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Drug Maker Licenses Low-Dose Vaccine Patch

Nanopatch system

Vaccine patch system in use (Vaxxas Pty Ltd)

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, in Brisbane, Australia and Cambridge, Massachusetts, maker of the vaccine patch, is also collaborating with German medical technology company Harro Höfliger for high-volume production of ready-to-use vaccine patches.

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 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.

In the deal with Merck, the drug maker is exercising an earlier option to license the Vaxxas technology for an undisclosed vaccine candidate. An option 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.

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.

The PLoS Medicine article, as described in Science & Enterprise 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.

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.

Harro Höfliger is a designer and manufacturer of medical components in Allmersbach im Tal, Germany. Vaxxas and Harro Höfliger 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.

“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,” says Vaxxas CEO David Hoey in a company statement 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 Höfliger’s aseptic process automation platforms.”

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