NeoVac recently announced positive results from first-in-human Phase I/II clinical study  of NeomiVac, its investigational mRNA-LNP COVID-19 vaccine candidate. The clinical findings, now publicly available as a preprint on The Lancet platform, demonstrate encouraging biological activity together with a superior safety profile when compared with currently authorized mRNA COVID-19 vaccines. 

mRNA-based pharmaceuticals have emerged as a transformative therapeutic modality, validated by their application as vaccines against infectious diseases. Beyond prophylactic vaccination, mRNA technology has the potential to be applied in a wide range of indications, including cancer immunotherapy, treatment of inflammatory and autoimmune diseases, protein replacement therapies, and gene-based interventions. To date, broader clinical adoption has been limited, in part due to challenges related to tolerability, safety and biological activity at  clinically meaningful levels.

NeoVac has developed a proprietary next-generation mRNA-LNP technology platform designed to address key limitations of existing mRNA delivery systems. The platform enables the rational tuning and customization of immunogenicity, biodistribution, and pharmacokinetic profiles, with the objective of improving both safety and activity relative to current delivery technologies. NeomiVac uses LNPs optimized specifically for vaccination against infectious diseases. The findings of the current study also support broader use of NeoVac’s mRNA‑LNP technology beyond COVID‑19, including therapy.

The study represents the first clinical evaluation of NeoVac’s proprietary LNP delivery technology. The clinical trial evaluated the safety, tolerability, and immunogenicity of NeomiVac in healthy adult volunteers vaccinated against SARS-CoV-2. Conducted using a dose-escalation design, the trial assessed multiple dose levels to generate early human data essential for advancing mRNA-based preventive and therapeutic product candidates.

The results demonstrate that NeomiVac was well tolerated and biologically active, with a safety profile that compares favorably to approved mRNA vaccines from Moderna and Pfizer/BioNTech. Importantly, the improved tolerability observed in this study suggests that NeoVac’s technology platform may enable broader applications for mRNA-based pharmaceuticals overcoming current limitations.

With the successful demonstration of clinical proof-of-concept for its LNP technology, NeoVac is expanding product development efforts in infectious diseases, vaccines, and additional indications. Ongoing programs include product candidates for cancer immunotherapy and the treatment of inflammatory and immune-mediated diseases. In collaboration with development partners, NeoVac is also advancing mRNA-based products across a variety of additional therapeutic areas.

“The publication of this clinical study represents a significant milestone for NeoVac and for the mRNA field as a whole,” said Dr. Jan Egberts, Chief Executive Officer of NeoVac. “Our data suggest that next-generation mRNA-LNP technologies can combine meaningful biological activity with improved tolerability, opening the door to entirely new therapeutic possibilities.”

Sir Adrian Hill, co-founder and co-inventor of the AstraZeneca COVID-19 vaccine and a leading developer of vaccines for malaria and global health indications, commented: “This work highlights how advances in delivery platforms can materially change the risk–benefit profile of vaccines and other mRNA-based interventions. 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.”

Dan Peer, co-founder of NeoVac and a recognized leader in the field of nucleotide delivery, added: “mRNA is a remarkably powerful therapeutic modality, but its success depends critically on how it is delivered. These clinical results validate years of research into next-generation lipid nanoparticles and demonstrate that rationally designed delivery systems can significantly improve tolerability while preserving biological activity.”

Heinrich Haas, PhD, Chief Technology Officer of NeoVac, emphasized the translational importance of the findings: “Drawing on decades of experience in both academic research and industrial development of mRNA nanoparticles, we designed these formulations with clinical practicality in mind. 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.”

The study underscores the importance of delivery technology in determining both the efficacy and safety of mRNA medicines. By refining LNP composition and formulation, NeoVac aims to enable repeat dosing, chronic administration, and applications in therapeutic areas where traditional mRNA approaches have previously been constrained.

The full manuscript, titled Safety, tolerability, and immunogenicity of NeomiVac, a candidate next-generation lipid nanoparticle (LNP) mRNA vaccine against SARS-CoV-2 in healthy volunteers, is publicly available in The Lancet’s preprint server.

NeoVac is a clinical-stage pharmaceutical company developing next-generation lipid nanoparticle (LNP) technologies for mRNA-based vaccines and therapeutics. The company’s platform is designed to improve the safety, tolerability, and versatility of mRNA medicines and to enable applications across infectious diseases, oncology, and immune-mediated disorders.