San Diego-based Arcturus Therapeutics Inc. announced plans to initiate a human clinical trial this summer for its COVID-19 vaccine, also known as LUNAR-COV19.
The company said that under the guidance of the Singapore Health Sciences Authority (HSA), the trial plans to enroll up to 76 healthy volunteer adults including elderly individuals, with follow-up over several months to evaluate extent and duration of immune response.
“Arcturus had a very productive meeting with the HSA where the clinical development plan was discussed in detail,” said Joseph Payne, president and CEO of Arcturus. “We foresee continuing to work with the HSA in a collaborative fashion as we approach initiation of the first clinical trial.”
According to Arcturus, "LUNAR-COV19 is a very low dose, potential single-shot (i.m.), self-replicating mRNA vaccine that is devoid of any viral material or co-adjuvants. Utilizing Arcturus processes, the mRNA vaccine product is readily manufactured, with the initial GMP batch to be delivered in June. Preclinical in vitro data shows that administration of LUNAR-COV19 generates effective expression of the COVID-19 virus spike protein – the antigen to which protective antibodies will be formed."
Arcturus is developing messenger RNA drugs, designed to get the body to make its own medicine.
It’s difficult to coax RNA into cells without the body destroying them first. So, Arcturus developed its own RNA delivery system.
The GMP-manufactured batch of LUNAR-COV19 is to be delivered in June 2020 and human dosing is expected to begin in summer 2020.
In early March, Arcturus announced a grant of up to $10 million from a Singapore government agency to co-develop a COVID-19 vaccine.
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