VAXESS ANNOUNCES MESSENGER RIBONUCLEIC ACID (mRNA) STABILITY RESULTS FROM TESTS ASSESSING THE POTENTIAL FOR ROOM-TEMPERATURE STORAGE

Vaxess’s silk fibroin formulations protect mRNA lipid nanoparticles (LNPs) through drying, and maintain in vivo potency after storage at 37°C for two weeks

CAMBRIDGE, Mass., April 25, 2023 — Vaxess Technologies, Inc., a life sciences company developing a shelf-stable vaccine patch with potential for self-application, today announced mRNA stability results from testing at a range of above-freezing temperatures. Vaxess conducted the study in collaboration with the Santangelo Lab at Emory University and The Georgia Institute of Technology, using Vaxess’s patented silk protein matrix stabilization technology.  

“One of the biggest challenges associated with mRNA vaccines is the need to store them at very low temperatures,” said Michael Schrader, CEO of Vaxess. “Vaxess is working towards a world where mRNA vaccines can be stored and distributed without the need for refrigeration. The tests Vaxess conducted with Emory University and The Georgia Institute of Technology demonstrate that using Vaxess’s proprietary silk fibroin as a novel biomaterial for stabilization and delivery of mRNA LNPs can address storage and distribution limitations of current mRNA vaccines.” 

The Defense Advanced Research Projects Agency (DARPA), a branch of the US Department of Defense, funded the mRNA testing. Results include:

• Encapsulation efficiency and LNP diameter: mRNA LNPs recovered from silk fibroin matrices maintain encapsulation efficiency > 85% compared with total loss of encapsulation efficiency upon drying in the absence of silk fibroin. Encapsulation efficiency and LNP diameter remain stable in dried silk fibroin matrices at 4°C, 25°C, and 37°C for at least two weeks.

• Functional activity and nanoluciferase expression in mice testing: Functional activity of mRNA LNPs stored in silk fibroin matrices at elevated temperatures was confirmed when injected into mice. 24 hours after injection, strong nanoluciferase expression as measured by IVIS imaging was observed in quads, lymph nodes, and liver. No statistical difference in expression was observed in any organ between mRNA LNPs recovered from silk matrices stored at 4°C, 25°C, and 37°C versus liquid mRNA LNP control.

“We had not seen a technology that produced such stable formulations of mRNA and LNPs, until working with Vaxess.” Philip J. Santangelo, PhD, Wallace H. Coulter Department of Biomedical Engineering, Emory University and The Georgia Institute of Technology. 

Future research will focus on translation of the mRNA LNPs stored in silk fibroin matrices into a Vaxess MIMIX™ sustained release patch.

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.