24 Mar. 2022. A company developing a needle patch for vaccine delivery is acquiring the rights to a synthetic SARS-Cov-2 spike protein for its Covid-19 vaccine patch. Vaxxas in Cambridge, Massachusetts is licensing a protein known as HexaPro, developed by biomedical and engineering researchers at University of Texas in Austin.
HexaPro is the work of a research team led by molecular biologist Jason McLellan, with molecular biologist Ilya Finkelstein and chemical engineering professor Jennifer Maynard, all at UT-Austin. Most Covid-19 vaccines target the protein covering spikes on the SARS-CoV-2 virus, which binds with angiotensin-converting enzyme 2 or ACE2 receptors in cells to start infections. Proteins in their wild-type form are unstable and break down easily, and have a short shelf life. Thus, vaccine developers need synthetic proteins like HexaPro with a similar chemistry to generate an immune response, but last a longer time and need no special handling such as deep-freezing.
The UT-Austin researchers also designed HexaPro to be produced inexpensively, with the vaccine manufactured in eggs as most influenza vaccines today. In June 2021, Science & Enterprise reported on a preclinical test of HexaPro with lab mice reported on a preprint server, but later peer-reviewed and appearing in October in the journal Science Advances. In the study, researchers administered HexaPro with a high-density micro-array needle patch, or HD-MAP, where one dose of the vaccine resulted in neutralizing antibodies against the original SARS-CoV-2 as well as alpha and beta variants. And the vaccine delivered through the patch protected healthy mice against infection-related disease, but also better than vaccines delivered with a syringe.
Clinical trial planned later this year
Vaxxas is a developer of high-density microneedle patches for vaccine delivery. Each patch is made of ultra-short (0.25 mm) microneedles coated with a dry form of the vaccine. The tiny patch is packaged in a single-use spring-loaded applicator that pushes the microneedles into the skin. Once under the skin, the vaccine contents enter capillaries and travel to lymph nodes where they trigger an immune response. Vaxxas offered its microneedle patch to HexaPro researchers for the team’s preclinical studies published last year.
UT-Austin is providing Vaxxas with an exclusive license for HexaPro delivered via a patch device. Financial terms of the agreement are not disclosed. Vaxxas says it also acquired a related background technology from National Institutes of Health. The company says the license will enable Vaxxas to begin clinical trials of the HexaPro patch, with an early-stage clinical study planned for late this year.
“The compelling preclinical results published in Science Advances,” says Vaxxas CEO David Hoey in a company statement released through BusinessWire, “established the potential superiority of the HD-MAP/HexaPro Covid-19 vaccine compared to delivery using the traditional needle and syringe. We can now rapidly advance our clinical trials with our next-generation Covid-19 vaccine patch.”
“Just as the virus has changed and evolved,” notes McLellan, “our vaccines need to keep up with the latest challenges, too, and a key challenge now is vaccinating the world. It’s exciting to see HexaPro on the cusp of entering clinical trials with a patch-based technology that could be a real game-changer for parts of the globe where access to vaccines has been limited so far.”
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