Precision Vaccinations Arcturus Therapeutics Holdings Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to enhance the expression of haemagglutinin and neuraminidase antigens, thereby enabling lower doses than conventional mRNA vaccines.