Another Avian Influenza mRNA Vaccine Candidate Advances

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.

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics, in a press release on November 11, 2024.

“The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”

The clinical study is funded by the U.S. Biomedical Advanced Research and Development Authority.

The U.S. and European vaccine agencies have previously approved avian and pandemic influenza vaccines and have recently awarded funding grants for (bird flu) vaccine candidates.