HD-MAP

CAMBRIDGE, MA, USA & BRISBANE, Australia I September 11, 2024 I Vaxxas today announced that it has initiated a multi-center Phase I clinical trial of a vaccine against pre-pandemic avian influenza strain H7N9, using the company’s high-density microarray patch (HD-MAP). Conducted in collaboration with Australian clinical sites, the multi-center trial is being led by Vaxxas with oversight by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, and is designed to expand foundational novel countermeasure capabilities in response to potential future pandemic threats to public health. Vaxxas’ HD-MAP platform delivers vaccines by applying a small patch briefly to the skin, avoiding many of the costs and complexities of needle and syringe vaccination. The HD-MAP enables the delivery of vaccine directly to the dense populations of skin-resident immune cells enhancing immune responses with potential dose-sparing benefits . The HD-MAP is easy to use, and vaccines can be stable at room temperature , avoiding or minimizing the need for cold-chain refrigeration and facilitating distribution of vaccine patches by mail and courier for potential self-administration. The clinical study includes 258 healthy participants between the ages of 18 and 50 years, making it the largest Phase I trial conducted-to-date by Vaxxas with its HD-MAP technology. The trial will compare the safety and immune response of participants to this H7N9 vaccine, when dosed with Vaxxas’ novel HD-MAP as well as through conventional needle and syringe. Initial results from the trial are expected in 2025 and will be provided to BARDA and published by Vaxxas and its clinical collaborators. “Global pandemic threats require the world’s health organizations to have better and more accessible vaccine delivery options. With potential benefits such as thermostability, ease of use, and patient acceptability, Vaxxas’ HD-MAP is designed to be rapidly and broadly deployed to accelerate vaccination uptake and rates,” David L. Hoey, President and CEO of Vaxxas, said. “Market research indicates that – given the choice – vaccination by HD-MAP is significantly preferred over conventional needle-and-syringe.” The influenza A virus circulates as numerous strains across the globe. The World Health Organization (WHO) states the H7N9 avian influenza strain is ‘of concern’ as most patients have become severely ill . This Australian-based Phase I clinical study is being conducted at three of the University of the Sunshine Coast’s clinical trial centers in Queensland and the Doherty Clinical Trial center in Melbourne, Victoria. About Avian influenza A (H7N9) This selected variant of avian influenza A (H7N9), or bird flu, is a subtype of influenza viruses that have been detected in birds, livestock, and people in the past. The World Health Organization (WHO) states the H7N9 avian influenza strain is ‘of concern’ as most patients have become severely ill . H7N9 has an observed Infection Fatality Rate (IFR) of 39%, meaning for every 100 infected people 39 people are likely to die and many are likely to become seriously sick. To date, more than 1,500 people have been infected by H7N9 worldwide since early 2013, according to WHO . About HD-MAP needle-free vaccines The Vaxxas high-density microarray patch ( HD-MAP ) is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is ‘printed’ with a small dose of vaccine in a dried formulation. When applied to the skin, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface. HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore potentially reducing the need for cold-chain storage and distribution. Vaxxas’s HD-MAPs have proven safe and tolerable in hundreds of trial participants to date , and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, HD-MAP vaccines are also much easier to administer and are likely to have greater acceptability. Ultimately, HD-MAP patches could enable a future in which vaccine patches could be delivered directly to peoples’ homes, workplaces, and schools for self-administration, avoiding the delay and inconvenience of traditional needle-and-syringe vaccine scheduling and administration. In a pandemic situation, this distribution method could also avoid large groups of people having to congregate in central locations for vaccination, reducing the risk of further infections. 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 targeting pandemic influenza, funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, 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. SOURCE: Vaxxas

A simple-to-apply, needle-free vaccine patch is being developed to protect people from the potentially deadly mosquito-borne Zika virus. A simple-to-apply, needle-free vaccine patch is being developed to protect people from the potentially deadly mosquito-borne Zika virus. A prototype using The University of Queensland-developed and Vaxxas-commercialised high-density microarray patch (HD-MAP) has delivered a University of Adelaide-developed vaccine and elicited an effective immune response to Zika virus in mice. UQ alum and Vaxxas researcher Dr Danushka Wijesundara said Zika virus was a risk to people across the Pacific, Southeast Asia, India, Africa and South and Central America. "We can change the way we combat Zika virus with the HD-MAP patch because it is an effective, pain-free, simple to apply, and easy to store vaccination method," Dr Wijesundara said. "HD-MAP delivers the vaccine to immune cells beneath the skin's surface with thousands of tiny microprojections. "In our pre-clinical trial, the vaccine provided rapid protection against live Zika virus, targeting a specific protein called NS1 which is crucial to the virus's survival. "The vaccine patch evoked T-cell responses that were about 270 per cent higher than from a needle or syringe vaccine delivery." Zika virus generally causes a mild illness but infection in pregnancy can lead to miscarriage and stillbirths or infants born with congenital malformations. In February 2016, the World Health Organization declared a Public Health Emergency of International Concern when Zika virus spread across 40 countries in Latin America, causing more than 1.5 million confirmed or suspected cases in a 6-month period. The University of Adelaide's Associate Professor Branka Grubor-Bauk said limited global surveillance shows Zika virus is active in at least 89 countries and territories but there is no currently licensed vaccine. "This vaccine is unique because it targets a protein inside, rather than outside of the virus meaning it won't enhance the symptoms of closely related viruses such as dengue fever, in people who've been vaccinated," Dr Grubor-Bauk said. Dr David Muller from UQ's School of Chemistry and Molecular Biosciences said the microarray patch and the vaccine could have benefits beyond the ability to protect from Zika virus. "Because the protein we're targeting plays a central role in replication in a virus family known as flaviviruses, there's the potential to apply our approach to target other flaviviruses such as dengue or Japanese encephalitis," Dr Muller said. "It could also deliver a vaccine mixture to target the whole family of viruses, providing greater protection. "A major benefit of the HD-MAP delivery platform is vaccine stability at elevated temperatures -- we found the patch retained vaccine potency when stored at 40 degrees Celsius for up to four weeks. "This increases the reach of vaccines in low- and middle-income countries where refrigeration is challenging." The research team would like to acknowledge the National Health and Medical Research Centre (NHMRC) for funding awarded to Dr Muller and The Hospital Research Foundation Group Fellowship awarded to Dr Branka Grubor-Bauk, who supported the project.