Arcturus Therapeutics believes it’s “highly unlikely” it will lose the promised government funding for its bird flu mRNA vaccine trial, despite reports swirling that Moderna’s own financial support will be revoked.
San Diego-based Arcturus moved the self-amplifying mRNA vaccine, dubbed LUNAR-H5N1, into a phase 1 trial in December. The study aims to enroll 200 healthy adults in the U.S., and is fully funded by a Biomedical Advanced Research and Development Authority (BARDA) contract of up to $63 million.
“Clinically validating our low-dose STARR mRNA technology in H5N1 flu is a crucial step towards pandemic preparedness,” Arcturus’ CEO Joseph Payne said in January. “Our team is working diligently with our partners, BARDA and CSL, in the United States and globally in this effort.”
The trial launched as certain forms of bird flu continue to spread throughout chickens and dairy cows, occasionally jumping into humans as well, although not on a wide scale. That, however, remains a concern for virologists given the potential for another human pandemic.
Moderna is further ahead in the race to develop a defence against the virus and as a result saw much more money funnelled into its contract, having secured a $590 million from BARDA in January to help the biopharma run two phase 3 studies of its mRNA vaccine against different strains of bird flu, as well as bring four new influenza vaccines into phase 1 trials. However, these plans were thrown into doubt last month following a report from Bloomberg that the Department of Health and Human Services is reevaluating the contract.
At the time, Moderna declined to comment while an HHS spokesperson told Fierce that “four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production.”
When contacted by Fierce, Arcturus didn’t seem concerned that its own BARDA funding was under threat. The company pointed to the trial’s timeline, which will see an interim readout in the second half of the year.
“We have not heard anything from BARDA regarding termination of our contract and it would be highly unlikely due to the timing of this trial and the follow-up safety reviews for the participants in the trial,” a spokesperson for the biopharma told Fierce this morning.
Arcturus’ self-amplifying mRNA tech already scored a regulatory success last month when the European Commission approved the company’s COVID-19 vaccine, called KOSTAIVE.