The grant has been awarded under the Australian Federal Government’s Modern Manufacturing Initiative (MMI).
In 2021, Vaxxas received AU$4.4m in first round MMI funding to support the specialized infrastructure necessary to manufacture its high-density microarray patch (HD-MAP) device at its facility currently under construction at Northshore, Brisbane.
That new site will support late-stage clinical trials and early commercial production. It is due to open in early 2023.
The latest funding will allow the team to develop and establish a sterile production line using proprietary aseptic fill and finish processes, further advancing the company’s vaccine coating, device sealing and quality control technologies.
In addition to relocating its existing workforce of more than 100 employees to the site, the Brisbane facility will support the creation of 29 new highly skilled jobs and the ongoing growth and development of the biotech and MedTech sectors in South-East Queensland, said the developer.
The company’s core technology was initially developed at the University of Queensland.
David Hoey, Vaxxas CEO, told BioPharma-Reporter that the HD-MAP platform can be used with any vaccine. “Clinically, we had more than 300 participants spanning three phase I studies to date (2 x seasonal influenza, 1 x measles-rubella), and we are about to commence a phase I study with an advanced COVID-19 vaccine. In preclinical models, we’ve worked with vaccines for more a dozen disease indications and many different types of vaccine constructs. Much of this work is peer-reviewed and published.”
How do the patches work?
The HD-MAP has thousands of micro-projections about 250-300um in length that Vaxxas coats with the vaccine.
“When applied to the skin, the micro-projections deposit the vaccine antigen directly and intimately amongst dense populations of immune cells that reside in the skin. These immune cells capture the vaccine antigens and traffic them to the lymph nodes for processing. We are essentially delivering the vaccine directly to the lymphatic system, whereas, with needle/syringe injection, the vaccine antigens injected into muscle have a much more circuitous route to get to a lymph node, for generation of response,” continued Hoey.
Vaxxas has a large project underway with the US government focused on pandemic influenza. “We also have a relationship with Merck, working on a key vaccine; and for the Bill and Melinda Gates Foundation, we are advancing clinical development of a measles-rubella HD-MAP into phase II next year. We’ll be announcing some new ‘global’ relationships over the next few months,” added the CEO.
Improving pandemic and routine vaccination
The vaccination technology has the potential to fundamentally improve pandemic and routine vaccination, he said. “In areas such as pandemic preparedness/response, the HD-MAP can add extraordinary value by accelerating vaccination speed.”
Vaxxas is already working with the US government in that respect, and the company is also holding discussions with other governments on the same topic.
“Similarly, in lower-and-middle income countries, as HD-MAP vaccines can be stable outside cold-chain refrigeration and can be applied with low-skill, they can extend the reach of vaccines significantly. However, products sold into these markets are at extremely low margins, so clinical and CAPEX investment needs to come from global-health bodies.
“We believe that in high income countries, over time, skin-delivery of vaccines will become the standard. Based on the underlying science, it doesn’t actually make sense to use needle/syringe intramuscular delivery. And certainly, from a marketing perspective, most people will overtly prefer a patch to needle-syringe injection.”
In 2020, the Gavi-led Vaccine Innovation Prioritization Strategy (VIPS) Alliance identified micro-array patches as the highest priority innovation to improve vaccine coverage and contribute to pandemic preparedness. It has since developed an integrated end-to-end (from product development to country uptake) strategy to hasten their availability, with input from vaccine manufacturers and developers.