INOVIO’s DNA-encoded monoclonal antibodies (dMAbs) have been able to maintain biologically relevant levels in 100% of Covid-19 in a Phase I proof-of-concept trial.
Out of the 24 healthy volunteers recruited onto the open-label trial (NCT05293249) that made it to week 72, all still had biologically relevant levels of dMAb antibodies in their systems.
Go deeper with GlobalData
Volunteers were dosed with synthetic DNA plasmids encoding AZD5396 and AZD8076, derived from AstraZeneca’s cilgavimab and tixagevimab, delivered by INOVIO’s proprietary CELLECTRA 2000 electroporation (EP) device. Additionally, the trial found that no patient developed anti-drug antibodies (ADA).
Researchers sought to develop in vivo expressed dMAbs that are able to successfully bond to the SARS-CoV-2 Spike protein receptor-binding domain (RBD).
The dose escalation trial initially recruited 61 volunteers at a single site in the company’s home state of Pennsylvania. Primary endpoints sought to determine the number of participants detected with monoclonal antibody dMAbs as well as endpoints tracking resulting pain and adverse events (AE).
Laurent Humeau, chief scientific officer at INOVIO, said: “We believe this data highlights the potential to apply our DNA medicines technology to deliver a broad spectrum of therapeutic proteins that could be used to treat diseases with missing or defective proteins.”
The trial is currently run as a collaboration between INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania.
An extract from an early non-peer reviewed article on the ongoing trial argued that dMAbs may represent a valuable strategy against a wide range of diseases which can be targeted with mAbs and their derivatives. Currently dMAbs are used as a potential therapy against a wide range of notable infectious diseases ranging from its use in malaria and zika virus.
Executive vice president of The Wistar Institute and lead investigator for the study, Dr. David Weiner said: “These findings could represent a breakthrough as they demonstrate the potential of DMAb technology to overcome traditional monoclonal antibody production challenges, such as short half-life and anti-drug immune responses, making it a promising platform for a broad range of diseases. This technology has the potential to transform treatments for infectious diseases, as well as cancer and metabolic disorders by enabling long-term expression of therapeutic antibodies and other proteins.”
In terms of market competition, the other marketed monoclonal antibody treatment for Covid-19, AstraZeneca’s Kabigail (sipavibart) is set to bring in $38m by the end of 2025 according to GlobalData’s Pharmaceutical Intelligence Centre. That figure is predicted to rise to $321m by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the field of monoclonal antibody therapies, Biogen has begun dosing in the Phase III TRANSCEND trial to assess felzartamab in adult kidney transplant recipients.
