Vaxxas Announces Interim Phase I Study Results for First Needle-Free HD-MAP COVID-19 Vaccine
June 6, 2023
Vaxxas, a clinical-stage biotechnology company commercialising a novel vaccination platform, today announced 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 patch is based upon HD-MAP delivery of a SARS-CoV-2 spike subunit vaccine candidate from The University of Texas at Austin (UTA). The vaccine candidate is a second-generation version of the spike protein used in the major US-approved COVID-19 vaccines, and has been modified for stability and immunogenic response, giving potential coverage of all known SARS-CoV-2 variants.
The interim data from the study showed the HD-MAP COVID-19 vaccine patches were well tolerated, with no serious or severe adverse events. Analysis of samples from day 28 shows the HD-MAP COVID-19 vaccine increased relevant antibody levels by eight-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 assessed the safety, tolerability, and immunogenicity of the HD-MAP COVID-19 vaccine candidate in 44 healthy adults, aged 18 – 50 years inclusive. Participants were required to have had three doses of an authorised COVID-19 vaccine prior to enrollment in the study, with the last dose received at least four months prior to participating.
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.
The interim data supports Vaxxas’ progress toward seeking approvals for a COVID-19 vaccine patch with the Therapeutic Goods Administration (TGA) in Australia and Food and Drug Administration (FDA) in the United States. With successful completion of the Phase I clinical study, and following subsequent Phase II and Phase III studies, the COVID-19 vaccine patch could be available as early as 2025. Preclinical research published in Science Advances and Vaccine, undertaken with The University of Queensland and other collaborators, demonstrated that the UTA COVID-19 vaccine candidate delivered using Vaxxas’ HD-MAP resulted in enhanced virus neutralising 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.
Vaxxas is a privately held biotechnology company focused on enhancing the performance of vaccines with its core proprietary technology, the high-density microarray patch (HD-MAP).
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 The University of Queensland joining the most recent financing.
Vaxxas has six clinical programs underway with various 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 at the University of the Sunshine Coast. 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 working towards improving access to vaccines in hard-to-reach areas by simplifying vaccine distribution and administration.
About the HD-MAP
The HD-MAP utilises 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. Early clinical studies have shown 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 HD-MAP projections. The dry-coating technology offers the potential to eliminate the need for refrigeration of the vaccine patches during storage and transportation – reducing the resource and logistics burden of maintaining the refrigerated “cold chain.” Ease of use of the HD-MAP shown in early clinical studies has been found to potentially enable simplified administration, potentially encompassing lower-skilled or self-administration.
Vaxxas is targeting initial applications for the HD-MEP in infectious diseases and oncology. For more information, visit www.vaxxas.com.
About OneVentures and Brandon BioCatalyst
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.