Synopsis
Vaxxas is commercializing a novel vaccination technology that dramatically enhances the performance of existing and next-generation vaccines. Developed at the University of Queensland, Vaxxas’ high density micro array patch technology (HD-MAP) technology uses a patch with thousands of vaccine-coated microprojections that is applied to the skin for a few seconds to efficiently deliver vaccine to the abundant immune cells immediately below the skin surface. The technology aims to provide a needle-free vaccine delivery product that safely and cost effectively increases vaccine effectiveness.
Vaxxas’ approach shifts the value paradigm of vaccines. Vaxxas’ HD-MAP platform has been productized for commercial use, validated in human clinical studies and designed for manufacture at scale.
Important benefits of use of the HD-MAP include thermostability with potential to eliminate the cold chain and cold storage, robust and dose efficient with faster and enhanced immune response, accessibility with potential for self-administration which could dramatically reduce costs in a pandemic to deliver a vaccinated person, reduction in needle stick injuries and needle phobia– overall resulting in significant cost savings and greater compliance with vaccination programs.
Strengths
Lower dose
- Only a fraction of the vaccine dose is needed, compared to when administered by needle and syringe – studies in humans to date indicate that as little as 20% of the dose administered by needle and syringe is needed
Robust and Enhanced Immune Response
- Direct delivery of the vaccine to key immune cells just below the outer surface of the skin enables the HD-MAP to potentially enhance the immune response generated by a vaccine
- Response time to a vaccinated person is shortened: Potential for faster and more durable antibody response giving rise to earlier and longer lasting immunity.
No cold chain
- Temperature stability is achieved through a novel proprietary coating technology, eliminating the need for costly cold distribution chains.
- Vaccines could therefore be administered in parts of the world where cold chain infrastructure is unreliable or non-existent. This is a prevalent issue with vaccine delivery today
Cost effective
- High volume, low-cost production would be possible, by taking advantage of both established and proprietary manufacturing techniques
Potential for self-administration
timeline
2010
OneVentures explores research projects at the University of Queensland
After exploring opportunities at the University of Queensland, Anne-Marie Birkill identifies Vaxxas’ needle-free high density micro array patch technology (HD-MAP) as a truly innovative product with major potential, also fitting OneVentures’ investment criteria.
OneVentures’ three founding partners (Dr Paul Kelly, Dr Michelle Deaker and Anne-Marie Birkill) perform due diligence and explore the opportunity further. The decision to invest in Vaxxas is based on its potential to address a large and growing global market need, initial proof of concept and science, and strong validation in terms of commercial partner interest with a clear path to market. Initial diligence also focused on the ability of the technology to meet the challenges and regulations around large-scale manufacturing for human vaccination applications and commercialisation.
2011
OneVentures leads investment syndicate of $15M in initial fundraising round to transform Vaxxas into a product-driven company
OneVentures leads the initial investment into Vaxxas, one of its earliest investments out of the OneVentures Innovation Fund I, with other investors joining the syndicate including Brandon Capital and Boston based HealthCare Ventures.
OneVentures’ deal team of Kelly, Deaker and Birkill establishes the investment syndicate, negotiates licencing and service agreements with the University of Queensland, negotiates for key researchers to join the company from the university and establishes the infrastructure and management needed to enable the company’s transition from research into product development.
OneVentures partner, Dr Paul Kelly, joins the Vaxxas Board as 1V’s director and is appointed Chairman of Vaxxas.
2012
Vaxxas appoints David Hoey as its first CEO and expands into the US
Boston based Australian expat David Hoey is recruited to lead and oversee the transition from animal-based university research to commercially driven product development with further proof of concept and a path to human clinical trials. David had more than 20 years of executive-level experience in North America, spanning business development, licensing, strategic planning and financing for technology companies, including as board member and vice president of Business Development for PathoGenetix. Dr Angus Forster is then hired as Chief Development and Operating Officer from the UK to relocate to Australia to run the company’s research and development program in Brisbane. Prior to joining Vaxxas, Angus worked as a pharmaceutical consultant, a technology consultant at PA Consulting Group and as a pharmaceutical development scientist at GSK.
The company establishes a commercialization office in Cambridge, Massachusetts, to expand access to global pharmaceutical partners and complement its research and development operations based in Queensland.
2012
The World Vaccine Congress votes the Vaxxas investment the best Vaccine Venture Capital deal at the 2012 Vaccine Industry Excellence Awards
The award recognises the quality of the deal, the investment syndicate, the deal structure and the promise of the HD MAP technology.
2012
Collaboration with Merck
Vaxxas announces a research collaboration with Merck, the world’s most established pharmaceutical and chemical company and one of the leading global vaccine companies, to evaluate Vaxxas’ proprietary HD-MAP platform.
