Galena Biopharma, a Portland, Oregon-based biopharmaceutical company that develops and commercializes oncology treatments to address unmet medical needs in cancer care, today announced delivery of an oral presentation at the American College of Surgeons Clinical Congress 2013. Entitled “Predicting Clinical Benefit after Completion of Treatment with the Adjuvant Breast Cancer Vaccine, NeuVax(TM) (nelipepimut-S or E75),” the presentation investigated biomarker data and clinical outcomes from the second phase trial of NeuVax. The conference is occurring October 6-10, 2013 in Washington, D.C.
NeuVax is a cancer immunotherapy that uses the immune system’s power to locate and destroy HER2-presenting cancer cells. The HER2 is a well-noted target for therapeutic action against breast carcinoma. This immunotherapy is injected into the body to destroy tumor cells present at the time of therapy as well as optimize the immune system for future action against these tumor cells. The National Cancer Institute reports that over 230,000 women in the United States are diagnosed with cancer, among whom about 25 percent are HER2-positive (IHC 3+). NeuVax focuses on approximately 50 to 60 percent of this population, which is HER2-low to -intermediate (IHC 1+/2+ or FISH).
The presentation analyzed multiple variables including HER2 levels, effect of boosters, induction and amplification of the NeuVax T-cell response. It noted that the data signifies that induction anti-HER2 immune response brings about the best clinical benefit and may partially account for why NeuVax works in HER2 IHC 1+/2+ patients with low-to-intermediate HER2 antigen exposure. The data is consistent with previously published biomarker data that shows a correlation between increasing NeuVax specific T-cells following vaccination and reductions in breast cancer recurrence rates.
“The presentation by Dr. Berry reinforces two key aspects of the NeuVax Phase 3 PRESENT trial. First, the data supports the correlation of the mechanism of action of NeuVax during the induction dosing. Second, immune T-cell response targeting HER2 expressing cancer cells correlates with reduction in recurrences in the target patient population, and that PRESENT is targeting the patient population with women who have a low-to-intermediate expression of HER2 with an unmet medical need,” said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma.
NeuVax had a successful Phase 2 trial that achieved its primary end goal of disease-free survival (DFE). As a result, the U.S. Food and Drug Administration (FDA) granted the immunotherapy a Special Protocol Assessment (SPA) for its Phase 3 study with the primary endpoint of recurrence prevention in low to intermediate HER2 women. The study is currently ongoing.
More information about Galena Biopharma can be found at www.galenabiopharma.com. Additional in-depth medical and scientific information about NeuVax can be found at www.neuvax.com
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