Galena Biopharma, Inc.,a Portland, Oregon-based biopharmaceutical company, and Leica Biosystems ink partnership to develop a companion diagnostic for Galena's NeuVax (nelipepimut-S or E75) breast cancer therapeutic. Leica Biosystems provides a comprehensive product range with easy-to-use and consistently reliable solutions for the entire laboratory.

Leica's Bond Oracle HER2 IHC System companion diagnostic will be used to support the selection of the appropriate patients for the NeuVax phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study. NeuVax targets HER2 negative patients (IHC 1+, or 2+ and FISH < 2.2) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

"This agreement with Leica marks a significant milestone for Galena, and is a continuation of our focus on developing personalized and targeted medicines to advance cancer care," said Mark J. Ahn, Ph.D., president and chief executive officer. "By partnering with Leica, we will be able to help pioneer personalized medicine for patients while ensuring the proper and accurate assessment of breast cancer patients considering participation in the NeuVax PRESENT trial."

Leica's Bond Oracle HER2 IHC System is an FDA cleared semi-quantitative immunohistochemical (IHC) assay to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in breast cancer tissue processed for histological evaluation.

"The Leica Bond Oracle HER2 IHC System is validated as a fully-automated HER2 IHC test, and delivers the diagnostic confidence that comes with proven HER2 FISH concordance. We are pleased to be working with Galena Biopharma to potentially expand our indication for this product to HER2 negative patients," added Arnd Kaldowski, president of Leica Biosystems.

NeuVax (nelipepimut-S) is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). 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. Based on a successful phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its phase 3 PRESENT (P revention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.

According to the National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50-60% of HER2-negative patients (IHC 1+/2+ or FISH < 2.2) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.

Galena Biopharma, Inc. is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.

Leica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients' lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting.