Lemonex Announces IND Approval for Phase 1 Clinical Trial of LEM-S401, siRNA Gene Therapeutics With Nano-Drug Delivery Platform DegradaBALL®

SEOUL, South Korea–()–Lemonex Inc., a biotechnology company pioneering messenger RNA (mRNA) and siRNA therapeutics based on novel nanoparticle drug delivery system announced on the 19th of April that The Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) for siRNA gene therapy LEM-S401 with their nano-drug delivery platform, DegradaBALL® on 15th of April.

LEM-S401 is a siRNA gene therapy drug that can treat and prevent hypertrophic scars. Instead of using excessive amounts of siRNA without any drug delivery system, Lemonex used their proprietary nano-drug delivery technology, DegradaBALL, to increase safety and high therapeutic outcomes with siRNA technology. The company expects to be able to provide differentiated treatment options for hypertrophic scars, especially for people of various ethnic groups, such as Asians and Hispanics, who have three times higher occurrences of hypertrophic scars after surgery. LEM-S401 claims to minimize the incidence of scars and the ability to remove pre-existing scars, increasing quality of life for patients.

This phase 1 clinical trial is the first RNA gene therapy using Lemonex’s DegradaBALL drug delivery platform technology, and designed to evaluate the safety on healthy participants. With this IND approval, the company is going to accelerate to develop not only LEM-S401, but also dual-acting oligonucleotide-DegradaBALL immunotherapy (LEM-S403), and a mRNA-DegradaBALL vaccine (LEM-mR203).

Dr. Cheolhee Won, CEO of Lemonex, said, “During the COVID-19 pandemic, lots of people suffered from adverse reactions by Lipid Nanoparticles (LNPs) drug delivery formulations. The global market shows a high interest in safer RNA gene therapy and mRNA vaccines. Through the development of LEM-S401, I expect Lemonex to show more incredible outcomes with our DegradaBALL drug delivery technology in the global market by confirming the clinical safety data of DegradaBALL.” Dr. Won continued to say, “Usable drug delivery technologies in existing RNA gene therapy markets have been very limited; such as liposomes, Gal-NAc, and LNP only. However, DegradaBALL platform technology is diversely applicable to siRNA, mRNA, cytokines, and so on. We are planning on a wide range of business development programs such as collaborations with various partners, changes in the formulation and license-out.”

Lemonex is a bio-venture company co-founded in Dec 2013 by CEO Dr. Cheolhee Won and CTO Prof. Dal-Hee Min at Seoul National University Department of Chemistry. The Ministry of SMEs and Startups and the Korea Technology Guarantee Fund, to promote the emergence of unicorn companies, awarded Lemonex as a preliminary unicorn in 2021. CTO Dal-Hee Min was awarded by ‘Order of Science and Technological Merit (Do-Yak Medal)’ from Korea Government in 2019, in recognition of her contribution to science and technology. She also gave presentations on DegradaBALL® technology at the World Economic Forum in 2018. Lemonex has put in a lot of hard work to secure the drug delivery technology platform, DegradaBALL, in a time period lacking development of original technology for RNA gene therapy in South Korea following the COVID-19 Pandemic. They have currently received patent registration for DegradaBALL drug delivery technology in South Korea, the United States, and Japan.

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.

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