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ARCT-2304 is a self-amplifying mRNA (sa-mRNA) vaccine candidate developed by Arcturus Therapeutics for the prevention of Pandemic Influenza A Virus H5N1. The vaccine utilizes Arcturus's proprietary STARR sa-mRNA platform and LUNAR lipid-mediated delivery system. Unlike conventional mRNA vaccines, sa-mRNA is designed to replicate within the cell, potentially allowing for lower dosing levels while maintaining robust immunogenicity. The development of ARCT-2304 is supported by a cost-reimbursement contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) for up to $63.2 million, covering preclinical activities through Phase 1 clinical trials. A Phase 1 study in healthy adults is currently ongoing in the United States to evaluate safety, reactogenicity, and immunogenicity.
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