• Vaxxas to complete Phase 1 clinical studies in 2022 with the world’s first needle-free COVID-19 vaccine (HexaPro) to be delivered using Company’s proprietary microarray patch (HD-MAP) technology
• HexaPro is a second-generation SARS-CoV-2 spike protein that is similar to the spikes used in all COVID-19 vaccines on the U.S. market, but modified to be more stable and more immunogenic
• Vaxxas’ proprietary HD-MAP patch has been designed to eliminate the need for refrigerated distribution and to allow for administration by individuals with minimal training, or even self-administration, making distribution during a pandemic more efficient

Vaxxas, a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform, today announced that The University of Texas at Austin has granted Vaxxas an exclusive license to a next-generation SARS-CoV-2 spike subunit vaccine (HexaPro), for vaccination using a patch.

The license from UT Austin, along with a companion background technology license obtained by Vaxxas from the United States’ National Institutes of Health (NIH), enables Vaxxas to create the first needle-free, room-temperature stable COVID-19 vaccine patch to enter clinical studies.

HexaPro, a highly stabilized protein that is designed to mimic the structure of the spike protein on the surface of the coronavirus to train the human immune system to recognize and fight SARS-CoV-2 infection, is the most advanced spike protein from UT Austin’s world-renowned vaccine development team.

Preclinical research recently published in Science Advances demonstrated that HexaPro delivered using Vaxxas’ HD-MAP (HD-MAP/HexaPro) resulted in enhanced virus neutralizing antibody and T-cell responses against all variants of concern, including alpha, beta, gamma, delta, and omicron, when compared to needle and syringe vaccination with HexaPro.

“The compelling preclinical results published in Science Advances established the potential superiority of the HD-MAP/HexaPro COVID-19 vaccine compared to delivery using the traditional needle and syringe,” said David L. Hoey, President and CEO of Vaxxas. “We can now rapidly advance our clinical trials with our next-generation COVID-19 vaccine patch.” Vaxxas plans to complete a Phase 1 clinical study of its proprietary HexaPro/HD-MAP COVID-19 vaccine this year.

"The current pandemic has underscored the lifesaving potential of innovative technologies, and we think novel vaccination approaches clearly offer unique benefits. Vaxxas’ proprietary HD-MAP technology can enable cost-effective distribution without the need for extensive refrigeration, and our easy-to-use device offers the potential for self-administration,” Mr. Hoey said. “These attributes offer a truly scalable, distinct, and differentiated approach to greatly improve pandemic vaccination capabilities globally.”

“Just as the virus has changed and evolved, our vaccines need to keep up with the latest challenges, too, and a key challenge now is vaccinating the world,” said Dr. Jason S. McLellan, Professor of Molecular Biosciences and Robert A. Welch Chair in Chemistry at the University of Texas at Austin. “It’s exciting to see HexaPro on the cusp of entering clinical trials with a patch-based technology that could be a real game-changer for parts of the globe where access to vaccines has been limited so far.”

About Spike Proteins and HexaPro

The University of Texas at Austin’s Jason McLellan and his collaborators at the NIH are the designers of an early version of the SARS-CoV-2 spike protein that was genetically altered by swapping in two amino acids called prolines, used to stabilize the spike protein and allow the immune system to better fight off infection. The earlier spike protein is used in leading existing COVID-19 vaccines, including all of the vaccines currently distributed in the United States and others approved under emergency use authorization in multiple countries. In 2020, McLellan and his lab teamed up with the labs of two other UT Austin faculty members—Ilya Finkelstein, an associate professor in the Department of Molecular Biosciences, and Jennifer Maynard, a professor in the Cockrell School of Engineering—in designing a new spike protein, this time stabilized with six genetic alterations and so named HexaPro. In July of 2020, the team published findings in Science that HexaPro expresses up to 10 times as much protein as the spike protein found in the current vaccines, making it a powerful second-generation vaccine antigen.

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 to rapidly deliver 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 – easing 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.

In extensive laboratory testing, Vaxxas’ HD-MAP delivered vaccines have been shown to be stable and remain active when stored and transported at room temperature and shown greater safety and protection, along with a potential for a lower dose, when compared to needle and syringe delivery of HexaPro.

Vaxxas has completed three human clinical studies of HD-MAP involving more than 300 participants, demonstrating safety, and enhanced immune response of vaccine administration by HD-MAP.

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. In addition to the planned HD-MAP HexaPro clinical studies, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions.

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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