The H1 influenza vaccine uses the Cambridge, Massachusetts company’s MIMIX technology, with pre-clinical trials showing the system enhanced humoral and cellular immune responses in mice compared to vaccine intramuscular injection. The study also showed that sustained release immunization promotes strong and long-lasting anti-influenza antibody responses, and enhanced protection against fatalities.
Now the company is taking the project into clinical trials: with the H1 influenza vaccine delivered by VX-103 (a MIMIX Array Patch System). Vaxess has enrolled 45 healthy adult volunteers ages 18-39 to evaluate the safety, reactogenicity, tolerability, and immunogenicity profiles for two influenza vaccine dose levels, fractional H1 vaccine dose level 7.5 μg and standard H1 vaccine dose level 15 μg vs placebo.
Vaxess will also evaluate the durability of the immune response for each vaccine dose level, and assess, in at least a subset of samples, the breadth of the influenza A H1 antigen responses.
The initial findings of the trial are expected in Q4 of 2022.
“Today, getting a vaccine usually means receiving an injection via syringe and needle at a clinic — which is uncomfortable and time-consuming for the person who needs to travel to the clinic, and requires extraordinary supply chain resources to distribute temperature-controlled vaccines to pharmacies, hospitals, and doctors’ offices,” said Lynda Tussey, chief development officer at Vaxess.
“Vaxess’s MIMIX patch will make distributing and administering vaccines infinitely easier. Soon, we’ll live in a world where you can have a vaccine patch mailed right to your door, and put it on in the comfort of your home, whether for a seasonal vaccination or to address a future COVID-like pandemic.”
Meanwhile, Vaxess is also applying the MIMIX Array Patch System to COVID-19 vaccines with the aim of developing a seasonal booster which overcomes challenges for existing COVID-19 vaccines, such as frozen storage and clinical administration.
The company's pipeline also includes a combined influenza and COVID patch.
Focusing on the skin as an active immune organ, Vaxess engineers MIMIX therapies to mimic natural infection kinetics. Implanted into the immunologically-active dermal barrier, the microneedle arrays leave behind slow-release fibroin (silk protein) tips loaded with slowly-releasing bioactive molecules.
What sets MIMIX apart from other intradermal patch therapies is the 'pioneering utilization of the unique qualities of silk proteins', originally conceived at MIT and Tufts University.
"We pair the unique qualities of silk proteins with breakthrough immune-activating biology, to create highly adaptive silk biomaterials that interact with the body in remarkable ways," says the company. "Once applied to the skin, our unique microneedle array dissolves into the body, delivering a bioactive payload over time. This combination is unlike any other existing technology and is designed to support the broadest possible range of pharmaceuticals and applications."