On August 16, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported 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 (Press release, Inovio, AUG 16, 2018, View Source;for-Advanced-or-Metastatic-Bladder-Cancer-in-Combination–with-RocheGenentechs-Atezolizumab/default.aspx [SID1234528951]). 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."
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. Exploratory endpoints are correlation of biomarkers to anti-tumor activity. A safety run-in will be performed for the first six patients enrolled in Cohort A to monitor emergence of any dose limiting toxicities. INO-5401 and INO-9012 (10 mg DNA combined in 1ml) will be administered by intramuscular injection followed by electroporation every 3 weeks for first 4 doses, every 6 weeks for 6 doses and every 12 weeks until disease progression. Atezolizumab (1200 mg IV) will be administered every 3 weeks until disease progression. Tumor imaging, disease assessment (per RECIST and iRECIST) and biopsies, blood and urine samples will be collected at set time points including prior to study treatment, on treatment and at disease progression (see www.clinicaltrials.gov, identifier NCT03502785).
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.
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.