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Galena Biopharma Expands Patient Population in NeuVax(TM) (nelipepimut-S) and trastuzumab Phase 2b Combination Clinical Trial in HER2 1+/2+ Patients

PORTLAND, Ore., March 26, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that human leukocyte antigen (HLA) - A24+ or HLA-A26+ women are now eligible for enrollment into the ongoing Phase 2b clinical trial with NeuVax™ (nelipepimut-S) in combination with trastuzumab (Herceptin®; Genentech/Roche). The trial evaluates node positive and triple negative, node negative breast cancer patients with immunohistochemistry (IHC) HER2 1+/2+ expressing tumors who are disease-free after standard of care therapy.

"Adding patients with HLA-A24 and/or A26 broadens the utilization of NeuVax in the ongoing Phase 2b combination trial with trastuzumab," stated principal investigator COL (ret) George E. Peoples, MD, FACS, Professor, Surgery, Uniformed Services University and Professor (adjunct), Surgical Oncology, MD Anderson Cancer Center. "Women with HER2 1+/2+ breast cancer currently have no other HER2-directed treatment options available to prevent the recurrence of their disease. We are pleased to expand our patient eligibility to offer NeuVax to more women, particularly those of Asian descent where HLA-A24 and A26 are prevalent."

The nelipepimut-S peptide works by binding to specific HLA proteins, or molecules key to immunological activity and are involved in the induction of protective T-cell immune responses. To date, NeuVax has been tested in trials with patients who are HLA-A2+ or A3+, representing more than 60% of the North American, European and Chinese populations. NeuVax has also been shown to bind to HLA-A24 and A26, which represents an additional 10-15% of the population in the U.S., but more importantly, represents up to approximately 70% of the population in Japan.1

"We continuously look for ways to expand the use of NeuVax both in our current indications as well as in new diseases, and this protocol enhancement of our combination trial is a perfect example of these efforts. We are now able to treat more women and the expanded patient population could significantly increase the overall market potential for NeuVax worldwide. We are grateful to Dr. Peoples and all of our investigators for their ongoing efforts and creativity around the use of our investigational compounds," added Mark W. Schwartz, Ph.D., President and Chief Executive Officer.

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. NeuVax has been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26 molecules. 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.

In addition to the Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ patients (clinicaltrials.gov identifier: NCT01570036), 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). Additional information on the PRESENT trial can be found at www.neuvax.com (clinicaltrials.gov identifier: NCT01479244). Galena also has one additional breast cancer study ongoing with NeuVax in combination with trastuzumab (Herceptin®; Genentech/Roche): a Phase 2 trial in neoadjuvantly treated node positive and negative HER2 IHC 3+ patients not achieving a pathological complete response (pCR) or adjuvantly treated node positive HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698).

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. In China and Japan, the combined incidence of breast cancer is approximately 322,0002. 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. (Nasdaq:GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.

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, including the conduct, timing and patient enrollment in our clinical trials, as well as statements about our expectations, plans and prospects. 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.

Abstral and NeuVax are trademarks of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.

Sources:

1 http://www.allelefrequencies.net/

2Global Data: PharmaPoint: HER2-Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2023

CONTACT: Remy Bernarda SVP, Investor Relations & Corporate Communications (503) 405-8258 rbernarda@galenabiopharma.com

Source:Galena Biopharma