Galena Biopharma Doses First Patient In Phase 2 Clinical Trial With NeuVax In Combination With Herceptin To Treat High-Risk HER2 3+ Or HER2 Gene-Amplified Breast Cancer Patients

Galena Biopharma, Inc.

, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the dosing of the first patient in a new NeuVax™ (nelipepimut-S) Phase 2 clinical trial to prevent breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified breast cancer patients in combination with Herceptin® (trastuzumab; Genentech/Roche). The patients will be defined as 3+ by immunohistochemistry (IHC) or are HER2 2+ and/or fluorescence in situ hybridization (FISH) >2.0, also described as gene-amplified. The multi-center, prospective, randomized, single-blinded, placebo-controlled, Phase 2 trial will enroll 100 patients with a diagnosis of HER2 3+ or gene-amplified breast cancer, are HLA A2+ or HLA A3+, and are determined to be at high-risk for recurrence. "This trial is a significant addition to our portfolio of NeuVax clinical trials that are exploring the potential of the agent to prevent recurrence in a variety of cancer settings," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "Herceptin has shown efficacy in HER2 3+ patients; however, those patients who fall into the high risk category are at much greater risk for a recurrence following standard of care treatment. Based on early studies and pre-clinical data, the combination of NeuVax and Herceptin has shown that the two agents utilize different mechanisms of action to target the same protein, leading to a potentially strong synergistic effect that may provide clinical benefit in this high-risk population. We are excited for the potential to help these high risk patients." This trial is co-funded via a grant from the Department of Defense through the Congressionally Directed Medical Research Program. The grant comes via a Breast Cancer Research Program Breakthrough Award and was obtained by Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, who will oversee this investigator-initiated trial. "The women we are treating in this trial are at a high risk for their disease to recur, particularly because their initial treatment regimen failed to give them a complete response. I believe that NeuVax and Herceptin are complementary to one another and the combination of these agents may provide clinical benefit to these patients," added Dr. Mittendorf. Eligible breast cancer patients will be randomized to receive NeuVax + GM-CSF (granulocyte macrophage-colony stimulating factor) + trastuzumab or trastuzumab + GM-CSF alone in the adjuvant setting following surgery. The primary endpoint of the study is invasive disease-free survival and enrollment is expected to complete in the second half of 2016, followed by a 3-year follow-up period. There are three categories of high-risk patients that qualify for the trial: Patients who received neoadjuvant therapy (before surgery) with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy but fail to obtain a pathological complete response (pCR) at surgery, regardless of hormone receptor status. Patients who undergo surgery as a first intervention and are found to be pathologically node-positive with at least four positive lymph nodes, regardless of hormone receptor status. Hormone receptor negative breast cancer patients who undergo surgery as a first intervention and are found to have one, two or three positive lymph nodes. On October 8, 2014, Galena announced the Notice of Allowance of a U.S. patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax™ (nelipepimut-S) in combination with Herceptin® (trastuzumab; Genentech/Roche).