The Phase 1/2/3 trial to be funded and sponsored by Arcturus’ manufacturing partner Vinbiocare

ARCT-154 to be developed in parallel with ARCT-021, Arcturus’ lead investigational COVID-19 vaccine

SAN DIEGO, CA, USA I August 02, 2021 I Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, announced today that the company’s partner Vinbiocare has received approval for a Clinical Trial Application (CTA) from the Vietnam Ministry of Health to advance ARCT-154, a next generation Arcturus vaccine targeting SARS-CoV-2 variants of concern, including the Delta variant.

The ARCT-154 Phase 1/2/3 clinical study is a randomized, observer-blind, placebo-controlled design, and is sponsored and completely funded by Arcturus’ manufacturing partner Vinbiocare – a subsidiary of Vingroup, the largest private industry conglomerate in Vietnam. The study is to assess the safety, immunogenicity and efficacy of the SARS-CoV-2 self-amplifying mRNA vaccine in adults 18 years or older and will enroll up to 21,000 participants across the 3 phases, with 20,000 in Phase 3. Primary endpoints include safety and efficacy with immunogenicity being evaluated in a subgroup. Participants will receive two doses of study vaccine separated by 28 days. Placebo participants will receive active vaccine after 6 months. All participants will be followed up for 1 year. If the clinical trial proves successful at interim evaluations, Emergency Use Approval (EUA) by the Vietnam Ministry of Health is anticipated in December 2021.

Preclinical research demonstrates that non-human primate immunization with ARCT-154 elicits neutralizing antibodies to SARS-CoV-2 variants of concern, including to the widely circulating and highly infectious Delta variant (see table below).

Neutralizing Antibody Titers to Variants of Concern (Geometric Mean NT50)
  Alpha Beta Gamma Delta
STARR™ Vaccine ARCT-154 9080 874 1297 6876
Non-Human primate (NHP) data collected one month after second dose; Analysis of NHP serum was performed using non-replicating vesicular stomatitis virus pseudo-typed with the spike protein of the SARS-CoV-2 VOCs indicated. Titers were determined by calculating the dilution that resulted in 50% inhibition of cells expressing GFP encoded by the pseudovirus, a surrogate of virus infection.

“We are very pleased to advance ARCT-154 into a significant, staged Phase 3 clinical development study with our partner to target SARS-CoV-2 variants of concern, including the Delta variant. ARCT-154 utilizes Arcturus’ STARR™ mRNA technology, and our preclinical immunogenicity data demonstrates that our newly developed vaccine candidate elicits a strong neutralizing antibody immune response against the Delta variant and other variants of concern,” said Joseph Payne, President and CEO of Arcturus.

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, and Cystic Fibrosis along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (222 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit In addition, please connect with us on Twitter and LinkedIn.

SOURCE: Arcturus Therapeutics