Viral peptides and uses thereof

HK40138703APending Publication Date: 2026-10-09REGENERON PHARMACEUTICALS INC
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Patent Information

Application Number
HK62026126928
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-19
Filing Date
2026-07-31
Publication Date
2026-10-09
Estimated Expiration
2044-09-17

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Abstract

The present disclosure provides isolated peptides derived from human T-lymphotropic virus type-1 (HTLV-1), peptide-based molecules (e.g., peptide-MHC (pMHC) complexes), polynucleotides and vectors encoding the peptides or peptide-based molecules, pharmaceutical compositions (e.g., vaccine compositions), and their use for treatment, prevention, or reduction of the likelihood of HTLV-1 infection and / or HTLV-1 -induced diseases. The present disclosure also provides binding moieties that bind to the peptides or peptide-based molecules disclosed herein, and their use for treatment, prevention, or reduction of the likelihood of HTLV-1 infection and / or HTLV-1 -induced diseases. The present disclosure further provides methods and systems for identifying immunogenic virus-derived peptides.
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Description

This disclosure provides isolated peptides derived from human T-lymphotropic virus type 1 (HTLV-1), peptide-based molecules (e.g., peptide-MHC (pMHC) complexes), polynucleotides and carriers encoding said peptides or peptide-based molecules, pharmaceutical compositions (e.g., vaccine compositions), and their uses for treating, preventing, or reducing the likelihood of HTLV-1 infection and / or HTLV-1-induced disease. This disclosure also provides binding moieties that bind to the peptides or peptide-based molecules disclosed herein, and their uses for treating, preventing, or reducing the likelihood of HTLV-1 infection and / or HTLV-1-induced disease. This disclosure also provides methods and systems for identifying immunogenic viral-derived peptides. Abstract

Claims

Attorney Docket No.250298.000682 CLAIMS 1. An isolated peptide comprising an amino acid sequence that is at least 90% identical to the amino acid sequence of any one of SEQ ID NOs: 1-89 and 143-146, or a pharmaceutically acceptable salt thereof, or a fragment or derivative thereof, wherein the isolated peptide is 5-20 amino acids in length.

2. The isolated peptide of claim 1, wherein the isolated peptide comprises an amino acid sequence of any one of SEQ ID NOs: 1-89 and 143-146.

3. The isolated peptide of claim 1 or 2, wherein the isolated peptide consists essentially of an amino acid sequence of any one of SEQ ID NOs: 1-89 and 143-146.

4. The isolated peptide of any one of claims 1-3, wherein the isolated peptide consists of an amino acid sequence of any one of SEQ ID NOs: 1-89 and 143-146.

5. An isolated peptide comprising two or more amino acid sequences selected from any one of SEQ ID NO: 1-89 and 143-146, or a pharmaceutically acceptable salt thereof, or a fragment or derivative thereof.

6. The isolated peptide of any one of claims 1-5, wherein the isolated peptide comprises one or more reverse peptide bonds, one or more non-peptide bonds, one or more D- isomers of amino acids, one or more chemical modifications, or any combination thereof.

7. The isolated peptide of any one of claims 1-6, wherein the isolated peptide is produced by expression in a heterologous host cell.

8. The isolated peptide of any one of claims 1-6, wherein the isolated peptide is produced synthetically.

9. The isolated peptide of any one of claims 1-8, wherein the isolated peptide, or pharmaceutically acceptable salt thereof, or fragment or derivative thereof induces aAttorney Docket No.250298.000682 Human T-Lymphotropic Virus Type-1 (HTLV-1)-specific immune response in a subject when presented in a complex with a major histocompatibility complex (MHC) molecule on the surface of an antigen presenting cell (APC).

10. A fusion protein comprising one or more isolated peptides of any one of claims 1-9 fused to one or more heterologous molecules.

11. The fusion protein of claim 10, wherein the one or more heterologous molecules enhance a peptide-specific immune response in a subject.

12. The fusion protein of claim 10, wherein the one or more heterologous molecules mediate peptide delivery to a specific site within a subject.

13. The fusion protein of any one of claims 10-12, wherein the one or more heterologous molecules are a MHC molecule, or a fragment or derivative thereof.

14. A conjugate comprising one or more isolated peptides of any one of claims 1-9 conjugated to one or more heterologous molecules.

15. The conjugate of claim 14, wherein the one or more heterologous molecules enhance a peptide-specific immune response in a subject.

16. The conjugate of claim 14, wherein the one or more heterologous molecules mediate peptide delivery to a specific site within a subject.

