HexaPro (Vaxxas)

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 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. CAMBRIDGE, Mass. & BRISBANE, Australia--(BUSINESS WIRE)-- 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. View source version on businesswire.com: Contacts Media Enquiries In United States: Kathryn Morris The Yates Network +1 914 204 6412 kathryn@theyatesnetwork.com In Australia: Amy Miller WE Communication +61 431 072 422 amymi@we-worldwide.com Source: Vaxxas View this news release online at: