Lemonex, mRNA-DegradaBALL vaccine LEM-mR203 clinical phase 1 trial IND submission

SEOUL, South Korea--(BUSINESS WIRE)--Lemonex Inc., a biotechnology company pioneering messenger RNA (mRNA) and siRNA therapeutics based on a novel nanoparticle drug delivery system announced on the 14h of February that an Investigational New Drug (IND) application has been submitted to the Ministry of Food and Drug Safety (MFDS) for mRNA vaccine LEM-mR203 with its nano-drug delivery platform, DegradaBALL^® on 20th of January.

This clinical trial is the first mRNA vaccine to which Lemonex's proprietary drug delivery platform technology, DegradaBALL^®, is applied. It is a booster shot clinical trial for Covid-19, and safety and reactogenicity will be evaluated in healthy adults.

Compared to existing antigen protein vaccines, mRNA vaccines can be developed quickly, making it easier to respond to pandemics, but drug delivery technology is essential for mRNA delivery in the body. However, LNP, a drug delivery technology applied to existing mRNA vaccines, has shown limitations such as safety issues including myocarditis, pericarditis, and anaphylaxis, the necessity of ultra-low-temperature cold chain and intellectual property disputes due to complex rights relations, which suggests a need for next-generation drug delivery technology. Lemonex has secured intellectual property rights for the drug delivery technology of DegradaBALL^®.

Dr. Dal-Hee Min, CTO of Lemonex, Professor at Seoul National University, said, “LEM-mR203 is a safer and more efficient mRNA vaccine candidate by applying DegradaBALL^® technology that can complement the limitations of LNP.” she said. “We already confirmed the safety of DegradaBALL in healthy people through the phase 1 clinical trial of LEM-S401 (a siRNA gene therapy product). By applying DegradaBALL with proven safety in healthy humans to mRNA vaccines, we will accelerate technology transfer and commercialization by securing the safety and proof-of-concept (PoC) of the mRNA-DegradaBALL® platform.”

Dr. Cheolhee Won, CEO of Lemonex, said, “LEM-mR203 is a global first-in-class mRNA vaccine applied with DegradaBALL^® drug delivery technology. In the case of LNP, mRNA fragmentation, and impurities may occur during the complex mRNA encapsulation process that must be performed immediately after mRNA synthesis in a dedicated facility. However, DegradaBALL^® can be pre-produced and stored in stock and can increase mRNA stability. Through this platform technology, we plan to focus all of our core development capabilities on the ‘Pandemic Vaccine Development within 100 Days’ project.”

Meanwhile, Lemonex is developing various new drug candidates based on the DegradaBALL^® drug delivery platform. siRNA gene therapy LEM-S401: Completed administration and observation of the last subject in the phase 1 clinical trial, Dual-acting RNA immuno-oncology drug LEM-S403: Production of clinical samples for clinical entry after completion of the GLP-tox studies. In addition, Lemonex is strengthening its global network by signing an MOU with the International Vaccine Institute (IVI).

References

1. RNAi nanotherapy for fibrosis: highly durable knockdown of CTGF/CCN-2 using siRNA-DegradaBALL (LEM-S401) to treat skin fibrotic diseases. Nanoscale. 2020, 12(11): 6385-6393.
2. Nanoparticle delivery of recombinant IL-2 (BALLkine-2) achieves durable tumor control with less systemic adverse effects in cancer immunotherapy. Biomaterials. 2022, 280, 121257.
3. Small but mighty: transforming immuno-oncology and RNA medicine with the power of nanobiotechnology. Nature Biopharma Dealmakers, 2021.