Trial to Test Efficacy in Diffuse Large B cell Lymphoma Patients with Measurable Disease
Immunovaccine Inc. (“Immunovaccine” or “IMV”) (TSX: IMV), 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.
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% of cases are non-Hodgkin lymphoma
(NHL) and about 40% 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 (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.
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% reduction in
tumor size, demonstrating a durable clinical benefit associated with the
DPX-Survivac therapy.
About DPX-Survivac
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.
About DepoVax™
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.
About Immunovaccine
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 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 (RSV), anthrax and
Ebola virus.
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