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• Publication describes a new delivery platform (Piezopen) that augments gene expression and immunogenicity to a "naked" mRNA vaccine comparable to benchmark LNP formulations
• Piezopen delivers diverse cargos (mRNA, saRNA, circRNA, and DNA) and across species (mice, rats, human skin)
• Potential to improve dosing, reactogenicity, durability, cost, and manufacturing hurdles of mRNA vaccines by eliminating LNPs

ATLANTA, Feb. 11, 2025 /PRNewswire-PRWeb/ -- Piezo Therapeutics, a biotechnology company pioneering formulation-free delivery of nucleic acid vaccines and therapeutics, today announced promising preclinical results demonstrating Piezopen drives robust immune responses to "naked" mRNA vaccines without lipid nanoparticles (LNPs) or other formulations. This innovation has the potential to significantly reduce costs, simplify manufacturing, and improve the tolerability and versatility of mRNA vaccines.

Published on and submitted for peer review, the study highlights Piezopen's ability to match the immune potency of LNP-based vaccines at low doses despite administering naked mRNA. Piezopen delivers multiple RNA and DNA payloads—including self-amplifying RNA (saRNA), circular RNA (circRNA), and plasmid DNA. Notably, Piezopen effectively delivers naked mRNA across species, showing efficient uptake in live ex vivo human skin at low doses comparable to a benchmark LNP.

While mRNA vaccines have transformed infectious disease prevention, LNPs introduce hurdles in reactogenicity, durability, manufacturing, and cost. Attempts to bypass LNPs have largely failed due to rapid mRNA degradation and poor intracellular uptake—until now. Piezopen uniquely achieves robust immune activation at low doses, with the potential to enable high-dose, multivalent, and combination RNA vaccines with attractive reactogenicity and efficacy profiles.

"Our work introduces a simple yet powerful way to deliver mRNA vaccines without costly and complex formulations to improve their adoption and application," said Eleftheria Michalaki, senior scientist and lead author of the study. "Piezopen preserves the potency and programmability of formulations but at the cost of a needle-syringe. We look forward to advancing Piezopen to unlock a new class of formulation-free vaccines and therapeutics."

"We set out to develop a new delivery platform for RNA vaccines to address challenges with LNP delivery," said Gaurav Byagathvalli, Chief Executive Officer. "We have achieved that goal at incredible speed in just under a year. This work forms the foundation for ongoing collaborations and studies as we bring Piezopen closer to the clinic to deliver transformative outcomes for patients."

About Piezopen Platform

Our proprietary Piezopen platform enables localized yet highly efficient delivery of RNA and DNA without the need for lipid nanoparticles or viral vectors, with applications in infectious disease, cancer, chronic disease, and dermatology. In preclinical models, we have demonstrated robust induction of humoral and cellular responses to infectious disease and cancer vaccines with increased tolerability, dosing flexibility, and payload versatility. In human subjects, Piezopen was well accepted and shown to elicit superior tolerability compared to a hypodermic needle. Piezopen combines two innovations to surpass the limitations of formulations: piezoelectric pulses and microelectrodes for skin-targeted "naked" nucleic acid delivery. Piezopen improves the tolerability and efficacy of RNA/DNA medicines while slashing costs, simplifying manufacturing, and transforming scalability.

About Piezo Therapeutics

Piezo Therapeutics is a spinout from Georgia Tech focused on enabling next-gen nucleic acid vaccines and therapeutics via formulation-free delivery. Integrating innovations in drug delivery and genetic medicine, Piezo is advancing its delivery platform and investigational therapeutics in collaboration with global pharma and biotech companies to prevent and treat debilitating diseases. The company raised its initial financing in 2023 backed by Good Ventures. For more information, please visit .

Media Contact

Gaurav Byagathvalli, Piezo Therapeutics, 1 4049973263, [email protected],  

SOURCE Piezo Therapeutics