Date: 2016-04-27
Type of information: Initiation of development program
phase: 1
Announcement: initiation of a development program
Company: Inovio Pharmaceuticals (USA - PA)
Product: INO-8000
Action
mechanism: plasmid/DNA vaccine/immunotherapy product. Inovio's SynCon® DNA immunotherapy, INO-8000, is encoded for the antigens NS3/4A, NS4B, and NS5A of HCV genotypes 1a and 1b. The product is designed to induce robust T cells to eliminate cells displaying these antigens and has been shown in published preclinical studies to generate powerful HCV-specific T cell responses throughout the body and in the liver.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: USA
Trial
details: This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill cancer cells that express HCV infection. (NCT02822079)
Latest
news: * On April 27, 2016, Inovio Pharmaceuticals announced its immunotherapy for hepatitis C (INO-8000) will be evaluated in a phase I trial in chronically infected patients who are not receiving other hepatitis C virus (HCV) treatments. The study will enroll patients who are in the early stages of chronic HCV infection to determine the therapy’s ability to decrease and potentially eliminate HCV viral load, measure HCV specific immune responses and durability of these immune responses, and evaluate safety and tolerability. In this dose-escalation study INO-8000 will be combined with increasing doses of DNA-based IL-12 (INO-9012), an immune activator, which in previous studies has been shown to increase the therapeutic immune response to DNA immunotherapies. The study is funded by the National Cancer Institute’s Division of Cancer Prevention and will be conducted at the Mayo Clinic and other U.S. sites. Inovio previously announced that it signed a collaborative agreement with GeneOne Life Sciences to develop INO-8000, along with a DNA IL-28 immune activator, in drug-resistant HCV patients in a phase I study in Korea. That study is on-going.
