Vaxxas and CEPI Advance US$4.8 million (AU$7.2 million) Program for Needle-Free Thermostable mRNA Vaccines

CAMBRIDGE, Mass. & BRISBANE, Australia--(BUSINESS WIRE)--Vaxxas, a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform, today announced that CEPI, the Coalition for Epidemic Preparedness Innovations, has approved the progression of a US$4.8 million (AU$7.2 million) program to develop heat-stable, dried-formulation mRNA vaccines delivered using Vaxxas’ needle-free high-density microarray patch (HD-MAP). The approval follows promising results from Vaxxas’ preclinical work, including expression of a seasonal influenza antigen that demonstrated dose-dependent immunogenicity of mRNA in lipid nanoparticles (LNPs) when delivered by Vaxxas’ HD-MAP technology. The studies also showed that, once loaded onto the HD-MAP, the mRNA-LNPs could maintain stability at 2–8°C and 25°C for at least 12 months, and 40°C for at least one month. Vaxxas will partner with leading global vaccine developer SK bioscience in this next phase of the program, advancing the company’s mRNA vaccine for Japanese Encephalitis Virus (JEV) on Vaxxas’ HD-MAP towards a Phase I clinical study. The work will focus on further optimising mRNA vaccine formulations for assessment by in vitro and in vivo preclinical studies. Vaxxas expects the development work performed with the JEV vaccine candidate to be transferrable across all mRNA vaccine antigens delivered by LNPs, providing a platform approach that can be advanced to human trials. Currently, mRNA vaccines require expensive and challenging end-to-end, ultra-cold-chain distribution and storage requirements, a significant barrier to vaccine accessibility in low-and middle-income countries and hard-to-reach areas around the world. Vaxxas’ HD-MAP technology has demonstrated improved thermostability with several vaccines, with the potential to reduce the cost and complexities associated with current cold-chain requirements. The technology is also easy to use, potentially requiring less training to administer, and even supporting self-administration. The continued success of this program could enable increased global access to innovative, life-saving mRNA vaccines. “Our HD-MAP technology offers a potential solution to the growing need to significantly expand global access to innovative mRNA vaccines by eliminating the current ultra-cold storage requirements for these vaccines,” said David L. Hoey Vaxxas CEO and President. “With compelling proof-of-concept results in hand, we’re excited to have CEPI’s commitment to advance to the next stage of development. We’re equally excited to be working with SK bioscience and its JEV mRNA vaccine on this program to realize the promise of our HD-MAP technology to move the world closer to a commercially available, thermostable patch-based mRNA vaccine.” This program was funded by CEPI in 2023, as part of its aim to improve the thermostability, and therefore equitable access, of mRNA vaccines. “The tremendous success of mRNA vaccines in recent years provides the world with a powerful alternative to traditional vaccines for fighting global infectious diseases – but only if we can get them to the regions and people who need them most,” said Dr Raafat Fahim, Executive Director of Vaccine Manufacturing Supply Chain, CEPI (Acting). “Vaxxas’ technology has the potential to help address current inequities in access to mRNA vaccines, by eliminating the need for ultra-cold storage to increase equitable global distribution, while also being needle-free and easy to use.” This program is Vaxxas’ second collaboration with global vaccine developer SK bioscience. The companies are also working on a program, funded by global charitable organisation Wellcome, to advance the development of a HD-MAP/Typhoid conjugate vaccine candidate. “We are excited to extend our collaboration with Vaxxas, whose innovative HD-MAP technology has the potential to transform mRNA vaccine delivery, aiming to overcome the challenges of cold-chain dependency,” said Jaeyong Ahn, CEO and President of SK bioscience. “This partnership underscores our shared mission to contribute to global public health and ensure equitable access to life-saving vaccines for communities worldwide. We are committed to working together to create solutions that drive innovation in vaccine technology.” Vaxxas plans to progress this stage two program of work from Q1 2025. About HD-MAP needle-free vaccines The Vaxxas HD-MAP is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary, easy-to-use applicator, 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’ 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 by healthcare workers and vaccine recipients. Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to peoples’ homes, workplaces, and schools, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration. About Vaxxas Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary 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 seasonal influenza and COVID-19; 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 OneVentures and Brandon Capital. About CEPI CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens or a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. SK bioscience Website SK bioscience Linkedin Note to Editor: CEPI and Vaxxas are committed to enabling global equitable access to the vaccines they develop including those incorporating patch technology. Under the terms of the funding agreement, Vaxxas has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-income and middle-income countries (LMICs), production of vaccine volumes required to meet public health needs, with affordable pricing, and the potential technology transfer to LMIC manufacturers in line with CEPI’s Equitable Access Policy. 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.

Vaxxas and CEPI Advance US$4.8 million (AU$7.2 million) Program for Needle-Free Thermostable mRNA Vaccines

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