) an effective amount of an IL-15N72D:IL-15RαSu complex.

32 . The composition of claim 31 , wherein the IL-15N72D:IL-15RαSu complex is comprised of IL-15N72D noncovalently bound to IL-15RαSu, wherein at least one binding partner of the IL-15N72D:IL-15RαSu complex is a fusion protein, and wherein the at least one binding partner is covalently bound to a biologically active polypeptide.

33 . The composition of claim 32 , wherein the IL-15RαSu is genetically fused to an immunoglobulin Fc domain, or functional fragment thereof, wherein an IL-15RαSu/Fc fusion protein is formed.

34 . The composition of claim 33 wherein the IL-15N72D/IL-15RαSu/Fc fusion protein comprises a dimeric complex comprising a dimeric IL-15RαSu/Fc and two IL-15N72D molecules.

35 . The composition of claim 34 , wherein the IL-15N72D molecule comprises SEQ ID NO: 3.

36 . The composition of claim 34 , wherein the IL-15RαSu/Fc comprises SEQ ID NO: 6.

37 . The composition of claim 34 , wherein the dimeric complex is ALT-803.

38 . A method for treating cancer comprising administering to a subject in need thereof, the composition of claim 31 .

39 . The method of claim 38 , wherein the cancer is bladder cancer.

40 . The method of claim 39 , wherein the bladder cancer is non-muscle invasive bladder cancer.

41 . A kit for use in the treatment of cancer, the kit comprising:
(a) a first vial comprising an effective amount of Bacillus Calmette-Guerin (BCG), wherein the BCG is formulated for administration to a subject; (b) a second vial comprising an IL-15N72D:IL-15RαSu complex, wherein the IL-15N72D:IL-15RαSu complex is formulated for administration to a subject; and (c) directions for use in the treatment of cancer.

42 . The kit of claim 31 , wherein the IL-15N72D:IL-15RαSu complex comprises a dimeric IL-15RαSu/Fc fusion protein and two IL-15N72D molecules, thereby forming an IL-15N72D:IL-15RαSu/Fc complex.

43 . The kit of claim 42 , wherein the IL-15N72D:IL-15RαSu/Fc complex is ALT-803.

44 . The kit of claim 41 , wherein the cancer is bladder cancer.

Assignees

• Altor Bioscience Llc

Inventors

• Liu Bai
• Rhode Peter
• Xu Wenxin
• Wong Hing C

Classifications

• C07K2319/32

  fusions with soluble part of a cell surface receptor, "decoy receptors" · CPC title

• A61K2039/505

  comprising antibodies · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K38/1793

  for cytokines; for lymphokines; for interferons · CPC title

• A61K39/39558

  against tumor tissues, cells, antigens · CPC title