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news.Galena Biopharma (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, has announced the notice of allowance of a US Patent for NeuVax (nelipepimut-S) covering the use of NeuVax alone or in combination to prevent recurrence of any HER2/neu expressing tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0.
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NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials. Once issued, the patent will expire in 2028, not including any patent term extensions.
FISH is a diagnostic test used to identify patients with high levels of HER2 gene expression, or FISH greater than 2.0.
These patients are eligible for existing approved HER2-directed treatments. Currently there are no approved HER2-directed therapies for patients who express lower levels of HER2, or less than 2.0 by the FISH testing scale.
The patent will cover the use of NeuVax in patients with a FISH of less then about 2.0, as a stand-alone therapy or in combination with an adjuvant and/or other agents (e.g. other drugs such as Herceptin(R) (trastuzumab; Genentech/Roche)).
Importantly, this NeuVax patent provides Galena with coverage for any tumor expressing low-to-intermediate levels of HER2.
"This allowance further strengthens our broad patent estate for NeuVax, covering all tumor types expressing low-to-intermediate levels of HER2 both as a monotherapy and in combination with other agents," said Mark J. Ahn, Ph.D., President and Chief Executive Officer.
"Our clinical development program with NeuVax continues to grow with ongoing and planned clinical trials in breast and gastric cancers. We look forward to completing enrollment in our Phase 3 PRESENT trial this year and advancing NeuVax in other programs to prevent cancer recurrence for patients."