On December 14, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported 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 (Press release, Galena Biopharma, DEC 14, 2016, View Source [SID1234517077]). 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. Schedule your 30 min Free 1stOncology Demo! Ductal Carcinoma in Situ (DCIS) is a noninvasive cancer in which abnormal cells are found in the lining of the breast duct and have not spread outside the milk duct to invade other parts of the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently it is extremely challenging to identify which lesions may convert to invasive cancer.1 DCIS is the most common type of breast cancer and the rate at which DCIS is diagnosed has increased dramatically in recent years as a result of increased cancer screening.1
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"The Phase 2 VADIS trial will broaden the development footprint for NeuVax into this new indication as we assess its safety and immunologic efficacy in patients with DCIS," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The challenge with DCIS is that the exact course of the disease cannot be determined and consequently the outcomes for patients may be undefined. 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. Positive study results from the VADIS trial could provide potential evidence for NeuVax as a first of its kind treatment for the primary prevention of invasive breast cancer, thereby sparing significant numbers of women from disfiguring surgery and radiation treatments. We are grateful to be working on this innovative initiative with the NCI and the MD Anderson Cancer Center, two of the finest oncology institutions in the country."
Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the VADIS trial, added, "We are pleased to collaborate with the NCI and Galena on the development of NeuVax in DCIS which affects more than 60,000 women a year. In breast cancer, DCIS may be a precursor to invasive disease, and it is possible that vaccination before tumor cells become genetically unstable and begin dividing rapidly could prevent evolution to malignancy. NeuVax is currently the most advanced breast cancer vaccine in the clinic and we think its broad immune response not only to the specific antigen targeted by the drug, but also to other antigens, speaks to why NeuVax could be an ideal therapeutic candidate in this indication. By vaccinating patients in early-phase disease, we may be giving them long-lasting immunity to protect them down the line."
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.
Source: 1Pang, J-MB, et al, Histopathology 2016.
About VADIS
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.
The trial design via poster presentation is available on the Company’s website here. Additional information on the trial can be found on the ClinicalTrials.gov site here (identifier: NCT02636582).
About Ductal Carcinoma in Situ
Ductal Carcinoma in Situ (DUK-tul KAR-sih-NOH-muh in SY-too), or DCIS, is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct, and is the most common type of breast cancer. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, DCIS may become invasive cancer and spread to other tissues; currently there is no way to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. According to the American Cancer Society, in 2015 there were over 60,000 diagnoses of ductal carcinoma in situ.
About NeuVax (nelipepimut-S)
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 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 (APCs). 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 also 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). A Phase 2 clinical trial is planned in patients with gastric cancer.