Vaxess Announces Interim Results from Phase I ClinicalTrial of MIMIX-Flu Vaccine Patch
CAMBRIDGE, Mass. December 14, 2022 — Vaxess Technologies, Inc., a life sciences company developing a shelf-stable vaccine patch with potential for self-application, today announced positive interim results from a first-in-man trial of VX-103, a monovalent seasonal influenza vaccine patch.
The trial, conducted in 45 healthy patients, evaluated H1N1 influenza antigen from Vaxess’s partner, GC Biopharma Corp., delivered via the MIMIX Patch. Vaxess enrolled 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. The MIMIX patches were worn for only five minutes.
The vaccine patches were well tolerated, with no serious or severe adverse events. The overall rate of reported systemic events was favorable as compared to traditional vaccines delivered by needle and syringe. Day 57 results show MIMIX-Flu significantly exceeded the 2007 FDA criteria for accelerated licensure of influenza vaccines, with the 15ug and 7.5ug patches leading to seroconversion rates of 85% and 77% respectively along with seroprotection rates of 92% and 92%.
“Only half of US adults get a seasonal influenza vaccine,” said Michael Schrader, CEO and co-founder of Vaxess. “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. We look forward to working with GC Biopharma Corp. to rapidly move this product through the clinic to positively impact patients’ lives.”
The trial will follow subjects out to 180 days to evaluate the long-term safety profile of the patch. 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. Preclinical studies have shown potential for both improved durability and improved breadth of protection for influenza vaccines when administered via the MIMIX patch platform.
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.
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 grant and venture capital funding from groups such as RA Capital Management, 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.
About GC Biopharma Corp.
GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma Corp. is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand as GC Biopharma Corp. in early 2022. The company’s quadrivalent seasonal influenza vaccine, GCFlu, is the world’s fifth best-selling influenza vaccine. It is approved in Korea, WHO prequalified, and sold in more than thirty-five countries around the world with a demonstrated track record of safety and efficacy.
