27 April 2022 - - South Korea's Ministry of Food and Drug Safety has approved the Investigational New Drug for siRNA gene therapy LEM-S401 with South Korea-based biotechnology company Lemonex Inc's nano-drug delivery platform DegradaBALL, the company said.

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 said it 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).

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.

Lemonex have currently received patent registration for DegradaBALL drug delivery technology in South Korea, the United States, and Japan.