The European Patent Office has intended to grant a Pharmaceutical Use Patent for Galena Biopharma's NeuVax (nelipepimut-S). The patent covers the use of NeuVax as a vaccine for the prevention of relapse in breast cancer 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.
The patent protection is afforded in all of the European countries and will expire in April 2028.
"This patent expands our intellectual property protection for NeuVax in Europe, and further validates our novel, cancer immunotherapy approach to preventing the recurrence of breast cancer in women who otherwise have no treatment options," said Mark J Ahn, Ph.D., president and CEO. "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."
NeuVax (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful phase II trial, which achieved its primary endpoint of disease-free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is a randomized, multi-centre investigator sponsored, 300 patient phase IIb clinical trial is also enrolling patients to study NeuVax in combination with Herceptin (trastuzumab; Genentech/Roche).
Galena Biopharma, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.