Vaxess Technologies has generated early clinical evidence in support of its delivery patch, linking the device to seroprotection rates of over 90% when used to administer an influenza vaccine in a phase 1 trial.
The technology, the MIMIX patch, delivers a microarray of slow-release, bioactive tips into the dermal barrier. After the patch is removed, the tips gradually dissolve and release their payloads into a part of the skin that is immunologically active. Vaxess sees the technology as a way to elicit a stronger, more durable immune response, eliminate the need for refrigeration and simplify vaccine administration.
Working with South Korea’s GC Biopharma, Vaxess has now delivered preliminary clinical evidence to validate its claims. The results come from a phase 1 clinical trial that enrolled 45 healthy volunteers aged 18 to 39 years and tested delivering one of two doses of GC Biopharma’s influenza vaccine using Vaxess’ patch.
After wearing the patches for five minutes, the participants were tracked to gather safety, reactogenicity, tolerability and immunogenicity data. At Day 57, the immunogenicity results “significantly exceeded the 2007 FDA criteria for accelerated licensure of influenza vaccines,” according to Vaxess. Seroconversion rates in the 15-ug and 7.5-ug arms were 85% and 77%, respectively. Seroprotection was 92% in both arms.
Investigators will follow subjects out to 180 days to evaluate the long-term safety profile of the patch and the durability of the immune response. So far, Vaxess likes what it sees, noting the absence of serious or severe adverse events and an overall rate of reported systemic events that “was favorable as compared to traditional vaccines delivered by needle and syringe.”
The partners plan to advance the candidate through the clinic quickly. Michael Schrader, CEO and co-founder of Vaxess, outlined the opportunity that awaits the candidate in a statement to disclose the data.
“Only half of U.S. adults get a seasonal influenza vaccine,” Schrader said. “This exciting early data combining GC Biopharma Corp.’s safe and effective influenza vaccine with the MIMIX patch points to a future product that will overcome many of the barriers keeping this rate so low, including needlephobia, inconvenience, and side effects such as injection site pain.”