Date: 2015-09-30
Type of information: Clinical research agreement
Compound: NeuVax™ (nelipepimut-S)
Company: Galena Biopharma (USA - OR)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: peptide/immunotherapy product. NeuVax™ (nelipepimut-S) is an immunodominant nonapeptide 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 leading to a broader, more robust anti-tumor immune response.
Disease: Ductal Carcinoma in Situ (DCIS)
Details: * On September 30, 2015, Galena Biopharma announced a collaboration with the National Cancer Institute (NCI) to initiate a new, Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in patients diagnosed with Ductal Carcinoma in Situ (DCIS). The trial will be entitled, VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast. The University of Texas M.D. Anderson Cancer Center (MDACC) Phase I and II Chemoprevention Consortium is the lead for this multi-center trial with Elizabeth Mittendorf, MD, PhD serving as the study Principal Investigator. The Consortium is funded through the Division of Cancer Prevention at NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as additional financial and administrative support. The trial is expected to initiate in the fourth quarter of 2015.
The Phase 2 clinical trial will be a single-blind, double arm, randomized, controlled trial comparing NeuVax combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) versus GM-CSF alone. Adult women eligible for the trial will be pre- or post-menopausal with DCIS diagnosed via their core needle biopsy and will be positive for the human leukocyte antigen (HLA) allele A2, or HLA-A2 positive. The trial will enroll a total of 48 patients randomized in a 2:1 ratio, 32 in the active arm and 16 in the control arm. After completion of local therapy to include surgery and when indicated, radiation, the treatment regimen will consist of three doses prior to, and three doses after surgery, for a total of six injections of either vaccine or control, depending on the arm in which the patients are randomized. The primary endpoint for the trial is immunological, evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients compared to patients receiving GM-CSF alone. Secondary endpoints include safety, immune response via epitope spreading, presence of DCIS at resection, and difference in HER2 expression.
Financial terms:
Latest news:
