Galena and Leica to Develop CDx for Breast Cancer Therapeutic
Galena Biopharma and Leica Biosystems are partnering to develop a companion diagnostic for Galena's NeuVax™ (nelipepimut-S or E75) breast cancer therapeutic. Leica's Bond Oracle™ Human Epidermal Growth Factor Receptor 2 (HER2) IHC System companion diagnostic will be used to support the selection of the appropriate patients for the NeuVax Phase III PRESENT 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.
Leica's Bond Oracle HER2 IHC System is an FDA cleared semi-quantitative immunohistochemical assay to determine HER2 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,” said Arnd Kaldowski, president of Leica Biosystems.
Galena is developing NeuVax to prevent recurrence in the 50% of breast cancer HER2 patients with low to intermediate protein expression who are not eligible to receive other therapies after initial treatment. According to the company, NeuVax immunotherapy uses the patients’ own immune system to target tumor cells in a highly specific, less toxic, and more convenient way than conventional cancer therapies.
Earlier this week, Galena announced that Teva Pharmaceutical Industries will develop and market NeuVax in Israel. Under the agreement, Teva will handle the development and regulatory process and conduct at least four clinical trials of NeuVax in the country.