Press release
Arcturus Therapeutics & Duke-NUS Received Approval to Proceed with Phase 1/2 Clinical Trial for COVID-19 Vaccine Candidate, LUNAR-COV19
Human dosing of LUNAR-COV19 expected soon Anti-Spike Glucoproteins Differentiated STARR™ mRNA vaccine expected to produce humoral and cellular immunity at
About this update from Arcturus Therapeutics Holdings Inc.
[{"type":"text","content":"Human dosing of LUNAR-COV19 expected soon\n\n \n \n \n \n \n \n \n \n \n \n \n Anti-Spike Glucoproteins\n \n \n \n \n \n \n \n \n\n Differentiated STARR™ mRNA vaccine expected to produce humoral and cellular immunity at very low doses New preclinical data demonstrates neutralizing antibody titers continue to increase for 50 days after a single administration SAN DIEGO and SINGAPORE, July 21, 2020 (GLOBE NEWSWIRE) -- Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the discovery, development and commercialization of therapeutics for rare diseases and vaccines, and Duke-NUS Medical School, Singapore’s flagship research-intensive graduate entry medical school, today announced that the Clinical Trial Application (CTA) for COVID-19 vaccine candidate LUNAR-COV19 has been approved to proceed by the Singapore Health Sciences Authority (HSA). Arcturus and Duke-NUS partnered to develop a coronavirus vaccine using Arcturus’ STARR™ technology and a unique platform developed at Duke-NUS allowing rapid screening of vaccines for potential effectiveness and safety. Arcturus & Duke-NUS will initiate human dosing of LUNAR-COV19 as soon as possible. The healthy volunteer study will evaluate several dose levels of LUNAR-COV19 in up to 108 adults, including older adults. Follow-up will be conducted to evaluate safety, tolerability and the extent and duration of the humoral and cellular 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,” said Joseph Payne, President & CEO of Arcturus. 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 findings, including the possibility that a single dose of this vaccine may be sufficien...