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1. WO1997026784 - INDUCTION OF IMMUNE RESPONSE AGAINST DESIRED DETERMINANTS

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[ EN ]

WHAT IS CLAIMED IS:

1. A composition for eliciting an immune response to a non-proteinaceous antigenic determinant, the composition comprising a PADRE oligopeptide of less than about 50 residues and the antigenic determinant.

2. The composition of claim 1, wherein the oligopeptide and the antigenic determinant are attached to each other.

3. The composition of claim 2, wherein the oligopeptide and the antigenic determinant are covalently linked.

4. The composition of claim 3, wherein the antigenic determinant is covalently linked to the PADRE peptide through a linker.

5. The composition of claim 4, wherein the linker comprises a cysteine residue.

6 The composition of claim 4, wherein the linker consists of an aminocaproic acid residue and a cysteine residue.

7. The composition of claim 1, wherein the antigenic determinant is linked to the C-terminus of the oligopeptide.

8. A composition of claim 1, wherein the antigenic determinant comprises one carbohydrate epitope.

9. The composition of claim 8, wherein the carbohydrate epitope is derived from a bacterium.

10. The composition of claim 8, wherein the carbohydrate epitope is derived from a virus.

11. The composition of claim 8, wherein the carbohydrate epitope is derived from a cancer cell.

12. The composition of claim 8, wherein the carbohydrate epitope is derived from a fungus.

13. The composition of claim 8, wherein the carbohydrate epitope is derived from a parasite.

14. The composition of claim 1, wherein the PADRE peptide is further covalently linked to a lipid moiety.

15. The composition of claim 14, wherein the lipid moiety comprises palmitic acid.

16. The composition of claim 15, wherein the lipid moiety is PAM2K, wherein K is a lysine residue and PAM is a palmitic acid residue.

17. The composition of claim 14, wherein the lipid moiety is linked to the N-terminus of the PADRE peptide.

18. The composition of claim 1, wherein the PADRE peptide has the formula R1 -R2-R3-R4-R5, proceeding from the N-terminus to the C-terminus, wherein:

R, consists of at least 2 residues;

R2 is selected from the group consisting of a cyclohexylalanine residue, a tyrosine residue, a phenylalanine residue and conservative substitutions therefor;

R3 is 3 to 5 residues;

R4 is selected from the group consisting of threonine-leucine-Iysine, lysine-threonine, and tryptophan-threonine-leucine-lysine, and conservative substitutions therefor; and

R5 consists of at least 2 residues.

19. The composition of claim 18, wherein each amino acid of R3 is independently selected from the group consisting of alanine, isoleucine, serine and valine.

20. The composition of claim 18, wherein each amino acid of R5 is independently selected from the group consisting of alanine, serine and valine.

21. The composition of claim 18, wherein:

R1 is D-alanine followed by an L- Alanine or L-Lysine;

R2 is clyclohexylalanine or phenylalanine;

each residue of R3 is selected from the group consisting of L- Alanine, isoleucine, and valine; and

R5 is 2 or 4 L-Alanines followed by D-alanine.

22. The composition of claim 18, wherein:

R1 is L-Alanine followed by an L-Alanine or L-Lysine;

R2 is clyclohexylalanine or phenylalanine;

each residue of R3 is selected from the group consisting of L-Alanine, isoleucine, and valine; and

R5 is 2 or 4 L-Alanines followed by L-Alanine.

23. The composition of claim 18, wherein the PADRE peptide is selected from the group consisting of aAXAAAKTAAAAa, aAXAAAATLKAAa,

aAXVAAATLKAAa, aAXVAAATLKAAa, aAXIAAATLKAAa, aKXVAAWTLKAAa, and aKFVAAWTLKAAa wherein a is d-alanine, A is L-Alanine, X is cyclohexylalanine, K is lysine, T is threonine, L is leucine, V is valine, I is isoleucine, W is tryptophan, and F is phenylalanine.

24. The composition of claim 23, wherein the PADRE peptide is aKXVAAWTLKAAa.

AAXVAAATLKAAA, AAXVAAATLKAAA, AAXIAAATLKAAA,

AKXVAAWTLKAAA, and AKFVAAWTLKAAA wherein A is L-Alanine, X is

cyclohexylalanine, K is lysine, T is threonine, L is leucine, V is valine, I is isoleucine, W is tryptophan, and F is phenylalanine.

26. The composition of claim 18, wherein the PADRE peptide is selected from the group consisting of AAXAAAKTAAAAa, AAXAAAATLKAAa,

AAXVAAATLKAAa, AAXVAAATLKAAa, AAXIAAATLKAAa, AKXVAAWTLKAAa, and AKFVAAWTLKAAa wherein a is D-alanine, A is L-Alanine, X is cyclohexylalanine, K is lysine, T is threonine, L is leucine, V is valine, I is isoleucine, W is tryptophan, and F is phenylalanine

27. The composition of claim 18, wherein the P.ADRE peptide is selected from the group consisting of aAXAAAKTAAAAA, aAXAAAATLKAAA,

aAXVAAATLKAAA, aAXVAAATLKAAA, aAXIAAATLKAAA, aKXVAAWTLKAAA, and aKFVAAWTLKAAA wherein a is D-alanine, A is L-Alanine, X is cyclohexylalanine, K is lysine, T is threonine, L is leucine, V is valine, I is isoleucine, W is tryptophan, and F is phenylalanine

28 A pharmaceutical composition comprising a pharmaceutically acceptable carrier, a non-proteinaceous antigenic determinant and a PADRE oligopeptide of less than about 50 residues.

29. The composition of claim 28, further comprising an adjuvant.

30. The composition of claim 29, wherein the adjuvant is Freund's complete adjuvant or Freund's incomplete adjuvant.

31. A method of inducing a humoral immune response comprising introduction into a mammal the composition of claim 28.

32. The method of claim 31, wherein the introduction is parenteral.

33. The method of claim 31, wherein the immune response is prophylactic.

34. The method of claim 31, wherein the immune response is therapeutic.

35. The method of claim 31, wherein the immune response comprises an IgG response directed against the antigenic determinant of claim 1.