PLYMOUTH MEETING, Pa., August 16, 2018 – Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has dosed its first patient in a Phase 1/2a study designed to evaluate the safety, immunogenicity and clinical efficacy of INO-5401, Inovio’s novel cancer immunotherapy that encodes multiple cancer antigens, plus INO-9012, a T cell activator, in combination with atezolizumab, (F. Hoffman-La Roche Ltd.) a PD-L1 inhibitor, for the treatment of advanced or metastatic bladder cancer. The trial, which is being managed by Inovio, is expected to enroll approximately 85 patients at sites located in the United States and Spain.

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Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, “We are very encouraged to dose our first patient with the aspiration that we can demonstrate the immense potential of our INO-5401 immunotherapy to treat advanced bladder patients as well as those with other cancers. This also marks the second time in less than a month that Inovio has dosed a cancer patient, combining INO-5401, our T cell-generating immunotherapy with a checkpoint inhibitor. Bladder cancer is considered an immunogenic tumor and our approach is to combine INO-5401/INO-9012 with atezolizumab as we believe this may provide a synergistic therapeutic effect by generating functional and activated T cells while simultaneously inhibiting PD-L1. We remain on track and look forward to producing interim clinical results in 2019.”

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This open-label, multi-center Phase 1/2a study plans to enroll 85 patients divided into two cohorts. Cohort A includes patients with confirmed disease progression during or following prior checkpoint inhibitor therapy, while Cohort B patients are treatment naïve and unfit for cisplatin-based therapy. Primary endpoints are incidence of AEs, antigen-specific immunologic activation and objective response rate (ORR) in Cohort A. Secondary endpoints are Cohort B’s ORR, duration of response, progression free survival and overall survival.

About Advanced Bladder Cancer

The prognosis for patients with advanced unresectable or metastatic bladder cancer is poor, with limited treatment options. It is a disease that has seen no major advances for more than 30 years until the approvals of checkpoint inhibitors. Expected survival is generally less than 12 months; in the U.S., five-year survival of patients with distant metastasis is 5%. In the U.S., an estimated 81,190 new cases of bladder cancer are expected in 2018.
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About INO-5401INO-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.

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About Inovio Pharmaceuticals, Inc.

Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialisation of DNA immunotherapies that transform the treatment of cancer and infectious diseases. The Inovio technology platform is designed to activate an individual’s immune system to generate a robust, targeted T cell and antibody response against targeted diseases. Inovio is the only immunotherapy company that has reported generating T cells entirely in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical precancer.

For more information, please visit www.inovio.com