Canadian-based immuno-oncology company Immunovaccine is set to evaluate its DPX-Survivac in combination with a PD-1 checkpoint inhibitor and a low-dose cyclophosphamide in its Phase II clinical trial to treat measurable or recurrent diffuse large B-cell lymphoma (DLBCL).
Developed based on the firm’s DepoVax delivery platform, DPX-Survivac contains survivin-based peptide antigens and is designed to induce a cytotoxic T-cell immune response.
Expected to recruit 25 subjects at five clinical sites in the country, the investigator-sponsored, non-randomised, open-label Phase II trial will assess the efficacy and safety of the combination in patients with survivin-expressing DLBCL.
Patient enrolment in the trial is expected to start after securing regulatory clearance from Health Canada.
Immunovaccine chief executive officer Frederic Ors said: “While immunotherapies, such as checkpoint inhibitors, are rapidly changing the standard of care in many cancers, it has been reported that only about 20% of patients are able to respond to these therapies alone, leaving the vast majority of patients with a significant unmet medical need.
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“Our clinical strategy builds on our earlier research, which indicated that novel combination immunotherapies, particularly those with the ability to increase T-cell tumour infiltration may work together synergistically to increase the number of patients responding to today’s advanced treatments.”
The current trial is the third triple-combination study with DPX-Survivac plus immuno-modulating agents and low-dose cyclophosphamide.
The firm has identified more than 15 cancer indications in which DPX-Survivac can be used to target the over-expression of survivin.
DPX-Survivac also secured fast-track designation from the US Food and Drug Administration (FDA) as maintenance therapy for advanced ovarian cancer, and orphan drug designation from both the FDA and the European Medicines Agency (EMA).
Image: DPX-Survivac to enter Phase II trial for DLBCL. Photo: courtesy of David Castillo Dominici/FreeDigitalPhotos.net.