Claims
- 1. A composition, comprising: an antibody-immunostimulant fusion protein, wherein the fusion protein comprises an effective adjuvant of a disease-related antigen.
- 2. The composition of claim 1, further comprising the antigen.
- 3. The composition of claim 1, wherein the antibody-immunostimulant fusion protein comprises antibody specificity against the antigen.
- 4. The composition of claim 1, wherein the antibody-immunostimulant fusion protein comprises a cytokine domain, a cytokine sequence, a subsequence of a cytokine, a chemokine domain, a chemokine sequence, a subsequence of a chemokine, or an immunostimulant other than a cytokine or a chemokine.
- 5. The composition of 1, wherein the antibody-immunostimulant fusion protein comprises an immunostimulant domain chosen from the group consisting of: cytokines, chemokines, interleukins, interferons, C-X-C chemokines, C-C family chemokines, C chemokines, CX3C chemokines, super antigens, growth factors, IL-1, IL-2, IL-4, IL-6, IL-7, IL-8, IL-1, IL-12, IL-13, IL-17, IL-18, RANTES, mip1α, mip1β, GMCSF, GCSF, gamma interferon, alpha interferon, TNF, CSFs, mip2α, mip2β, PF4, platelet basic protein, hIP10, LD78, Act-2, MCAF, 1309, TCA3, IP-10, lymphotactin, fractalkine, KLH, and fragments thereof.
- 6. The composition of claim 1, wherein the antibody-immunostimulant fusion protein comprises a linker.
- 7. The composition of claim 1, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for a HER2/neu antigen.
- 8. The composition of claim 1, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for a tumor antigen, a bacterial antigen, a viral antigen, a mycoplasm antigen, a fungal antigen, a prion antigen, an autoimmune disorder antigen, or a parasite antigen.
- 9. The composition of claim 1, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for an antigen other than a tumor antigen.
- 10. The composition of claim 1, wherein the antibody-immunostimulant fusion protein comprises a domain selected from the group consisting of: an antibody fragment, an Fab domain, an Fab′ domain, an F(ab′)2domain, an F(ab)2 domain and an scFv domain.
- 11. The composition of claim 1, wherein the antibody-immunostimulant fusion protein comprises a domain selected from the group consisting of: IgG, IgA, IgE, IgM, IgD, IgG1, IgG2, and IgG3.
- 12. The composition of claim 1, wherein the antigen comprises one more antigen chosen from the group consisting of: a soluble antigen, a soluble antigen bound to a matrix, an insoluble antigen bound to a matrix, an insoluble aggregate of antigens, a nonviable cell-associated antigen, or a nonviable organism-associated antigen, an antigen conjugated with a liposome.
- 13. The composition of claim 1, wherein the antigen comprises HER2/neu or HER2/neu shed from a tumor cell, a fragment thereof.
- 14. The composition of claim 15, wherein the antigen comprises an antigen other than a tumor antigen.
- 15. The composition of claim 1, wherein the antigen comprises an antigen arising from a subject, arising from a disease state within the subject, or arising from a disease related organism within the subject.
- 16. The composition of claim 15, wherein the disease state within the subject is caused by one or more of: a tumor, a bacteria, a virus, a mycoplasm, a fungus, a prion, an autoimmune disorder, or an infectious parasite.
- 17. The composition of claim 15, wherein the antigen comprises a tumor antigen, a bacterial antigen, a viral antigen, a mycoplasm antigen, a prion antigen, an autoimmune disorder related antigen, or an infectious parasite antigen.
- 18. The composition of claim 1, wherein the antigen comprises an exogenous antigen.
- 19. The composition of claim 18, wherein the exogenous antigen comprises a antigen substantially identical to an antigen arising from a disease state within a subject or from a disease related organism within the subject.
- 20. The composition of claim 2, wherein the antigen comprises a first number of molecules and the antibody-immunostimulant fusion protein comprises a second number of molecules.
- 21. The composition of claim 20, wherein a ratio of the first number of molecules to the second number of molecules is approximately 1:1, wherein the first number of molecules is greater than the second number of molecules, wherein the first number of molecules is less than the second number of molecules, or wherein the second number of molecules is substantially saturated by the first number of molecules.
- 22. The composition of claim 2, wherein the antigen and the antibody-immunostimulant fusion protein are incubated together for a specific period of time under specific conditions.
- 23. The composition of claim 1, wherein the composition further comprises an excipient or a pharmaceutically acceptable excipient
- 24. A method of administering an immunological composition, the method comprising: providing an antibody-immunostimulant fusion protein and administering the fusion protein to a subject, wherein the fusion protein comprises an effective adjuvant to a disease-related antigen and wherein the fusion protein and the antigen in combination elicit an immune response in the subject.
- 25. The method of claim 24, wherein administering an immunological composition, comprises: providing an antibody-immunostimulant fusion protein, providing a disease-related antigen, and administering the fusion protein and the antigen to a subject, wherein the fusion protein comprises an effective adjuvant of the antigen.
- 26. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises a cytokine domain, a cytokine sequence, a subsequence of a cytokine, a chemokine domain, a chemokine sequence, a subsequence of a chemokine, or a domain other than a cytokine or a chemokine.
- 27. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises an immunostimulant domain chosen from the group consisting of: cytokines, chemokines, interleukins, interferons, C-X-C chemokines, C-C family chemokines, C chemokines, CX3C chemokines, super antigens, growth factors, IL-1, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, IL-18, RANTES, mip1α, mip1β, GMCSF, GCSF, gamma interferon, alpha interferon, TNF, CSFs, mip2α, mip2β, PF4, platelet basic protein, hIP10, LD78, Act-2, MCAF, 1309, TCA3, IP-10, lymphotactin, fractalkine, KLH, and fragments thereof.
