KING OF PRUSSIA, PA — CSL (ASX: CSL; USOTC: CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) have made a significant leap forward in the fight against COVID-19, as revealed by a recent publication in Lancet Infectious Diseases. The Phase 3 study demonstrates that ARCT-154, a unique self-amplifying messenger RNA (sa-mRNA) vaccine, produced a numerically superior immune response against both the original Wuhan-Hu-1 strain and the Omicron BA.4/5 subvariant of the SARS-CoV-2 virus compared to a booster dose of Comirnaty®, a conventional mRNA vaccine.
The results of the ARCT-154 study are particularly striking given that the successful immune response was achieved with just one-sixth of the dose of Comirnaty® (5 μg vs 30 μg).
The study involved healthy adults who had initially received two doses of an mRNA vaccine (Comirnaty® or Spikevax™), followed by a third dose of Comirnaty® at least three months before receiving a booster dose of either ARCT-154 or Comirnaty® in the study. Both vaccines were well-tolerated, with no severe or serious adverse events causally linked to the vaccines.
Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, expressed excitement over the initial head-to-head results. “These results show that our sa-mRNA vaccine platform has the potential to produce immunogenicity against COVID-19 in previously vaccinated patients that is as good or better—and at a much lower dose—than first-generation mRNA vaccines,” he said.
The study was conducted in collaboration with Meiji Seika Pharma, a global health company based in Japan. The findings have already led to the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November.
Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics, hailed the results as a significant achievement. “This study represents the first phase of CSL and Arcturus’ plans to launch this innovative vaccine platform globally,” he said.
The ARCT-154 study is set to continue, with researchers planning to collect further safety data and assess the durability of the immune response in participants at 3-, 6- and 12-months post-vaccination. As the biotechnology industry closely watches these developments, the promising results of the Phase 3 study offer renewed hope for more effective and efficient COVID-19 vaccination strategies.
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