Immunovaccine has received Health Canada clearance to conduct a Phase II clinical trial of its lead cancer vaccine candidate, DPX-Survivac, to treat patients with diffuse large B cell lymphoma (DLBCL).
The company-sponsored trial will evaluate DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL.
A total of 24 patients with recurrent survivin-expressing DLBCL with measurable disease will be enrolled in this open label Phase II trial, which will determine the clinical response rate in patients receiving the DPX-Survivac therapy.
In the trial, investigators will also monitor immune responses and changes in tumour biopsies from these patients.
The company said that in previous DPX-Survivac trials carried out in ovarian cancer patients, robust and durable CD8 T cell responses were observed in almost all patients who received a specified regimen of the vaccine.
Majority of the ovarian cancer patients enrolled in these trials were in remission with no evidence of disease, however one patient with stable but measurable disease achieved a 43% reduction in tumour size, showing a durable clinical benefit with the DPX-Survivac therapy.
Immunovaccine chief executive officer Dr Marc Mansour said: "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."
First patient in the Phase II trial will be enrolled at the Odette-Sunnybrook Cancer Centre in Toronto in early 2015.
The company expects to have multiple clinical trial sites in Canada to ensure the efficient conduct of this trial as well as report initial data in the second half of 2015.
DPX-Survivac includes survivin-based peptide antigens formulated in the DepoVax adjuvanting platform.
The National Cancer Institute (NCI) has recognised survivin as a promising tumour-associated antigen (TAA) because of its therapeutic potential and its cancer specificity.
Image: Micrograph of a diffuse large B cell lymphoma, abbreviated DLBCL. Photo: courtesy of Nephron.