On November 1, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported initiated a phase 1b/2a immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) designed to evaluate cemiplimab (also known as REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), in combination with Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens and INO-9012, an immune activator encoding IL-12 (Press release, Inovio, NOV 1, 2017, View Source [SID1234521388]).
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The open-label trial of 50 patients will be conducted at approximately 30 U.S. sites, and the primary endpoints are safety and tolerability. The study will also evaluate immunological impact, progression-free survival and overall survival.
GBM is a devastating disease for both patients and caregivers. It is the most aggressive brain cancer and its prognosis is extremely poor, despite a limited number of new therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months and the average five-year survival rate is less than three percent.
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “Inovio is successfully executing on its immuno-oncology strategy through both combination and in monotherapy trials. Our clinical partnerships and collaborations with MedImmune, Genentech and Regeneron each provide for clinical evaluation of Inovio immunotherapies combined with checkpoint inhibitors, given a strong scientific rationale to combine an immunotherapy, which generates antigen-specific killer T cells, with a checkpoint inhibitor which augments T cell activity. I believe that INO-5401, a three antigen product targeting WT-1, PSMA and hTERT, offers great potential to address multiple cancers. Our INO-5401 combination study in GBM, as well as its sister study in advanced bladder cancer, represents an important opportunity for Inovio and its collaborators to address significant unmet medical need.”
Under a May 2017 agreement between Inovio and Regeneron, the combination trial will be solely conducted and funded by Inovio, based upon a mutually agreed upon trial design, and Regeneron will supply cemiplimab. Inovio and Regeneron will jointly conduct immunological analyses in support of the study. Regeneron, as part of their immuno-oncology collaboration with Sanofi, is developing cemiplimab both as a monotherapy and in combination with other therapies for the treatment of various cancers.