Viral particles for the treatment of SARS-CoV-2

JP2026520617APending Publication Date: 2026-06-23SEKIRAS INC
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Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
SEKIRAS INC
Filing Date
2024-06-14
Publication Date
2026-06-23

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Abstract

This disclosure relates to virus-like particles (VLPs) containing one or more antigens for use as a vaccine. This disclosure further relates to the use of vaccines for the treatment of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19).
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Claims

1. Recombinant virus-like particles (VLPs) containing one or more antigens from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), wherein the one or more antigens are (a) Spike (S) protein, (b) Membrane (M) proteins, (c) Envelope (E) protein, (d) Selected from nucleocapsid (N) proteins, Recombinant virus-like particles (VLPs) in which at least one antigen is derived from the Omicron strain of SARS-CoV-2.

2. The recombinant VLP according to claim 1, wherein the VLP comprises an antigen from the S protein of the Omicron strain of SARS-CoV-2.

3. The recombinant VLP according to claim 1 or 2, wherein the VLP comprises antigens from each of the S protein, M protein, and E protein of SARS-CoV-2.

4. The recombinant VLP according to claim 3, wherein the VLP comprises antigens from each of the S protein, M protein, and E protein of the Omicron strain of SARS-CoV-2.

5. A recombinant VLP according to any one of claims 1 to 4, wherein the VLP comprises an antigen from the S protein of an omicron variant of SARS-CoV-2 selected from the group consisting of B. 1.1.529, BA. 1, BA. 2, BA. 4, BA. 5, BA. 2.12.1, and BA. 2.

75.

6. The recombinant VLP according to claim 5, wherein the S protein is from the omicron variant BA.1 of SARS-CoV-2 and comprises one or more or all of the mutations selected from the group consisting of A67V, T95I, Y145D, L212L, S371L, G446S, G496S, T547K, N856K, L981F, G142D, Q493R, G339D, S373P, S375F, K417N, N440K, S477N, T478K, E484A, Q498R, N501Y, Y505H, D614G, H655Y, N679K, P681H, N764K, D796Y, Q954H, N969K, and del69-70.

7. The recombinant VLP according to claim 5, wherein the S protein is from the omicron variant BA.2 of SARS-CoV-2 and contains one or more or all of the mutations selected from the group consisting of G142D, Q493R, del24-26, G339D, S373P, S375F, K417N, N440K, S477N, T478K, E484A, Q498R, N501Y, Y505H, D614G, H655Y, N679K, P681H, N764K, D796Y, Q954H, N969K, T19I, A27S, G142D, V213G, S371F, T376A, D405N, and R408S.

8. The aforementioned S protein is the omicron variant BA.4 or BA. of SARS-CoV-2. The recombinant VLP according to claim 5, comprising one or more or all of the mutations selected from the group consisting of L452R, F486V, R493Q, del24-26, del69-70, G339D, S373P, S375F, K417N, N440K, S477N, T478K, E484A, Q498R, N501Y, Y505H, D614G, H655Y, N679K, P681H, N764K, D796Y, Q954H, N969K, T19I, A27S, G142D, V213G, S371F, T376A, D405N, and R408S.

9. The recombinant VLP according to claim 3 or 4, wherein each of the S protein, the M protein, and the E protein is provided as a fusion polypeptide.

10. The recombinant VLP according to any one of claims 1 to 9, wherein each of the antigens is formulated in a separate VLP or in the same VLP.

11. A recombinant VLP according to any one of claims 1 to 3 or 5 to 10, wherein at least one of the antigens is from the delta, beta, alpha, gamma, or 2019-nCoV / USA-WA1 / 2020 strain of SARS-CoV-2.

12. The recombinant VLP according to claim 3 or 4, wherein the VLP further comprises an antigen from the N protein of SARS-CoV-2.

13. The recombinant VLP according to any one of claims 1 to 12, wherein each of the S protein, the E protein, the M protein, and optionally the N protein is provided as a fusion polypeptide.

14. The recombinant VLP according to claim 13, wherein each of the antigens is formulated in a separate VLP or in the same VLP.

15. The recombinant VLP according to any one of claims 1 to 14, wherein the VLP has a diameter of about 70 nm to 160 nm.

16. The recombinant VLP according to claim 15, wherein the VLP has a diameter of about 80 nm.

17. The recombinant VLP according to any one of claims 1 to 16, wherein the VLP is formulated in lipid nanoparticles (LNPs).

18. An isolated, recombinant, or synthetic nucleotide sequence encoding the VLP according to any one of claims 1 to 17.

19. An expression vector comprising the nucleotide sequence described in claim 18.

20. An immunogenic composition comprising the VLP described in any one of claims 1 to 17.

21. A pharmaceutical composition comprising a VLP according to any one of claims 1 to 17 and a pharmaceutically acceptable carrier.

22. The pharmaceutical composition according to claim 21 for use as a vaccine.

23. A vaccine comprising the pharmaceutical composition described in claim 22.

24. The immunogenic composition according to claim 20, the pharmaceutical composition according to claim 21, or the vaccine according to claim 23, further comprising an adjuvant.

25. The immunogenic composition, pharmaceutical composition, or vaccine according to claim 24, wherein the adjuvant is MF59.

