Australian biotech company, Vaxxas, has announced two important new partnerships in its bid to revolutionise vaccine delivery.
TRI-based Vaxxas, which is commercialising a needle-free vaccine delivery technology based on innovative University of Queensland research, has formed alliances with global biotechnology company Merck & Co (MSD) and German pharmaceutical manufacturer Harro Höfliger in two separate deals.
Merck, a world leader in vaccine development, will access Vaxxas’ HD-MAP technology for the development and manufacture of an undisclosed vaccine. Merck also retains the option to license the Vaxxas platform for two additional vaccines.
Vaxxas will receive A$18 million (US$12 million) in a combination of equity funding and option fees and is eligible to receive future option, development, and commercial milestone payments.
Vaxxas President and CEO David L. Hoey said the latest milestone with Merck, who is an early adopter of the Vaxxas HD-MAP platform, was exciting.
“With their strong legacy of vaccine development, MSD is a tremendous partner in our efforts to enhance the efficiency, effectiveness and reach of vaccination,” said Mr Hoey.
Vaxxas also announced it would work with pharmaceutical process engineering and manufacturing company Harro Höfliger to develop a manufacturing line with the potential to produce millions of vaccine-HD-MAP products per week.
Together they will develop the world’s first high‐throughput, aseptic manufacturing line for production of vaccine products based on Vaxxas’ HD‐MAP technology.
Single, aseptic‐based lines will have a targeted throughput of up to 5 million vaccine products/week. Initially, efforts will focus on a pilot line operating in 2021 to support late‐stage clinical studies.
“We’re excited to be working on this project with Harro Höfliger,” said Mr Hoey.
"A major challenge in commercialising microarray patches – like Vaxxas’ HD‐MAP – for vaccination is the ability to manufacture at industrially‐relevant scale, while meeting stringent sterility and quality standards.
“Our novel device design along with our innovative vaccine coating and quality verification technologies are an excellent fit for integration with Harro Höfliger’s aseptic process automation platforms. Adopting a modular approach, it will be possible to achieve output of tens‐of millions of vaccine‐HD‐MAP products per week.”
The company’s HD-MAP technology, based on research originating from the Australian Institute for Bioengineering and Nanotechnology, uses tens of thousands of projections that deliver a vaccine to the immune cells just beneath the skin’s surface.
This approach could significantly reduce the need for vaccine refrigeration and storage and result in the production of more patient doses from limited quantities of vaccine.
In a recent clinical study, the HD‐MAP demonstrated that 1/6 dose of influenza vaccine by Vaxxas’ HD‐MAP resulted in comparable immune response to full dose by intramuscular injection and 2/3 dose by HD‐MAP was capable of generating significantly faster and higher overall antibody responses. By drying the vaccine onto the HD‐MAP, it remains stable outside of cold‐chain; vaccines in the clinical study were verified to be stable at 40oC for 12 months.
