Galena Biopharma (GALE) Announces Presentation of Significant NeuVax Preclinical Data at PIVAC Conference

September 13, 2016 10:03 AM EDT

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Galena Biopharma, Inc. (Nasdaq: GALE) announced that preclinical data from the Company’s NeuVax (nelipepimut-S) program is being presented today at the Progress in Vaccination Against Cancer (PIVAC) Conference in Winchester, UK. NeuVax contains the immunodominant peptide derived from the extracellular region of the HER2 protein, which is expressed in ovarian and pancreatic cancers as well as in breast cancer.

The poster, entitled, “Preclinical study on the efficacy of NeuVax peptide vaccine against human Her2+/ HLA-A2.1+ ovarian and pancreatic cancer,” demonstrated the results of HLA-A2 transgenic mice that were immunized with NeuVax (E75) mixed with recombinant mouse GM-CSF (NeuVax mice). As control, a group of mice received GM-CSF alone (control mice). CD8+ T cells purified from the spleens of HLA-A2 transgenic immunized mice were adoptively transferred to NSG (NOD/SCID/IL2Rγnull) mice bearing human ovarian or pancreatic tumors which were HER2+, HLA-A2+.

Administration of the NeuVax vaccination resulted in a specific, delayed-type hypersensitivity (DTH) reaction and in the induction of E75 specific CD8+ T cells that express PD-1 (programmed T-cell death protein). Both ovarian and pancreatic tumor growth rate was significantly reduced in NSG mice that received the CD8+ T cells from NeuVax-immunized mice compared to those receiving CD8+ T cells from control mice. Additionally, PD-1 was identified on activated CD8+ T cells.

“The findings from this preclinical mouse model provide scientific bases about the efficacy of NeuVax vaccination in hampering ovarian and pancreatic tumor progression by showing both DTH reactions and NeuVax specific CD8+ T cells,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Importantly, the expression of PD-1 on activated CD8+ T cells suggests an opportunity to investigate the efficacy of NeuVax in combination with PD-1 inhibitors. We appreciate the work and dedication on this study run by our partners at the University of Torino in Italy.”

The abstract (#2) can be found on the conference website here, and the poster presentation from the conference will be available on Galena’s website here.

About NeuVax™ (nelipepimut-S)

NeuVax™ (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy currently 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. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies 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.



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