2014
Vaxxas is granted WHO Funding to evaluate the effectiveness of HD-MAP in polio vaccine delivery
The World Health Organization (WHO) announces that it will fund Vaxxas to test and evaluate the effectiveness of the HD-MAP in delivering a new polio vaccine.
Upon successful completion of the trial, Vaxxas will supply HD-MAPs to help secure a lasting polio-free world by enabling vaccine delivery in regions where polio has re-emerged, and eradication is most challenging.
2014
Awarded World Economic Forum Technology Pioneer
Vaxxas, one of only 24 leading start-ups, is selected by the World Economic Forum (WEF) as a Technology Pioneer in 2015.
The program recognises start-up phase companies from around the world that are involved in the design, development and deployment of new technologies that will have a significant impact on business and society.
2015
$36M Series B financing led by OneVentures
OneVentures partners Deaker and Kelly lead a $25 to 30M financing round which is oversubscribed to advance a series of clinical programs and develop a pipeline of new vaccine products for major diseases. The round closes at $36M.
This new round of financing brings the total capital raised by Vaxxas to A$51M (US$38M).
2016
Commencement of first human trials of the HD-MAP in Australia to demonstrate safety and tolerability
$4M granted by the Gates Foundation to fund pre-clinical development targeting the measles rubella vaccine
Through the pre-clinical development of HD-MAP technology for the delivery of the vaccine, the grant aims to address gaps in measles rubella coverage in low and middle-income countries.
2018
Publishing of first results of first in human study administering flu vaccine using the HD-MAP demonstrating safety and efficacy
Vaxxas publishes the first results on the safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (HD-MAP). This is a world first: the first ever demonstration in human clinical trials of the dose sparing benefits of intradermal delivery of vaccine by a micro-array patch.
See: Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial, Angus H Forster, Katey Witham, Alexandra C I Depelsenaire, Margaret Veitch, James W Wells, Adam Wheatley, Melinda Pryor, Jason D Lickliter, Barbara Francis, Steve Rockman, Jesse Bodle, Peter Treasure, Julian Hickling, Germain J P Fernando, 2018 Jun 18;36(26):3779-3788. doi: 10.1016/j.vaccine.2018.05.053. Epub 2018 May 17.
2020
Partnership with Merck, the world’s largest vaccine company by sales
Vaxxas partners with Merck once again, under which Merck exercised a license option for exclusive commercialization rights to one of their vaccines. Merck also retains the option to license Vaxxas’ platform for two additional vaccines. Vaxxas receives $18M (US$12M) upfront in a combination of equity funding and option fees.
In addition, Vaxxas is eligible to receive substantial future option, development, and commercial milestone payments.
Merck is now engaged with Vaxxas in a way that builds on the technology core and clinical capabilities, propelling the company towards in market products that can enhance vaccine performance and extend the reach of vaccination.
2020
Alliance with Harro Höfliger, a world-leader in sterile pharmaceutical process automation engineering
Vaxxas establishes its alliance with Harro Höfliger (HH), a world-leader in sterile pharmaceutical process automation engineering.
A critical element of Vaxxas’ commercial success is the development of aseptic manufacturing lines capable of true industrial scale production – that is, the production of tens-of millions of vaccine dosages per week. Vaxxas has developed unique product componentry designed for high-speed robotic handling along with a suite of technologies for vaccine-printing and QC (quality control) verification. These technologies will be integrated into an overall sterile manufacturing architecture engineered by Harro Höfliger.
Vaxxas works with Harro Höfliger to build a non-sterile proof-of-concept system that demonstrates key elements operating at speeds of up to 10 units/second (~5 million units/week). Vaxxas commences engineering of the first aseptic pilot-line – the key first step toward full-scale production systems.
The Merck (above) and Harro Höfliger deals, together with other initiatives, have Vaxxas poised to be a world leader in vaccination, especially in an era where pandemics are likely to be omnipresent. The world will need to be prepared for the challenges that will arise as a result of evolving pandemic situations, such as making vaccination more accessible across the globe.
This is an opportunity for Australia to become a leader in innovative vaccination and build a local multibillion-dollar business, serving global markets and leveraging our local biomedical innovation, and local investment support.
2020
Awarded $30.6M (US$22M) funding from U.S. Government to advance needle-free vaccine patch technology for pandemic response
Vaxxas announces a major United States government award to support the deployment of Vaxxas’ proprietary HD-MAP technology platform in response to pandemic threats to public health. The phase 1 US$22M payment is received by the company.
The award is funded through the Biomedical Advanced Research and
Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and is aimed at advancing clinical demonstration of Vaxxas’ proprietary HD-MAP patch for pandemic influenza. Aligned with this approach, Vaxxas is actively investigating opportunities to improve performance of other pandemic vaccines including against COVID-19, as well as a broad range of non-pandemic infectious disease vaccines.
