The partners intend to commence dosing in the Phase I/II Covid-19 trial at the earliest. Credit: Gerd Altmann from Pixabay.

US-based Arcturus Therapeutics and Duke-NUS Medical School in Singapore have received approval from the country’s Health Sciences Authority (HSA) to assess Covid-19 vaccine candidate LUNAR-COV19 in a Phase I/II clinical trial.

Arcturus and Duke-NUS collaborated to create a Covid-19 vaccine based on the company’s STARR technology and a Duke-NUS platform designed for the quick screening of vaccines for safety and effectiveness.

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The STARR technology uses self-replicating mRNA in combination with LUNAR, a nanoparticle delivery system for mRNA molecules.

In animal studies, LUNAR-COV19 was able to induce humoral and cellular immunity at doses as low as 0.2µg. Arcturus also showed 100% seroconversion for anti-SARS-CoV-2 neutralising antibodies with a single 2µg dose.

Recent preclinical findings revealed that neutralising antibody levels in response to a single LUNAR-COV19 dose continue to rise over 50 days. The increasing antibody levels are said to be due to the self-replicating mRNA in the vaccine product.

Duke-NUS Emerging Infectious Diseases Program deputy director professor Ooi Eng Eong said: “Preclinical studies on LUNAR-COV19 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.

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“We are very eager to start the first-in-human clinical trial here in Singapore and advance LUNAR-COV19 on its journey to becoming a potential commercial vaccine.”

The partners intend to commence dosing in the Phase I/II trial at the earliest. The study will assess various LUNAR-COV19 dose levels in up to 108 healthy adult participants, including older adults.

Follow-up will be carried out to determine the vaccine candidate’s safety and tolerability, along with the extent and duration of the humoral and cellular immune response.

Arcturus Therapeutics president and CEO Joseph Payne noted: “The LUNAR-COV19 profile is meaningfully differentiated and may facilitate the mass vaccine campaigns necessary to target hundreds of millions of individuals globally.”