PORTLAND, Ore., Feb. 28, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that it has received a Notice of Acceptance from the Australian Patent Office for a patent covering the use of Galena's development product candidate, NeuVax™ (nelipepimut-S), a HER2/neu peptide vaccine, for inducing protective or therapeutic immunity to breast cancer recurrence in patients having low-to-intermediate HER2 IHC ratings of 1+ or 2+ and a FISH rating of less than 2.0 ± 20% for CYP17 to HER2/neu gene expression ratio. The patent provides NeuVax the exclusivity for this indication until 2028, not including any patent term extensions.
"With our Phase 3 PRESENT trial currently ongoing in 13 countries, the continued addition of commercial partnerships, and a future clinical trial to be conducted in India, we are positioning NeuVax to be a potential treatment option for HER2 cancer patients worldwide," stated Mark J. Ahn, Ph.D., President and CEO. "This Australian patent strengthens our global intellectual property portfolio to potentially provide a tool to prevent recurrence in women with breast cancer."
NeuVax is currently in two clinical breast cancer trials, including the Phase 3 PRESENT ( Prevention of Recurrence in Early- Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial and a Phase 2b trial in combination with Herceptin® (trastuzumab). A Phase 2 gastric cancer trial is also expected to initiate this year and will be run by Galena's partner in India, Dr. Reddy's.About NeuVax™ (nelipepimut-S) 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-S 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 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 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 ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche). According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.