galena biopharma inc (GALE) Key Developments
Galena Biopharma, Inc. Completes Over-Enrollment of NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial
Apr 14 15
Galena Biopharma, Inc. announced the completion of enrollment in the NeuVax (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial. NeuVax 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. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events (recurrence or death) occur, whichever comes later. PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is the most advanced study in Galena's pipeline. The trial is being run in 13 countries at more than 140 sites. The PRESENT trial targets the approximately 50%-60% of women with breast cancer who have low to intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in situ hybridization [FISH] < 2.0) HER2 expression and achieved no evidence of disease following current standard of care treatment (surgery, chemotherapy, and radiation therapy). Patients enrolled must be lymph node positive, haplotype (HLA) A2 or A3 positive, and have Stage IIa-IIIa breast cancer. Once patients completed their current standard of care treatment, they are administered an injection once a month for six months (Primary Vaccine Series), then receive five booster injections once every six months for a total of eleven injections over a three year period. Currently there are no other treatment options for these patients to maintain their disease-free status.
PCI Biotech Initiates Pre-Clinical Research Collaboration in RXi Pharmaceuticals
Apr 7 15
PCI Biotech announced that it is initiating a pre-clinical research collaboration with RXi Pharmaceuticals. The partnership is governed by a pre-clinical research collaboration agreement. Initially, the purpose of the pre-clinical research collaboration is to utilize the companies' complementary scientific platforms to explore potential synergies. In brief the pre-clinical research collaboration will evaluate technology compatibility based on in vitro and in vivo studies. The costs related to the research collaboration will be covered by each company separately. The companies will evaluate results achieved from this research collaboration and then explore the potential for a closer collaboration. Both companies will retain exclusive ownership rights to existing registered intellectual property. However, any inventions arising from the collaboration will be jointly owned by the companies.
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.