Galena Biopharma (GALE), Leica Biosystems Enter NeuVax Partnership
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Galena Biopharma, Inc. (Nasdaq: GALE) and Leica Biosystems announced a partnership to develop a companion diagnostic for Galena's NeuVax (nelipepimut-S or E75) breast cancer therapeutic. Galena Biopharma is a United States based biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care. Leica Biosystems is a global leader in workflow solutions and laboratory automation for anatomic pathology, bringing clinicians and researchers high workflow efficiency and confidence in cancer diagnostics. 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.
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.
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