On January 29, 2020 Geneos Therapeutics reported that its personalized neoantigen-targeting vaccine, GNOS-PV02 (based on its proprietary GT-EPIC platform), will be evaluated in a clinical trial for patients with advanced Hepatocellular Carcinoma (HCC) (Press release, Geneos Therapeutics, JAN 29, 2020, View Source [SID1234553675]). GNOS-PV02 is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations (neoantigens) identified by sequencing each patient’s tumors. In the trial, GNOS-PV02 will be combined with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).
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This innovative trial is an open-label, non-randomized, exploratory study designed to assess the safety, immunogenicity, and antitumor activity of the combination treatment in advanced HCC patients who have progressed on or are intolerant to first-line treatment with a Tyrosine Kinase Inhibitor (TKI). The primary study goals are to evaluate safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.
Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. The two DNA based products, GNOS-PV02 and INO-9012, will be administered to cancer patients via intradermal (ID) administration using the CELLECTRA 2000 ID device.
Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics, said "We are excited about this first clinical trial for the Geneos GT-EPIC neoantigen-targeting platform. This trial will seek to demonstrate that Geneos can produce personalized neoantigen-targeting immunotherapies in a clinically meaningful time frame, which drive strong T cell responses (both CD4+ and CD8+) and that these immunotherapies can enhance the efficacy of a PD-1 inhibitor alone. Enabled by our industry leading rapid biopsy to treatment turnaround time and the unique design of this study, the Geneos personalized therapy will be initiated at the same time the patient receives the first dose of the PD-1 inhibitor – we believe this is a critical success factor for neoantigen-based combination trials."
Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes. However, every patient’s tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical. I’m excited about this clinical trial utilizing Geneos’ innovative personalized treatment approach in combination with an approved immunotherapy for the treatment of advanced HCC. HCC is one of the fastest growing cancers in the U.S., and a significant unmet need exists to find more efficacious treatments."
HCC accounts for the majority of primary liver cancers. Globally, liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of annual incidence. The rate of death from liver cancer in the U.S. has increased 43% from 2000 to 2016 and with a 5-year survival rate of 18% for advanced liver cancer, it is the second most deadly tumor behind pancreatic. To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second line treatments following a tyrosine kinase inhibitor.