LACTOFERRIN AS AN ADJUVANT IN CANCER VACCINES

1 . A method of treating cancer comprising the step of administering to a subject a cancer immunotherapy and an adjuvant, wherein said adjuvant is a lactoferrin composition that is administered orally for gastrointestinal delivery in an amount sufficient to provide an improvement in the cancer in said subject and wherein any N-terminal lactoferrin variant in the lactoferrin composition has a deletion, substitution, or combination thereof, from 1 to 16 N-terminal amino acid residues and the N-terminal lactoferrin variant retains the same biological function as full length lactoferrin, wherein said lactoferrin composition comprises recombinant bovine lactoferrin or recombinant human lactoferrin.

2 . The method of claim 1 , wherein said lactoferrin composition is dispersed in a pharmaceutically acceptable carrier.

3 . The method of claim 1 , wherein any N-terminal lactoferrin variant in the lactoferrin composition lacks at least the N-terminal glycine residue.

4 . The method of claim 1 , wherein the lactoferrin composition comprises an amount of the lactoferrin and/or N-terminal lactoferrin variant such that about 10 mg to about 100 g of the lactoferrin and/or N-terminal lactoferrin variant is administered per day.

5 . The method of claim 1 , wherein the immunotherapy comprises administration of a nucleic acid sequence expressing a cancer antigen to the subject, wherein expression of the antigen is transient.

6 . The method of claim 5 , wherein the nucleic acid sequence is contained in a vector, wherein expression of the antigen is transient.

7 . The method of claim 1 , wherein the immunotherapy comprises administration of a vector containing a nucleic acid sequence expressing an immunomodulatory cytokine to the subject, wherein expression of the immunomodulatory cytokine is transient.

8 . A method of treating cancer comprising the step of administering to a subject a cancer immunotherapy and an adjuvant, wherein said adjuvant is a lactoferrin composition that is administered orally for gastrointestinal delivery in an amount sufficient to provide an improvement in the cancer in said subject and wherein any N-terminal lactoferrin variant in the lactoferrin composition has a deletion, substitution, or combination thereof, from 1 to 16 N-terminal amino acid residues and the N-terminal lactoferrin variant retains the same biological function as full length lactoferrin, wherein the immunotherapy comprises administering antigen presenting cells.

9 . The method of claim 8 , wherein the cells are allogeneic.

10 . The method of claim 8 , wherein the cells are syngeneic.

11 . A method of treating cancer comprising the step of administering to a subject a cancer immunotherapy and an adjuvant, wherein said adjuvant is a lactoferrin composition that is administered orally for gastrointestinal delivery in an amount sufficient to provide an improvement in the cancer in said subject and wherein any N-terminal lactoferrin variant in the lactoferrin composition has a deletion, substitution, or combination thereof, of from 1 to 16 N-terminal amino acid residues and the N-terminal lactoferrin variant retains the same biological function as full length lactoferrin, wherein the lactoferrin composition is administered sequentially with the immunotherapy.

12 . A method of enhancing the immune system in a subject suffering from cancer comprising the step of administering to the subject a cancer immunotherapy and an adjuvant, wherein the adjuvant is an orally administered lactoferrin composition and wherein any N-terminal lactoferrin variant in the lactoferrin composition has a deletion, substitution, or combination thereof, of from 1 to 16 N-terminal amino acid residues and the N-terminal lactoferrin variant retains the same biological function as full length lactoferrin, wherein said lactoferrin composition comprises recombinant human lactoferrin or recombinant bovine lactoferrin.

13 . The method of claim 12 , wherein said lactoferrin composition_stimulates the production of interleukin-18, GM-CSF, or MIP-3alpha.

14 . The method of claim 13 , wherein said interleukin-18, GM-CSF or MIP-3alpha stimulate the production, maturation, migration or activity of immune cells.

15 . The method of claim 12 , wherein the immune cells are T lymphocytes, natural killer cells, dendritic cells, antigen presenting cells or progenitor cell.

16 . The method of claim 15 , wherein the T lymphocytes are selected from the group consisting of CD4+, CD8+ and CD3+ cells.