PORTLAND, Ore., April 24, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that the 2014 Award for Excellence in Technology Transfer was granted to The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and the Uniformed Services University of the Health Sciences (USU). The award was presented by the Federal Laboratory Consortium for Technology Transfer for work by George Peoples, M.D., chief of surgical oncology at the San Antonio Military Medical Center, and his colleagues, for the licensing of NeuVax™ (nelipepimut-S), a breast cancer vaccine to reduce breast cancer recurrence.
Dr. Peoples and other researchers at the University of Texas M.D. Anderson Cancer Center in Houston discovered the E75 peptide, now known as NeuVax. Galena owns the worldwide license for NeuVax for all uses and is currently developing the drug in multiple clinical trials including its pivotal, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The official announcement can be found here: USU-HJF Effort to License Promising Breast Cancer Vaccine Wins Award.
"The pioneering scientific and clinical work done by Dr. Peoples and his team has brought NeuVax from discovery to a pivotal Phase 3 trial with the aim of preventing breast cancer recurrence for women with no current treatment options," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "We offer our heartfelt congratulations to the teams at the HJF and USU, and are grateful for our ongoing affiliations with these esteemed organizations."
About NeuVax™ (nelipepimut-S)
NeuVax™ (nelipepimut-S) is the immunodominant nonapeptide 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 HLA-A2/A3 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 immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the U.S. Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
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 the 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.
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 our 2014 target revenue from the sale of Abstral® and the progress of Galena's clinical trials, 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, 2013 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.