Biopharmaceutical company Galena Biopharma has announced patent notification from the European Patent Office for pharmaceutical use of NeuVax (nelipepimut-S) as a vaccine for the prevention of relapse in breast cancer patients.
The patent protects the use of NeuVax in patients with an immunochemistry (IHC) rating of 1+ or 2+ for HER2/neu protein expression and a fluorescence in situ hybridization (FISH) rating of less than 2.0 for HER2/neu gene expression in all of the European countries with expiry date of April 2028.
Galena president and CEO Mark Ahn said the patent expands intellectual property protection for NeuVax in Europe, and further validates novel, cancer immunotherapy approach to prevent the recurrence of breast cancer in women who otherwise have no treatment options.
"NeuVax is the only drug currently in Phase 3 development for patients with early-stage, node-positive breast cancer with low-to-intermediate HER2 expression status," Ahn added.
The immunodominant nonapeptide, NeuVax, is derived from the extracellular domain of the HER2 protein.
Following binding to HLA-A2/A3 molecules on antigen presenting cells (APC), the nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs).
The activated specific CTLs recognize, neutralize and destroy HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci, through cell lysis.
CTLs to other immunogenic peptides can also be generated by the nelipepimut immune response through inter- and intra-antigenic epitope spreading.