Arcturus Therapeutics Holdings Inc., a leading clinical-stage messenger RNA drug company specializing in the discovery, progression and marketing of curative products for rare diseases and vaccines, and Duke-NUS School of Medicine, Singapore’s leading research intensive medicine school, today announced that the clinical trial request for the COVID-19 LUNAR-COV19 candidate vaccine has been approved by the Health Authority. Arcturus and Duke-NUS have partnered to expand a coronavirus vaccine using the STARR ™ generation of Arcturus and an exclusive platform developed at Duke-NUS to detect vaccines for possible efficacy and safety.
Arcturus and Duke-NUS will begin handling LUNAR-COV19 in humans as soon as possible. The Healthy Volunteer Study will compare the dosage grades of LUNAR-COV19 in up to 108 adults, adding older adults. Follow-up will be monitored to assess the safety, tolerability and extent and duration of cellular and fun immune response.
The approval of the Clinical Trial Application for LUNAR-COV19 is a critical milestone for Arcturus. We are excited to advance this promising vaccine candidate into clinical trials. Based on our preclinical data, we believe that our self-replicating mRNA-based approach may produce high rates of seroconversion and robust T-cell induction with a potential single administration, at very low doses. The LUNAR-COV19 profile is meaningfully differentiated and may facilitate the mass vaccine campaigns necessary to target hundreds of millions of individuals globally.”
Professor Ooi Eng Eong, Deputy Director of the Emerging Infectious Diseases Program at Duke-NUS, said: “Preclinical studies on LUNAR-COV19 have shown very promising results, and adding the option that a single dose of this vaccine is possibly sufficient to cause long-lasting immune responses opposite to SARS-CoV-2. We took a look before we begin the first human clinical trial here in Singapore and advance at LUNAR-COV19 on the way to adapt a possible advertising vaccine.”
There is a massive global imperative to expand effective preventive measures opposed to COVID-19 infections. We are encouraged by the promising progress of our vaccine collaboration with Arcturus as we progress in clinical trials. “
The STARR ™ generation platform used in LUNAR-COV19 combines self-replicating mRN with LUNAR®, a patented nanoparticle management formula optimized for mRN molecules. The efficacy and self-replicating nature of the technique were designed to allow very low doses and possible administration of unwrified vaccines. Prior animal knowledge has demonstrated physically powerful mobile and humoral immunity at doses as low as 0.2 oz of LUNAR-COV19. In addition, Arcturus demonstrated 100 percent seroconversion for anti-SARS-CoV-2 neutralizing antibodies with a very low single dose (2.0 g).
New preclinical data demonstrate that neutralising antibody levels in response to a single administration of LUNAR-COV19 (0.2, 2.0, 10.0 μg) continue to increase over 50 days. The increasing antibody levels are attributed to the self-replicating mRNA of LUNAR-COV19. These results were obtained using a Luminex bead assay. A 1/2000 serum dilution was assayed for neutralizing IgG antibodies in the mouse serum every 10 days for 60 days post vaccination.
Duke-NUS School of Medicine
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