Vaxxas Opens World-Class Manufacturing Facility To Produce Proprietary Needle-Free Vaccine Patch For Late-Stage Clinical Trials and First Commercial Products

• Vaxxas opens 5,500 square meter (60,000 square feet) state-of-the-art biomedical manufacturing facility in Brisbane, Queensland, which will support the production of millions of Vaxxas’ high-density microarray patches (HD-MAPs) per year for future late-stage clinical trials and first commercial vaccine products.
• Funded by the Queensland Government and Vaxxas, the facility showcases world-class and first-of-a-kind biomedical manufacturing capabilities.
• The facility contains two independent Good Manufacturing Practice (GMP), qualified aseptic cleanrooms, a medical device manufacturing space, a device assembly cleanroom, and supporting infrastructure including laboratories and office space.
• The facility is Vaxxas’ new global headquarters and home to 130 employees including highly-skilled and experienced engineering and scientific experts. The company expects to grow to 200 employees in the next three to five years.
• Vaxxas’ proprietary HD-MAP technology platform has the potential to improve vaccination by creating vaccine products that are easy to use (potentially enabling self-administration) and which can be stable at room temperature, reducing the complexities and costs associated with refrigerated distribution required for many existing vaccines.

CAMBRIDGE, Mass. & BRISBANE, Australia–(BUSINESS WIRE)–Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform technology, today announced the opening of its first, state-of-the-art manufacturing facility in Brisbane, Queensland. The custom-built 5,500 square meter (60,000 square feet) Vaxxas Biomedical Facility will serve as the company’s global headquarters and support the scale-up of its operations to produce HD-MAP vaccines for future late-stage clinical trials and first commercial products.

The Queensland Government provided funding and operational support to Vaxxas in developing the facility. Vaxxas has received additional funding from the Australian Government through its Modern Manufacturing Initiative to support the installation of specialized manufacturing and production infrastructure. The facility represents a significant investment in the future of Queensland’s and Australia’s biotech sectors.

Queensland Deputy Premier, Minister for State Development, Infrastructure, Local Government and Planning and Minister Assisting the Premier on Olympic and Paralympic Games Infrastructure, The Honorable Dr. Steven Miles officiated the opening.

“Queensland is fast shaping up as a global research and innovation hub thanks to the Palaszczuk Government’s investment in state-of-the-art facilities like this one. Economic Development Queensland worked closely with Vaxxas to progress designs and approval for this facility, so it’s fantastic to be here to open it,” Deputy Premier Steven Miles said.

“The Government is committed to supporting Queensland biomedical start-ups to scale up successfully and ensure we keep this innovation and our best and brightest researchers on home soil.

“This world-renowned technology has the potential to play a vital role in pandemic-preparedness because it allows vaccines to be deployed quickly and easily to our communities.

“Queensland is going from strength to strength as the place to work and invest in science, and Vaxxas is a fantastic example of a home-grown biotech success story that we need to retain here in Queensland. The opening of the Vaxxas Biomedical Facility in Brisbane’s Northshore is taking us one step closer to achieving that goal,” the Deputy Premier concluded.

Vaxxas’ proprietary HD-MAP technology platform has the potential to improve vaccination by creating vaccine products that are easy to use (potentially enabling self-administration) and can be stable at room temperature, reducing the complexities and costs associated with refrigerated distribution required for many existing vaccines.

Vaxxas Chief Executive Officer David Hoey said the facility’s opening marked a significant milestone for the biotech company which was founded in 2011 on research from The University of Queensland.

“The Vaxxas Biomedical Facility represents a new and exciting chapter for our company, as it is foundational for our next phase of growth. With the support of the Queensland State and Australian Federal Governments, the Vaxxas Biomedical Facility will firmly position Australia at the forefront of vaccine technology innovation. The site will significantly increase our manufacturing capacity, creating new local, skilled jobs, while enabling Vaxxas to progress through late-stage clinical trials that will bring our first commercial vaccine products to the market,” said Mr. Hoey.

Vaxxas currently employs 130 people in its Queensland operations, and is planning for an increase to 200 employees over the next three to five years. The new facility will enable Vaxxas’ R&D teams to work side by side with manufacturing teams, to expand existing R&D work and streamline the translation from research to eventual commercialization.

The facility also provides a blueprint for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally as demand for its platform technology grows.

Manufacturing will be conducted in compliance with Good Manufacturing Practice (cGMP) standards which will also meet the requirements of the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the European Medicines Agency as well as other global health regulators.

With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for COVID-19 and seasonal influenza; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), and a measles-rubella study funded by the Bill & Melinda Gates Foundation, expected to start in 2024, Vaxxas’ HD-MAP vaccine delivery platform is advancing rapidly toward commercialization.

About Vaxxas’ HD-MAP technology

The Company’s proprietary HD-MAP technology platform utilizes an ultra-high-density array of projections – invisible to the naked human eye – applied to the skin as a patch sitting inside a small applicator device. When applied to the skin, the patch delivers vaccine to the abundant immune cells immediately below the skin surface. This approach can enhance the efficiency and effectiveness of resulting immune responses of vaccines.

Vaxxas uses proprietary dry-coating technology to apply an active and stable vaccine onto the projections, which offers the potential to eliminate the need for vaccine refrigeration during storage and transportation – reducing the resource and logistics burden of maintaining the refrigerated “cold chain.” Ease of use of the HD-MAP could enable simplified administration, potentially encompassing self-administration.

Vaxxas has six clinical programs underway with multiple vaccines and partners. Among these programs the Vaxxas HD-MAP is currently being evaluated in Phase I human clinical trials for Covid-19 and seasonal influenza. In addition, Vaxxas is preparing for clinical evaluation of a pandemic influenza vaccine under contract with the United States Biomedical Advanced Research and Development Authority (BARDA).

With leading global health organisations investing in the company’s HD-MAP technology and programs, including the Bill and Melinda Gates Foundation, World Health Organization (WHO) and CEPI (Coalition for Epidemic Preparedness Innovations), Vaxxas is also working towards improving access to vaccines in hard-to-reach areas by simplifying vaccine distribution and administration.

About Vaxxas

Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology. For more information, visit https://www.vaxxas.com/.

Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners, Brandon BioCatalyst, and US-based HealthCare Ventures, followed by a further financing rounds led by OneVentures with UQ joining the most recent financing.

OneVentures Innovation Fund I and Brandon BioCatalyst 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.vc.

Caution

Vaxxas’ HD-MAP delivered vaccines are under investigation and available only for investigational uses. They are not available anywhere in the world for sale or purchase. As such, Vaxxas makes no claim that the vaccines are reliable, durable, dependable, safe or effective, and makes no claim that it is superior to any other vaccine or vaccine delivery technology.

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