Vaxess Technologies, a biotechnology startup developing the MIMIX sustained-release intradermal microneedle patch, has opened its 3,600 sqft pilot GMP (Good Manufacturing Practices) manufacturing facility.
The facility, which is located in Woburn, MA at one of the Cummings Park properties, will feature a state-of-the-art cleanroom where manufacturing of vaccine patches for clinical trials will take place.
Using the clinical-grade patches produced in the facility, Vaxess plans to enter the clinic in 2022. A MIMIX Phase I proof-of-concept trial using seasonal flu and COVID-19 antigens is slated to begin in the first half of 2022.
In addition to the manufacturing suite, Vaxess has announced plans to expand their Woburn footprint by another 6,300 sqft to provide additional GMP space as well as lab space for a host of other development activities to further the MIMIX platform.
A Phase I proof-of-concept trial using seasonal flu and COVID-19 antigens is slated for 2022
"After years of development, the company is thrilled to establish GMP manufacturing capabilities in Massachusetts for both our lead MIMIX-Flu vaccine programme as well as a host of other pipeline products to follow," said Vaxess CEO Michael Schrader.
About the MIMIX tech
The MIMIX patch is designed to be the easiest and most effective way to deliver vaccines and therapeutics. The patch releases treatments to the body at their most beneficial rate and duration.
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.
Vaxess has announced plans to expand their Woburn footprint by another 6,300 sqft
Engineered for stability, Vaxess' patch does not require refrigeration and can be shipped to and applied in low resource settings. It is virtually painless and resembles an adhesive bandage. After the minutes-long prescribed wear time, the MIMIX patch is removed and discarded while leaving behind microscopic intradermal depots to present the therapeutic payloads to the immune system over ensuing days or weeks.
The patch technology was originally conceived at MIT and Tufts University and uses the unique qualities of silk proteins and breakthrough immune-activating biology to enable best-in-class vaccines and therapeutics.
Vaxess has raised more than $60m in grant and venture capital funding from groups.
