Vaxess Announces Production of The First GMP Batch of MIMIX™ Technology Vaccine Patches for an Upcoming Phase 1 Seasonal Influenza Clinical Trial; Clinical Entry Expected This Summer Based on a Successful February Pre-CTA Meeting With Health Canada.

• Vaxess’s new GMP facility in Woburn has successfully produced clinical trial drug product consisting of a proprietary silk fibroin microneedle patch loaded with influenza vaccine antigen 
• The company engaged in a positive Pre-CTA meeting for this future Phase 1 MIMIX-Flu proof-of-concept trial with Health Canada this winter in anticipation of clinical entry this summer.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Vaxess Technologies, Inc., an innovative life sciences company developing a pipeline of shelf-stable and simple-to-apply vaccines on the MIMIX patch platform announced significant progress towards clinical entry for the company’s lead program, MIMIX-Flu.

MIMIX-Flu, developed in collaboration with GC Pharma, combines GC’s commercial seasonal influenza vaccine antigen with Vaxess’s innovative MIMIX patch-based intradermal controlled release delivery system. MIMIX-Flu offers ease of topical application in combination with shelf-stability to reimagine the distribution and administration of seasonal influenza vaccines worldwide. Preclinical studies of MIMIX-based vaccines have demonstrated dose sparing and improved immunogenicity.

Vaxess’s 10,000 sq ft purpose-built GMP (Good Manufacturing Practices) manufacturing facility. opened in Woburn, MA, in June 2021, includes a state-of-the-art cleanroom for clinical-scale patch production as well as a GLP QC lab. Production of the first clinical materials in the facility under Vaxess’s quality system represents a corporate transition to a multiple clinical product capability.

Vaxess’s first clinical trial, evaluating the safety and immunogenicity of MIMIX-Flu in healthy adults, will be conducted in Canada this summer. The initial engagement with Health Canada, the Canadian counterpart to the US FDA, supported Vaxess’s CMC (Chemistry, Manufacturing and Controls) plan and other CTA components as proposed.”

“Greenfielding the Woburn facility and the production of this clinical-grade material demonstrates the ability of Vaxess to advance the MIMIX technology to true drug candidates,” said Vaxess CEO Michael Schrader. “This is a key step in our quest to produce shelf-stable, patient-friendly vaccine products in seasonal flu and other prophylactic disease areas.”

About the MIMIX™ Technology

The MIMIX patch is the easiest and most effective way to administer vaccines and therapeutics. The patch achieves controlled release of treatments to the intradermal region of the body at the 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. Engineered for stability, Vaxess’s patch does not require refrigeration and can be shipped to and applied in low resource settings. Application is virtually painless, and the applied patch resembles an adhesive bandage. After the prescribed wear time of just minutes, the MIMIX patch is peeled off and discarded: Microscopic intradermal therapeutic depots are left behind to present the payload to the immune system over a precision-engineered timespan.

About Vaxess Technologies

Vaxess Technologies is developing the MIMIX™ sustained release patch technology, originally conceived at MIT and Tufts University. MIMIX™ 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 such as The Engine, BARDA, DARPA, NIH, NSF and the Gates Foundation. A MIMIX Phase I proof-of-concept trial using a seasonal influenza antigen is slated to begin in the first half of 2022. For more information, please visit the company website at www.vaxess.com or send additional inquiries to [email protected].

About GC Pharma

GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Pharma 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 to GC Pharma in early 2018. Green Cross Corporation remains the company’s legal name.

Contacts

Livio Valenti

[email protected]