Phase 1 Study Will Target Zika Vaccine Candidate With DNA-Encoded Monoclonal Antibody
The Food and Drug Administration (FDA) has approved the initiation of a first-in-human phase 1 clinical trial investigating the safety and tolerability of a novel synthetic DNA-encoded monoclonal antibody (dMAb) therapeutic technology, for the prevention of Zika virus infection.
This is important news since the Zika virus remains a health risk in over 90 countries around the world.
Moreover, nearly 1 in 7 babies born to women infected with the Zika virus while pregnant had one or more health problems, possibly caused by the virus, reported a recent study.
This dMAb therapeutic technology is unlike conventional therapeutic antibodies in that dMAbs are made inside of people, not manufacturing plants, said Inovio Pharmaceuticals, Inc., in a press release.
Inovio’s dMAb technology was issued 2 U.S. Patents during October 2018.
This Phase 1 dose-escalation study of INO-A002, instructs the body's cells to become the factory which manufactures the therapeutic antibody products, enabling a major leap in antibody technology.
The human clinical study will be led by Pablo Tebas, M.D., professor of infectious diseases at the Perelman School of Medicine at the University of Pennsylvania. It is a single center, open-label, dose escalation trial that will enroll up to 24 healthy volunteers who will receive up to four doses of Inovio vaccine/product INO-A002.
“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,” said J. Joseph Kim, Ph.D., president and CEO, Inovio Pharmaceuticals, Inc.
“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. While there are still questions to be answered, this could be useful not only for Zika but for other emerging infections as well,” said Dr. Tebas.
To alert Americans of the risk of the Zika virus, the Centers for Disease Control and Prevention (CDC) updated Alert Level 2 notices during August 2018.
These CDC travel alerts include countries in Africa, Asia, the Caribbean, Central America, Mexico, the Pacific Islands, and South America.
Because a Zika infection during pregnancy can cause birth defects, pregnant women should not travel to these countries, says the CDC.
In 2016, The Bill & Melinda Gates Foundation awarded funding to move dMAb technology from prototype into a clinical candidate for eradicating an emerging infectious disease.
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