26. A method for treating, preventing, or delaying the progression of SARS-CoV-2 infection in a subject requiring treatment, prevention, or delay of its progression, wherein the method comprises administering to the subject a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25.

27. The use of a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25 in the manufacture of a pharmaceutical for treating, preventing, or delaying the progression of SARS-CoV-2 infection in a subject.

28. A VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25, for use in the treatment or prevention of SARS-CoV-2 infection or delaying its progression.

29. A VLP, composition, or vaccine for the method according to claim 26, the use according to claim 27, or the use according to claim 28, wherein the subject has or is suspected of having COVID-19.

30. A method for inducing an immune response in a subject, the method comprising administering to the subject in need of a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25.

31. Use of a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25, in the manufacture of a pharmaceutical for inducing an immune response in a subject requiring induction of an immune response.

32. A VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25, for use in inducing an immune response in subjects requiring induction of an immune response.

33. A VLP, composition, or vaccine for the method according to claim 30, the use according to claim 31, or the use according to claim 32, wherein the immune response is a humoral and / or cell-mediated immune response.

34. The method, use, or VLP, composition, or vaccine for use according to claim 33, wherein the immune response is sufficient to treat, prevent, or delay the progression of at least one symptom of SARS-CoV-2 infection caused by the Omicron strain of SARS-CoV-2.

35. The method, use, or VLP, composition, or vaccine for use according to claim 33, wherein the immune response is sufficient to treat, prevent, or delay the progression of at least one symptom of SARS-CoV-2 infection caused by the delta, beta, alpha, gamma, or 2019-nCoV / USA-WA1 / 2020 strain of SARS-CoV-2.

36. A method for reducing the SARS-CoV-2 viral load in a subject having coronavirus disease 2019 (COVID-19), comprising administering to the subject in need a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25.

37. Use of a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25 in the preparation of a pharmaceutical for reducing the SARS-CoV-2 viral load in a subject having coronavirus disease 2019 (COVID-19).

38. A VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25, for use in reducing the SARS-CoV-2 viral load in subjects having coronavirus disease 2019 (COVID-19).

39. A method for treating, preventing, or delaying the progression of acute respiratory distress syndrome in a subject having coronavirus disease 2019 (COVID-19), comprising administering to the subject in need a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25.

40. Use of a VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25 in the preparation of a pharmaceutical for treating, preventing, or delaying the progression of acute respiratory distress syndrome in a subject having coronavirus disease 2019 (COVID-19).

41. A VLP according to any one of claims 1 to 17, an immunogenic composition according to any one of claims 20, 24, or 25, a pharmaceutical composition according to any one of claims 21, 22, 24, or 25, or a vaccine according to any one of claims 23 to 25, for use in treating, preventing, or delaying the progression of acute respiratory distress syndrome in subjects having coronavirus disease 2019 (COVID-19).

42. A VLP, vaccine, or composition for use according to any one of claims 26, 29, 30, 33-36, or 39, for use according to any one of claims 27, 31, 33-35, 37, or 40, or for use according to any one of claims 28, 32-35, 38, or 41, wherein the subject is a human being 18 years of age or older.

43. The method, use, or VLP vaccine or composition for use according to claim 42, wherein the VLP, the vaccine, or the composition is administered in a single-dose regimen.

44. The method, use, or VLP, vaccine, or composition for use according to claim 42, wherein the VLP, vaccine, or composition is administered in a two, three, or four-dose regimen, with the doses administered at intervals of about one, two, or three months.

45. A eukaryotic cell for expressing the VLP according to any one of claims 1 to 17.

46. A method for producing VLP, (a) To provide an expression vector comprising a polynucleotide encoding one or more antigens from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), wherein the antigen is (i) Spike (S) protein, (ii) Membrane (M) proteins, (iii) Envelope (E) protein, (iv) Selected from nucleocapsid (N) proteins, The provision includes at least one antigen that is derived from the Omicron strain of SARS-CoV-2. (b) Providing host cells, (c) Transfecting the host cells with the vector to produce virus-like particles (VLPs) containing one or more antigens, A method for expressing the polynucleotide under conditions sufficient for VLP formation.

47. The method according to claim 46, further comprising purifying the VLP.

48. The method according to claim 46 or 47, wherein the polynucleotide encodes an antigen from each of the S protein, the M protein, and the E protein expressed from a monocistronic polynucleotide, and the polynucleotide is operably linked to a promoter sufficient to produce the expression of the antigen encoded by the polynucleotide.

49. The method according to claim 46 or 47, wherein the polynucleotide encodes an antigen from each of the S protein, the M protein, and the E protein expressed from a polycistronic polynucleotide, and the polynucleotide is operably linked to a promoter sufficient to produce the expression of the antigen encoded by the polynucleotide.

50. It's a kit, (a) A VLP according to any one of claims 1 to 17, a pharmaceutical composition according to any one of claims 21, 22, or 24 to 25, an immunogenic composition according to any one of claims 20, 24, or 25, or a vaccine according to any one of claims 23 to 25, (b) The instruction manual, and optionally, (c) A kit comprising a pharmaceutically acceptable carrier, excipient, or diluent.