$63.2 Million base award to fund development from preclinical stage through Phase 1 over three-year period.
A lower-dose, freeze-dried, pandemic influenza vaccine candidate will use Arcturus’ STARR™ self-amplifying mRNA vaccine platform technology which demonstrated favorable safety and efficacy against SARS-CoV-2 infection combined with a stable cold chain profile that may help support U.S. government pandemic preparedness goals.
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, the Biomedical Advanced Research and Development Authority (BARDA) is partnering with Arcturus Therapeutics Holdings, Inc. 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.
The award to Arcturus is for an initial three years to support preclinical, manufacturing, nonclinical safety studies, along with development and regulatory support for Arcturus’ self-amplifying mRNA vaccine platform technology for rapid pandemic influenza response through Phase 1 clinical studies.
“We are very pleased to have won this substantial award from the BARDA and look forward to working with the U.S. government to support the development of our proprietary self-amplifying mRNA vaccine technology for rapid pandemic influenza response. Arcturus’ next generation mRNA platform has been administered to over 10,000 individuals globally demonstrating favorable safety, strong immunogenicity, and protection against SARS-COV-2 infection,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “Our lyophilized vaccines have the potential to provide safe and effective protection against disease with the specific advantage of rapid scale-up, lower doses, and easier transport and storage. These are qualities that are essential to a rapid response against pandemic influenza and are consistent with strategic objectives of the U.S. government’s National Strategy for Pandemic Influenza.”
Supporting Pandemic Influenza Countermeasure Capacity Building
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.
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 project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract Number: 75A50122C00007.
Sources: BARDA, Arcturus Therapeutics Holdings, Inc.