100% of animals seroconverted by day 19 at a low dose (2 µg)
LUNAR-COV19 remains on track to initiate human clinical trials this Summer
SAN DIEGO, CA, USA I April 27, 2020 I 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, today announced positive immunogenicity data from its preclinical study for the Company’s COVID-19 Vaccine. These data for LUNAR-COV19 were measured by Duke-NUS Medical School in Singapore.
“These preclinical studies done in partnership with Arcturus establish a strong package of data to support initiation of human clinical trials this Summer,” said Professor Ooi Eng Eong, Deputy Director of the Emerging Infectious Diseases Programme at Duke-NUS Medical School. “There is a tremendous urgency to develop an effective vaccine in this global fight against COVID-19.”
Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics, stated “These data show that Arcturus’ STARR™ mRNA is superior to conventional mRNA at all equivalent doses and timepoints. Self-replicating mRNA significantly increases spike protein expression, yielding many-fold higher seroconversion rates. The results at the 2 µg dose suggest LUNAR-COV19 has the potential to immunize millions more people.”
Seroconversion, using a gold standard virus neutralization assay (Vero-E6 cells with a SARS-CoV-2 Singapore Clinical Isolate), and IgG/IgM antibody titers were assessed at day 10 and day 19. Rodents were immunized with a single dose (0.2, 2, and 10 µg, i.m.) of LUNAR-COV19 vaccine. The study results showed self-transcribing and replicating (STARR™) mRNA induced higher seroconversion relative to conventional mRNA at equivalent doses. In conjunction, anti-SARS-CoV-2 IgG and IgM antibody titers were also higher.
Seroconversion1 Rate (% of Animals) – STARR™ mRNA vs. Conventional mRNA
Single Dose (µg)2 |
LUNAR® Delivery | |||
STARR™ mRNA (%) | Conventional mRNA (%) | |||
Day 10 | Day 19 | Day 10 | Day 19 | |
0.2 | 40 | 60 | 20 | 20 |
2 | 80 | 100 | 20 | 0 |
10 | 100 | 100 | 40 | 80 |
1 Seroconversion is the transition from a seronegative condition where no neutralizing antibodies are in the serum to a seropositive condition, in which neutralizing antibodies can be detected in serum following a 1/10 dilution. Definition set forth by the World Health Organization (WHO).
2 One microgram (µg) is 1 millionth of a gram, 1 billionth of a kilogram (i.e. 1 kilogram contains 500 million doses at 2 ug/dose).
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 candidates includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, non-alcoholic steatohepatitis (NASH) and a self-replicating mRNA vaccine for SARS-CoV-2. 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 (187 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, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com
About STARR™ Technology
The STARR™ Technology platform combines self-replicating RNA with LUNAR®, a leading nanoparticle delivery system, into a single solution to produce proteins inside the human body. The versatility of the STARR™ Technology affords its ability upon delivery into the cell to generate a protective immune response or drive therapeutic protein expression to potentially prevent against or treat a variety of diseases. The self-replicating RNA-based therapeutic vaccine triggers rapid and prolonged antigen expression within host cells resulting in protective immunity against infectious pathogens. This combination of the LUNAR® and STARR™ technology is expected to provide lower dose requirements due to superior immune response, sustained protein expression compared to non-self-replicating RNA-based vaccines and potentially enable us to produce vaccines more quickly and simply.
SOURCE: Arcturus Therapeutics