17. The conjugate of any one of claims 14-16, wherein the one or more heterologous molecules are an MHC molecule, or a fragment or derivative thereof.

18. The conjugate of any one of claims 14-16, wherein the one or more peptides are conjugated to a particle.

19. An oligomeric complex comprising two or more isolated peptides of any one of claims 1-9.Attorney Docket No.250298.000682 20. A non-covalent complex comprising the isolated peptide of any one of claims 1-9 and an MHC molecule, or a fragment or derivative thereof.

21. The non-covalent complex of claim 20, wherein the MHC molecule, or the fragment thereof, is a class I MHC molecule.

22. The non-covalent complex of claim 21, wherein the class I MHC molecule is a class I human leukocyte antigen (HLA) molecule.

23. The non-covalent complex of claim 20, wherein the MHC molecule, or the fragment thereof, is a class II MHC molecule.

24. The non-covalent complex of claim 23, wherein the class II MHC molecule is a class II HLA molecule.

25. A fusion protein comprising the isolated peptide of any one of claims 1-9 and an MHC molecule, or a fragment or derivative thereof.

26. The fusion protein of claim 25, wherein the MHC molecule, or the fragment thereof, is a class I MHC molecule.

27. The fusion protein of claim 26, wherein the class I MHC molecule is a class I human leukocyte antigen (HLA) molecule.

28. The fusion protein of claim 25, wherein the MHC molecule, or the fragment thereof, is a class II MHC molecule.

29. The fusion protein of claim 28, wherein the class II MHC molecule is a class II HLA molecule.

30. A conjugate comprising the isolated peptide of any one of claims 1-9 and a MHC molecule, or a fragment or derivative thereof.Attorney Docket No.250298.000682 31. The conjugate of claim 30, wherein the MHC molecule, or the fragment thereof, is a class I MHC molecule.

32. The conjugate of claim 31, wherein the class I MHC molecule is a class I human leukocyte antigen (HLA) molecule.

33. The conjugate of claim 30, wherein the MHC molecule, or the fragment thereof, is a class II MHC molecule.

34. The conjugate of claim 33, wherein the class II MHC molecule is a class II HLA molecule.

35. A pharmaceutical composition comprising (i) one or more isolated peptides of any one of claims 1-9, one or more fusion proteins of any one of claims 10-13 and 25-29, one or more conjugates of any one of claims 14-18 and 30-34, one or more oligomeric complexes of claim 19, or one or more non-covalent complexes of any one of claims 20-24, or any combination thereof; and (ii) a pharmaceutically acceptable carrier or excipient.

36. The pharmaceutical composition of claim 35, further comprising an adjuvant.

37. An isolated molecule that binds the isolated peptide of any one of claims 1-9, the fusion protein of any one of claims 10-13 and 25-29, the conjugate of any one of claims 14-18 and 30-34, the oligomeric complex of claim 19, or the non-covalent complex of any one of claims 20-24.

38. The isolated molecule of claim 37, wherein the molecule is an antibody or an antigen- binding fragment thereof.

39. The isolated molecule of claim 38, wherein the antibody is a bispecific antibody.Attorney Docket No.250298.000682 40. The isolated molecule of claim 37, wherein the molecule is an alternative scaffold.

41. The isolated molecule of claim 37, wherein the molecule is a chimeric antigen receptor (CAR).

42. The isolated molecule of claim 37, wherein the molecule is a T cell receptor (TCR).

43. An isolated cell comprising the CAR of claim 41.

44. The isolated cell of claim 43, wherein the isolated cell is an immune cell.

45. The isolated cell of claim 44, wherein the immune cell is a T cell, an NK cell, or a macrophage.

46. An isolated cell comprising the TCR of claim 42.

47. The isolated cell of claim 46, wherein the isolated cell is an immune cell.

48. The isolated cell of claim 47, wherein the immune cell is a T cell, an NK cell, or a macrophage.

49. A pharmaceutical composition comprising (i) the isolated molecule of any one of claims 38-43, or the isolated cell of any one of claims 43-48; and (ii) a pharmaceutically acceptable carrier or excipient.

50. An isolated polynucleotide comprising a nucleotide sequence encoding one or more isolated peptides of any one of claims 1-9 or the fusion protein of any one of claims 10-13 and 25-29.

51. The isolated polynucleotide of claim 50, wherein the nucleotide sequence is operably linked to a promoter.Attorney Docket No.250298.000682 52. The isolated polynucleotide of claim 50 or claim 51, wherein the isolated polynucleotide comprises DNA.

