Vaxxas Announces Interim Results from Phase I Clinical Study of First Needle-Free COVID-19 Vaccine Delivered Using Proprietary High-Density Microarray Patch (HD-MAP)

• Encouraging interim results from Phase 1 human clinical trial show COVID-19 vaccine candidate, called HexaPro, to be safe and well tolerated with positive signals of antibody responses to SARS-CoV-2.
• HexaPro is a second-generation version of the spike proteins used in all U.S. approved COVID-19 vaccines, which has been modified to be more stable and immunogenic, giving potential coverage of all SARS-CoV-2 variants.
• Vaxxas’ proprietary HD-MAP patch has the potential to simplify vaccination logistics and administration by eliminating or reducing the need for refrigerated distribution and storage, and potentially enable self-administration.
• These interim study results will be presented at the 2023 BIO International Convention.

Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced positive interim results from a Phase I human clinical trial with the first needle-free COVID-19 vaccine candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.

The COVID-19 vaccine involves HD-MAP delivery of HexaPro, a second-generation version of the spike protein used in all major U.S. approved COVID-19 vaccines, which was modified to be more stable and immunogenic than its predecessor, giving potential coverage of all known SARS-CoV-2 variants. The HD-MAP COVID-19 vaccine patches were well tolerated, with no serious or severe adverse events. Analysis of samples from day 28 show the HD-MAP COVID-19 vaccine increased relevant antibody levels by 8-fold on average, and the antibody responses indicated a dose dependent trend.

“We are very encouraged by the compelling early data and rapid progress of our needle-free COVID-19 vaccine candidate,” said Vaxxas Chief Executive Officer David L. Hoey. “We believe our patch-based delivery of a next generation spike protein has the potential to offer best-in-class protection against COVID-19 along with cost-effective distribution without the need for extensive refrigeration.”

The Phase I clinical trial is designed to assess the safety, tolerability and immunogenicity of the HD-MAP COVID-19 vaccine candidate in 44 healthy adults, aged 18 – 50 years inclusive, who have had three doses of an authorized COVID-19 vaccine prior to enrollment in this study, with the last dose at least four months prior to participating in the study. The Phase I clinical study was fully enrolled and all participants have now completed the final step in the study. In addition to the above measured outcomes, the trial is also designed to gather signals related to antibody and T-cell responses, including mucosal responses, to dosing with the patch-delivered vaccine candidate.

Preclinical research published in Science Advances and Vaccine, undertaken with The University of Queensland and other collaborators, demonstrated that HexaPro delivered using Vaxxas’ HD-MAP resulted in enhanced virus neutralizing antibody and T-cell responses against all major variants of concern, including alpha, beta, gamma, delta, and omicron, when compared to needle and syringe vaccination with HexaPro.

About Vaxxas’ HD-MAP Technology and COVID-19 vaccine candidate

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.

To create the COVID-19 vaccine candidate, Vaxxas' HD-MAP is coated with HexaPro vaccine and integrated into a single-use applicator, ready-for-vaccination. HexaPro is a highly stabilized protein 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. HexaPro is the most advanced spike protein from UTA’s world-renowned vaccine development team.

In extensive laboratory testing published in PLoS Med, Vaxxas’ HD-MAP delivered vaccines have been shown to be stable and remain active when stored and transported at room temperature and demonstrate greater safety and protection, along with a potential for a lower dose, when compared to needle and syringe delivery of vaccine antigens, including the HexaPro SARS-CoV-2 spike protein.

Vaxxas has completed three human clinical studies with its HD-MAP involving more than 300 participants, demonstrating safety and enhanced immune response of vaccine administration by HD-MAP. Two additional human clinical studies with a further 200 participants are currently underway.

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 this Phase I clinical study of the COVID-19 vaccine candidate patch, 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 (UQ), and the company was established as a start-up in 2011 by UQ’s commercialisation company 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 further financing rounds led by OneVentures, with University of Queensland 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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