Granted Patent
B2
US 12,257,311 · App. 18/395,042 · Granted Mar 25, 2025
Multimeric T-cell modulatory polypeptides and methods of use thereof
Inventors:
Saso Cemerski (Boston, MA); Ronald D. Seidel, III (Boston, MA); Rodolfo J. Chaparro (Cambridge, MA); John F. Ross (Boston, MA)
Assignee:
Cue Biopharma, Inc.
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Abstract
The present disclosure provides T-cell modulatory multimeric polypeptides that comprise an immunomodulatory polypeptide and that comprise an epitope-presenting Wilms tumor peptide. A T-cell modulatory multimeric polypeptide is useful for modulating the activity of a T cell, and for modulating an immune response in an individual.
Claims (44)
1. A method of treating a patient having a Wilms Tumor-1-associated cancer, the method comprising administering to the patient a therapeutically effective amount of a pharmaceutical composition, wherein the pharmaceutical composition comprises a homodimer consisting of two heterodimers, wherein each heterodimer comprises:
a) a first polypeptide having the amino acid sequence set forth in SEQ ID NO:423 comprising:
i) a Wilms tumor-1 (WT1) peptide;
ii) a β2-microglobulin (β2M) polypeptide; and
iii) a peptide linker between the WT1 peptide and the β2M polypeptide, wherein the peptide linker comprises a Cys residue, and
b) a second polypeptide having the amino acid sequence set forth in SEQ ID NO:486 comprising:
i) two variant IL-2 polypeptides;
ii) a major histocompatibility complex (MHC) class I heavy chain polypeptide; and
ii) an immunoglobulin (Ig) Fc polypeptide,
wherein each heterodimer comprises a first disulfide bond formed between (i) the Cys residue in the peptide linker between the WT1 peptide and the β2M polypeptide, and (ii) a Cys residue in the MHC class I heavy chain polypeptide,
wherein each heterodimer comprises a second disulfide bond formed between a Cys residue in the β2M polypeptide and a Cys residue in the MHC class I heavy chain polypeptide, and
wherein two disulfide bonds link the Ig Fc polypeptide of one heterodimer to the Ig Fc polypeptide of the other heterodimer.
2. The method of claim 1 , wherein the amount of homodimer administered to the patient is from 1 mg/kg of body weight to 5 mg/kg of body weight.
3. The method of claim 1 , wherein the amount of homodimer administered to the patient is from 5 mg/kg of body weight to 10 mg/kg of body weight.
4. The method of claim 2 , wherein the cancer is myeloma, non-small cell lung cancer, breast cancer, Wilms tumor, mesothelioma, soft tissue sarcoma, neuroblastoma, or nephroblastoma.
5. The method of claim 2 , wherein the cancer is acute myeloid leukemia, ovarian cancer, pancreatic cancer, colorectal cancer, or gastric cancer.
6. The method of claim 2 , further comprising administering one or more immune checkpoint inhibitors to the individual.
7. The method of claim 6 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-1.
8. The method of claim 7 , wherein the antibody specific for PD-1 is nivolumab or pembrolizumab.
9. The method of claim 6 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-L1.
10. The method of claim 9 , wherein the antibody specific for PD-L1 is avelumab, atezolizumab or durvalumab.
11. The method of claim 6 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for CTLA4.
12. The method of claim 11 , wherein the antibody specific for CTLA-4 is ipilimumab.
13. The method of claim 6 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for TIGIT.
14. The method of claim 6 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for LAG3.
15. The method of claim 5 , further comprising administering one or more immune checkpoint inhibitors to the individual.
16. The method of claim 15 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-1.
17. The method of claim 16 , wherein the antibody specific for PD-1 is nivolumab or pembrolizumab.
18. The method of claim 15 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-L1.
19. The method of claim 18 , wherein the antibody specific for PD-L1 is avelumab, atezolizumab or durvalumab.
20. The method of claim 15 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for CTLA4.
21. The method of claim 20 , wherein the antibody specific for CTLA4 is ipilimumab.
22. The method of claim 15 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for TIGIT.
23. The method of claim 15 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for LAG3.
24. The method of claim 4 , further comprising administering one or more immune checkpoint inhibitors to the individual.
25. The method of claim 24 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-1.
26. The method of claim 25 , wherein the antibody specific for PD-1 is nivolumab or pembrolizumab.
27. The method of claim 24 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for PD-L1.
28. The method of claim 27 , wherein the antibody specific for PD-L1 is avelumab, atezolizumab or durvalumab.
29. The method of claim 24 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for CTLA4.
30. The method of claim 24 , wherein the one or more immune checkpoint inhibitors comprises an antibody specific for TIGIT or LAG3.
31. The method of claim 1 , wherein the amount of homodimer administered to the patient is from 100 μg/kg of body weight to 1 mg/kg of body weight.
32. The method of claim 31 , wherein the cancer is myeloma, non-small cell lung cancer, breast cancer, Wilms tumor, mesothelioma, soft tissue sarcoma, neuroblastoma, or nephroblastoma.
33. The method of claim 31 , wherein the cancer is acute myeloid leukemia, ovarian cancer, pancreatic cancer, colorectal cancer, or gastric cancer.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 10, 2024
From: SEIDEL, RONALD D., III; CHAPARRO, RODOLFO J.; ROSS, JOHN F.; CEMERSKI, SASO
To: CUE BIOPHARMA, INC.
Reel/Frame 067378/0213 →
Continuity (6)
Continuation
PCTUS2021031707
· May 11, 2021
Provisional Application
63041451
· Jun 19, 2020
Provisional Application
63023834
· May 12, 2020
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