Clinical Trials

Date: 2016-12-14

Type of information: Initiation of patient enrollment

phase: 2

Announcement: initiation of patient enrollment

Company: Galena Biopharma (USA - OR)

Product: NeuVax™ (nelipepimut-S)

Action mechanism:

peptide/immunotherapy product. NeuVax™ (nelipepimut-S) is an immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, which is expressed in ovarian and pancreatic cancers as well as in breast cancer. 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 breast carcinoma in situ

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

VADIS (Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast) is a Phase 2 trial to evaluate women diagnosed with DCIS who are HLA-A2 positive, who express HER2 at IHC 1+, 2+, or 3+ levels, and who are pre or post menopausal. Patients will be randomized to one of two arms (n=48): NeuVax plus GM-CSF (n=32 randomized / 27 evaluable) or GM-CSF alone (n=16 randomized / 13 evaluable). The primary endpoint is immunologic and will evaluate the effect of the NeuVax vaccine on NeuVax -specific cytotoxic T lymphocytes to determine whether long-lasting immunity is induced. Secondary endpoints include evaluation of toxicity, In vivo immune response (delayed type hypersensitivity reaction (DTH)), epitope spreading, T-cell functional capacity, and histologic response measured by degree of lymphocyte infiltration, proliferation, and apoptosis. (NCT02636582)

Latest news:

• On December 14, 2016, Galena Biopharma announced that the NeuVax™ (nelipepimut-S) Phase 2 clinical trial entitled VADIS: Phase 2 trial of the Nelipepimut-S Peptide VAccine in Women with DCIS of the Breast is now open for enrollment and screening patients. The trial is being run in collaboration with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center Phase I and II Chemoprevention Consortium . This study will evaluate NeuVax in its capacity to generate the immune response, including tumor-infiltrating lymphocytes (TILs), that could potentially prevent the progression of the disease. The MD Anderson Consortium is funded through the Division of Cancer Prevention at the NCI, which will provide financial and administrative support for the trial. Galena will provide NeuVax, as well as some financial and administrative support.