The first patient has been treated in the Galena Biopharam, Inc. phase 2 clinical trial addressing patients with high risk HER2 3+ and/or HER2 gene-amplified breast cancer. Treatment consists of Galena’s new NeuVax (nelipepimut-S) breast cancer vaccine along with granulocyte macrophage-colony stimulating factor (GM-CSF) and Genentech’s Herceptin (trastuzumab).

“I believe that NeuVax and Herceptin are complementary to one another, and the combination of these agents may provide clinical benefit to these patients,” said Elizabeth A. Mittendorf, MD, PhD, in a news release from Galena. Dr. Mittendorf is from the University of Texas MD Anderson Cancer Center and is overseeing the trial.

Patients enrolled in the trial, which are expected to number 100, have HER2 3+ breast cancer, as defined by immunohistochemistry, or HER2 gene-amplified breast cancer, as defined by fluorescence in situ hybridization (FISH) >2.0, with either HLA A2+ or HLA A3+ status. These patients are especially susceptible to recurrence and make up approximately 25% of the breast cancer patient population.

“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,” explained Dr. Mittendorf.

Galena obtained a patent for the method of treating HER2/neu expressing cancer with the combination of NeuVax and Herceptin. “This trial is a significant addition to our portfoli 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, PhD, who is President and Chief Executive Officer of Galena. “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.”

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NeuVax acts on specific CD8+ cytotoxic T lymphocytes by binding to HLA-A2/A3 molecules on the surface of antigen presenting cells. It is the immunodominant portion of the HER2 protein shown to play a major role in breast carcinoma treatment. Administration of NeuVax is expected to enable greater disease-free survival in treated patients.

“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,” said Dr. Schwartz. “We are excited for the potential to help these high risk patients.”