SAN RAMON, Calif., Jan. 21, 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 presented data from an observational study in gastric cancer patients at the American Society of Clinical Oncology (ASCO) 2016 Gastrointestinal Cancers Symposium in San Francisco, CA. The study was conducted by Galena’s partner, Dr. Reddy’s Laboratories Ltd, under the license agreement for NeuVax™ (nelipepimut-S) which includes the commercialization rights in India. As part of the license agreement, Dr. Reddy’s will conduct a Phase 2 clinical trial of NeuVax in gastric cancer patients in India.
“This observational study and the planned Phase 2 clinical trial in gastric cancer are part of the broad pipeline of NeuVax studies currently underway and planned,” stated Bijan Nejadnik, Executive Vice President and Chief Medical Officer of Galena. “Gastric, or stomach cancer, is the second-most common cancer among males and third-most among females in Asia and worldwide with over 35,000 new cases a year in India.1 The planned Phase 2 clinical study will assess the effectiveness of NeuVax to prevent recurrence and the effect on the disease free survival in gastric cancer patients with all levels of HER2 expression and who are HLA A2 and/or A3 positive. The data presented today demonstrated that, as expected, about 25% of the patient population suffering from gastric cancer in India are likely to be eligible for the Phase 2 trial. This study by Dr. Reddy’s supports their plans to run a Phase 2 trial in India.”
This prospective, observational study was undertaken to estimate the expression of HER2 (1+, 2+, or 3+) with HLA-A2 and/or HLA-A3 type positive gastric cancer patients in the Indian population. The poster, entitled, “An observational study evaluating the expression of HER2 (1+, 2+, and 3+) with HLA A2+/A3+ in gastric adenocarcinoma patients” is being presented during today’s poster session. Of the 50 patients evaluated, 12 (24%) were positive for HER2 (1+, 2+, 3+) with HLA A2/A3 alleles. Of the 12 patients, 9 (75%) and 3 (25%) expressed HLA A2/A3, respectively, with no patient demonstrating HER2 3+ expression. Results from this study suggest patients with gastric or GE junction adenocarcinoma have HLA A2 and/or A3 expressing tumors with mostly HER2 1+, 2+ expression. The estimated incidence of HER2 3+ expression in this population may be limited by the size of the current study (n=50). Approximately 25% of the patients met the projected clinical protocol population of all levels of expression of HER2 and HLA A2+ and/or A3+ as defined for the planned NeuVax Phase 2 clinical trial. Results indicate an acceptable potential for enrollment rate, given the high incidence of gastric cancer in this population, and will inform the screen failure rate in the planned Phase 2 clinical study.
Tumor tissue samples from gastric or GE junction adenocarcinoma patients were collected from S. L. Raheja Hospital, Mumbai, India. A serum sample was collected for HLA testing by quantitative PCR (polymerase chain reaction). Immunohistochemistry (IHC) (DAKO, 1:600 dilution) was employed for detection of HER2. All patients were consented for the study.
1Rajesh P. Dikshit, Garima Mathur, Sharayu Mhatre, and B.B. Yeole; Epidemiological review of gastric cancer in India; Indian Journal of Medical and Paediatric Oncology 2011 Jan-Mar; 32(1): 3–11.
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 (clinicaltrials.gov 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+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov 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 Gastric Cancer
According to the National Cancer Institute, gastric (stomach) cancer is a disease in which malignant (cancer) cells form in the lining of the stomach. Almost all gastric cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Other types of gastric cancer are gastrointestinal carcinoid tumors, gastrointestinal stromal tumors, and lymphomas. Infection with bacteria called Helicobacter pylori (H. pylori) is a common cause of gastric cancer and age, diet, and stomach disease can affect the risk of developing gastric cancer. Gastric cancer is often diagnosed at an advanced stage because there are no early signs or symptoms.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to accelerating access to affordable and innovative medicines, because it believes Good Health Can’t Wait. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – the company offers a portfolio of products and services that include active pharmaceutical ingredients, (APIs), custom pharmaceutical services, generics, biosimilars and differentiated formulations. With operations in 26 countries across the globe, the major therapeutic areas of Dr. Reddy’s are gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infectives. For more information, log on to: www.drreddys.com
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 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 NeuVax, 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.