First In Human Clinical Trial For DMAb Against Zika Approved By FDA
The Wistar Institute, together with Penn Medicine & Inovio Pharmaceuticals Inc., announced that FDA has approved their initiation of a first-in-human clinical trial for investigating the safety and tolerability of a novel synthetic DNA-encoded monoclonal antibody (DMAb) therapeutic technology to prevent Zika virus infection. The research is being led by David B. Weiner, Ph.D. executive vice president – director of the Vaccine Center, and W.W. Smith, Charitable Trust Professor in Cancer Research at Wistar.
DMAb curative technology is different from all other known conventional therapeutic antibodies as DMAbs are made inside people and are not manufactured outside. Under the process, patients are administered with DNA instructions to equip their bodies with the essential tools to produce their own highly specific antibodies against pathogenic targets such as bacteria, virus-infected cells along with cancer cells.
The Wistar Institute received funding by the Bill & Melinda Gates Foundation in 2016 for enhancing their DMAb technology from prototype into a clinical candidate. In just 2 years of time, phase 1 clinical trial for Zika DMAbs is now rolled out and is seeking participants. The trial is a single center, open-label & dose escalation that will enroll up to 24 healthy volunteers who
will receive up to four doses of Inovio vaccine/product INO-A002. Pablo Tebas, M.D., Professor of Medicine at the Hospital of the University of Pennsylvania will be heading the trial.The traditional monoclonal antibodies market for various diseases is approx $100 billion, representing a huge chunk of the pharma market. dMab is considered to be a disruptive entrant in the market owing to its synthetic design and in-patient production. It will prove to play a pivot role in fighting global infectious disease threats and for addressing critical vaccine limitations.
About Inovio Pharmaceuticals, Inc.
Inovio is a biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio’s proprietary platform technology applies next-generation antigen sequencing and DNA delivery to activate potent immune responses to targeted diseases. The technology functions exclusively in vivo and has been demonstrated to consistently activate robust and fully functional T cell and antibody responses against targeted cancers and pathogens. Inovio is the only immunotherapy company that has reported generating T cells whose killing capacity correlates with relevant clinical outcomes. Inovio’s most advanced clinical program, VGX-3100, is in Phase 3 for the treatment of HPV-related cervical pre-cancer. Also, in development are Phase 2 immuno-oncology programs targeting head and neck cancer, bladder cancer, and glioblastoma, as well as platform development programs for hepatitis B, Zika, Ebola, MERS, and HIV. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Bill & Melinda Gates Foundation, The Wistar Institute, University of Pennsylvania, Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.
Press Release: Inovio’s DNA-Encoded Monoclonal Antibody (dMAb™) Platform Leaps Forward with First-in-Human Trial
