Naivek, Next-Generation mRNA Vaccine National Project... 'Securing LNP Alternative Delivery System'

[Asia Economy Reporter Hyungsoo Park] Naivek, a peptide fusion bio company, announced that its self-developed drug delivery platform ‘NIPEP-TPP’ has been selected for a national project by domestic quarantine authorities to conduct a demonstration study on messenger ribonucleic acid (mRNA) delivery technology.

Naivek revealed on the 19th that it was finally selected for a national project on ‘mRNA delivery-related research’ by the Korea Disease Control and Prevention Agency. Naivek plans to demonstrate the excellent targeting ability and powerful drug delivery technology of ‘NIPEP-TPP’.

The project is being conducted jointly with the Seoul National University Industry-Academic Cooperation Foundation. The main focus is to verify the applicability of NIPEP-TPP as a delivery vehicle for mRNA vaccines and its differentiation from the well-known ‘lipid nanoparticles (LNP)’ delivery vehicles for existing mRNA vaccines. Naivek aims to enter vaccine commercialization using NIPEP-TPP through this.

mRNA vaccines are known to inject antigen information, which is a substance that produces antibodies capable of fighting viruses, into our body, thereby activating the immune system against viruses and enabling proactive response to diseases.

Genes such as mRNA and short interfering ribonucleic acid (siRNA) have limitations in reaching the desired treatment site because they are rapidly degraded by enzymes called nucleases upon entering the human body. Even if they reach the targeting site, their large molecular size prevents them from penetrating the cell membrane, making it difficult to maximize efficacy.

To overcome these drawbacks, lipid nanoparticles (LNP) have mainly been used for delivering mRNA and siRNA. Recently, with the use of mRNA vaccines applying LNP technology during the COVID-19 pandemic, issues such as immune responses (cytokine storms) and allergic reactions (anaphylaxis) caused by polyethylene glycol (PEG) components included in LNP have drawn attention. Globally, the need for new delivery vehicles to replace LNP has increased.

NIPEP-TPP enables precise immune system targeting and can be widely applied to prevent various infectious diseases, including diverse new variants of the coronavirus. Since it utilizes peptide fragments of proteins, concerns about side effects are minimal.

Naivek has developed oligonucleotide delivery and application technologies broadly applicable to mRNA and siRNA. They have completed related patent applications and succeeded in solving LNP problems through gene drug delivery technology using NIPEP-TPP applied in tumor research.

Since NIPEP-TPP has proven safety in toxicity tests, the company explains that it does not have issues such as liver toxicity caused by LNP or cytokine storms and anaphylaxis reactions caused by PEG introduced in LNP.

A Naivek official stated, "We have already confirmed that NIPEP-TPP for mRNA delivery has technology that stably binds and compresses large mRNA molecules compared to LNP, maintaining stable nanoparticles for a long time."

He added, "We also verified that applying NIPEP-TPP transporter microparticles containing mRNA to cells significantly increased intracellular delivery of mRNA and the expression of proteins encoded by the mRNA."

This means that therapeutic substances can penetrate inside cells. It is expected that the national project will also prove the safety and efficacy of the NIPEP-TPP and mRNA nanocomplex formulation, as well as its superior function compared to existing LNP. The process design for mass production of mRNA has also been completed.

Last year, the Korea Disease Control and Prevention Agency allocated a new budget for this year to strengthen health care R&D and research infrastructure, including ▲support for new technology-based vaccine platform development ▲clinical support for mRNA vaccines responding to new variants of infectious diseases ▲development of technologies to overcome virus infectious diseases causing national crises (R&D) ▲public vaccine development support projects (R&D) ▲and chronic disease management technology development research (R&D).