{"id":39186,"date":"2020-05-28T11:00:54","date_gmt":"2020-05-28T15:00:54","guid":{"rendered":"https:\/\/sciencebusiness.technewslit.com\/?p=39186"},"modified":"2020-05-28T11:00:54","modified_gmt":"2020-05-28T15:00:54","slug":"drug-maker-licenses-low-dose-vaccine-patch","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=39186","title":{"rendered":"Drug Maker Licenses Low-Dose Vaccine Patch"},"content":{"rendered":"
\"Nanopatch<\/a>
Vaccine patch system in use (Vaxxas Pty Ltd)<\/figcaption><\/figure>\n

28 May 2020. The pharmaceutical company Merck is licensing a microneedle patch device that delivers vaccines with a small fraction of the dose normally needed by syringes. Vaxxas Pty<\/a>, in Brisbane, Australia and Cambridge, Massachusetts, maker of the vaccine patch, is also collaborating with German medical technology company Harro H\u00f6fliger<\/a> for high-volume production of ready-to-use vaccine patches.<\/p>\n

Vaxxas developed the high density microarray patch, or HD-MAP, that quickly delivers vaccines in much smaller quantities than needed in conventional syringes. HD-MAP, described in a March 2020 PLoS Medicine<\/em><\/a> journal article, is a polymer wafer about nine millimeters square with some 3,100 microscale needles applied to the arm for a few seconds. The patch is designed for ease of use, as well as to overcome fear and pain of injections, and can also be stored and shipped without refrigeration, a limiting requirement for conventional vaccines.<\/p>\n

In the deal with Merck<\/a>, the drug maker is exercising an earlier option to license the Vaxxas technology for an undisclosed vaccine candidate. An option<\/a> deal provides access to license the rights to a technology later on. Under the agreement, Merck receives exclusive worldwide rights to develop and commercialize the HD-MAP technology for this particular vaccine. Vaxxas receives $12 million in option fees and an equity stake from Merck, and is eligible for future option, development, and commercial milestone payments.<\/p>\n

Merck is also funding further research by Vaxxas on the HD-MAP patch, if needed, as well as clinical trials of the device with the candidate vaccine. In addition, Merck still has option agreements with Vaxxas for two more vaccines.<\/p>\n

The PLoS Medicine<\/em> article, as described in Science & Enterprise<\/a> in March, reported on an early-stage clinical trial testing the HD-MAP patch for safety and ability to generate an immune response with an H1N1 influenza A antigen. The trial tested the device in Australia delivering H1N1 antigens in healthy adults against the standard intramuscular-injected four-strain influenza vaccine, a standard injection with the same amount of H1N1 antigens as in the patch, and an empty microarray patch.<\/p>\n

The researchers found the lowest dose of 2.5 micrograms of antigen on an HD-MAP patch generated about the same level of antibody concentrations in participants as the full vaccine dose delivered by a standard syringe injection with six times the antigen. Also, the full dose of influenza vaccine on the HD-MAP patch produced faster and higher antibody concentrations compared to standard influenza injections. And the antigens on HD-MAP patches remained stable, even when stored for 12 months in temperatures of 40 degrees C, or 104 F.<\/p>\n

Harro H\u00f6fliger is a designer and manufacturer of medical components<\/a> in Allmersbach im Tal, Germany. Vaxxas and Harro H\u00f6fliger are collaborating on creating a sterile manufacturing process for HD-MAP vaccine patches. The deal calls for a pilot line operating next year, producing vaccine patches for late-stage clinical trials, with the eventual goal of producing 5 million units per week. The companies expect to spend up to $25 million on the project over the next three years.<\/p>\n

“A major challenge in commercializing microarray patches, like Vaxxas\u2019 HD-MAP, for vaccination is the ability to manufacture at industrially-relevant scale, while meeting stringent sterility and quality standards,” says Vaxxas CEO David Hoey<\/a> in a company statement<\/a> released through BusinessWire. “Our novel device design along with our innovative vaccine coating and quality verification technologies are an excellent fit for integration with Harro H\u00f6fliger\u2019s aseptic process automation platforms.”<\/p>\n

More from Science & Enterprise:<\/p>\n