The Wistar Institute, Penn Medicine and Inovio Pharmaceuticals have announced the receipt of FDA approval for commencement of a first-in-human clinical trial to probe the safety and tolerability of a new synthetic DNA-encoded monoclonal antibody (DMAb) therapy to prevent Zika virus infection.
In DMAb therapeutic technology, the DMAbs are made inside of people rather than at manufacturing plants as in case of other therapeutic antibodies.
Patients are given the DNA instructions so that their bodies are equipped with the required tools to generate particular antibodies to combat pathogenic targets such as bacteria, virus-infected cells, and cancer cells.
The research and development of DMAb technology is led by David Weiner, executive vice president and director of the Vaccine Center and professor of cancer research at the W.W. Smith Charitable Trust at Wistar.
Weiner said: “DMAb technology is changing the clinical story as we know it. 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.
“This approach represents the potential for major advancement over traditional monoclonal antibody approaches and may broaden therapeutic strategies opening new patient markets to the benefits of antibody-based therapies for disease prevention or treatment.”
The Bill & Melinda Gates Foundation granted funding to The Wistar Institute in 2016 to push DMAb technology from prototype into a clinical candidate for prevention of an emerging infectious disease.
In a span of around two years, a Phase I clinical trial for Zika DMAbs is enrolling patients.
The study will be led by Pablo Tebas, a professor for infectious diseases at University of Pennsylvania’s Perelman School of Medicine.
This is a single centre, open-label, dose escalation trial that will enrol up to 24 healthy volunteers.
Participants will receive up to four doses of inovio vaccine / product INO-A002.
Tebas said: “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.”
Inovio Pharmaceuticals president and CEO Joseph Kim said: “While this trial targets Zika virus infection, we will gain important data from this study towards development of a broad range of our DMAb programs targeting infectious diseases, cancer, inflammation, as well as cardiovascular disease.
“Our collective goal is to develop this new and unique approach to monoclonal antibody technology that would allow for a new pipeline of high-impact DMAb products, which can be developed with corporate partnerships, external funding and collaborations.”