Vaxxas Secures New U.S. Patent For its Needle-Free Vaccination Manufacturing Technology

Vaxxas, a clinical-stage biotechnology company, today announced it has secured a new patent from the United States patent office covering proprietary manufacturing technology for its novel vaccination platform, the high-density microarray patch (HD-MAP).

The HD-MAP is comprised of thousands of microscopic projections moulded into a small patch. The claims included in the new patent relate to the company’s proprietary printhead system that accurately and consistently dispenses a dried formulation of vaccine onto the HD-MAP microprojections in small doses. When the patch is applied to the skin, it delivers the vaccine to the abundant immune cells below the skin surface.

“The printhead system has been specifically designed to coat the HD-MAP with vaccines in an aseptic environment that complies with government regulations for clinical and commercial manufacturing of vaccines,” Dr. Scott Fry, Vaxxas Chief Operating Officer, said. “This is a critical phase of our manufacturing process. It enables us to coat the HD-MAP at high speed and in a consistent manner to achieve large volumes without compromising the quality of the end product.”

“The precision by which the printhead system coats the vaccine onto each microprojection is quite incredible, and a significant achievement by our team of engineers,” Dr. Fry said. “It’s great to have this recognised and covered by the U.S. patent office.”

The issuance of this recent U.S. patent adds to Vaxxas’ expanding international intellectual property portfolio of 43 issued patents, and supports the company’s exclusive claim to manufacture and sell its proprietary vaccination technology, in the United States, Europe, Asia and Australia.

More broadly, Vaxxas’ patent portfolio covers all significant proprietary aspects of the company’s vaccine delivery platform and products, including the manufacture and use of the HD-MAP technology and novel applicator device; vaccine formulations; and methods for formulating, loading and coating vaccines on HD-MAP technology.

“Vaxxas is aiming to transform the vaccine market by improving the performance of vaccines and reducing the economic and logistical challenges typically associated with needle-and-syringe vaccination,” David Hoey, Vaxxas Chief Executive Officer, said. “The breadth of our patent portfolio protects our exclusive use of the technologies necessary to achieve this goal, as well as freely manufacture and sell our products at commercial scale and in a safe and regulatory compliant manner.”

Vaxxas is scaling up to manufacture and distribute the world’s first commercially available vaccine patches from its global headquarters and state of the art biomedical facility in Brisbane.

Vaxxas’ HD-MAP technology has completed five successful Phase I clinical trials involving over 500 participants with vaccines that address some of the world’s biggest health challenges including COVID-19, flu, and measles and rubella.

Vaxxas has recently completed the enrollment for a U.S. IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants, with funding from the United States Biomedical Advanced Research and Development Authority (BARDA). Preliminary results from that trial are expected in June of this year.

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, Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialisation. The company has completed Phase I clinical trials for COVID-19, seasonal influenza, and measles and rubella vaccine patches involving more than 500 participants; and conducted other vaccine studies targeting pandemic influenza with funding from 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’ 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 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 further financing led by OneVentures, joined by UQ.

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 HD-MAP needle-free vaccines

The Vaxxas high-density microarray patch (HD-MAP) is comprised of thousands of microscopic projections moulded 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 has the potential to overcome challenges faced by traditional needle and syringe delivery of vaccines. For example, the dried form of the vaccine has been shown in early clinical studies to be more stable at higher temperatures than vaccines in liquid formulations, potentially reducing the need for cold-chain storage and distribution.¹

Previous studies have also shown the safety and tolerability of Vaxxas’ HD-MAP for use in vaccine delivery and inducing equal or greater immune responses to injected vaccines at lower doses.¹ Compared with needle and syringe systems, HD-MAP vaccines are designed to be easier to administer and have potential use in future pandemic responses.¹

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.

References

¹ Baker, B., Hacker, E., Siller, G., Lee, M., Mursaliyev, N., & Forster, A. (2023). Evaluation of the self-administration potential of high-density microarray patches to human skin: A preliminary study. Human Vaccines & Immunotherapeutics, 19(1). https://doi.org/10.1080/21645515.2023.2189409

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