Vaxess Announces Results from Completion of MIMIX-Flu Vaccine Patch Phase 1 Trial

CAMBRIDGE, Mass. —  Vaxess Technologies, Inc., a life sciences company developing a shelf-stable vaccine patch with potential for self-application, today announced results from the phase 1 trial completion of VX-103, a seasonal influenza vaccine patch.

The trial, conducted in 45 healthy patients, evaluated delivery of an H1N1 influenza antigen from Vaxess’s partner, GC Biopharma Corp., delivered via the Vaxess 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. Vaxess also evaluated the durability of the immune response for each vaccine dose level, and assessed the breadth of the influenza A H1 antigen responses.

Vaxess released its interim 57-day results in 2022, and just completed the phase 1 trial, which followed subjects out to 180 days. Results included:

• Immune responses: The MIMIX-Flu vaccine patch elicited robust, durable and broadly protective immune responses. Clinical trial subjects experienced robust rises in HAI, anti-HA IgG and virus microneutralizing (MN) titers to the vaccine strain. Seroconversion and seroprotection rates were consistent with FDA criteria for accelerated licensure. There was a strong correlation between HAI and HA-IgG or MN titers, with responses persisting through study day 180 (end of study) for both dose levels. The MIMIX-Flu vaccine patch also elicited strong HAI Titers against the antigenically differentiated  strain A/Victoria/2570/2019, which demonstrated breadth of the immune response.
• Safety: MIMIX-Flu vaccine patch was well tolerated systemically and locally. Solicited local and systemic events occurring within seven days post vaccination were similar for all treatment groups. No pain, no bruising, and limited tenderness were reported. Systemic adverse events were limited to mild headache and fatigue.
• Dose sparing potential: Titers did not differ significantly for the two dose levels, indicating a fractional dose can be delivered without significantly impacting immunogenicity.

"One of the most promising findings from our 180-day data is the immune response durability coupled with the potential for the VX-103 patch to protect against drifted strains," said Lynda Tussey, PhD, chief development officer of Vaxess. "This means that receiving a ‘flu shot’ via a Vaxess MIMIX patch has the potential to improve a flu vaccine’s effectiveness relative to administering the vaccine via needle and syringe — in addition to a patch being far more comfortable than a traditional injection.”

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.