Galena Biopharma doses first high-risk breast cancer patients in clinical trial with NeuVax plus Herceptin

Oct. 2014 patent allowance provides intellectual property protection for NeuVax in combination with Herceptin in any HER2/neu expressing cancer

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PORTLAND, Ore.—Galena Biopharma, Inc., a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments, has dosed 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. Galena’s NeuVax will be used in combination with Herceptin® (trastuzumab; Genentech/Roche). The patients will be defined as 3+ by immunohistochemistry or HER2 2+ 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 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 CEO. "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; and, third, 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 in combination with Herceptin.
NeuVax (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast cancer. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APCs). These activated, specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration. Two additional Phase 2 trials are ongoing with NeuVax in combination with Herceptin.
According to the National Cancer Institute, more than 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 25 percent are HER2 positive, which means their breast cancer cells significantly over express the HER2 protein. HER2 is a member of the epidermal growth factor receptor family of receptor tyrosine kinases. Increasing levels of HER2 expression have been shown to be a prognostic indicator for poor outcomes in breast cancer. Patients with HER2 3+ tumors, or HER2 2+ and/or gene-amplified tumors may receive trastuzumab, a humanized mAb targeting HER2, as a component of their standard-of-care therapy. In HER2 3+ breast cancer patients who receive neoadjuvant chemotherapy plus trastuzumab, the 3-year estimate of recurrence free survival are 95.7 percent for patients that achieve a pCR versus 80.1 percent for patients that do not achieve a pCR (p=.02). For HER2 3+ or gene-amplified breast cancer patients that undergo surgery as a first intervention and are found to be node-positive, 5-year disease free survival rates are 72 percent for those with four or more positive lymph nodes and 78 percent for those with 1, 2 or 3 positive lymph nodes. 
Galena Biopharma, Inc. is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax (nelipepimut-S) currently in an international, Phase 3 clinical trial. The company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects.

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