Phase 1b/2a clinical trial combines Regeneron’s PD-1 inhibitor cemiplimab and Inovio’s T cell activator INO-5401 in brain cancer

PLYMOUTH MEETING, PA, USA I November 01, 2017 I Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today 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.

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.

About Glioblastoma

Glioblastoma, also known as glioblastoma multiforme (GBM), is the most common and aggressive type of brain cancer. GBM is usually found in the area of the brain which controls some of the most advanced processes, such as speech and emotions. GBM treatment is often limited by the tumor location and ability of a patient to tolerate surgery. Consequently, it is a particularly difficult cancer to treat. Worldwide there are an estimated 240,000 cases of brain and nervous system tumors per year; GBM is the most common and most lethal of these tumors.

About INO-5401

INO-5401 includes Inovio’s SynCon® antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development. WT1 was at the top of the list. The hTERT antigen relates to 85 percent of cancers, and WT1 and PSMA antigens are also widely prevalent in many cancers.

About Inovio Pharmaceuticals, Inc.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio Corporation, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit

SOURCE: Inovio Pharmaceuticals