October 2, 2022

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Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced



 

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced, with a protection rate of 55% and a severe protection rate of 95%.

With the widespread use of mRNA COVID-19 vaccines around the world, mRNA technology has shown great capabilities.

In addition to the mRNA types already on the market, there are several novel mRNAs that are undergoing clinical trials or preclinical studies and have demonstrated potential effects.

 

Among them, self-amplifying RNA vaccines (saRNA) have attracted widespread attention as a new generation of mRNA.

Compared with traditional mRNA vaccines , the new saRNA vaccines add replicable sequences to the delivered mRNA sequences, which can act like viruses after entering cells.

It can use host cells for self-replication, so that in the case of extremely low injection doses (a fraction to several tenths of the conventional mRNA vaccine dose) , the high expression of antigens can be achieved and a strong immune response can be generated Ability.

 

This ultra-low injection dose has three important advantages:

  1. It has greater manufacturing potential, and the same origin and production equipment can produce more vaccines;
  2. Because the dose is low, the risk of side effects is reduced;
  3. The characteristics of low dose can be used in combination with other vaccines.

 

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announcedComparison of traditional mRNA vaccines and saRNA vaccines

 

 

Among them, the self-amplifying RNA vaccine ARCT-154 developed by Arcturus Therapeutics has the fastest progress. It will start a phase 1 clinical trial in the summer of 2020 and is currently in a phase 3 clinical trial.

 

 

On April 20, 2022, Arcturus Therapeutics announced the results of its Phase 3 clinical trial of its self-amplifying RNA COVID-19 vaccine.

In this Phase 3 clinical trial in Vietnam, a total of more than 17,000 people who had not been vaccinated against the COVID-19 vaccine were killed.

Randomly assigned to two groups, the experimental group received two doses of ARCT-154 vaccine of 5 micrograms each, and the control group received two doses of the same amount of placebo.

 

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced

 

 

During this phase 3 clinical trial, it was confirmed that Vietnam has transitioned from the Delta mutant to the Omicron mutant.

The test results show that the self-amplifying RNA COVID-19 vaccine has a protective effect of 55% against symptomatic COVID-19 pneumonia, and the protective effect against severe and death is 55%. 95.3% .

There were 9 COVID-19-related deaths in the control group, only 1 in the experimental group, 41 people in the control group had severe COVID-19s, and only 2 people in the experimental group had severe COVID-19s.

 

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced

 

In the mRNA vaccine space, Moderna and Pfizer/BioNTech are leading the charge, and they are also aggressively pushing for booster programs.

In the face of the competition between these two mRNA vaccines, Arcturus Therapeutics tried to get a share of the pie by using a differentiated self-amplifying RNA vaccine as a booster vaccination, but it is still doubtful whether the vaccine can be finally approved.

 

 

 

 

Arcturus R&D Pipeline

Arcturus Therapeutics currently has a total of 5 R&D pipelines. In addition to the two COVID-19 vaccine pipelines, there is also an influenza mRNA vaccine, and two genetic diseases of ornithine carbamoyltransferase deficiency (OTCD) and cystic fibrosis (CF). mRNA therapy.

 

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced

 

 

 

 

 

References:
https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-announces-self-amplifying-covid-19-mrna-vaccine

Phase 3 trials results of the first self-amplifying mRNA COVID-19 vaccine were announced

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