Vaxxas Announces and Publishes Successful Phase I Clinical Trial for Measles and Rubella Vaccine Delivered Using its Proprietary High-Density Microarray Skin Patch; Plan for Phase I/II Trial in The Gambia, Africa

• A single dose of measles and rubella (MR) vaccine delivered to adults by the Vaxxas high-density microarray patch (HD-MAP) provided antibody responses comparable to the same vaccine delivered by needle and syringe.
• Higher antibody responses in study participants with the lowest levels of pre-existing antibodies to MR; providing a solid foundation for an upcoming trial in a population never before immunized for MR.
• There were no serious adverse events in any study group in this Phase I study.
• Results support initiation of Phase I/II age de-escalation trial in adults and children, which will be conducted by PATH, a globally respected healthcare institution, in The Gambia, Africa.
• MR program development has been and will continue to be supported by the Bill & Melinda Gates Foundation, expanding Vaxxas’ clinical pipeline, which also includes vaccines for COVID-19, influenza, and typhoid.

Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, has published positive results from a human clinical trial involving its potentially game-changing technology that enables vaccines to be applied to the skin using a small patch, instead of using traditional needle and syringe.

The study, completed by the University of the Sunshine Coast, in Queensland, Australia, involved the delivery of a measles and rubella (MR) vaccine using the Vaxxas high-density microarray patch (HD-MAP) technology. The trial involved 60 (total) young, healthy adult participants; 30 of whom received the HD-MAP delivered vaccine at different doses; 15 of whom received a comparative vaccine delivered by needle and syringe; and 15 of whom received an HD-MAP delivered placebo product.

Study participants receiving the MR vaccine delivered by HD-MAP, showed a significant increase in neutralizing antibodies compared to placebo and a comparable response to the same comparator vaccine delivered with needle and syringe.

There was also a strong correlation between starting levels of neutralizing antibodies and impact of the HD-MAP delivered vaccine, with participants having the lowest levels of pre-existing antibodies to MR showing the strongest response after vaccination.

There were no serious adverse events or treatment-related adverse events that led to study withdrawal in any study group.

Data from the study has been published in the Switzerland-based journal MDPI Vaccines.

The Vaxxas HD-MAP uses a high-density array of microprojections – invisible to the human eye – that is applied to the skin as a patch sitting in a small applicator device. When applied to the skin, the patch rapidly delivers vaccine to the abundant immune cells that are naturally present immediately below the skin surface. This approach has been shown to enhance immune responses to vaccines. The HD-MAP technology also offers the potential to eliminate or minimize 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.

“We are incredibly pleased with the results of this groundbreaking clinical trial,” David Hoey, Vaxxas Chief Executive Officer, said. “Measles and rubella remain significant health concerns in many parts of the world, and we look forward to moving this product forward to later stage clinical trials.”

Prior to COVID-19, vaccination rates against measles and rubella had plateaued and there is now evidence to suggest they have dropped further during the pandemic, putting millions of children at risk.

Peter McIntyre, Professor in the Discipline of Child and Adolescent Health and the School of Public Health, The University of Sydney, Australia and Professor in the Department of Women’s and Children’s Health, University of Otago, New Zealand, said the Vaxxas technology has the potential to revolutionize vaccine delivery and significantly extend the global reach of vaccines.

“The HD-MAPs thermostability qualities and potential to be administered with less training, even self-administered, could allow us to take much-needed vaccines into traditionally hard-to-reach communities,” Professor McIntyre said. “Particularly in lower- and middle-income countries, where vaccination rates are low and deaths caused by vaccine-preventable diseases are still too high.”

The completed clinical trial was conducted with funding provided by a grant from the Bill & Melinda Gates Foundation.

“We are incredibly grateful to have received these grants from the foundation,” Mr. Hoey said. “Without their ongoing support we would not be able to advance the program.”

Based on this data, Vaxxas is progressing toward a Phase I/II clinical trial in The Gambia, Africa. Sponsored by PATH, this trial will again investigate the safety of the HD-MAP, as well as its potential to produce similar immune responses to needle-and-syringe vaccination. The Phase I component will be a small age de-escalation study which, safety outcomes allowing, will progress to the Phase II component including 400 infants aged between nine and eleven months not previously immunized against measles or rubella.

This planned Phase I/II MR clinical program will be supported in part by an additional grant from the Bill & Melinda Gates Foundation. Continued funding of this MR HD-MAP program by the Bill & Melinda Gates Foundation supports Vaxxas’ expanding clinical pipeline, which includes vaccines for COVID-19, influenza, and typhoid.

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 diseases and oncology.

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), Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization.

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 and US-based HealthCare Ventures, followed by a further financing 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 One-Ventures and Brandon Capital

Caution

The 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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