Galena Biopharma, Inc., a Portland, Oregon-based biopharmaceutical company, has received key patent from the US Patent and Trademark Office (USPTO) covering the use of its product candidate, NeuVax, a HER2/neu peptide vaccine, for inducing immunity to breast cancer recurrence in patients having low-to-intermediate IHC levels of 1+ or 2+ and a FISH rating of less than 2.0. These patients represent a significant unmet medical need, with as much as 80 per cent of breast cancer patients who do not qualify for Herceptin therapy. The key patent was orginally allowed in March 2012.

“As we continue to make progress with the clinical development of NeuVax, issuance of this patent from the USPTO underscores our commitment to support and advance our proprietary oncology pipeline,” stated Mark J Ahn, PhD., president and CEO.

NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful phase II trial that achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment 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.

According to the National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually. Of these women, about 75 per cent of them have breast cancer tissue that tests positive for some level of HER2 staining (IHC 1+, 2+ or 3+). Only 25 per cent of all breast cancer patients, those with HER2 3+ disease, are eligible for Herceptin (trastuzumab; Roche-Genentech), which had revenues of over $6 billion in 2011. NeuVax targets the 50-60 per cent of patients with tumours that stain low or intermediate for HER2 (HER2 1+ and 2+), who would not receive Herceptin after they successfully complete their surgery, adjuvant chemotherapy and radiation. This provides this large group of early-stage breast cancer patients an option for a HER2-targeted adjuvant treatment to maintain their disease-free status.

Galena Biopharma, Inc. a biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.