Publish Date: 
Thursday, September 10, 2020 - 08:15

Aussie invention propelling needle-free vaccine delivery

The Translational Research Institute is home to Australian biotech, Vaxxas, which is set to both disrupt and revolutionise vaccine delivery through their innovative High-Density Microarray Patch (HD-MAP).

The company is gearing up for large-scale clinical trials of its needle-free vaccine delivery platform, which could be approved for commercial use within three to five years.

Vaxxas’ advanced technology comprises a small patch with a surface of thousands of micro-projections, just a quarter of a millimetre long, which are dry-coated in vaccine. When applied to the skin for a few seconds, the technology directly deposits vaccine within the dense population of key immune cells in the skin, developing an efficient and effective immune response.

Vaxxas Chief Executive, David Hoey says the technology is likely to play an important role in future pandemics because it allows vaccines to be quickly and easily deployed to people.

“Vaxxas’ HD-MAP will make it possible to post vaccines directly to people in their homes,” said Mr Hoey.

“The patch is easy to use and doesn’t require a nurse or doctor to administer the vaccine,” he said.

Vaxxas demonstrated in recent clinical trials that vaccine delivered through its patch can produce six times the response from antibodies, in a much shorter timeframe, as the same amount of vaccine delivered into the muscle via needle and syringe.

"So if you can use one-sixth the vaccine to get the same results faster, you can get it made up and deployed far more quickly and, as we're learning, speed is everything in a pandemic response," Mr Hoey said.

“Even without the threat of a pandemic, we believe our product will improve vaccine access around the world and improve global healthcare.

“Our vision for vaccines is that they will be delivered using our patch technology in the future. That all vaccinations could be done without a needle and a syringe.”

In late 2020, the Queensland Government announced that it will partner with Vaxxas to establish a facility at Brisbane’s Northshore Hamilton for the manufacture of products for late stage (Phase II and III) clinical studies.

The deal followed Vaxxas securing US$22 million, through the U.S. Government's Biomedical Advanced Research and Development Authority (BARDA), to support pandemic deployment of their patch. The initial focus will be on a pandemic influenza vaccine, but Vassas will also invetigate opportunities to improve the performance of other pandemic vaccines, including against COVID-19.

While the patch is still in the research and development phase, Vaxxas also recently announced two other major R&D milestones. The first was an US$12 million investment injection by the global pharmaceutical company, Merck – a partner to Vaxxas since 2012 – for the use of Vaxxas’ patch with an undisclosed vaccine. The second was an alliance with production and packaging specialist, Harro Höfliger, to collaborate on a production line for its patches, ensuring that as soon as a vaccine is ready, manufacturing capacity will be in place. A pilot line is scheduled for 2021, and then targeted modular lines with capacity of five million units a week. Production is currently on a proof-of-concept rig. 

Vaxxas’ R&D pipeline has included several large research development programs underway funded by the Bill & Melinda Gates Foundation, the World Health Organisation, global pharmaceutical companies and Australian universities.

Vaxxas currently has three clinical studies planned, including a Phase I study with the Bill & Melinda Gates Foundation for a measles/rubella vaccine program using the HD-MAP in developing countries.

Being based at the TRI provides the company with access to the necessary office, laboratory and cGMP cleanroom space it requires to support these early stage clinical development programs and the ability to manufacture the clinical product in‐house and conducting early-stage clinical trials, all within the one connected precinct.

Since relocating to the TRI in 2014, Vaxxas has completed several local and international clinical studies including the largest-ever vaccine clinical trial with skin vaccine patch technology. It has also grown from a team of seven to more than 45.

About Vaxxas’ vaccine delivery platform

Vaxxas’ vaccine delivery platform is a proprietary High Density Micro‐projection Array Patch or ‘HD-MAP’ technology. This HD-MAP is made of a biomedical grade polymer with an ultra-high density array of projections – invisible to the naked human eye – applied to the skin. Vaxxas uses proprietary dry-coating technology to apply vaccine to the HD-MAP.

The Vaxxas HD-MAP comes in small, sealed containers that are easy to transport that do not need to be kept cool during transportation or storage due to the stable nature of the dried vaccine (with the vaccine remaining stable at below 40oC for 12 months). When gently applied onto the skin, the projections on the HD-MAP pass through the skin’s outer layer to rapidly deliver a vaccine directly to the abundant immune cells immediately below the skin surface

Vaxxas has shown through clinical trials that split, inactivated influenza vaccines can be stable for at least 12 months stored at 40°C. The high density of micro-projections, combined with dynamic application to the skin, delivers vaccine to the abundant immune cells in the epidermis/dermis, acting as a physical immune enhancer to increase vaccine efficiency. This results in significantly improved immune responses in preclinical animal models and in humans.The amount of vaccine delivered is optimised; and the administration of the vaccine is simple and seamless allowing potential self‐vaccination at home and highly efficient mass immunisation programs in urban and remote communities.

