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news.Galena Biopharma and Leica Biosystems have joined forces to develop a companion diagnostic for Galena's NeuVax (nelipepimut-S or E75), a breast cancer therapeutic.
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As part of the partnership, Leica’s Bond Oracle HER2 IHC System companion diagnostic will be used in choosing eligible 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 aims HER2 negative patients (IHC 1+, or 2+ and FISH < 2.2) who achieve remission but have no ancillary treatment options to maintain the remission.
Galena Biopharma president and Chief Executive Officer said, "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.”
Bond Oracle HER2 IHC System is a semi-quantitative immunohistochemical (IHC) assay to find HER2 oncoprotein status in breast cancer tissue processed for histological evaluation.
Leica Biosystems president Arnd Kaldowski said, "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."
NeuVax is the immuno dominant nonapeptide evolved from the extracellular domain of the HER2 protein.