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February 08, 2016 4:28 AM ET

Biotechnology

Company Overview of Galena Biopharma, Inc.

Company Overview

Galena Biopharma, Inc., a biopharmaceutical company, focuses on developing and commercializing oncology therapeutics that address major unmet medical needs across cancer care. Its commercial products include Abstral, a sublingual tablet that is used for the management of breakthrough pain in patients with cancer; and Zuplenz, an oral soluble film for use in the prevention of chemotherapy-induced, radiotherapy-induced, and post-operative nausea and vomiting. The company’s lead product candidate, NeuVax (nelipepimut-S), is in Phase III clinical trials for the prevention of recurrence in early- stage and node-positive breast cancer with low to intermediate human epidermal growth factor receptor...

4640 SW Macadam Avenue

Suite 270

Portland, OR 97239

United States

Founded in 2003

57 Employees

Phone:

855-855-4253

Fax:

503- 400-6611

Key Executives for Galena Biopharma, Inc.

Chief Executive Officer, President, Director and Member of Ad Hoc (Strategy, Pricing, Etc) Committee
Age: 60
Total Annual Compensation: $707.1K
Compensation as of Fiscal Year 2014.

Galena Biopharma, Inc. Key Developments

Galena Biopharma, Inc. Presents Observational Study Data in Gastric Cancer Patients at the ASCO 2016 Gastrointestinal Cancers Symposium

Galena Biopharma, Inc. announced that it has 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. Dr. Reddy's will conduct a Phase 2 clinical trial of NeuVax in gastric cancer patients in India. 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 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. 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. 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.

Galena Biopharma Expects Safety Data on NeuVax in Breast Cancer, Launch of Ovarian Cancer Drug Trials in 2016

Galena Biopharma expects to reach two key milestones in 2016 with the readout of its NeuVax Phase 3 PRESENT interim safety and futility analysis in second quarter and the launch of a randomized, Phase 2b trial for GALE-301/302 in the second half of the year. The company said the pivotal, Phase 3 PRESENT trial of Neuvax in breast cancer is fully enrolled and expected to reach two key milestones in the first half of the year. In first quarter, the trial should see the 70th patient event, which is defined as a recurrence or death from any cause. Once this occurs, the Independent Data Safety and Monitoring committee will evaluate the data and provide the company with the safety and futility interim analysis. The company expects to initiate a Phase 2 trial in patients with ductal carcinoma in situ in first quarter. For the Phase 2b randomized, combination trial with NeuVax and trastuzumab, Galena expects to present interim safety data as well as patient immunology data on the A24 and A25 Human Leukocyte Antigen status in fourth quarter. Galena's second immuno-oncology program consists of two assets, GALE-301 and GALE-302, targeting folate binding protein receptor-alpha, a therapeutic target in ovarian cancer. The company plans to initiate a randomized, Phase 2b trial in ovarian cancer in the second half of the year. GALE-301/302 booster data will be presented in second quarter and GALE-301 Phase 2a, two-year data will be disclosed in fourth quarter. The company's GALE-401 has completed its Phase 2 proof-of-concept clinical trial for the reduction of elevated platelet counts in patients with thrombocythemia and plans to publish the final Phase 2 report and confirm the 505(b)2 pathway with the U.S. Food and Drug Administration in the second half of the year.

Galena Biopharma, Inc. Presents at NobleCon12, the 12th Annual Emerging Growth Investor Conference, Jan-18-2016 02:30 PM

Galena Biopharma, Inc. Presents at NobleCon12, the 12th Annual Emerging Growth Investor Conference, Jan-18-2016 02:30 PM. Venue: Club Med Sandpiper Bay, Port St. Lucie, Florida, United States. Speakers: Mark W. Schwartz, Chief Executive Officer, President, Director and Member of Ad Hoc (Strategy, Pricing, Etc) Committee.

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Recent Private Companies Transactions

Type
Date
Target
Merger/Acquisition
December 18, 2015
Galena Biopharma, Inc., Certain Assets
Merger/Acquisition
November 20, 2015
Galena Biopharma, Inc., Abstral (fentanyl) Sublingual Tablet
 

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