53. The isolated polynucleotide of claim 50 or claim 51, wherein the isolated polynucleotide comprises RNA.

54. The isolated polynucleotide of claim 53, wherein the RNA is mRNA.

55. The isolated polynucleotide of claim 53, wherein the RNA is self-replicating RNA.

56. A vector comprising the isolated polynucleotide of any one of claims 50-55.

57. The vector of claim 56, wherein the vector is an expression vector.

58. The vector of claim 56 or claim 57, wherein the vector is a viral vector.

59. A host cell comprising the isolated polynucleotide of any one of claims 50-55 or the vector of any one of claims 56-58.

60. The host cell of claim 59, wherein the host cell is a prokaryotic cell.

61. The host cell of claim 59, wherein the host cell is a eukaryotic cell.

62. The host cell of claim 61, wherein the host cell is an APC.

63. A pharmaceutical composition comprising (i) the isolated polynucleotide of any one of claims 50-55, or the vector of any one of claims 56-58; and (ii) a pharmaceutically acceptable carrier or excipient.

64. The pharmaceutical composition of claim 63, wherein the pharmaceutically acceptable carrier is a lipid nanoparticle carrier.Attorney Docket No.250298.000682 65. A method of inducing an immune response against a HTLV-1infection in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of: a) one or more isolated peptides of any one of claims 1-9; b) the fusion protein of any one of claims 10-13 and 25-29; c) the conjugate of any one of claims 14-18 and 30-34; d) the oligomeric complex of claim 19; e) the non-covalent complex of any one of claims 20-24; f) the pharmaceutical composition of any one of claims 35, 36, 49, 63, and 64; g) the molecule of any one of claims 37-42; h) the isolated cell of any one of claims 43-48 and 59-62; i) the isolated polynucleotide of any one of claims 50-55; or j) the vector of any one of claims 56-58.

66. A method of inducing an immune response against a HTLV-1 infection in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of one or more isolated peptides of any one of claims 1-9.

67. A method of inducing an immune response against a HTLV-1 infection in a subject in need thereof, the method comprising administering to the subject an activated T cell that is produced by contacting a T cell with an APC that presents the isolated peptide of any one of claims 1-9 in complex with an MHC molecule.

68. A method of treating a HTLV-1-induced disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of: a) one or more isolated peptides of any one of claims 1-9; b) the fusion protein of any one of claims 10-13 and 25-29; c) the conjugate of any one of claims 14-18 and 30-34; d) the oligomeric complex of claim 19; e) the non-covalent complex of any one of claims 20-24;Attorney Docket No.250298.000682 f) the pharmaceutical composition of any one of claims 35, 36, 49, 63, and 64; g) the molecule of any one of claims 37-42; h) the isolated cell of any one of claims 43-48 and 59-62; i) the isolated polynucleotide of any one of claims 50-55; or j) the vector of any one of claims 56-58.

69. A method of preventing or reducing the likelihood of a HTLV-1-induced disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of: a) one or more isolated peptides of any one of claims 1-9; b) the fusion protein of any one of claims 10-13 and 25-29; c) the conjugate of any one of claims 14-18 and 30-34; d) the oligomeric complex of claim 19; e) the non-covalent complex of any one of claims 20-24; f) the pharmaceutical composition of any one of claims 35, 36, 49, 63, and 64; g) the molecule of any one of claims 37-42; h) the isolated cell of any one of claims 43-48 and 59-62; i) the isolated polynucleotide of any one of claims 50-55; or j) the vector of any one of claims 56-58.

70. A method of treating a HTLV-1-induced disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one or more isolated peptides of any one of claims 1-9.

71. A method of preventing or reducing the likelihood of a HTLV-1-induced disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of one or more isolated peptides of any one of claims 1-9.

72. The method of any one of claims 69-71, wherein the HTLV-1-induced disease or disorder is adult T-cell leukemia / lymphoma (ATL) or HTLV-1-myelopathy / tropical spastic paraparesis (HAM / TSP).Attorney Docket No.250298.000682 73. A kit comprising: (i) a) one or more isolated peptides of any one of claims 1-9; b) the fusion protein of any one of claims 10-13 and 25-29; c) the conjugate of any one of claims 14-18 and 30-34; d) the oligomeric complex of claim 19; e) the non-covalent complex of any one of claims 20-24; f) the pharmaceutical composition of any one of claims 35, 36, 49, 63, and 64; g) the molecule of any one of claims 37-42; h) the isolated cell of any one of claims 43-48 and 59-62; i) the isolated polynucleotide of any one of claims 50-55; or j) the vector of any one of claims 56-58; and (ii) packaging and / or instructions for use for the same.