Inovio Pharmaceuticals has completed enrolment in a Phase I/II clinical trial of a INO-5401 combination to treat patients with newly diagnosed glioblastoma (GBM).
The trial involves a combination of INO-5401, INO-9012 and cemiplimab-rwlc (Libtayo or REGN2810).
INO-5401 is a T cell activating immunotherapy designed to encode various antigens expressed by GBM, while INO-9012 is an immune activator encoding IL-12.
Cemiplimab-rwlc is a PD-1 inhibitor co-developed by Regeneron Pharmaceuticals and Sanofi.
The open-label, multi-centre Phase I/II trial will assess the safety, immunogenicity and preliminary efficacy of the combination in 52 participants.
INO-5401 and INO-9012 will be administered intramuscularly after electroporation (EP) in combination with cemiplimab and chemoradiation and radiation.
The primary outcome measure of the trial is the proportion of subjects with adverse events, while secondary outcomes include overall survival and a change in antigen-specific humoral response from baseline.
Interim data is expected to be available by the end of this year, and the trial is set to be completed in January 2021.
Inovio Pharmaceuticals president and CEO Joseph Kim said: “This is an important step for Inovio's cancer combination strategy using our T cell-generating therapies in combination with PD-1/PD-L1 inhibitors for GBM and for multiple other cancers to improve overall efficacy of immunotherapy.
“In this GBM trial, our goal is to increase the overall survival of patients facing a disease where neither the standard of care, nor clinical outcomes have changed in a clinically significant way in more than a decade.”
Glioblastoma is an aggressive form of brain cancer. Patients on standard of care are said to have a median overall survival of approximately 15 months, with the average five-year survival rate being less than 5%.