First-in-Human Study Validates Safety of Next-Generation mRNA–LNP Platform

NeoVac reported positive first-in-human Phase I/II clinical results on Feb. 5, 2026 for an investigational messenger RNA (mRNA)–lipid nanoparticle (LNP) COVID-19 vaccine candidate, marking the initial clinical validation of the company’s proprietary next-generation mRNA delivery platform (1). The findings were published as a preprint on The Lancet platform and indicate favorable safety and biological activity compared with currently authorized mRNA COVID-19 vaccines (2).

mRNA-based therapeutics have demonstrated transformative potential, most notably through prophylactic vaccines for infectious diseases. However, broader application of the modality, such as in cancer immunotherapy, autoimmune and inflammatory diseases, and protein replacement therapies, has been constrained by challenges related to tolerability, safety, and achieving sufficient biological activity at clinically meaningful doses.

“The publication of this clinical study represents a significant milestone for NeoVac and for the mRNA field as a whole,” said Dr. Jan Egberts, CEO of NeoVac, in a company press release (1). “Our data suggest that next-generation mRNA–LNP technologies can open the door to entirely new therapeutic possibilities.”

NeoVac’s mRNA–LNP platform is designed to address limitations by enabling rational tuning of immunogenicity, biodistribution, and pharmacokinetic properties. According to the company, NeomiVac uses LNPs optimized specifically for vaccination against infectious diseases, while the broader platform is intended to support therapeutic as well as preventive applications (1).

What did the Phase I/II study evaluate?

The Phase I/II clinical study represented the first clinical evaluation of NeoVac’s proprietary LNP delivery technology. Conducted in healthy adult volunteers vaccinated against SARS-CoV-2, the trial assessed safety, tolerability, and immunogenicity using a dose-escalation design across multiple dose levels. The study generated early human data intended to inform the advancement of mRNA-based vaccines and therapeutics built on the platform.

Results showed that NeomiVac was well tolerated and biologically active across evaluated doses. The safety profile compared favorably with authorized mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech, with improved tolerability observed in the study population (1,2). According to NeoVac, these findings suggest that optimized LNP design may mitigate safety constraints that have limited repeat dosing and broader therapeutic use of mRNA medicines.

How does delivery technology influence mRNA safety and scope?

Experts involved in the study emphasized the role of delivery systems in shaping both the efficacy and risk profile of mRNA-based interventions. Sir Adrian Hill, co-founder and co-inventor of the AstraZeneca COVID-19 vaccine, noted that improvements in delivery platforms could materially affect the range of diseases addressable with mRNA technologies. “Improved safety is not only beneficial for patients, it is also essential for expanding the scope of diseases that can realistically be addressed using mRNA technologies,” Hill said in the release (1).

Dan Peer, co-founder of NeoVac, highlighted the importance of delivery design in unlocking the modality’s full potential. “mRNA is a remarkably powerful therapeutic modality, but its success depends critically on how it is delivered,” he said in the release (1). “These clinical results validate years of research into next-generation lipid nanoparticles…”

“The favorable safety profile observed in this study supports the idea that mRNA–LNPs can be optimized not only for vaccines, but also for a wide range of therapeutic indications,” added Heinrich Haas, PhD, NeoVac’s chief technology officer (1).

What are the broader implications for mRNA development?

With proof-of-concept established in humans, the company is expanding development efforts across infectious diseases, oncology, and immune-mediated disorders, including programs in cancer immunotherapy and inflammatory disease. The study results underscore how advances in delivery technology may enable repeat dosing, chronic administration, and therapeutic applications that have previously been challenging for mRNA-based medicines (2).

References

1. NeoVac. NeoVac Announces Positive Phase I/II Results Demonstrating Superior Safety Profile of Next-Generation mRNA-LNP Vaccine Platform. Press Release. Feb. 5, 2026.
2. Vaccaro, A.; Rolt, J.; Frumento, N.; et al. Safety, Tolerability, and Immunogenicity of NeomiVac, a Next-Generation mRNA–Lipid Nanoparticle Vaccine Comprising a Novel Ionisable Lipid: A First-In-Human, Phase 1, Dose-Escalation Trial. Preprints with The Lancet. Posted Jan. 28, 2026 (accessed Feb. 6, 2026.