Its platform uses a high density micro-array patch (HD-MAP), which vaccinates by applying a patch to the skin for a few seconds. It is engineered to directly deposit the vaccine among a dense population of key immune cells in the skin for an ‘efficient and effective immune response’.
Vaxxas – a privately held biotech using technology developed by the University of Queensland in Australia – hopes its technology can become ‘the needle-free future of vaccination’.
Phase 1 study
The $22m US government award, announced yesterday, has been funded through the Biomedical Advanced Research and Development Authority (BARDA). It will go towards a $24.1m phase 1 clinical study for the HD-MAP technology (Vaxxas will contribute the remaining $2.1m). The trial will deliver pandemic influenza vaccine to more than 400 people using both unadjuvanted and adjuvanted vaccine formulations.
Vaxxas says its platform is attractive for a pandemic response as it has ‘clinically shown the potential to transform vaccine delivery with lower dose requirements, enabling more patient-doses to be manufactured more quickly from limited vaccine supply’.
In addition, the patch ‘enables faster immune onset kinetics and higher antibody responses’, which could mean more rapid and durable disease protection.
While more than 750 million vaccinations are carried out routinely around the world each year, Vaxxas points out that in a pandemic response, billions are required.
Vaxxas also says its vaccine has several logistical advantages: it does not need refrigeration thus enabling distribution in mass non-specialist channels (the company has shown that vaccine on HD-MAP is stable for 12 months at temperatures up to 40oC.)
Another plus is that vaccines could be self-administered rather than requiring a healthcare setting. A prototype compact manufacturing system has been designed to be capable of delivering more that 250m vaccine doses per year.
Vaxxas’ initial target applications are in infectious disease and oncology; while the company says it is investigating opportunities to improve performance of other pandemic vaccines including against COVID-19.
David L. Hoey, chief executive, Vaxxas, said: “We are excited to partner with BARDA to rapidly deploy Vaxxas’ HD-MAP technology, which holds the promise of significantly improving pandemic response with needle-free vaccine delivery that is more effective and readily accepted.
“Having validated our HD-MAP technology in clinical studies at commercial scale, we stand ready to be among the leading innovators who can solve critical challenges to global pandemic health crises, going beyond and enhancing the capabilities enabled by promising vaccines.”
$9.5m from Bill & Medlinda Gates Foundation
Vaxxas was founded in 2011, setting out with a pipeline of influenza, polio and bacterial infection vaccines. Its strategy is to develop its own vaccine pipeline and license out the patch technology to other drug developers.
In May this year, Merck announced it was exercising its option to use Vaxxas’ technology exclusively for an undisclosed vaccine candidate (a 2012 agreement between the two companies also gives Merck the right to license the technology for two additional vaccines).
In March, it also announced a $5m grant from the Bill & Melinda Gates Foundation - building on an earlier grant for $4.5m for preclinical development – focusing on measles and rubella vaccinations. The philanthropic organisation noted the potential of the platform to reach children in poorer countries with a lack of trained health workers and unreliable transportation and storage facilities.
Vaxxas HD-MAP is a 9x9mm array of thousands of very short (~250µm) projections, invisible to the naked eye, coated with vaccine. Application of the HD-MAP to the skin delivers vaccine to abundant populations of immune cells.
Earlier this year Vaxxas published data from the largest microarray patch clinical vaccination study ever performed in PLoS (the study used an influenza vaccine in Australian participants). In this first clinical microarray patch study to show dose sparing against standard intramuscular injection with comparable immune responses at a 1/6 dose, Vaxxas’ HD-MAP immune response was shown to be 'significantly higher and have faster onset' than by intramuscular injection at comparable doses.