IP Library › Granted Patent US 12,303,552
Granted Patent B2
US 12,303,552 · App. 18/808,392 · Granted May 20, 2025

Treatment of immunosuppressed subjects

Inventor: Patrick Soon-Shiong (Culver City, CA)
Assignee: NantCell, Inc.
A61K38/2086A61K31/427A61K31/4418A61K31/496A61K31/513A61K31/52A61K31/536A61K31/635A61K31/675A61K31/7068A61K31/7072A61K38/1793A61K47/642A61K47/6425A61P31/18
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Quick Facts
Patent No.
US 12,303,552
App. No.
18/808,392
Granted
May 20, 2025
Kind
B2
Abstract

An IL-15 super agonist (IL-15N72D:IL-15RαSU/IgGIFc; N-803) increases circulating NK cells, effector memory and effector memory RA cells in post-allogeneic hematopoietic stem cell transplant patients (HCT). Methods of treatment include administration of N-803 to subjects in need of such treatment.

Claims (18)

1. A method of modulating an immune response in an immunosuppressed subject, comprising administering to the subject a composition comprising a therapeutically effective amount of an IL-15:IL-15Rα complex, wherein the IL-15:IL-15Rα complex modulates amounts of circulating immune effector cells, immune effector cell activity, and/or activates immune effector cells, wherein the immune effector cells comprise CD45RA − /CCR7 − effector memory (T EM ) T cells or CD45RA + /CCR7 − effector memory RA (T EMRA ) T cells.

2. The method of claim 1 , wherein the IL-15:IL-15Rα complex is an IL-15N72D:IL-15RαSu/Fc complex (N-803) comprising a dimeric IL-15RαSu/Fc and two IL-15N72D molecules.

3. The method of claim 1 , wherein the immune effector cells further comprise natural killer cells (NK), cytolytic T cells (CTLs), T helper cells (T H ), or a combination thereof.

4. The method of claim 1 , wherein the activated immune effector cells comprise one or more markers comprising CD38, perforin, granzyme B, Ki-67, or a combination thereof.

5. The method of claim 1 , wherein the immunosuppressed subject is a subject having undergone organ transplantation, bone marrow transplantation, radiotherapy, chemotherapy and/or have a viral infection, chronic viral infection, recurrent viral infection, or a combination thereof.

6. The method of claim 1 , comprising administering one or more chemotherapeutic agents, compounds, cytokine antagonists, cytokine receptor antagonists, cytokines, adoptive cell therapies, anti-viral agents, checkpoint inhibitors, adjuvants, or a combination thereof.

7. The method of claim 6 , wherein the adoptive cell therapy comprises administration of natural killer (NK) cells and/or T cells.

8. The method of claim 1 , wherein the IL-15:IL-15Rα complex is administered at a dose of about 1.0 μg/kg.

9. The method of claim 1 , wherein the IL-15:IL-15Rα complex is administered at a dose of about 3.0 μg/kg.

10. The method of claim 9 , wherein the IL-15:IL-15Rα complex is administered intravenously.

11. The method of claim 1 , wherein the IL-15:IL-15Rα complex is administered at a dose of about 6.0 μg/kg.

12. The method of claim 11 , wherein the IL-15:IL-15Rα complex is administered subcutaneously.

13. The method of claim 1 , wherein CD34, CD8, and/or NK cells proliferate after each administration of the IL-15:IL-15Rα complex.

14. The method of claim 1 , wherein HIV genes are transcribed in lymphocytes after each administration of the IL-15:IL-15Rα complex.

15. The method of claim 1 , wherein detectable HIV reservoir in lymphocytes decline after each administration of the IL-15:IL-15Rα complex.

16. The method of claim 1 , wherein detectable HIV reservoir in blood mononuclear cells decline after each administration of the IL-15:IL-15Rα complex.

17. The method of claim 1 , wherein anti-IL-15 antibodies do not form after administration of the IL-15:IL-15Rα complex.

18. The method of claim 1 , wherein cytokine-related side effects do not occur after administration of the IL-15:IL-15Rα complex.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 20, 2024
From: SOON-SHIONG, PATRICK
To: NANTCELL, INC.
Reel/Frame 068337/0518 →
Continuity (4)
Division 18326293 · May 31, 2023
Continuation 17284406
Provisional Application 62744601 · Oct 11, 2018
Related Publication 20240398900A1 · Dec 5, 2024
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