Pandemic influenza vaccine was selected for this clinical validation study to comprehensively baseline the immune responses and safety of the novel HD-MAP vaccination platform when used for pandemic preparedness and response.
More than 750 million vaccinations are given routinely worldwide each year though, in the case of a pandemic response, billions of vaccinations may need to be administered in a variety of settings. Vaxxas’ HD-MAP has the potential to create new needle-free vaccine products with enhanced immune response that would be designed for improved safety, ease of administration, storage, and distribution logistics to extend the reach of vaccines and improve vaccinationefficiency and effectiveness.
Vaxxas has prototyped a compact manufacturing system designed to be capable of delivering more than 250 million vaccine doses per year.
2020
Partnership with Queensland Government to invest $26M into Queensland-based advanced manufacturing and R&D facility
Vaxxas announces a development alongside the Queensland Government with plans for a combined $46M investment in the construction of a new, state-of-the-art biotech manufacturing facility in Brisbane’s Northshore. The new facility will house the production of Vaxxas’ novel patch technology and will include manufacturing and research and development facilities to support Vaxxas’ clinical and commercialisation programs.
Vaxxas’ research and development operations are currently based at the Translational Research Institute (TRI), a Queensland Government facility, designed to enable biotech start-ups to conduct early-stage and pre-clinical research, as well as support Phase I clinical trial manufacturing. The move to a purpose-built, Therapeutics Goods Administration (TGA) accredited facility at Northshore Hamilton Priority Development Area will, for the first time, enable Vaxxas to manufacture products for late stage (Phase II and III) clinical studies.
The space also provides expansion capacity to ramp-up to commercial-scale production for Vaxxas’ HD-MAP patch products.
The deal will create more than 130 manufacturing jobs in Qld and will inject around half a billion dollars into the economy over the next 10 years.
The Northshore facility is expected to be operational from the start of 2022.
2021
Preclinical studies from Vaxxas and Collaborators Reveal Potential of Vaxxas’ Novel High-Density Microarray Patch (HD-MAP) to Effectively Deliver SARS-CoV-2 Spike Vaccine
Vaxxas announces that research demonstrating the potential of the novel high-density microarray patch (HD-MAP) for vaccination against COVID-19 has been published in a manuscript posted to the preprint server BioRxiv.
Using a novel SARS-CoV-2 spike subunit vaccine, this preclinical study of Vaxxas’ HD-MAP showed enhancement of immune response compared to vaccination by needle-and-syringe, including significantly enhanced T-cell and spike-specific antibody responses as compared to needle-and-syringe delivery.
Notably, complete protection from COVID-19 by a single dose skin patch delivery using HD-MAP was shown in a lethal virus challenge in a relevant COVID-19 animal model.
Comparable protection against COVID-19 was not seen with the same vaccine when delivered by needle-and-syringe, even when the spike subunit vaccine formulation included appropriate adjuvantation.
The research underlying the study was co-funded by Vaxxas and the Queensland Government and was performed in collaboration with researchers at the University of Queensland and Griffith University and led by principal investigator, David A. Muller, PhD, of the School of Chemistry and Molecular Biosciences at the University of Queensland.
Learn more here
2022
Vaxxas receives $34m capital injection to advance manufacturing of needle-free vaccines
Brisbane-based medtech Vaxxas has today announced the completion of a $34 million financing round which will fund the expansion of its manufacturing capabilities towards a commercial scale, and advance ongoing clinical trials of its needle-free vaccine technology.
It adds to an $8 million Federal Government grant received by Vaxxas in September and comes just a month after the company commenced clinical trials of its proprietary high-density microarray patch (HD-MAP) at the University of Sunshine Coast’s Sippy Downs clinical research labs.
The latest round was led by existing investors OneVentures and UniQuest, with new backers including members of the Vaxxas board of directors, management personnel, and a number of individual investors.
“Our confidence has only been reinforced by Vaxxas’ tremendous progress in building a promising clinical pipeline based on its novel HD-MAP vaccination platform,” OneVentures founding partner and head of healthcare Dr Paul Kelly said.
“Vaxxas’ needle-free vaccination technology has shown in preclinical and clinical studies to have the potential to improve the availability and efficacy of vaccines for a range of serious and prevalent diseases, including COVID-19 and influenza.
“We are pleased to continue supporting the Vaxxas team through this pivotal time in the company’s growth.”
testimonials
Wendye Robbins
CEO, Blade Therapeutics
“I first met the OneVentures team in July 2018. They quickly impressed me with their broad knowledge and capabilities. Shortly afterwards, they led our Series C round. It has been a pleasure to build the company with the support of Paul, Sarah, Michelle, and Gabriel, and their LP’s over the past 3 years. The fund is a true value add investor with deep connections to academic institutions and opinion leaders.”
