On October 22, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that new data from the company’s recently completed Phase 1b study with INO-5150 demonstrated a slowing of Prostate-Specific Antigen Doubling Time (PSADT) in men with prostate cancer (Press release, Inovio, OCT 22, 2018, View Source;PSA-Doubling-Time-Improvements-in-Prostate-Cancer-Patients-Treated-with-INO-5150/default.aspx [SID1234530272]). Eighty six percent (86%) of patients remained progression-free at Week 72 of the study. These data were presented in a poster entitled "Synthetic DNA immunotherapy in Biochemically Relapsed Prostate Cancer" at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 congress in Munich today.

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In this study, Inovio evaluated the tolerability and immunogenicity of INO-5150, a DNA vaccine encoding PSA and PSMA, with or without INO-9012 (encoding IL-12 immune adjuvant), in men with biochemically relapsed prostate cancer. The study demonstrated a slowing of PSA doubling time, a measure of disease progression, in a majority of patients on the study. In addition, 86% of patients were progression-free at Week 72 of the study, which in this treatment-refractory, high-risk patient population, is thought to be clinically promising. Importantly, analyses demonstrated that immunogenicity was observed in 77% (47/61) of patients by multiple immunologic assessments.

Previous results from the Phase 1b study were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and demonstrated that of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Results presented at ASCO (Free ASCO Whitepaper) provided clinical data through week 72 and immunology data through week 27. The latest results being presented at ESMO (Free ESMO Whitepaper) update these data and report that 80% of evaluable patients in the trial demonstrated either INO-5150 specific T cell or antibody reactivity.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "The follow-up data and opportunity to showcase INO-5150 from our Phase 1 prostate cancer study further helps Inovio’s efforts to enter into a strategic development partnership to expand into a Phase 2 study. These follow-up results support the rationale for further development and provides the basis for a novel checkpoint combination cancer trial."

This patented approach of INO-5150 in combination with CELLECTRA delivery device is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. Moreover, PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

About Prostate Cancer and Biochemically Recurrent Prostate Cancer (BRPC)

Prostate cancer is the second most frequently diagnosed cancer in men. Nearly three-quarters of the registered cases occur in developed countries. Accounting for nearly 300,000 deaths each year, prostate cancer is the sixth leading cause of death from cancer in men. There are about 60,000 patients each year in the US that develop biochemically recurrent prostate cancer (BRPC). The development of a new treatment for prostate cancer would be a significant medical advance given that current standard-of-care treatment options (surgery, radiation and hormone deprivation), while somewhat effective, all carry deleterious side effects and are often not a long-term cure.