- 28. The method of claim 24, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for a HER2/neu antigen.
- 29. The method of claim 24, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for a tumor antigen, a bacterial antigen, a viral antigen, a mycoplasm antigen, a fungal antigen, a prion antigen, an autoimmune disorder related antigen, or an infectious parasite antigen.
- 30. The composition of claim 24, wherein an antibody domain of the antibody-immunostimulant fusion protein comprises an antibody specific for an antigen other than a tumor antigen.
- 31. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises a domain selected from the group consisting of: an antibody fragment, an Fab domain, an Fab′ domain, an F(ab′)2domain, an F(ab)2domain and an scFv domain.
- 32. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises IgG, IgA, IgE, IgM, IgD, IgG1, IgG2, or IgG3.
- 33. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises a specificity for the antigen.
- 34. The method of claim 24, wherein the antigen comprises a tumor antigen, a bacterial antigen, a viral antigen, a mycoplasm antigen, a prion antigen, an autoimmune disorder related antigen, or an infectious parasite antigen.
- 35. The method of claim 24, wherein the antigen comprises an antigen other than a tumor antigen
- 36. The method of claim 24, wherein the antigen comprises an antigen arising from the subject, arising from a disease state within the subject, or arising from a disease related organism within the subject.
- 37. The method of claim 36, wherein the disease state within the subject is caused by one or more of: a tumor, a bacteria, a virus, a mycoplasm, a fungus, a prion, an autoimmune disorder, or an infectious parasite.
- 38. The method of claim 25, wherein the antigen comprises an exogenous antigen.
- 39. The method of claim 38, wherein the exogenous antigen is substantially identical to a disease-related antigen arising from the subject, arising from a disease state within the subject, or arising from a disease-related organism within the subject.
- 40. The method of claim 38, wherein the exogenous antigen is administered prior to an administration of the antibody-immunostimulant fusion protein to the subject, is administered after an administration of the antibody-immunostimulant fusion protein to the subject, or is administered approximately concurrently with an administration of the antibody-immunostimulant fusion protein to the subject.
- 41. The method of claim 40, wherein prior to concurrent administration, the exogenous antigen is incubated for a specific time and under specific conditions with the antibody-immunostimulant fusion protein.
- 42. The method of claim 24, wherein the antigen comprises HER2/neu or comprises HER2/neu shed from tumor cells, or a fragment thereof.
- 43. The method of claim 25, wherein the antigen comprises a first number of molecules and the antibody-immunostimulant fusion protein comprises a second number of molecules.
- 44. The method of claim 43, wherein a ratio of the first number of molecules to the second number of molecules is approximately 1:1, wherein the second number of molecules is substantially saturated by the first number of molecules, wherein the first number of molecules is greater than the second number of molecules, or wherein the second number of molecules is greater than the first number of molecules.
- 45. The method of claim 24, wherein the antibody-immunostimulant fusion protein comprises a first fusion protein with a first immunostimulant domain and at least a second antibody-immunostimulant fusion protein with at least a second immunostimulant domain.
- 46. The method of claim 45, wherein the first domain and the at least second domain comprise different immunostimulant domains.
- 47. The method of claim 45, wherein the first and at least second domain comprise one or more of: a chemokine, a cytokine, or a non-cytokine/non-chemokine-immunostimulant molecule.
- 48. The method of claim 45, wherein the first and at least second domain are chosen from the group consisting of: cytokines, chemokines, interleukins, interferons, C-X-C chemokines, C-C family chemokines, C chemokines, CX3C chemokines, super antigens, growth factors, IL-1, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, IL-18, RANTES, mip1α, mip1β, GMCSF, GCSF, gamma interferon, alpha interferon, TNF, CSFs, mip2α, mip2β, PF4, platelet basic protein, hIP10, LD78, Act-2, MCAF, 1309, TCA3, IP-10, lymphotactin, fractalkine, KLH, and fragments thereof.
- 49. The method of claim 45, wherein the first fusion protein comprises a first antibody specificity and the at least second fusion protein comprises a second antibody specificity.
- 50. The method of claim 49, wherein the first and at least second antibody specificities are for different antigens present on a single molecule, for different antigens present on a single cell, for different antigens present on a single tumor cell, for different antigens present on a single organism.
- 51. The method of claim 50, wherein the single organism comprises a virus, a bacteria, a fungus, a mycoplasm, a prion, or an infectious parasite.
- 52. The method of claim 24 or 25, wherein administering elicits an immune response in the subject
- 53. A method of prophylactically or therapeutically treating a disease state in a subject, the method comprising: administering to the subject an effective amount of an antibody-immunostimulant fusion protein, wherein the fusion protein comprises an effective adjuvant of a disease related antigen arising from the subject, arising from a disease state within the subject, or arising from a disease related organism within the subject and wherein such administration elicits an immune response within the subject against the disease related antigen.
- 54. The method of claim 53, wherein the method comprises administering to the subject an effective amount of an antibody-immunostimulant fusion protein, administering a disease related antigen, wherein the fusion protein comprises an effective adjuvant of the disease related antigen
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] Pursuant to 35 USC §119(e), this application claims priority to and benefit of U.S. Provisional Patent Application Serial Nos. 60/366917, filed on Mar. 21, 2002, the disclosure of which is incorporated herein in its entirety for all purposes.
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT
[0002] This invention was made with Government support under Grant Nos. CA86915 & DAMD17-99-1-9098, awarded by the National Institutes of Health and Army. The Government has certain rights in this invention.
Provisional Applications (1)
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Number |
Date |
Country |
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60366917 |
Mar 2002 |
US |