Regeneron Pharmaceuticals has entered a clinical study agreement with Inovio Pharmaceuticals to conduct its Phase Ib/IIa clinical trial of REGN2810 in combination with INO-5401 and INO-9012 to treat patients with newly diagnosed glioblastoma multiforme (GBM).
REGN2810 is a PD-1 inhibitor, while Inovio's INO-9012 is an immune activator that encodes IL-12 and INO-5401 is a T-cell activating immunotherapy that encodes various antigens.
Set to be commenced in the coming months, the open-label Phase Ib/IIa trial will assess the safety and efficacy of the combination in up to 50 subjects at 30 US clinical centres.
Regeneron translation sciences and oncology vice-president Israel Lowy said: "Regeneron's approach to oncology includes evaluating the combination of innovative therapies that act on diverse pathways and targets.
"Using our PD-1 inhibitor as a therapeutic backbone alongside Inovio's T-cell-generating therapies offers a new path for exploration and heightens the potential to develop new, desperately needed treatment options for patients."
The primary endpoints of the trial are safety and tolerability, while the immunological impact, progression-free survival and overall survival will also be examined during the treatment period.
Inovio president and chief executive officer Joseph Kim said: "This step with INO-5401 is very important for us in 2017, as we believe INO-5401 has the potential to be a powerful cancer immunotherapeutic in combination with promising checkpoint inhibitors such as Regeneron's REGN2810, and we look forward to investigating its potential for GBM and multiple other challenging cancers."
Under the clinical study agreement, Inovio will conduct and fund the trial with mutually agreed design, while Regeneron will supply REGN2810, which is currently being developed in partnership with Sanofi.
Regeneron and Inovio will jointly perform the immunological analyses related to the trial.