galena biopharma inc (GALE) Key Developments
Galena Biopharma, Inc. Announces Human Leukocyte Antigen (HLA) - A24+ or HLA-A26+ Women Now Eligible for Enrollment into the Ongoing Phase 2B Clinical Trial with Neuvax (Nelipepimut-S) in Combination with Trastuzumab
Mar 26 15
Galena Biopharma, Inc. 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. 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. 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 monodominant 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 NeuVaxTreatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA).
Galena Biopharma Mulls Acquisition
Mar 13 15
Galena Biopharma, Inc. (NasdaqCM:GALE) is seeking acquisition. Galena Biopharma said in Sec filling about use of proceed from composite units offerings, “General corporate purposes may include repayment of our existing long-term debt, capital expenditures, milestone payments under our existing license and other agreements and payments in connection with possible future acquisitions and strategic investments."
Galena Biopharma, Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 10:00 AM
Mar 12 15
Galena Biopharma, Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 10:00 AM. Venue: Grand Hyatt Hotel, Tokyo, Japan.
Galena Biopharma, Inc. Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014; Re-Iterates Revenue Guidance for the Full Year of Fiscal 2015
Mar 5 15
Galena Biopharma, Inc. announced unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter, the company announced net revenue of $3,195,000 compared to $1,317,000 for the same period a year ago. Operating loss was $11,382,000 compared to $12,350,000 for the same period a year ago. Loss before income taxes was $7,956,000 compared to $47,387,000 for the same period a year ago. Net loss was $7,956,000 compared to $48,501,000 for the same period a year ago. Net loss per common share, basic and diluted was $0.06 compared to $0.46 for the same period a year ago. The increase in net operating loss year-over-year is primarily the result of the company’s increased activity and enrollment in its Phase 3 PRESENT trial for NeuVax, the company’s investigator sponsored trials for NeuVax, and its Phase 2 trial for GALE-401, as well as increased selling and marketing expenses associated with the growth of its commercial activities.
For the full year, the company announced net revenue of $9,319,000 compared to $2,487,000 for the same period a year ago. Operating loss was $52,222,000 compared to $33,840,000 for the same period a year ago. Loss before income taxes was $36,606,000 compared to $75,626,000 for the same period a year ago. Net loss was $36,606,000 compared to $76,678,000 for the same period a year ago. Net loss per common share, basic and diluted was $0.31 compared to $0.85 for the same period a year ago.
The company re-iterated revenue guidance for the full year of fiscal 2015. The company expects net revenue to increase throughout 2015 based on increased Abstral demand combined with the launch of the company’s second commercial product, Zuplenz. The company reiterated 2015 net revenue guidance between $15 million and $18 million for the combined commercial programs.
Galena Biopharma, Inc. to Report Q4, 2014 Results on Mar 05, 2015
Feb 19 15
Galena Biopharma, Inc. announced that they will report Q4, 2014 results at 5:00 PM, Eastern Standard Time on Mar 05, 2015