Phase 1 DNA-Encoded Monoclonal Antibody Trial for Zika Receives Approval
The FDA has approved the launch of the first in-human clinical trial evaluating the efficacy of a new synthetic DNA-encoded monoclonal antibody (DMAb) therapy to prevent Zika virus infection.
The Wistar Institute, Penn Medicine, and Inovio Pharmaceuticals have received approval from the US Food and Drug Administration (FDA) to launch the first in-human clinical trial to assess the safety and tolerability of a new synthetic DNA-encoded monoclonal antibody (DMAb) therapy to prevent Zika virus infection.
The phase 1 trial is an open-label, single-center study that will be led by Pablo Tebas, MD, a professor of medicine at the University of Pennsylvania. The trial will enroll up to 24 healthy volunteers in a dose-escalation format. The participants will each receive up to 4 doses of the candidate, INO-A002, beginning with lower doses and leading to higher ones.
Monoclonal antibodies are typically manufactured outside of the body in bioreactors but these DMAbs are made inside the human body and equip the body with the tools to develop antibodies that fight pathogens such as bacteria, viruses, and cancer cells.
“This is a completely novel technology that could change the way we deliver antibodies as therapeutic agents and may have the potential to be fast-tracked into clinical trials,” Dr. Tebas said in a statement.
According to Inovio, this technology uses novel plasmid vectors and unique formulations, which allow for rapid development, stability, and ease of manufacturing and deployment. Through this platform, the DMAbs are delivered into the cells and encoded monoclonal antibodies are produced by the locally transfected cells.
Previous in vivo preclinical studies have demonstrated that DMAb products have been protective against influenza, chikungunya, Lyme disease, and dengue in animal models.
“DMAb technology is changing the clinical story as we know it,” David Weiner, PhD, executive vice president and director of the Vaccine Center and professor of cancer research at the W.W. Smith Charitable Trust at Wistar, said in a statement. “In just the last few years we’ve conducted detailed preclinical studies developing this new platform and have demonstrated in vivo production of DMAbs using the CELLECTRA delivery system.”
Inovio has indicated that while this trial is assessing the efficacy of prevention of Zika virus infection, the investigators will be collecting valuable data that will assist in the development of other DMAb programs which are targeting infectious diseases, cancer immunotherapy, inflammation, and cardiovascular disease therapies.
Funding for the DMAb technology platform was provided to the Winstar Institute in 2016 from The Bill & Melinda Gates Foundation to help develop the technology into a promising candidate for the prevention of an emerging infectious disease.