There is also an improved ability to mass manufacture specific ready‐to‐use vaccine products. The availability of the device could boost immunisation rates with up to 20 per cent of people reported to avoid influenza vaccination due to fear of needles. It could also eliminate the needle‐stick injuries and cross‐contamination events that cause infection and death in healthcare workers worldwide.

About Vaxxas Pty Ltd

Vaxxas is a privately held, Australian biotechnology company developing a coated vaccination platform, an HD-MAP, to replace the needle and syringe for the global administration of vaccines.

The University of Queensland’s commercialisation company, UniQuest, launched Vaxxas in 2011 to develop technology that originated from the Australian Institute of Bioengineering & Nanotechnology at The University of Queensland. The spinout was funded by initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital, the Medical Research Commercialisation Fund (MRCF), and US-based HealthCare Ventures. This was followed by a further financing in 2015, led by OneVentures. The company has been headquartered at TRI since 2014, which has the specialised facilities required for its research and development program.

The Vaxxas journey

2006: The University of Queensland’s commercialisation company, UniQuest, begins working with Professor Mark Kendall on commercialising the ‘Nanopatch innovation for vaccine delivery

2011: UniQuest launches the spinout company, Vaxxas Pty Ltd, and raises AU$15 million in venture capital

2012: Enters a research collaboration and license agreement with Merck & Co., Inc

 2014: World Economic Forum names Vaxxas a ‘Technology Pioneer’

            Secures development funding from the World Health Organisation to improve polio vaccines.

            Awarded an AU$60,000 grant to develop an in-vitro release assay for their microinjection technology with TRI.

2015: Raises AU$25 million in Series B financing and awarded a World Health Organisation grant to support preclinical and manufacturing research in polio vaccination.

2016: Receives US$4.5 million from the Bill & Melinda Gates Foundation to fund preclinical development for the delivery of a measles and rubella vaccine for emerging economic countries.

2017: TRI and Vaxxas receive AU$500,000 MTPConnect grant to develop an Australian-first clinical manufacturing and training facility at TRI

             Vaxxas announces its device is more effective in combating poliovirus than needles and syringes

2020: Merck exercises license option with Vaxxas for exclusive commercialisation rights to a vaccine, Vaxxas receives US$12 million with future option, development, and commercial milestone payment eligibility

           Vaxxas announces alliance with Harro Höfliger, together they will develop the world’s first high‐throughput, aseptic manufacturing line for production of vaccine products based on Vaxxas’ HD‐MAP technology

           Vaxxas awarded an additional US$5 million from the Bill & Melinda Gates Foundation to run Phase I clinical trial of the measles and rubella vaccine program

 For more information, visit Vaxxas's website: http://www.vaxxas.com

Recent journal publications

  • Forster A.H., Witham K., Depelsenaire A.C.I., et al, “ Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial”, PLOS Medicine, March 17, 2020. https://doi.org/10.1371/journal.pmed.1003024
  • Fernando GJP, Hickling J, Jayashi Flores CM, Griffin P, Anderson CD, Skinner SR, Davies C, Witham K, Pryor M, Bodle J, Rockman S, Frazer IH, Forster AH., “Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch™).” Vaccine, 2018 Jun 18;36(26):3779-3788. doi: 10.1016/j.vaccine.2018.05.053.
  • Wan Y, Hickey JM, Bird C, Witham K, Fahey P, Forster A, Joshi SB, Volkin DB., “Development of Stabilizing Formulations of a Trivalent Inactivated Poliovirus Vaccine in a Dried State for Delivery in the Nanopatch™ Microprojection Array.”, J Pharm Sci. 2018 Jun;107(6):1540-1551. doi: 10.1016/j.xphs.2018.01.027.
  •  Griffin P, Elliott S, Krauer K, Davies C, Rachel Skinner S, Anderson CD, Forster A., “Safety, acceptability and tolerability of uncoated and excipient-coated high density silicon micro-projection array patches in human subjects.” Vaccine. 2017 Dec 4;35(48 Pt B):6676-6684. doi: 10.1016/j.vaccine.2017.10.021.
  • Muller D.A., Fernando G.J.P., Owens N.S., Agyei-Yeboah C., et al., “High-density microprojection array delivery to rat skin of low doses of trivalent inactivated poliovirus vaccine elicits potent neutralising antibody responses.”, Sci Rep. 2017 Oct 3;7(1):12644. doi: 10.1038/s41598-017-13011-0.