PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) has announced notable interim findings from a Phase 1 clinical trial testing DNA-encoded monoclonal antibodies (DMAbs) for COVID-19. Impressively, 100% of participants who reached 72 weeks maintained biologically relevant antibody levels, demonstrating the technology’s potential for durable in vivo antibody production. The trial also reported no cases of anti-drug antibodies (ADA), a challenge with other gene-based platforms, such as adeno-associated virus (AAV) vectors.
The trial, led by The Wistar Institute in collaboration with INOVIO, AstraZeneca, and the University of Pennsylvania, represents a first-of-its-kind clinical validation of DNA-encoded antibody technology. DMAbs showed favorable tolerability, with mild injection site reactions being the most common side effect.
“This study provides the first clinical proof-of-concept that DNA-encoded monoclonal antibodies can be durably and tolerably expressed in humans,” said Dr. David B. Weiner, Executive Vice President of The Wistar Institute. “These findings could represent a breakthrough, demonstrating DMAb technology’s potential to address challenges like short half-life and ADA responses, spearheading new solutions for infectious diseases, cancer, and metabolic disorders.”
Traditional monoclonal antibody production faces seasonality and distribution constraints. By contrast, INOVIO’s DMAb technology enables muscle cells to produce antibodies directly after injection of a synthetic DNA plasmid. The platform’s seamless delivery method allows prolonged therapeutic effects without provoking the immune system against the drug.
Dr. Pablo Tebas, a professor of Infectious Diseases at the University of Pennsylvania, emphasized the significance of the DNA approach. “Sustained antibody expression without generating ADA is a crucial development. This method offers a promising long-term solution for conditions requiring continuous therapeutic protein delivery.”
The trial utilized INOVIO’s CELLECTRA 2000 electroporation device, temporarily increasing muscle cell permeability to facilitate efficient DNA uptake. The open-label study began in May 2022 and completed enrollment in March 2024.
INOVIO Chief Scientific Officer Laurent Humeau also underscored the broader implications of the findings. “These data demonstrate the potential of DNA Medicines technology to deliver long-term therapeutic proteins for diseases caused by missing or defective proteins. We’re committed to advancing this technology alongside our partners to expand research and applications in the future.”
The trial, supported by funding from the CARES Act and DARPA, strengthens the promise of DMAbs as a transformational solution for antibody therapies not only in combating infectious diseases like COVID-19 but also in tackling broader therapeutic challenges. Collaboration efforts will continue as INOVIO and its partners finalize the study and prepare for broader applications of this groundbreaking technology.
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