Arcturus Therapeutics–Duke-NUS clinical trials for COVID-19 vaccine candidate approved to proceed
- Human dosing of LUNAR-COV19 expected soon.
- Differentiated STARR™ mRNA vaccine expected to produce humoral and cellular immunity at very low doses.
- New preclinical data demonstrates neutralising antibody titres continue to increase for 50 days after a single administration.
San Diego/Singapore, 21 July 2020 – 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 for COVID-19 vaccine candidate LUNAR-COV19 has been approved to proceed by the Singapore Health Sciences Authority. 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 and 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 and CEO of Arcturus.
Read the full article from Duke-NUS Medical School