Inovio is authorized by FDA to start phase 1 / 2 clinical trial of ino-3107

Inovio pharmaceuticals, Inc today announced that the U.S Food and Drug Administration (FDA) has accepted its application for new drug research, and evaluated the efficacy of its DNA drug ino-3107 for recurrent respiratory papillomatosis (RRP) through a 1 / 2-phase trial RRP is a rare disease caused by HPV type 6 and 11 infection, which can lead to the growth of non cancerous tumors, and then form life-threatening airway obstruction, and may also develop into cancer At present, the disease can not be cured, only through surgery to remove the tumor, temporarily restore air flow unobstructed However, the tumor will recur, so repeat the operation many times a year RRP can seriously affect the quality of life of patients The open label, multicenter phase 1 / 2 trial will recruit approximately 63 patients in the United States to evaluate the efficacy, safety, tolerability, and immunogenicity of ino-3107 in patients with HPV 6 and / or 11 related RRP who require at least two surgeries per year in the past three years to remove the associated mastoid tumor In this study, adult patients will first undergo surgery to remove the papilloma, then take four doses of ino-3107, once every three weeks The primary end point was a doubling or greater frequency of surgical intervention after the first dose of ino-3107 compared to the frequency before study therapy With sufficient data on adult safety and potential efficacy, inovio plans to expand the trial to include paediatric patients and possibly enhanced vaccination In addition to initiating the efficacy trial, inovio plans to qualify orphan drugs from the U.S Food and Drug Administration's orphan Product Development Office (OOPD) The U.S Food and Drug Administration qualifies orphan drugs for drugs and biological products designed to safely and efficiently treat, diagnose or prevent rare diseases affecting less than 200000 people in the United States OOPD provides certain benefits and rewards for drug developers, including marketing exclusivity for a period of time if they finally obtain regulatory approval for accreditation Inovio recently published data on its ino-3106 (DNA candidate therapy for RRP caused by HPV 6) clinical trial study in the scientific journal "vaccines" (published by MDPI) The results show that ino-3106 can produce immunogenicity, participate in and amplify HPV6 specific cell responses, including cytotoxic T cells The article also points out that inovio's immunotherapy has greatly reduced the need for surgery for two patients who need to have surgery about twice a year in order to control their condition One patient did not have surgery for more than one and a half years (584 days), and the other patient was more than two and a half years (915 days) The novel coronavirus is funded by Inovio Currently, 15 DNA medical clinical projects are being developed, focusing on HPV related diseases, cancer and infectious diseases, including the new type of coronavirus funded by CEPI DNA drugs are composed of optimized DNA plasmids DNA plasmids are small circular double stranded DNA synthesized or recombined by computer sequencing technology Their purpose is to produce specific immune response in vivo Inovio's DNA drug uses the proprietary mobile intelligent device cellectra of inovio to directly import the optimized plasmid into the cell by intramuscular or intradermal way Cellectra uses a short electrical pulse to reversibly open a small hole in the cell, allowing the plasmid to enter Once in the cell, the plasmid begins to replicate, strengthening the body's own natural response mechanism Managing with cellectra ensures that DNA drugs enter directly into human cells, where they can act immediately and produce an immune response Inobio's DNA therapy, like gene therapy or gene editing, does not interfere with or in any way alter an individual's own DNA In more than 6000 applications in a series of clinical trials, more than 2000 patients received inovio's investigational DNA drugs, which continuously activated safe, powerful and full-featured T cell and antibody responses against targeted pathogens and cancers.