Core Insights - INOVIO announced results from a Phase 1 trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19, published in Nature Medicine, demonstrating the potential of DMAbs as a long-acting alternative to traditional monoclonal antibody delivery [1][2][4] Phase 1 Trial Summary - The trial involved 39 participants, all of whom maintained biologically relevant levels of DMAbs through a 72-week follow-up, confirming the durability of in vivo antibody production [2][4] - DMAbs successfully bound to the SARS-CoV-2 Spike protein and neutralized the SARS-CoV-2 pseudovirus in all tested participants, confirming functional activity [2][7] - No participants developed anti-drug antibodies (ADA), a common issue in other gene-based delivery platforms, and the DMAbs were well tolerated with mild, temporary injection site reactions being the most common side effects [2][4][7] Technology and Methodology - The trial utilized synthetic DNA technology to enable in vivo production of monoclonal antibodies directly from muscle cells, delivered via INOVIO's CELLECTRA 2000 electroporation device [3][5] - The study was an open-label, single-center, dose-escalation trial, with primary endpoints focused on safety and pharmacokinetics [4] Results and Observations - DMAbs were detected in 100% of evaluable participants, with serum concentrations peaking at 1.61 g/mL, and sustained expression was observed throughout the follow-up period [4][7] - The most common side effects were mild, temporary injection site reactions, and there were three serious adverse events (SAEs) reported, all deemed unrelated to the study product [4][7] Company Overview - INOVIO is a biotechnology company focused on developing and commercializing DNA medicines aimed at treating HPV-related diseases, cancer, and infectious diseases [6][8] - The company's DNA medicines platform includes precisely designed DNA plasmids and proprietary delivery devices, optimizing the design and delivery of innovative DNA medicines [5][8]