Preclinical Studies From Vaxxas and Collaborators Reveal Potential of Vaxxas� Novel High-Density Microarray Patch (HD-MAP) to Effectively Deliver SARS-CoV-2 Spike Vaccine

• Vaccination via HD-MAP induced enhanced T-cell and spike-specific antibody responses as compared to needle-and-syringe delivery of the same vaccine in an animal model
• Complete protection from COVID-19 disease by a single dose skin patch delivery using Vaxxas� HD-MAP was demonstrated in a lethal challenge of the SARS-COV-2 virus in an animal model
• Serum antibody levels showed the potential to neutralize clinically-relevant isolates, including those from UK and South African SARS-CoV-2 strains
• SARS-CoV-2 vaccine, dry-coated on the patch, was stable for at least 30 days at 25?C, creating the potential for unrefrigerated distribution, including via commercial postal services for self-administration

CAMBRIDGE, Mass. & BRISBANE, Australia–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced that research demonstrating the potential of Vaxxas’ novel high-density microarray patch (HD-MAP) for vaccination against COVID-19 had been published in a manuscript posted to the preprint server BioRxiv. Using a novel SARS-CoV-2 spike subunit vaccine, this preclinical study of Vaxxas’ HD-MAP showed enhancement of immune response compared to vaccination by needle-and-syringe, including significantly enhanced T-cell and spike-specific antibody responses as compared to needle-and-syringe delivery. Notably, complete protection from COVID-19 by a single dose skin patch delivery using HD-MAP was shown in a lethal virus challenge in a relevant COVID-19 animal model. Comparable protection against COVID-19 was not seen with the same vaccine when delivered by needle-and-syringe, even when the spike subunit vaccine formulation included appropriate adjuvantation. The research underlying the study was co-funded by Vaxxas and the Queensland Government and was performed in collaboration with researchers at the University of Queensland and Griffith University and led by principal investigator, David A. Muller, PhD, of the School of Chemistry and Molecular Biosciences at the University of Queensland.

“We designed this research to address the serious on-going need to improve the global vaccination efforts against COVID-19 and future pandemics. Based on our results, we believe that Vaxxas’ HD-MAP could offer a compelling solution that importantly could use less vaccine and potentially could be readily distributed without refrigeration for self-administration,” said David A. Muller, Advance Queensland Industry Research Fellow, School of Chemistry and Molecular Biosciences, The University of Queensland. “This combination could make the HD-MAP extremely well suited to support the massive need for global population vaccination and, indeed, we believe that HD-MAP offers a superior alternative to conventional needle-and-syringe.”

For these studies, the SARS-CoV-2 spike subunit vaccine was dry-coated on the HD-MAP patch using proprietary systems and technology developed by Vaxxas. Once applied on the Vaxxas HD-MAP, the patch vaccine dose was shown to be stable for at least 30 days at 25?C which opens up the future potential for unrefrigerated distribution and potentially the use of commercial shipping to deliver HD-MAP patches to homes and businesses for self-administration. These dry-coating technologies and potential for self-administration build upon clinical and other demonstration work being done for the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic influenza vaccination.

“We are extremely excited about these compelling early results showing the potential of Vaxxas’ proprietary HD-MAP vaccination platform to deliver safe and effective vaccines against COVID-19,” said David L. Hoey, President and CEO of Vaxxas. “We believe that having a single dose vaccine that could be easily distributed and self-administered would greatly improve global pandemic vaccination capabilities. We would like to thank and recognize our incredible research collaborators at the University of Queensland and Griffith University and the support of co-funders within the Queensland Government for their vital parts in bringing us to these important findings.”

The vaccine used in these studies was a recombinant SARS-CoV-2 spike glycoprotein, termed HexaPro, which has been stabilized in its prefusion conformation by removal of the furin cleavage site and the inclusion of six stabilizing proline mutations. While this HexaPro SARS-CoV-2 spike subunit vaccine was designed based on the molecular spike structure inherent to the Wuhan-Hu-1 reference strain, it is observed in the published findings that serum antibody levels clearly demonstrated the potential to potently neutralize emerging isolates including those from the B.1.1.7 lineage (known as the UK strain) and B.1.351 lineage (known as the South African strain) among potentially other strains.

The preprint publication entitled, “Complete protection by a single dose skin patch delivery of SARS-CoV-2 spike vaccine,” by David A. Muller et al., is available as a preprint here.

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary HD-MAP technology platform, which uses an ultra-high density array of projections – invisible to the naked human eye – applied to the skin to rapidly deliver vaccine to the abundant immune cells immediately below the skin surface. This approach can enhance efficiency and effectiveness of immune response. Vaxxas uses proprietary dry-coating technology that can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation – easing the resource and logistics burden of maintaining the “cold chain.” Vaxxas is targeting initial applications in infectious disease and oncology.

Vaxxas core technology was initially developed at the University of Queensland. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital, the Medical Research Commercialisation Fund (MRCF), and US-based HealthCare Ventures, followed by a further financing led by OneVentures. OneVentures Innovation Fund I and the MRCF are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at www.one-ventures.com and www.brandoncapital.com.au.

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