A self-amplifying mRNA vaccine candidate for H5N1 avian influenza is set to begin phase 1 trials in the US after receiving FDA approval to proceed.
RT’s Three Key Takeaways:
- FDA Approves Early Trial for H5N1 mRNA Vaccine: The FDA has given the green light for a phase 1 trial to test a self-amplifying mRNA vaccine aimed at preventing H5N1 avian influenza.
- Innovative mRNA Technology Targets Pandemic Preparedness: The self-amplifying mRNA platform is designed to boost antigen expression, potentially enabling lower doses and faster vaccine production compared to traditional methods.
- Clinical Study to Enroll 200 Participants: The trial, funded by the Biomedical Advanced Research and Development Authority, will assess the vaccine’s safety, reactogenicity, and immunogenicity in healthy adults.
Arcturus Therapeutics Holdings Inc, a commercial messenger RNA (mRNA) medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, announced that the US Food and Drug Administration has issued a “study can proceed” notification for the company’s Investigational New Drug application for ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus.
The clinical study is funded by Biomedical Advanced Research and Development Authority and designed to enroll approximately 200 healthy adults in the United States.
“Arcturus is actively engaged with the US 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,” says Joseph Payne, president and CEO of Arcturus Therapeutics, in a release “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.”
Self-amplifying mRNA Tech
ARCT-2304 is a self-amplifying mRNA vaccine candidate formulated within a lipid nanoparticle. The self-amplifying mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin and neuraminidase antigens, thereby enabling lower doses than conventional mRNA vaccines.
Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals, according to a release from Arcturus Therapeutics. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.
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