On April 1, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM) has completed its enrollment three months ahead of schedule (Press release, Inovio, APR 1, 2019, View Source [SID1234534818]). The 52-patient trial is designed to evaluate Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens expressed by GBM and INO-9012, an immune activator encoding IL-12, in combination with cemiplimab-rwlc (also known as Libtayo or REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals in collaboration with Sanofi. This trial information will be presented today at Phase I-III Trials in Progress session at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held in Atlanta.
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Inovio expects to report interim results from this study before the end of this year evaluating safety, immunological impact, progression-free survival and overall survival (see www.clinicaltrials.gov, identifier NCT03491683).
Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "We sincerely thank the patients and their doctors for participating in our innovative combination trial. 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. We have previously shown in a Phase 1 head and neck cancer clinical study, combining Inovio’s T cell-generating immunotherapy MEDI0457 along with checkpoint inhibitors have resulted in two complete responders who remain cancer free for over two years. 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."
Inovio holds clinical partnerships with AstraZeneca for MEDI0457 (in HPV-related cancers) and collaborations with Roche/Genentech and Regeneron for INO-5401 (in bladder cancer and GBM), each providing for clinical evaluation of Inovio immunotherapies combined with checkpoint inhibitors. In particular, the INO-5401 collaborations are based on a strong scientific rationale to combine two immunotherapies: INO-5401, which generates antigen-specific killer T cells, and a checkpoint inhibitor, which augments T cell activity.
About Glioblastoma
Glioblastoma (GBM) is the most common and aggressive type of brain cancer and remains a devastating disease for both patients and caregivers. 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 five percent.
About INO-5401
INO-5401 includes Inovio’s SynCon antigens for hTERT, WT1, and PSMA, and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted hTERT, WT1, and PSMA among a list of important cancer antigens, designating them as high priorities for cancer immunotherapy development. These three antigens are known to be over-expressed, and often mutated, in a variety of human cancers, and targeting these antigens may prove efficacious in the treatment of patients with cancer.