Sbir phase i: a novel low cost intradermal delivery platform for nucleic acid vaccines

The National Science Foundation (NSF) awarded Piezo Therapeutics, Inc. a $304,742 Project Grant under the Technology, Innovation, and Partnerships program (CFDA 47.084) for a Phase I Small Business Innovation Research (SBIR) project running from October 1, 2025 through September 30, 2026. The awardee will develop and validate a novel intradermal vaccine delivery platform that eliminates the need for lipid nanoparticles (LNPs) by utilizing electroporation technology. The deliverables include optimization of a handheld pen device that creates temporary pores in skin cells through microelectrode electrical pulses, enabling direct nucleic acid vaccine delivery to immune cells without systemic exposure.

The specific products and services to be delivered comprise: (1) an optimized electroporation pen device with refined electrical pulse parameters (voltage, duration) and microneedle configurations to maximize gene delivery and protein expression; and (2) preclinical validation data demonstrating that the device achieves immune response efficacy equivalent to or superior to FDA-approved vaccines in a mouse model. This Phase I feasibility study will establish the technical and commercial viability of a simpler, lower-cost, scalable vaccine delivery platform applicable to infectious disease and cancer immunotherapies, with reduced production complexity and side effects compared to conventional LNP-based approaches. Performance will be conducted in Cumming, Georgia.

Abstract

The broader impact/commercial potential of this small business innovation research (sbir) phase i project is a new portable low cost vaccine delivery platform for nucleic acid vaccines, commonly used to treat infectious diseases and cancer. Current vaccines are delivered using lipid nanoparticles (lnps) which are generally considered complex and generally more costly to produce. Furthermore they can exhibit undesirable side effects. These challenges have caused a steady decline in actual adoption despite their demonstrated efficacy. This project aims to develop a new technology to deliver nucleic acid vaccines without lnps or carriers in general, using a simpler scalable approach leveraging electroporation. If successful, this platform could expand access to vaccine delivery with fewer side effects, improve their tolerability/acceptability, and support ultra-rapid deployment for biosecurity threats, to provide a new delivery method for vaccinations. This small business innovation research (sbir) phase i project will demonstrate the feasibility of delivering naked nucleic acid vaccines without lipid nanoparticles (lnps) using a simple handheld pen design. The device delivers electrical pulses through microelectrodes to create temporary pores in skin cells allowing direct vaccine delivery to immune cells without systemic exposure. In this project, the pen will be: 1) optimized in vivo to maximize gene delivery and protein expression by varying electric pulse voltage, duration, and mechanical micro needle configurations and 2) benchmarked for their vaccine delivery effectiveness against an FDA-approved vaccine with the goal of showing superior or comparable immune responses despite eliminating lipid nanoparticles, in a mouse model. These result will demonstrate preclinical feasibility of a novel delivery platform to match LNP efficacy for vaccines while reducing cost, complexity, and side effects compared to existing systems. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the foundation's intellectual merit and broader impacts review criteria.- subawards are not planned for this award.