IP Library Granted Patent US 11,896,617
Granted Patent B2
US 11,896,617 · App. 16/857,573 · Granted Feb 13, 2024

Polynucleotides encoding rituximab-resistant chimeric antigen receptors

Inventors: Thomas Charles Pertel (San Mateo, CA); Barbra Johnson Sasu (San Francisco, CA); Mark W. Leonard (Burlingame, CA)
Assignee: ALLOGENE THERAPEUTICS, INC.
A61K35/17A61P35/00C07K14/70517C07K14/70596C07K16/2803C12N5/0636A61K2039/505C07K2317/76C07K2319/33C12N2510/00C12N2740/15043
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Quick Facts
Patent No.
US 11,896,617
App. No.
16/857,573
Granted
Feb 13, 2024
Kind
B2
Abstract

Provided herein are polynucleotides encoding chimeric antigen receptors (CARs) comprising a CD19 antigen binding domain that specifically binds to CD19 and is resistant to rituximab binding; and immune cells comprising these CD19-specific CARs, e.g., CAR-T cells. Also provided are methods of making and using these CD19-specific CARs, and immune cells comprising these CD19-specific CARs.

Claims (23)

1. An isolated polynucleotide encoding a polypeptide comprising an anti-CD19 chimeric antigen receptor (CAR) that comprises the amino acid sequence of SEQ ID NO: 9, wherein the polypeptide does not comprise a rituximab binding site, wherein the polynucleotide comprises a nucleic acid sequence having at least 90% identity to SEQ ID NO: 3 and a short EF1a promoter that is capable of expressing the anti-CD19 chimeric antigen receptor (CAR) in a mammalian T cell, and wherein the short EF1a promoter comprises the nucleic acid sequence of SEQ ID NO:16 and does not comprise the nucleic acid sequence of SEQ ID NO:39.

2. The isolated polynucleotide of claim 1 , wherein the polypeptide further comprises a safety switch.

3. The isolated polynucleotide of claim 2 , wherein the safety switch is linked to the CD19 CAR using a linker peptide.

4. The isolated polynucleotide of claim 2 , wherein the safety switch is linked to the anti-CD19 CAR using a T2A linker.

5. The isolated polynucleotide of claim 2 , wherein the safety switch comprises an antibody binding site.

6. The isolated polynucleotide of claim 2 , wherein the polypeptide comprises a CD34 epitope.

7. The isolated polynucleotide of claim 6 , wherein the CD34 epitope is a QBEND-10 epitope.

8. The isolated polynucleotide of claim 1 , wherein the polypeptide further comprises a CD8 hinge/transmembrane domain.

9. The isolated polynucleotide of claim 1 , wherein the polynucleotide encodes a polypeptide that comprises any one of the amino acid sequences of SEQ ID NOs: 11-14.

10. A vector comprising the isolated polynucleotide of claim 1 .

11. The vector of claim 10 , wherein the vector is a retroviral vector, a DNA vector, a plasmid, an RNA vector, an adenoviral vector, an adenovirus associated vector, a lentiviral vector, or any combination thereof.

12. An engineered immune cell comprising the isolated polynucleotide of claim 1 , wherein the engineered immune cell does not express a rituximab binding site.

13. An engineered immune cell comprising the vector of claim 10 , wherein the engineered immune cell does not express a rituximab binding site.

14. The engineered immune cell of claim 12 , wherein the immune cell is a T cell, tumor infiltrating lymphocyte (TIL), NK cell, TCR-expressing cell, dendritic cell, or NK-T cell.

15. The engineered immune cell of claim 14 , wherein the cell is an autologous T cell.

16. The engineered immune cell of claim 14 , wherein the cell is an allogeneic T cell.

17. The engineered immune cell of claim 12 , wherein the cell is resistant to rituximab.

18. A pharmaceutical composition comprising the engineered immune cell of claim 12 and a pharmaceutically acceptable excipient.

19. The isolated polynucleotide of claim 1 , wherein the polynucleotide comprises a nucleic acid sequence having at least 95% identity to SEQ ID NO: 3.

20. The isolated polynucleotide of claim 1 , wherein the polynucleotide comprises a nucleic acid sequence having at least 96% identity to SEQ ID NO: 3.

21. The isolated polynucleotide of claim 1 , wherein the polynucleotide comprises a nucleic acid sequence having at least 98% identity to SEQ ID NO: 3.

22. The isolated polynucleotide of claim 1 , wherein the polynucleotide comprises a nucleic acid sequence having at least 99% identity to SEQ ID NO: 3.

23. The isolated polynucleotide of claim 1 , wherein the polynucleotide comprises the nucleic acid sequence shown in SEQ ID NO: 3.

Continuity (3)
Provisional Application 63005041 · Apr 3, 2020
Provisional Application 62839455 · Apr 26, 2019
Related Publication 20200384026A1 · Dec 10, 2020