Generex Biotechnology announces $444,000 phase I NIH SBIR award for melanoma peptide vaccine
The grant supports the design, synthesis and testing of potent Ii-Key/melanoma peptides for possible subsequent clinical studies. The laboratory experiments will be performed in test tubes with lymphocytes from melanoma patients. The most reactive Ii-Key/melanoma peptides from gp100 and tyrosinase will be tested in combination with corresponding cytotoxic T-cell stimulating peptides, which have been used previously in the clinic.
The goal is to induce a potent antigen-specific T-helper cell response in vivo using the Ii-Key/MHC hybrid peptides, in order to stimulate a more robust cytotoxic immune response against melanoma. Some of the pre-clinical studies needed before initiating clinical trials are also funded.
The Ii-Key/MHC Class II vaccine hybrids are a novel cassette structure joining a biologically active segment of the immunoregulatory Ii protein through a polymethylene linker to an HLA-DR-presented epitope. In vitro such Ii-Key/MHC Class II hybrids boost the potency of the cassette-inserted MHC Class II epitope 500 to 2000 times that of the epitope-only peptide.
The minimal potent structure of the Ii-Key peptide was defined with 160 homologs. It interacts with an allosteric site just outside the antigenic peptide-binding site on MHC class II molecules in a manner to loosen antigenic peptide binding in that site. Previously bound peptides can be spilled and synthetic antigenic peptides inserted.
Ii-Key/antigenic epitope hybrids might represent a quantum advance in peptide vaccination using MHC Class II epitopes, substantially boosting peptide and DNA vaccine strategies for cancer and infectious disease. Likewise, Th1 or Th2 immunodeviating effects of Ii-Key hybrids might be useful in controlling allergy and autoimmune disease.
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