Arcturus Therapeutics Launches Innovative H5N1 Vaccine Trial

Arcturus Therapeutics Launches Innovative H5N1 Vaccine Trial

Arcturus Therapeutics Holdings Inc. (the 'Company', 'Arcturus', Nasdaq: ARCT), a pioneering force in commercial messenger RNA (mRNA) medicines, has proudly announced the commencement of a Phase 1 clinical trial for the ARCT-2304 vaccine candidate, also known as LUNAR-H5N1. This self-amplifying mRNA (sa-mRNA) vaccine aims to foster active immunity and ultimately prevent disease caused by the H5N1 influenza virus, which presents considerable risk as a potential pandemic strain.

Trial Overview and Objectives

The Phase 1 trial, which is a randomized and placebo-controlled study, is set to take place across multiple sites within the U.S., with an objective to enroll around 200 healthy adults. The participants will consist of two distinct age groups: approximately 120 individuals aged 18 to 59 and 80 participants aged 60 to 80 years. Screening has already commenced, and the study is fully funded by the Biomedical Advanced Research and Development Authority (BARDA).

Safety and Immune Response Evaluation

Throughout this initial trial, Arcturus seeks to evaluate both the safety and immune response elicited by three different dosage levels and two distinct vaccination schedules of the ARCT-2304 vaccine. Immune responses will be rigorously measured through techniques like hemagglutination inhibition (HAI), virus microneutralization (MN), and neuraminidase enzyme-linked lectin assays (ELLA).

Technological Advancements Behind ARCT-2304

The ARCT-2304 vaccine harnesses the power of LUNAR® delivery and STARR® mRNA platform technologies, both of which have shown great promise in clinical settings. STARR® mRNA has previously demonstrated an ability to invoke a robust immune response even at lower dosage levels, maintaining the presence of neutralizing antibodies for an extended duration. These technologies have been validated across numerous COVID-19 and seasonal influenza vaccine studies, boasting a robust safety database that stems from more than 20,000 participants.

Statements from Leadership

Joseph Payne, President and CEO of Arcturus Therapeutics expressed, 'Validating our low-dose STARR® mRNA technology in the context of H5N1 flu is a vital step toward ensuring global pandemic preparedness. Our team is collaborating closely with BARDA and CSL to navigate this new frontier in vaccine development.'

The Significance of H5N1 Influenza

The H5N1 influenza virus poses a considerable threat not just to animal health, with over 10,000 wild birds and significant losses in the poultry industry, but it has also resulted in human infections, some of which have been severe. Elevated instances of H5N1 in animal populations have correlated with an increase in human cases, putting workers in agricultural sectors at heightened risk. This underscores the necessity for effective and rapid vaccine development.

Understanding Self-Amplifying mRNA

Self-amplifying (sa-mRNA) vaccines represent a significant advancement in immunization technology. Unlike traditional mRNA vaccines which introduce a strand of mRNA to produce a specific protein, sa-mRNA vaccines enhance the body's ability to create more copies of mRNA and protein, thereby amplifying the immune response and boosting protection against potential infections.

Introducing ARCT-2304

This innovative vaccine candidate, ARCT-2304, employs Arcturus' proprietary LUNAR® delivery technology to ensure effective vaccine delivery. Post-injection, this self-amplifying mRNA vaccine is designed to reproduce multiple copies of its mRNA within host cells. This mechanism contributes to a heightened expression of vital antigens, such as haemagglutinin (HA) and neuraminidase (NA), enabling the use of lower doses compared to conventional mRNA vaccines.

Advantages of the New Vaccine Technology

The formulation of this lyophilized vaccine is particularly noteworthy as it remains stable when stored under refrigeration, simplifying the logistics of cold-chain storage, which traditionally poses challenges during distribution. This stability could facilitate quicker responses to outbreaks and improve accessibility.

An Overview of Arcturus Therapeutics

Founded in 2013 and located in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) continues to be a trailblazer within the realm of mRNA medicines and vaccines. The company focuses on innovative technologies including LUNAR® lipid-mediated delivery and STARR® mRNA Technology, alongside its expertise in mRNA drug manufacturing. Among its notable achievements is KOSTAIVE®, recognized as the world's first self-amplifying messenger RNA (sa-mRNA) COVID vaccine to receive approval. With a robust pipeline that includes RNA therapeutic candidates for conditions like ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), as well as collaborative projects for mRNA vaccines targeting SARS-CoV-2 and influenza, Arcturus is well positioned for future advancements. The comprehensive patent portfolio, covering over 400 patents and applications globally, further underscores its commitment to innovation.

Frequently Asked Questions

What is the purpose of the Phase 1 trial for ARCT-2304?

The Phase 1 trial evaluates the safety and immune responses of the ARCT-2304 vaccine against the H5N1 virus.

How many participants are involved in the trial?

Approximately 200 healthy adults will participate, divided into age groups of 18-59 and 60-80 years.

What technologies are used in the ARCT-2304 vaccine?

The vaccine utilizes LUNAR® delivery and STARR® mRNA platform technologies.

What makes self-amplifying mRNA vaccines different?

Sa-mRNA vaccines enable the body to create more mRNA and protein, amplifying the immune response.

Where can I find more information about Arcturus Therapeutics?

For further details about Arcturus, visit their official website and corporate social media profiles.

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