US-based biopharmaceutical firm Galena Biopharma has entered into a collaboration with the National Cancer Institute (NCI) to start a new, Phase II clinical trial with NeuVax (nelipepimut-S) in patients diagnosed with ductal carcinoma in situ (DCIS).
NeuVax is a first-in-class, HER2-directed cancer immunotherapy being evaluated to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.
The study will be entitled: 'VADIS: Phase II trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast.'
The University of Texas MD Anderson Cancer Center (MDACC) Phase I and II Chemoprevention Consortium is the lead for this multi-centre trial and Elizabeth Mittendorf is serving as the principal investigator.
The consortium is funded through the NCI's Division of Cancer Prevention (DCP), which will provide financial and administrative support for the trial.
For the trial, which is expected to be initiated in the fourth quarter of this year, the company Galena will provide NeuVax, as well as additional financial and administrative support.
Galena president and chief executive officer Mark Schwartz said: "We are pleased to have been chosen by the NCI and MD Anderson, two world-renowned institutions, on this groundbreaking study to potentially advance NeuVax earlier in the treatment cycle towards primary prevention of breast cancer.
"NeuVax generates a significant and potent HER2 directed T-cell response, and this Phase II clinical trial will evaluate the CD8+ T cell response generated by NeuVax and whether this induced activation of the immune system suppresses the growth of DCIS cells. We look forward to initiating this trial with our partners before year end."
The single-blind, double arm, randomized, controlled Phase II trial includes NeuVax combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF) versus GM-CSF alone.
The company noted that adult women eligible for the trial will be pre or post-menopausal with DCIS diagnosed through their core needle biopsy and will be positive for the human leukocyte antigen (HLA) allele A2, or HLA-A2 positive.
A total of 48 patients will be enrolled in the trial and they will be randomised in a 2:1 ratio, 32 in the active arm and 16 in the control arm.
Upon completion of local therapy to include surgery and when indicated, radiation, the treatment regimen will include 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 randomised.
The trial's primary endpoint is immunological, evaluating NeuVax peptide-specific cytotoxic T lymphocyte (CTL; CD8+ T cell) response in vaccinated patients compared to patients receiving GM-CSF alone, while secondary endpoints include safety, immune response through epitope spreading, presence of DCIS at resection, and difference in HER2 expression.
The NCI's DCP conducts and supports research to determine a person's risk of cancer and to find ways to reduce the risk.
DCIS, which is the most common type of breast cancer, is defined by the NCI as a noninvasive condition, in which abnormal cells are found in the lining of a breast duct.