Arcturus Therapeutics Announces that it has Initiated Dosing of its COVID-19 STARR™ mRNA Vaccine Candidate, LUNAR-COV19 (ARCT-021) in a Phase 1/2 study
Potential for highly differentiated COVID-19 vaccine profile with a single administration, at a low dose
Clinical study data expected in Q4 2020
“We are very pleased to have initiated dosing in our ARCT-021 Phase 1/2 study, and in fact, we have already completed dosing of all subjects in the first cohort of the study. Based on preclinical immunogenicity data, our self-replicating mRNA-based investigational vaccine could have a highly differentiated safety and efficacy profile, and may potentially allow vaccination at very low doses, and with a single administration. These favorable attributes could greatly facilitate mass vaccination campaigns necessary to control this global pandemic,” said
The ARCT-021 Phase 1/2 study includes two parts. In Phase 1, escalating doses will be administered as a single injection to younger adults aged 21 to 55 years old. Based upon the safety, immunogenicity and T-cell response data from this group, dose regimens will be selected for further evaluation in Phase 2 which includes cohorts in younger adults and older adults aged 56 to 80 years old. The study is listed with ClinicalTrials.gov Identifier: NCT04480957.
ARCT-021 preclinical data has shown highly promising results with 100% seroconversion for neutralizing antibodies after a single administration using a very low 2 µg dose. Neutralizing antibodies continued to increase for 60 days after dosing. Preclinical results also demonstrated robust CD8+ T-cell Induction and a Th1 biased T-helper cellular immune response. The ARCT-021 vaccine candidate is devoid of viruses and does not utilize viral vectors or adjuvants. ARCT-021 utilizes Arcturus’ self-transcribing and replicating (STARR™) mRNA technology and is delivered with Arcturus’s proprietary LUNAR® lipid-mediated delivery system.
About Arcturus Therapeutics
Founded in 2013 and based in
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, including those regarding the likelihood of success, efficacy or safety of ARCT-021 as a vaccine against COVID-19 and therapeutic potential thereof based on the Company’s mRNA therapeutics, the timing of the release of ARCT-021 clinical data for human trials of a vaccine against COVID-19, the likelihood that ARCT-021 preclinical data will be predictive of clinical data, the expected dose size and required number of doses of ARCT-021 that may be approved for use by any applicable regulatory authority and the impact of general business and economic conditions are forward-looking statements. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading "Risk Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal year ended
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