NIAID’s Commercialization Readiness Program grant accelerates the company’s CMC activities for year-end IND filing for a clinical study of MIMIX with influenza and COVID-19 vaccines
Vaxess Technologies, Inc., a biotechnology company developing vaccines and therapeutics delivered through a next-generation sustained-release intradermal microneedle patch, announced it was awarded a Commercialization Readiness Program (CRP) grant from the National Institute of Allergy and Infectious Diseases (NIAID grant number SB1AI164584), a part of the U.S. National Institutes of Health (NIH). Vaxess will receive up to $2.85 million over the course of the award if the project milestones are met.
The CRP grant will be used to advance the commercialization of the MIMIX technology via CMC activities including design and quality control systems, clinical lot manufacturing, and continued engagement with regulatory stakeholders in preparation for a Phase I clinical trial. This first human trial of a MIMIX product will test a seasonal flu and a COVID-19 vaccine under an FDA IND projected to be filed within a year.
Despite the commercial availability of various vaccines, their public health impact is limited due to suboptimal efficacy and challenges with patient compliance and vaccine distribution. Vaxess is developing broadly protective vaccines using the needle-free MIMIX sustained release patch technology. The MIMIX patch is able to mimic natural infection kinetics using sustained release microneedles implanted into the immune cell dermal barrier, increasing immune responses to vaccine antigens compared to conventional administration techniques. For example, the MIMIX smart release patch demonstrated stronger, broader, and more durable HAI titers and influenza-specific T-cell responses in animal models against both the specific vaccine antigen contained in the patch and drifted influenza strains through the use of sustained antigen presentation. MIMIX products are designed to facilitate access by eliminating refrigerated distribution requirements and by virtually painless five-minute adhesive patch application to subjects.
"The NIH’s Commercialization Readiness Program fills a funding gap at the intersection of Research and Development, providing resources for scaling up critical activities and transitions a novel technology into the clinic," said Livio Valenti, Vaxess’ Senior Vice President of Strategy and Operations. "Our sustained-release skin patch represents a novel approach to increase immunization rates and effectiveness in the United States and globally."
About the MIMIX™ Technology
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. 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.
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 $28M 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 seasonal flu and COVID-19 antigens is slated to being in the first half of 2022. For more information, please visit the company website at www.vaxess.com
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Ted Hibben, Chief Business Officer