Clearance Paves Way for First DPX-Survivac Phase II Efficacy Trial
Health Canada Clears Immunovaccine to Conduct Phase II Clinical Trial of DPX-Survivac in Recurrent Lymphoma
Halifax, Nova Scotia; November 19, 2014 – Immunovaccine Inc. ("Immunovaccine" or "IMV") (TSX-V: IMV), a clinical stage vaccine and immunotherapy company, today announced that it has received clearance from Health Canada to conduct a Phase II clinical study of DPX-Survivac in patients with diffuse large B cell lymphoma (DLBCL). The Company-sponsored trial will evaluate DPX-Survivac, Immunovaccine's lead cancer vaccine candidate, in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL.
The study will be the first Phase II clinical trial specifically designed to evaluate the efficacy of DPX-Survivac. The open label trial will enroll up to 24 patients with recurrent survivin-expressing DLBCL with measurable disease. This will allow investigators to evaluate the clinical effect of DPX-Survivac in combination with oral cyclophosphamide and determine the clinical response rate in patients receiving the DPX-Survivac therapy. Investigators will also monitor immune responses and changes in tumor biopsies from these patients.
In previous DPX-Survivac studies conducted in ovarian cancer patients, robust and durable CD8 T cell responses were observed in almost all patients receiving a specified regimen of the vaccine. The vast majority of ovarian cancer patients enrolled in these studies were in remission with no evidence of disease. However one patient with stable but measurable disease achieved a 43% reduction in tumor size, demonstrating for the first time a durable clinical benefit with the DPX-Survivac therapy. The decision to test DPX-Survivac with cyclophosphamide in patients with DLBCL is supported by a growing body of research that shows clinical activity for immune modulatory agents such as metronomic cyclophosphamide in DLCBL.
"This study represents a significant milestone for Immunovaccine as it marks the first Phase II clinical trial intended to evaluate the therapeutic impact of DPX-Survivac in lymphoma, an indication with significant unmet medical need," Dr. Marc Mansour, chief executive officer of Immunovaccine.
The first patient is expected to be enrolled at the Odette-Sunnybrook Cancer Centre in Toronto in early 2015 Immunovaccine expects to have multiple clinical trial sites in Canada to ensure the efficient conduct of this trial. Immunovaccine expects that initial data from this study will be available in the second half of 2015. Positive trial results could provide rationale for the initiation of a pivotal trial in recurrent DLBCL.
Lymphoma is the most common form of blood cancer in the developed world. In 2013, according to the Leukemia and Lymphoma Society, there were more than 700,000 people living with lymphoma or in remission from the disease. About 90% of cases are non-Hodgkin lymphoma (NHL) and about 40% of NHL cases are diagnosed as DLBCL. Initial treatment of lymphoma often involves combination therapy including various chemotherapeutic agents with or without radiation therapy and supplemental drug therapy. In cases of relapse, the preferred treatment for patients with lymphoma is an autologous stem cell transplant (ASCT). The DPX-Survivac therapy will be applied to patients who are not transplant candidates or who experience recurrence following a stem cell transplant and lack additional treatment options.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in solid tumors and blood cancers including ovarian, breast, colon and lung cancers, among others. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in high percentage of cancer patients.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively search for tumor cells expressing survivin and destroy them.
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability.
Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on the Company's DepoVax™ platform, a patented formulation that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase I human clinical trials. Lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase II clinical studies in both ovarian cancer and glioblastoma (brain cancer), with Immunovaccine also exploring additional studies in other indications including lymphoma and recurrent ovarian cancer. The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV), anthrax and Ebola virus.
Connect at www.imvaccine.com