mRNAsolutions.com: Can you provide us with a brief overview of Lemonex and its mission?

Cheolhee Won: Lemonex is developing mRNA vaccines, gene therapies, and cancer immunotherapy drugs. As a core technology, we use a mesoporous nano-silica drug delivery system called DegradaBALL, and its characteristic is that it loads active pharmaceutical ingredients (APIs) inside the particles. The company’s name, Lemonex, was derived from a transmission electron microscope (TEM) image of mesoporous nanosilica particles that resemble a lemon slice, which contains substances useful to humans. It includes the founder’s will to develop this into a next-generation formulation.

mRNAsolutions.com: Can you provide us with a brief overview of Lemonex and its mission?

Cheolhee Won: Lemonex is developing mRNA vaccines, gene therapies, and cancer immunotherapy drugs. As a core technology, we use a mesoporous nano-silica drug delivery system called DegradaBALL, and its characteristic is that it loads active pharmaceutical ingredients (APIs) inside the particles. The company’s name, Lemonex, was derived from a transmission electron microscope (TEM) image of mesoporous nanosilica particles that resemble a lemon slice, which contains substances useful to humans. It includes the founder’s will to develop this into a next-generation formulation.

mRNAsolutions.com: Could you walk us through the pipeline of Lemonex and current partnerships of importance?

Cheolhee Won: Lemonex completed phase 1 clinical trials in healthy adults for LEM-S401 (siCTGF gene therapy, hypertrophic scar) and we obtained evidence of excellent safety and tolerability through clinical results. In addition, through clinical sample production, we confirmed the excellent stability of the DegradaBALL lyophilized formulation at room temperature for approximately 3 years. Recently, Lemonex signed a strategic partnership with CEPI (Coalition for Epidemic Preparedness Innovations) in December 2023 to develop a new “DegraderBALL-Reducerna” mRNA vaccine platform and is developing a COVID-19 mRNA vaccine (LEM-mR203, phase 1 clinical trial) was approved by the Ministry of Food and Drug Safety (MFDS), and administration to healthy adults was completed in March of this year.

mRNAsolutions.com: What are some of the biggest challenges you face with mRNA technology?

Dal-Hee Min: The weakness of existing lipid nanoparticle (LNP)-based mRNA vaccines is that they must be stored and distributed at extremely low temperatures (-70°C). This will be the biggest cause of a significant increase in the global supply price of mRNA vaccines in the future.

According to a paper published in the renowned international journal Nature Review

Immunology in April 2024, existing vaccines showed high immunogenicity against the COVID- 19 virus in Europe and the United States, but in regions with high temperatures such as Africa or the Middle East, the immunogenicity of the vaccine was low. It has been reported that this has decreased to about 25%. In addition, given the recent resurgence of COVID-19 amid extreme weather events and extreme heat, the development of an mRNA vaccine with improved temperature stability is a very important challenge.

mRNAsolutions.com: What sets your mRNA vaccine technology apart from other approaches?

Dal-Hee Min: Existing existing LNP-based mRNA vaccines can be summarized in two points. The first is the ultra-cold chain issue due to low thermos-stability of LNP, and the second is the issue of systemic side effects that spread throughout the body along the blood vessels after administration of LNP formulation. In addition, the existing mRNA-LNP vaccine requires encapsulation with LNP twice at the same time as mRNA production and storage at -70°C. Thus pre-production of mRNA-LNP vaccine is impossible until the sequence of the pandemic virus is analyzed. However, since DegradaBALL was developed so that it can be stored at room temperature for more than 2 years, it can be pre-produced and supplied in the form of a drug substance. When a pandemic variant or Disease X virus appears, it is possible to quickly produce mRNA

and produce a drug product with pre-produced DegradaBALL. Moreover, DegradaBALL was developed as a lyophilized formulation and has already accomplished clinical trials of two pipelines (LEM-S401, LEM-mR203), confirming thermo- stability data for more than two years at room temperature and safety results that minimize systemic side effects after administration. Under the support of CEPI, various types of DegradaBALL-Reducerna mRNA vaccine formulations are being developed.

mRNAsolutions.com: Can you share any upcoming projects or partnerships that are in the works for your company?

Dal-Hee Min: The field in which Lemonex is receiving support from CEPI is the development of a new mRNA vaccine platform for an unknown infectious Disease X. Lemonex is also developing various types of mRNA vaccine formulations using DegraderBALL-Reducerna mRNA vaccine platform. During the COVID-19 pandemic, CEPI formed the COVAX Alliance and received donations of approximately USD 6.5 billion from the US, Germany, UK, EU, Sweden, Japan, Saudi Arabia, etc., and approximately 60% of the vaccines supplied worldwide were supplied through the COVAX Alliance. According to the update on the portfolio of vaccine candidates supported by CEPI in March 2024, only about 40 companies or universities around the world, including Lemonex, BioNTech, Moderna, AstraZeneca, University of Oxford, and University of Washington, are supported by CEPI. Among these, Lemonex is leading alongside BioNTech in the field of Diseases X among the vaccine projects supported by CEPI. Through a strategic partnership with CEPI, Lemonex is advancing drug delivery technology that increases the thermos-stability of the mRNA vaccine, which is the biggest challenge in equitable mRNA vaccine supply around the world.

mRNAsolutions.com: What do you envision as the future of mRNA vaccine technology and its role in global health?

Cheolhee Won: Most pandemic viruses are single strand RNA (ssRNA) virus. There is a proof-reading (genome editing) process in the DNA replication process, but this process does not exist in the RNA replication process. For this reason, continuous and unpredictable mutant strains are created during the process of RNA virus amplification within an infectious body. The mRNA vaccine, which was first commercialized during the COVID-19 pandemic, showed that it was possible to develop and supply faster than existing vaccines, and showed immunogenicity similar to existing vaccines. However, recent temperature rises and heat waves due to abnormal climate will be a major obstacle to equitable supply around the world due to ultra-cold chain issues of existing mRNA vaccines. Therefore, the development of mRNA vaccines with improved thermo-stability will be a very important task for global health, and continuous support and bold investment from the international community are needed to develop technologies that can overcome this. In the near future, we expect that the “DegradaBALL-Reducerna” mRNA vaccine platform technology will contribute to a fair supply of mRNA around the world by improving mRNA thermo-stability and reduce supply cost by resolving cold chain issues.

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