On October 1, 2014 Immunovaccine reported a clinical development program update for DPX-Survivac, the Company’s lead cancer vaccine candidate. Following the presentation of positive Phase I/II clinical trial data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2014 Annual Meeting earlier this year, the Company plans to advance DPX-Survivac into a Phase II clinical study in diffuse large B cell lymphoma (DLBCL) later this year (Press release Immunovaccine, OCT 1, 2014, View Source [SID:1234501176]). The trial will evaluate DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. This combination therapy trial design fits with Immunovaccine’s clinical development strategy of maximizing therapeutic impact through concurrent treatment with various classes of promising immunotherapies.
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"Our presentation of the first evidence of clinical activity for DPX-Survivac at the ASCO (Free ASCO Whitepaper) conference generated considerable interest from researchers around the world for studying the cancer vaccine in a range oncologic indications and with various combination approaches," said Dr. Marc Mansour, chief executive officer of Immunovaccine. "Following discussions with many key thought leaders and clinical researchers, we have outlined a clinical development strategy designed to generate meaningful data supporting the therapeutic benefit of DPX-Survivac in multiple cancer types with important unmet treatment needs. To this end, we are excited to initiate this trial in recurrent lymphoma, as well as studies in other cancer types, in the coming quarters."
The efficacy Phase II trial will launch at the Odette-Sunnybrook Cancer Centre with the expectation of adding additional sites in the coming months. Researchers will seek to enroll up to 24 patients, with the first patient expected to be dosed by early 2015. The open label study is designed to determine the objective response rate of patients with recurrent survivin-expressing DLBCL when treated with DPX-Survivac in combination with low dose oral cyclophosphamide. Immunovaccine expects to have initial clinical data from this study available approximately mid 2015. Positive clinical data from this study could provide rationale for the initiation of a pivotal trial in recurrent DLBCL.
Study investigators will monitor patients’ immune response to treatment and examine lymphoma deposit biopsies to evaluate immunological changes and gene expression profiles in the tumor. Additionally, the duration of patient clinical responses will also be documented in extended follow-up.
Lymphoma is a relevant oncologic target for DPX-Survivac as more than half of all aggressive non-Hodgkin’s lymphomas such as DLCBL express survivin, the tumor-associated antigen that serves as the basis for the vaccine. Furthermore, there is a growing body of clinical research that shows activity for immune modulatory agents such as cyclophosphamide in DLCBL. Importantly, lymphoma represents a significant unmet medical need as patients who are not transplant candidates or who experience recurrence following an autologous stem cell transplant (ASCT) lack additional treatment options.
"The promising results from the DPX-Survivac Phase I/Ib ovarian cancer studies, as well as expanding scientific literature highlighting the clinical activity of immune modulators in lymphoma, provide a strong scientific rationale for this study. There is a clear and important unmet medical need in this area of lymphoma management and we are eager to evaluate the potential of this combination therapy to deliver clinical benefit to those patients," said Neil Berinstein, M.D., Professor, Department of Medicine at the University of Toronto and medical oncologist at the Odette-Sunnybrook Cancer Centre, one of the sites at which the lymphoma trial will be conducted.