HALIFAX, Nova Scotia—Immunovaccine Inc., a clinical stage vaccine and immunotherapy company, today announced that it has treated the first patient with diffuse large B cell lymphoma (DLBCL) in a Phase 2 clinical study of its lead cancer immunotherapy DPX-Survivac. The company-sponsored trial is evaluating DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. DPX-Survivac is designed to activate killer T cells of the immune system against the survivin antigen found in a wide variety of solid tumors and blood cancers.
“We believe that combining our T cell activating therapy with immune modulating agents is important to achieve a robust clinical response. Our data to date suggest that combining DPX-Survivac with low dose cyclophosphamide has the potential to provide a clinical benefit in some cancer patients. With cyclophosphamide often used as a low toxicity therapy in recurrent/refractory lymphoma, recurrent DLBCL represents an excellent indication to demonstrate the efficacy of the DPX-Survivac/cyclophosphamide combination in this patient population with a high unmet medical need,” said Dr. Marc Mansour, chief executive officer of Immunovaccine in a prepared statement.
The open label Phase 2 study designed to evaluate the efficacy of DPX-Survivac will enroll up to 24 patients with recurrent survivin-expressing DLBCL. Investigators for the multi-site study will determine the percentage of patients with measurable disease who respond clinically to the DPX-Survivac therapy. Immune responses and changes in tumor biopsies from these patients will also be monitored. Positive results could provide rationale for the initiation of a pivotal trial of DPX-Survivac in recurrent DLBCL, which is considered an orphan drug indication. The trial is being conducted at the Ottawa Hospital Research Institute and the Odette-Sunnybrook Cancer Centre, with additional sites planned as the trial progresses.
Lymphoma is the most common form of hematologic cancer in the developed world. According to the Leukemia and Lymphoma Society, there were more than 700,000 people in 2013 living with lymphoma or in remission from the disease. About 90 percent of cases are non-Hodgkin lymphoma (NHL) and about 40 percent of NHL cases are diagnosed as DLBCL. Initial treatment of DLBCL often involves various chemotherapeutic agents, with or without radiation therapy and supplemental drug therapy. In cases of relapse, the preferred treatment for many patients with DLBCL is an autologous stem cell transplant. 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.
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. Patients with a robust immune response to DPX-Survivac showed a trend of delayed disease progression which may potentially be attributed to the therapy. The vast majority of ovarian cancer patients enrolled in these studies were in remission with no evidence of disease. However one patient with measurable and stable disease achieved a 43 percent reduction in tumor size, demonstrating a durable clinical benefit associated with the DPX-Survivac therapy.
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 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 a 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. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials. Lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase 2 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, anthrax and Ebola.