CAMBRIDGE, Mass. & BRISBANE, Australia– Vaxxas, a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced the initiation of a Phase I clinical trial with the first needle-free COVID-19 vaccine candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.
The COVID-19 vaccine patch is based upon HD-MAP delivery of HexaPro, a second-generation version of the spike protein used in all major US approved COVID-19 vaccines, which was modified to be more stable and immunogenic than its predecessor, giving potential coverage of all major SARS-CoV-2 variants. Results from preclinical animal studies completed in July of this year and detailed below illustrate the potential efficacy of the COVID-19 vaccine patch against all currently known variants of concern.
“Attaining this clinical milestone and building upon compelling preclinical data, we are excited by the rapid progress of our needle-free COVID-19 vaccine candidate,” said Vaxxas Chief Executive Officer David L. Hoey.
“Vaxxas’ HD-MAP technology can enable cost-effective distribution without the need for extensive refrigeration, and our vaccination patch offers the potential for self-administration. This may enable an accelerated response in a pandemic situation and broader population coverage.”
The Phase I clinical trial will assess the safety and tolerability, and immunogenicity of the COVID-19 vaccine candidate in 44 healthy adults, aged 18 – 50 years inclusive, who have had three doses of an authorized COVID-19 vaccine, with the last dose at least four months prior to participating in the study.
In addition to demonstrating the safety of the vaccine candidate, the trial is designed to gather signals related to antibody and T-cell responses to dosing with the patch-delivered vaccine candidate.
HexaPro, a highly stabilized protein that is designed to mimic the structure of the spike protein on the surface of the coronavirus to train the human immune system to recognize and fight SARS-CoV-2 infection, is the most advanced spike protein from UTA’s world-renowned vaccine development team.
“At a time when the world is facing more emerging variants of the COVID-19 virus, it’s especially important to continue to build out our arsenal of tools to prevent infection and serious disease,” said Jason McLellan, a professor of molecular biosciences and Welch Chair in Chemistry at The University of Texas at Austin.
“Clinical testing of this patch-based vaccine that uses HexaPro represents a significant step towards equipping the globe for new phases of the fight against COVID-19.”
Preclinical research published in Science Advances and Vaccine and undertaken with The University of Queensland and collaborators demonstrated that HexaPro delivered using Vaxxas’ HD-MAP resulted in enhanced virus neutralizing antibody and T-cell responses against all known variants of concern, including alpha, beta, gamma, delta, and omicron, when compared to needle and syringe vaccination with HexaPro.
“We are pleased to see our COVID-19 patch transition from the lab to Vaxxas for Phase I clinical trials,” Dr David Muller from The University of Queensland said.
“Our work, demonstrated that this COVID-19 patch, when tested in mice, produces potent immune responses against every SARS-CoV-2 variant we tested, including delta and omicron in preclinical models. If these results translate to humans, this patch could be a great tool in the fight against COVID-19.” Dr Muller said.
“It is important to note that this is our first trial of this promising vaccine patch. We are starting at very low dose with no adjuvants which we know are used regularly with vaccines to stimulate a greater immune response,” Mr Hoey said.
“As such, the primary endpoint is safety. If the vaccine proves safe, we have a lot of flexibility to increase the dose or supplement the vaccine with an industry standard adjuvant or even mRNA delivery on the patch in future trials if we need or wish to drive an even greater immune response.”
