Merck has exercised its option to use Vaxxas‘ High Density Microarray Patch (HD-MAP) platform as a delivery platform for a vaccine candidate, the companies announced today.
The companies did not disclose what the vaccine candidate is supposed to treat. But Merck this month announced two COVID-19 vaccine development efforts: a collaboration with IAVI and plans to acquire vaccine developer Themis Bioscience. Vaxxas (Cambridge, Mass.; Brisbane, Australia) notes that any vaccine could be delivered with its dime-sized patch.
“We are excited by this latest milestone in our collaboration with Merck, an early adopter of our novel HD-MAP platform,” Vaxxas CEO David L. Hoey said in a news release. “With their strong legacy of vaccine development Merck is a tremendous partner in our efforts to enhance the efficiency, effectiveness, and reach of vaccination.”
Also today, Vaxxas announced that German manufacturing equipment maker Harro Höfliger will help Vaxxas develop a high-throughput, aseptic manufacturing line to make vaccine products based on Vaxxas’ HD-MAP technology. Initial efforts will focus on having a pilot line operating in 2021 to support late-stage clinical studies — with a goal of single, aseptic-based lines being able to churn out 5 million vaccine products a week.
“A major challenge in commercializing 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,” Hoey said.
Based on technology originally developed at the University of Queensland, Vaxxas’ HD-MAP includes a 9-by-9 mm array of thousands of very short projections around 250 microns in length. Invisible to the naked eye and coated with vaccine, the projections can quickly deliver vaccine to immune cells.
Vaxxas also claims that the patches can deliver vaccine more efficiently — a positive when people around the world are clamoring for a vaccine against COVID-19. The company points to a recent clinical study in which their micropatch delivering a sixth of an influenza vaccine dose produced an immune response comparable to a full dose by intramuscular injection. A two-thirds dose by HD-MAP generated significantly faster and higher overall antibody responses.
Because a vaccine is dried onto the patch, the vaccines are stable outside of cold-chain — a potential answer to the question of how to keep a traditional COVID-19 vaccine cold in developing countries and even developed countries. Vaccines delivered through HD-MAP in the clinical study stayed stable at 40 oC (104 oF) for 12 months.
