NeuVax induces a full immune response in treated patients and creates an immune memory to target residual cancer cells
Phase 3 PRESENT HER2 1+/2+ patients confirmed as optimal treatment population
PORTLAND, Ore., Oct. 7, 2013 (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 an oral presentation given today at the American College of Surgeons Clinical Congress 2013 taking place October 6-10, 2013 in Washington D.C. The oral presentation, entitled "Predicting Clinical Benefit After Completion of Treatment with the Adjuvant Breast Cancer Vaccine, NeuVax™ (nelipepimut-S or E75)," analyzed biomarker data and clinical outcomes from the NeuVax phase 2 trial. A number of variables were analyzed, including HER2 levels, effect of boosters, induction, and amplification of the NeuVax T-cell response. The data demonstrates that induction, rather than amplification, of an anti-HER2 immune response confers optimal clinical benefit and may partially explain why NeuVax works in HER2 IHC 1+/2+ patients with low-to-intermediate HER2 antigen exposure. This data is consistent with previously published biomarker data indicating 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 is a cancer immunotherapy that harnesses the power of the immune system to seek out and destroy HER2 presenting cancer cells. NeuVax is the most immunogenic peptide of the HER2 protein which is injected into the body to allow the immune system to develop a robust HER2-directed T-cell response, creating immune memory, and priming the immune system against tumor cells. This active immunotherapy can not only kill tumor cells present at the time of therapy, but with the additional advantage of immune memory, the boosted immune system is primed to eradicate any remaining or recurrent tumor cells in a patient.