Galena Biopharma Announces Notice of Allowance of U.S. Patent for NeuVax™ (nelipepimut-S)

Feb 08, 2016

Issued Patent Will Cover Multiple Additional Claims Around the Use of NeuVax

SAN RAMON, Calif., Feb. 08, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), 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 U.S. 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. 

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.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.  It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading.  

NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). PRESENT is targeting node positive HER2 IHC 1+/2+ patients ( identifier: NCT01479244).  Galena has two additional breast cancer studies ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ ( identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients ( identifier: NCT02297698).  Phase 2 clinical trials with NeuVax are also planned in patients with ductal carcinoma in situ (DCIS), and in patients with gastric cancer.

About HER2 1+/2+ Breast Cancer

According to the National Cancer Institute, over 230,000 women in the U.S. 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.

About Galena Biopharma

Galena Biopharma, Inc. is a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs. Galena’s development portfolio is focused primarily on addressing the rapidly growing patient populations of cancer survivors by harnessing the power of the immune system to prevent cancer recurrence. The Company’s pipeline consists of multiple mid- to late-stage clinical assets, including novel cancer immunotherapy programs led by NeuVax™ (nelipepimut-S) and GALE-301.  NeuVax is currently in a pivotal, Phase 3 clinical trial with several concurrent Phase 2 trials ongoing both as a single agent and in combination with other therapies. GALE-301 is in a Phase 2a clinical trial in ovarian and endometrial cancers and in a Phase 1b given sequentially with GALE-302.   For more information, visit

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such statements include, but are not limited to, statements about the progress of the development of Galena’s product candidates, patient enrollment in our clinical trials, as well as other statements related to the progress and timing of our development activities, present or future licensing, collaborative or financing arrangements, expected outcomes with regulatory agencies, and projected market opportunities for product candidates or that otherwise relate to future periods. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under “Risk Factors” in Galena’s Annual Report on Form 10-K for the year ended December 31, 2014 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.

NeuVax is a trademark of Galena Biopharma, Inc.


Remy Bernarda
SVP, Investor Relations & Corporate Communications
(925) 498-7709

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Source: Galena Biopharma, Inc.

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Remy Bernarda, IRC

SVP, Investor Relations & Corporate Communications