Inviragen will receive over $1.5 million of a more than $3 million National Institute of Allergy and Infectious Diseases (NIAID) grant awarded to the University of Texas Medical Branch (UTMB) for its part in a collaboration focused on characterizing and developing a recombinant chikungunya virus (CHIKV) vaccine. Originating from UTMB research, the preclinical-stage vaccine is being developed in collaboration with Inviragen under an exclusive worldwide license agreement.
Preclinical development is being carried out by Inviragen, the UTMB, the University of Wisconsin (UW), and the Centers for Disease Control and Prevention’s Division of Vector-Borne Diseases (DVBD). Preclincial safety and protective efficacy data from tests in preclinical models were reported in the July issue of PLoS Pathogens.
“Through our collaboration with UTMB, UW, and DVBD, we have established preclinical safety, immunogenicity, and efficacy of this chikungunya vaccine candidate in multiple animal models,” notes Jorge Osorio, Ph.D., Inviragen co-founder and CSO. “This grant from NIAID will partially fund efforts at UTMB and Inviragen to further characterize the vaccine, complete the remaining preclinical testing and manufacturing, and file an investigational new drug application with the FDA to begin human clinical testing.”
The chikungunya vaccine comprises an attenuated virus in which defined alterations have been engineered into regions of the CHIKV genome that control viral gene expression. Inviragen and the UTMB claim the resulting recombinant virus is genetically stable, shows reduced replication in host mammals, and is unable to replicate in mosquitoes, the vector for chikungunya transmission.
Preclinical results reported in November 2010 showed that in multiple mouse models of CHIKV infection the vaccine was found to be safe and immunogenic, generating neutralizing antibody responses after a single administration. 100% of mice immunized with the CHIKV vaccine candidate survived, showing no clinical signs of disease following challenge with wild type or mouse-adapted CHIKV.
Award of the NIAID grant comes within two weeks of Inviragen signing of a memorandum of understanding with the International Vaccine Institute (IVI), focused on accelerating the development of a dengue virus vaccine. The collaboration, with the IVI’s newly established Dengue Vaccine Initiative, will support development of Inviragen’s lead dengue virus vaccine candidate, which is in Phase I trials.