BARDA and Arcturus Therapeutics Holdings, Inc. partner to develop a self-amplifying mRNA-based vaccine for rapid pandemic influenza response


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During the early stages of a pandemic influenza outbreak, rapidly developing and distributing vaccines is essential to curbing the spread of disease and helping to save lives. As part of ongoing efforts to bolster pandemic preparedness, BARDA is partnering with Arcturus Therapeutics Holdings, Inc. (Arcturus) to develop a self-amplifying messenger RNA (samRNA) vaccine against pandemic influenza based on the company’s platform technology and using modern production practices to ensure rapid production.

Beginning in 2005, the U.S. Department of Health and Human Services—guided by the National Strategy for Pandemic Influenza (2005), the National Strategy for Pandemic Influenza Implementation Plan (2006), and the Department of Health and Human Services’ Pandemic Influenza Plan (2017)—began to develop sufficient domestic manufacturing surge capacity to provide pandemic influenza vaccine for the entire country and established a pre-pandemic influenza vaccine stockpile to expedite vaccination of the critical workforce. Additionally, in alignment with the second goal in BARDA’s 2022-2026 Strategic Plan, this program aims to enhance our response posture by leveraging a diverse portfolio of proven medical countermeasure technologies while continuing to identify opportunities for product development to address gaps in preparedness.

To achieve these strategic goals and to provide more vaccines sooner, BARDA is supporting the development of additional production platform technologies and adjuvants for the manufacturing of seasonal and pandemic influenza vaccines. This contract with Arcturus supports the non-clinical efficacy studies and pre-clinical development, early-stage clinical development, drug product manufacturing, and all associated regulatory and quality assurance activities for a samRNA-based pandemic influenza vaccine to enhance U.S. and global pandemic preparedness.

Arcturus’ vaccine candidate uses samRNA. samRNA is designed to make many copies of the viral protein within the cell, thereby enabling lower doses than conventional mRNA vaccines. Utilizing nucleic acid and recombinant-based technologies – which include mRNA-based platforms – for seasonal and pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. These technologies may make vaccines available much sooner than egg- and cell-based technologies. The mRNA-based vaccines for COVID-19 were developed within a 60-day time frame from sequence identification to initiation of clinical trials and a similar turnaround time is expected for samRNA vaccines for future pandemics.

Arcturus has used the samRNA platform technology in their leading lyophilized COVID-19 vaccine candidate, ARCT-154, which is currently in late-stage clinical trials. The lyophilized vaccine formulation is stable in standard refrigerators, thereby simplifying cold-chain storage and reducing distribution risks.

This agreement with Arcturus strengthens the U.S. government's pandemic preparedness and response capabilities by investing in innovative medical countermeasures that can help prevent the disease burden and loss of life caused by pandemic influenza and emerging infectious diseases.

About Arcturus Therapeutics

The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR lipid-mediated delivery, (ii) STARR mRNA Technology (samRNA) 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 III, and hepatitis B virus. Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations including, amongst others, with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Cystic Fibrosis Foundation, and now the US Government through the Biomedical Advanced Research and Development Authority (BARDA).  

Last Updated: August 31, 2022