Duke-NUS Medical School and a San Diego-based biotech company have been given the go-ahead to conduct human clinical trials for a COVID-19 vaccine at the earliest date possible.
A joint statement released by the partners on Tuesday (21 Jul) wrote that the Singapore Health Sciences Authority has approved a Clinical Trial Application for a COVID-19 vaccine candidate named ‘LUNAR-COV19’.
Arcturus Therapeutics Holdings Inc., a ribonucleic acid (RNA) medicines company focused on therapeutics for rare diseases and vaccines, have developed a vaccine using its STARR™ technology, and will be partnering with Duke-NUS which will monitor its effectiveness and safety using a special platform developed at the school.
Duke-NUS is Singapore’s flagship research-intensive graduate entry medical school.
An RNA vaccine consists of a messenger RNA (mRNA) strand, a type of RNA, that codes for a disease-specific antigen.
Just like a vaccine, once the mRNA strand is inside the body’s cells, the cells use the genetic information to produce the antigen which will bind to potential pathogens. This will then allow a body’s immune system to recognise it.
The STARR™ Technology platform used in LUNAR-COV19 will combine self-replicating mRNA with LUNAR®, a proprietary nanoparticle delivery system optimised for mRNA molecules.
LUNAR-COV19 has recruited 108 adult volunteers for its clinical trials in Singapore. The sample group will include older adults as well.
The trials will be monitored for its safety, tolerability as well as the extent and duration of the humoral and cellular immune response in the volunteers.
Professor Ooi Eng Eong, Deputy Director of the Emerging Infectious Diseases Program at Duke-NUS, said: “Preclinical studies on LUNAR-COV19 conducted on animals have shown very promising findings, including the possibility that a single dose of this vaccine may be sufficient to trigger robust and durable immune responses against SARS-CoV-2”.
“We are very eager to start the first-in-human clinical trial here in Singapore and advance its journey to becoming a potential commercial vaccine.”
Joseph Payne, President & CEO of Arcturus, echoed the same thoughts saying they were excited to advance the vaccine candidate into clinical trials based on their preclinical data.
“We believe the LUNAR-COV19 profile is meaningfully differentiated and may facilitate the mass vaccine campaigns necessary to target hundreds of millions of individuals globally.”
There are reportedly 24 other candidate vaccines globally in the clinical trial stage, with around 140 candidates in preclinical stages.