IP Library Granted Patent US 10,619,136
Granted Patent B2
US 10,619,136 · App. 15/373,012 · Granted Apr 14, 2020

Reducing immune tolerance induced by PD-L1

Inventor: Zhao Wu (Shanghai, CN)
Assignee: Innovative Cellular Therapeutics Co., Ltd.
C12N5/0636A61K35/17A61K39/0011C07K14/7051C07K14/70503C07K14/70521C07K16/2803C07K16/30C12N5/0638A61K2039/5156A61K2039/5158C07K2319/00C07K2319/02C07K2319/03C12N2510/02
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Quick Facts
Patent No.
US 10,619,136
App. No.
15/373,012
Granted
Apr 14, 2020
Kind
B2
Abstract

The present disclosure relates to compositions and methods for reducing immune tolerance associated with CAR T cell therapy. Embodiments of the present disclosure include isolated nucleic acid sequence comprising a nucleic acid sequence that encodes modified programmed cell death protein 1 (PD-1) and a nucleic acid sequence that encodes chimeric antigen receptor (CAR).

Claims (38)

1. A pharmaceutical composition comprising human T cells, wherein the human T cells comprising:

a first nucleic acid sequence that encodes a modified programmed cell death protein 1 (PD-1) that reduces an inhibitory effect of programmed death ligand 1 (PD-L1) on the human T cells, the modified PD-1 lacking a functional PD-1 intracellular domain for PD-1 signal transduction, wherein the modified PD-1 is a soluble receptor or comprises a mutation at amino acid 223 and/or 248; and

a second nucleic acid sequence that encodes a chimeric antigen receptor (CAR) comprising an extracellular domain that recognizes a tumor antigen of a target cell, a transmembrane domain, and an intracellular domain comprising a CD3-zeta signaling domain and a signaling domain of a costimulatory molecule; and

wherein the modified PD-1 and the CAR are expressed as gene products that are separate polypeptides.

2. The pharmaceutical composition of claim 1 , wherein the modified PD-1 interferes with a pathway between PD-1 of a human T cell of the human cells and PD-L1 of a certain cell.

3. The pharmaceutical composition of claim 1 , wherein the modified PD-1 comprises a PD-1 extracellular domain.

4. The pharmaceutical composition of claim 1 , wherein the modified PD-1 comprises:

a modified PD-1 intracellular domain comprising a substitution at amino acid 223 and/or 224; and

the amino acid sequence of SEQ ID NO: 9 or the amino acid sequence of SEQ ID NO: 10, or a combination thereof.

5. The pharmaceutical composition of claim 1 , wherein the modified PD-1 is a soluble receptor comprising a PD-1 extracellular domain that binds to PD-L1 of a certain cell.

6. The pharmaceutical composition of claim 1 , wherein the tumor antigen is CD19.

7. The pharmaceutical composition of claim 1 , wherein the costimulatory molecule comprises 4-1 BB or CD28, or a combination thereof.

8. The pharmaceutical composition of claim 3 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 12.

9. The pharmaceutical composition of claim 3 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 13.

10. The pharmaceutical composition of claim 3 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 14.

11. A method of reducing an inhibitory effect of PD-L1 on human T cells, the method comprising:

introducing a first nucleic acid sequence and a second nucleic acid sequence into the human T cells, wherein:

a first nucleic acid sequence encodes a modified PD-1 that reduces the inhibitory effect of PD-L1 on the human T cells, the modified PD-1 lacking a functional PD-1 intracellular domain for PD-1 signal transduction, wherein the modified PD-1 is a soluble receptor or comprises a mutation at amino acid 223 and/or 248; and

a second nucleic acid sequence encodes a CAR comprising an extracellular domain that recognizes a tumor antigen of a target cell, a transmembrane domain, and an intracellular domain comprising a CD3-zeta signaling domain and a signaling domain of a costimulatory molecule;

and wherein the modified PD-1 and the CAR are expressed as gene products that are separate.

12. The method of claim 11 , wherein the modified PD-1 interferes with a pathway between PD-1 of a human T cell of the human cells and PD-L1 of a certain cell.

13. The method of claim 11 , wherein the modified PD-1 comprises a PD-1 extracellular domain.

14. The method of claim 11 , wherein the modified PD-1 comprises:

a modified PD-1 intracellular domain comprising a substitution at amino acid 223 and/or 224; and

the amino acid sequence of SEQ ID NO: 9 or the amino acid sequence of SEQ ID NO: 10, or a combination thereof.

15. The method of claim 11 , wherein the modified PD-1 is a soluble receptor comprising a PD-1 extracellular domain that binds to PD-L1 of a certain cell.

16. The method of claim 11 , wherein the tumor antigen is CD19.

17. The method of claim 11 , wherein the costimulatory molecule comprises 4-1 BB or CD28, or a combination thereof.

18. The method of claim 13 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 12.

19. The method of claim 13 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 13.

20. The method of claim 13 , wherein an intracellular domain of the modified PD-1 comprises the amino acid sequence of SEQ ID NO: 14.

21. The pharmaceutical composition of claim 1 , wherein the first nucleic acid sequence comprises SEQ ID NO: 4.

22. The method of claim 11 , wherein the first nucleic acid sequence comprises sequence of SEQ ID NO: 4.

23. The method of claim 11 , wherein the modified PD-1 comprises a truncated PD-1 that does not include an intracellular domain.

24. The pharmaceutical composition of claim 1 , wherein the PD-1 is a soluble receptor.

25. The pharmaceutical composition of claim 1 , wherein the PD-1 comprises a mutation at amino acid 223 and/or 248.

26. The method of claim 11 , wherein the PD-1 is a soluble receptor.

27. The method of claim 11 , wherein the PD-1 comprises a mutation at amino acid 223 and/or 248.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 8, 2021
From: INNOVATIVE CELLULAR THERAPEUTICS CO., LTD.
To: INNOVATIVE CELLULAR THERAPEUTICS HOLDINGS, LTD.
Reel/Frame 055181/0119 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2016
From: WU, ZHAO
To: INNOVATIVE CELLULAR THERAPEUTICS CO., LTD.
Reel/Frame 040637/0712 →
Continuity (4)
Continuation 15093643 · Apr 7, 2016
Continuation PCTCN2016075061 · Mar 1, 2016
Provisional Application 62126804 · Mar 2, 2015
Related Publication 20170096638A1 · Apr 6, 2017