The development of antibodies administered by DNA to prevent COVID-19
A program funded by the United States Defense Advanced Research Projects Agency (DARPA) and the United States Joint Program Executive Office for Chemical
A program funded by the United States Defense Advanced Research Projects Agency (DARPA) and the United States Joint Program Executive Office for Chemical, Biological, Radio logical and Nuclear Defense (JPEO-CBRND, for its acronym in English) will begin clinical trials of a novel method of administering antibodies against COVID-19.
This team, in which researchers from the Wistar Institute, the University of Pennsylvania, AstraZeneca, INOVIO Pharmaceuticals, Boston Medical Center and the University of Indiana have participated, has received 37.6 million dollars to finance the rapid preclinical development of SARs-CoV-2 monoclonal antibodies encoded in DNA (DMAbs) to prevent COVID-19.
DMAbs use a person's own cells as a factory to make protective antibodies, simplifying the development and production process for biologics, potentially expanding the use of these novel drugs to the global community.
The first dose of this new research agent was produced in a clinical trial led by Spaniard Pablo Tebas, Professor of Infectious Diseases at the Perelman School of Medicine at the University of Pennsylvania (United States).
The clinical trial will assess the overall safety and tolerability of this novel approach that enables the body to produce multiple full-length monoclonal antibodies using advanced DNA technology in people.
"This development is the culmination of numerous steps taken in collaboration with our DARPA/JPEO leadership team and consortium members who are driving this product forward at this important time. We look forward to seeing the initial outcome of this first clinical trial in that studies this new concept", says David Weiner, one of the leaders of the work.
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In addition to evaluating safety and tolerability, they will also seek information on expression and biological activity in our trial subjects and whether they can be shown to influence viral infection.
"Despite all the progress made in the treatments and management of COVID-19, this disease continues to kill three times more Americans than the flu. We need better methods to prevent complications of this disease, especially in immunocompromised patients. Our This study will test a new way of administering antibodies against COVID-19 that has been shown to reduce hospitalizations and deaths from this terrible disease," Tebas said.
"The dosing of the first patient with a DMAb candidate against COVID-19 is the culmination of hard public-private collaboration. This trial offers an important opportunity to evaluate an innovative technology that could potentially transform the way antibodies are delivered and protect against serious infections," added AstraZeneca Vice President of Early Vaccines and Immune Therapies, Mark Esser.
The novel approach uses the genetic blueprints of antibodies encoded on DNA plasmids. Once introduced into the arm, the DMAbs instruct the body to assemble functional antibodies and secrete them into the blood as fully formed specific monoclonal antibodies against pathogens such as the SARS-CoV-2 virus. This approach avoids the need for immunization to generate protective immunity.
Studies conducted to date have successfully demonstrated protection against SARS-CoV-2 in both laboratory studies and animal models, with DMAbs showing the potential for both prevention and treatment of infection.
In theory, this approach to nucleic acid medicine has potential advantages over traditional monoclonal antibody treatment methods in terms of cost, specificity, production, storage, and delivery.
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