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news.US-based Galena Biopharma has received a Notice of Acceptance from the Australian Patent Office for a patent covering the use of NeuVax (nelipepimut-S) for inducing protective or therapeutic immunity to breast cancer recurrence in patients having low-to-intermediate HER2 IHC ratings of 1+ or 2+ and a FISH rating of less than 2.0 ± 20% for CYP17 to HER2/neu gene expression ratio.
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The company’s development product candidate NeuVax is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma.
The patent provides the vaccine the exclusivity for this indication until 2028, not including any patent term extensions.
Galena Biopharma president and CEO Mark Ahn said with the company’s Phase III PRESENT trial currently ongoing in 13 countries, the continued addition of commercial partnerships, and a future clinical trial to be conducted in India, it is positioning NeuVax to be a potential treatment option for HER2 cancer patients worldwide.
"This Australian patent strengthens our global intellectual property portfolio to potentially provide a tool to prevent recurrence in women with breast cancer," Ahn said.
According to the company, NeuVax is currently in two clinical breast cancer trials, including the Phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial and a Phase IIb trial in combination with Herceptin (trastuzumab).
A Phase II gastric cancer trial is also expected to be started in 2014 and will be run by the company’s Indian partner Dr. Reddy’s.