Ii-KEY/HER-2/NEU HYBRID CANCER VACCINE

Abstract

Provided are methods and compositions for treating cancer in humans, the cancer being characterized by expression of Her-2/neu. The methods involve vaccinating a patient with an Ii-Key/MHC class II hybrid construct and thereby stimulating an immune response to the native Her-2/neu protein. The construct may be in the form of an Ii-Key hybrid peptide or a nucleic acid encoding an Ii-Key hybrid peptide. Methods are described wherein the cancer being treated is breast cancer. Also claimed is a pharmaceutical composition comprising an Ii-Key/MHC class II hybrid construct with and without an adjuvant. The adjuvant can include GM-CSF. The Ii-Key hybrid construct includes the LRMK [SEQ ID NO: 2] residues of Ii-Key protein and an MHC Class II epitope of a protein or portion thereof which is used in the vaccine or a DNA encoding the same hybrid peptide.

What is claimed is: 
     
         1 . A method of treating breast cancer in a human patient, the breast cancer being characterized by expression of Her-2/neu, comprising:
 a) providing an Ii-Key/MHC class II hybrid construct in a pharmaceutically acceptable carrier, the construct consisting of:
 i) the LRMK (SEQ ID NO: 2) amino acid residues of Ii protein; and 
 ii) an MHC class II epitope-containing segment of Her-2/neu linked at its N-terminus at the residues of element a) wherein the MHC class II epitope is GVGSPYVSRLLGICL (SEQ ID NO.: 3); and 
   b) stimulating a breast cancer patient's immune system by vaccination with the hybrid construct of step a) under conditions appropriate for the stimulation of an immune response.   
     
     
         2 . The method of  claim 1  which is characterized by the stimulation of CD4+ T cell production. 
     
     
         3 . The method of  claim 1  which is characterized by the stimulation of a CD4+ T cell response specific to native Her-2/neu peptide.