Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. (Korean Stock Exchange: 011000) has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza. Inovio is co-developing VGX-3400 with Korea-based VGX International. The 30-patient three-dose Phase I study will be conducted in multiple clinical research sites in Korea. A parallel study in the U.S. is also planned for this year.
“If we achieve similar results in human studies, this universal vaccine concept has the potential to shift the current reactive paradigm of influenza vaccine design, manufacturing, and delivery. Such a shift would provide tremendous health and economic benefits worldwide”
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “Initiation of our H5N1 vaccine clinical trial marks an important milestone for our universal flu program. Inovio has been one of the first organizations to demonstrate a vaccine capable of providing protection against a broad set of unmatched influenza sub-types and strains, both seasonal and pandemic, in multiple animal models.”
“If we achieve similar results in human studies, this universal vaccine concept has the potential to shift the current reactive paradigm of influenza vaccine design, manufacturing, and delivery. Such a shift would provide tremendous health and economic benefits worldwide,” Dr. Kim added.
In pre-clinical studies, vaccination with VGX-3400 generated broadly protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals in five separate animal models - mice, ferrets, rabbits, pigs, and rhesus monkeys. Vaccination with VGX-3400 also protected animals from an unmatched, lethal H5N1 virus challenge in mouse, ferret, and monkey models. According to the World Health Organization, the H5N1 bird flu has infected 478 people in 15 countries since 2003 with 286 deaths (60% death rate). While H5N1 has never spread widely, one concern is the potential for the lethal H5N1 to “reassort” with another of the influenza sub-types that have been prone to spread more rapidly, possibly creating a more dangerous influenza strain.
Pfizer-BioNTech vaccine provides strong protection against MIS-C in children aged 5–17