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1. WO2021062374 - TABLETIZATION OF PEPTIDE SELF-ASSEMBLIES AND METHODS OF MAKING AND USING THE SAME

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[ EN ]

CLAIMS

What is claimed:

1. A dissolvable tablet formulation comprising

(a) self-assembling peptide-polymer nanofibers comprising a peptide-polymer conjugate comprising

(i) a self-assembling domain comprising a polypeptide and having a C-terminal and N-terminal end;

(ii) a peptide epitope or protein antigen; and

(iii) a mucus-inert domain, wherein (ii) and (iii) are linked opposite ends of the (i) self-assembling domain;

(b) an excipient; and

(c) an adjuvant,

wherein the dissolvable tablet is suitable for sublingual administration.

2. The dissolvable tablet of claim 1, wherein the excipient is a sugar, preferably the combination of mannitol and dextran.

3. The dissolvable tablet of any one of the preceding claims, wherein the dissolvable tablet is heat stable at 45°C for at least a seven days.

4. The dissolvable tablet of any one of the preceding claims, wherein the table has a suitable porosity such that the tablet is able to dissolve sublingually in less than a minute, preferably in less than 40 seconds.

5. The dissolvable tablet of any one of the preceding claims, wherein the self-assembling domain compri ses a polypeptide of 5 to 40 amino acids.

6. The dissolvable tablet of any one of the preceding claims, wherein the self-assembling domain comprises a polypeptide having an amino acid sequence selected from SEQ ID NOs:1 -67.

7. The dissolvable tablet of any one of the preceding claims, , wherein the self-assembling domain comprises a polypeptide having an amino acid sequence of SEQ ID NO: 1 (QQKFQFQFEQQ).

8. The dissolvable tablet of any one of the preceding claims, wherein the polymer domain comprises polyethylene glycol (PEG), optionally wherein the PEG domain has an average molecular weight of 300-5000 Da.

9. The dissolvable tablet of any one of the preceding claims, wherein the conjugate self-assembles into nanofibers.

10. The dissolvable tablet of any one of the preceding claims, wherein the tablet elicits an antibody response upon or after administration to a subject sublingually.

11. The dissolvable tablet of any one of the preceding claims, wherein the tablet elicits a T cell response upon or after administration to a subject sublingually.

12. The dissolvable tablet of any one of the preceding claims, wherein the tablet is able to dissolve when placed sublingually in less than 40 seconds.

13. The dissolvable table of any one of the preceding claims, wherein the epitope peptide or the protein antigen is a bacterial, viral or fungal epitope peptide or protein antigen.

14. Use of the dissolvable tablet of any one of claims 1-13 for a vaccine for eliciting an immune response in a subject.

15. A method of eliciting an immune response against a peptide or protein antigen in a subject, the method comprising administering a therapeutically effective amount of the dissolvable tablet of any one of claims 1-13 sublingually to the subject.

16. The method of claim 15, wherein the method comprises administering the dissolvable tablet two or more times.

17. A method of formulating a vaccine comprising dissolvable sublingual tablet, the method comprising the steps of:

(i) combining self-assembling a peptide-polymer conjugate with a buffer to form a peptide-polymer nanofiber;

(ii) adding at least one excipient and an adjuvant to the peptide-polymer nanofiber to form a vaccine solution;

(iii) placing the vaccine solution into a mold; and

(iv) removing the liquid from the vaccine solution to produce a tablet.

18. The method of claim 17, wherein step (iv) comprises freezing and lyophilizing the solution to produce the tablet.

19. The method of claim 17 or 18, wherein the buffer in step (i) is PBS.

20. The method of any one of claims 17-19, wherein the peptide-polymer conjugate comprises (i) a seif-assembling domain comprising a polypeptide and having a C -terminal and N-terminal end; (ii) a peptide epitope or protein antigen; and (iii) a polymer domain, wherein the peptide epitope or protein antigen and the polymer are linked to the opposite ends of the self-assembling domain;

21. The method of any one of claims 17-20, wherein step (ii) further comprises adding a cryoprotectant to form the vaccine solution.

22. A vaccine formulated in tablet form produced by the methods according to any one of claims 17-21.

23. The vaccine according to claim 22 in which the vaccine is additionally stable to heating for at least 1 week at 45°C.

24. The vaccine according to claim 22 or 23 in which the vaccine is specific for a bacteria, a virus or a fungus.

25. The vaccine according to claim 23, wherein the vaccine is a bacteria, preferably M. tuberculosis.

26. The vaccine according to claim 25 in which the vaccine comprises the epitope ESAT51-70 for M. tuberculosis.