Vaxess Announces Launch of Phase 1 Trial For H1 Influenza Vaccine Patch

Company focused on creating shot-free future of vaccines; first human trial of Vaxess MIMIX™ vaccine patch will focus on administering influenza vaccine

CAMBRIDGE, Mass. August 3, 2022 — Vaxess Technologies, Inc., a life sciences company developing a shelf-stable, sustained-release vaccine patch, today announced that it has launched a phase 1 trial for the H1 influenza vaccine delivered via Vaxess’s MIMIX™ patch.

“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.”

For the phase 1 trial of 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. Vaxess will report the initial finding of its phase I trial in Q4 of 2022.

Vaxess’s phase 1 trial builds on the groundbreaking research the company published in 2021, “Enhancing influenza vaccine immunogenicity and efficacy through infection mimicry using silk microneedles.” In testing Vaxess’s influenza MIMIX Array Patch system on mice, the company found enhanced humoral and cellular immune responses to the influenza vaccine when compared to receiving the vaccine via intramuscular injection. The study also showed that sustained release immunization promotes strong and long-lasting anti-influenza antibody responses, and enhanced protection against fatalities.

In parallel to its influenza vaccine trial, Vaxess is applying its MIMIX Array Patch System to COVID-19 vaccines. The effort, originally funded through a BARDA contract, is aimed at developing a seasonal booster that overcomes challenges with existing COVID vaccines, including the need for frozen storage and clinical administration.

About Vaxess Technologies

Vaxess Technologies is developing the MIMIX™ sustained release patch technology, the easiest and most effective way to administer vaccines and therapeutics. For vaccines, the controlled release simulates the pace of a natural infection, helping the body produce a slow, strong, and enduring ramp-up of immune response, ultimately boosting a vaccine’s effectiveness. Engineered for stability, Vaxess’s patch does not require refrigeration and can be shipped to and applied in low resource settings.

Vaxess has raised more than $60M in grant and venture capital funding from groups such as RA Capital, The Engine, BARDA, DARPA, NIH, NSF and the Gates Foundation. For more information, please visit the company website at www.vaxess.com or send additional inquiries to contact@vaxess.com.