INOVIO Announces Promising Interim Results from Ongoing Proof-of-Concept Clinical Trial of DNA-Encoded Monoclonal Antibodies (DMAbs) for COVID-19

Core Insights - INOVIO announced promising interim results from a Phase 1 trial evaluating DNA-encoded monoclonal antibodies (DMAbs) for COVID-19, with 100% of participants maintaining biologically relevant levels of DMAbs at week 72 [1][4] - The trial demonstrated no development of anti-drug antibodies (ADA), a significant advantage over traditional gene-based delivery platforms [1][4] - The DMAbs were well tolerated, with mild, temporary injection site reactions being the most common side effects [1][4] Company Overview - INOVIO is a biotechnology company focused on developing DNA medicines to treat HPV-related diseases, cancer, and infectious diseases [7] - The company utilizes a proprietary DNA medicines platform that includes precisely designed DNA plasmids and the CELLECTRA® delivery device [6][7] Trial Details - The Phase 1 trial is the first clinical study using synthetic DNA technology for in vivo production of monoclonal antibodies directly from muscle cells [3] - Participants received intramuscular injections of synthetic DNA plasmids delivered via INOVIO's CELLECTRA 2000 electroporation device [3] - The trial is an open-label, single center, dose-escalation study that began enrollment in May 2022 and completed in March 2024 [4][5] Results Summary - All participants (n=24) who reached week 72 maintained stable DMAb levels [4] - No ADA formation was detected across approximately 1,000 blood samples, indicating a successful immune response [4] - The expressed DMAbs effectively bound to the SARS-CoV-2 Spike protein receptor-binding domain, confirming functional activity [4] Future Directions - A manuscript detailing the interim results has been uploaded for early dissemination and is under peer review for publication [2] - The consortium plans to present these interim results at scientific conferences in 2025 [2]