SAN RAMON, Calif. - Galena Biopharma Inc., a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the United States Patent Office issued a Notice of Allowance for an additional US patent application covering multiple uses of NeuVax™ (nelipepimut-S).  NeuVax is a peptide immunotherapy currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials. This patent will expand both the protection and the potential population of cancer patients NeuVax may address.  Once issued, the patent will expire in 2028, not including any patent term extensions. 

A press release by the company stated that the patent will cover the use of NeuVax for the following indications:

• Inducing and maintaining an immune response to HER2 expressing tumor cells in patients in clinical remission with a tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0 (FISH <2.0)

• Inducing and sustaining a cytotoxic T-lymphocyte (CTL) response to HER2 in patients in clinical remission from a tumor with a FISH rating of less than about 2.0 (FISH < 2.0)

• Reducing risk of cancer recurrence in patients in clinical remission from a tumor with a FISH rating of less than about 2.0 (FISH < 2.0)

• Preventing bone only recurrence of a HER2 expressing cancer

Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated, “Galena has developed a broad development pipeline around NeuVax with five clinical trials targeting the prevention of recurrence in breast and gastric cancer patients, all of which are in areas of significant unmet medical need.  Expanding our patent portfolio remains a primary focus for Galena, particularly as we approach the final endpoint for our pivotal, PRESENT clinical trial, currently expected in 2018, and advance towards potential commercialization of NeuVax.”

HER2 is measured by both gene expression (FISH) and by protein expression via immunohistochemistry (IHC).

FISH is a diagnostic test used to identify patients with gene amplification (multiple copies) of the HER2 gene, or FISH greater than 2.0. The tumors for these patients express the highest levels of the HER2 protein (IHC 3+), and are therefore eligible for existing approved HER2-directed treatments.  Currently, there are no approved, HER2-directed therapies for patients who express lower levels of HER2 (IHC 1+ or 2+), or less than 2.0 by the FISH testing scale.  The additional claims from this NeuVax patent expand the coverage for the use of NeuVax to all patients who do not amplify the HER2 gene.  As well, the current claims also cover all HER2 expressing tumors.

According to the National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH < 2.0) and achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.