Kim Hae-jin, CEO of Ensol Biosciences, meets with ChosunBiz on the 24th and says, "If this year is a year of R&D leap, next year will be a year to commercialize those results," adding, "We will leap into a global market–leading innovative drug development company through KOSDAQ transfer." /Courtesy of Ensol Biosciences

"Sensing that the paradigm of life science research had no choice but to shift to 'experiments inside computers (in silico),' I decided to start a company."

Kim Hae-jin of Ensol Biosciences founded Ensol Biosciences (hereafter Ensol Biosciences) in 2001 to apply IT (information technology) to the bio industry. Kim has been an IT researcher who worked for 17 years at the Electronics and Telecommunications Research Institute (ETRI) starting in 1983.

Kim taught bioinformatics as an adjunct professor in the Department of Life Science at Chungnam National University from 2006 to 2017. Bioinformatics is a field that analyzes biological information with computers. It is a fusion of biology and computer science.

He set out to build a computer-based platform for discovering new drug candidates. Kim said, "Instead of the traditional new drug development approach that requires massive expense and time, the goal was to adopt an information-based approach to raise the odds of success."

The first fruit of that effort is KISDD (Knowledge-based In Silico Drug Discovery), Ensol Biosciences' platform for discovering new drug candidates. The company later integrated the KISDD platform with EPDS (Ensol Peptide Discovery System), a peptide discovery system.

Kim said, "We are also nearing completion of ESAIDD (Ensol AI Drug Discovery), an AI new drug discovery system that incorporates large language model (LLM) technology." Large language models are AI technologies like ChatGPT that learn massive amounts of sentence data to understand language and generate content a user requests.

Kim pointed to short peptides that modulate protein–protein interactions as the company's core technology. Peptides are the building blocks of proteins. Kim explained, "Short peptides regulate proteins so they do not bind incorrectly, fundamentally treating disease," adding, "This technology lets us approach diseases that have been difficult to develop treatments for with antibodies or small molecules, and discover new drug candidates with excellent efficacy while minimizing toxicity and side effects."

Ensol Biosciences has already derived several new drug candidates and is developing them. A representative case is "P2K," a candidate treatment for degenerative disc disease that is being developed after a transfer of technology to Spine Biopharma in the United States.

Spine Biopharma has completed a phase 3 clinical trial of P2K in the United States. Safety and efficacy were confirmed, but the placebo group, the comparator arm, also showed a treatment effect, so statistical significance was not secured.

Kim said, "Even so, the results sufficiently demonstrate clinical meaningfulness," adding, "Spine Biopharma will soon submit the clinical study report and enter talks to obtain accelerated approval from the Food and Drug Administration (FDA)." Kim said, "We expect approval as early as the second half of 2026, or by the first half of 2027 at the latest."

Kim said, "In addition to degenerative disc disease with Spine Biopharma, we also achieved a result by signing a contract to expand P2K's indications to three diseases, including other musculoskeletal disorders and fibrosis," adding, "It means the expansion potential is large." The contract size includes a 7.5 billion won upfront payment, with total fixed royalties of 215.4 billion won.

Ensol Biosciences is also developing candidate treatments for a range of intractable diseases, including Alzheimer's disease, osteoarthritis, and obesity. M1K, a candidate for treating Alzheimer's disease, is a peptide drug that prevents advanced glycation end-products (AGE), known as sugar toxins, from binding to the receptor for advanced glycation end-products (RAGE). Kim said animal studies confirmed efficacy in restoring cognitive function to normal and that the company is preparing to enter phase 1/2a.

The oral obesity candidate H1K, when used in combination with glucagon-like peptide (GLP)-1 drugs such as Wegovy, suppresses rebound weight gain and has shown effects in improving metabolic function, Kim said. The osteoarthritis candidate E1K is described as simultaneously achieving pain relief and cartilage regeneration.

Kim said, "All major pipelines, including E1K, H1K, and M1K, are in talks with global pharmaceutical companies," adding, "Next year's goals are to secure FDA accelerated approval for P2K, advance E1K into clinical trials, and sign at least two additional global technology transfer contracts."

Ensol Biosciences was listed on KONEX in Sep. 2018 and plans to pursue a transfer listing to KOSDAQ. Kim said, "If this year is a year for an R&D leap, next year will be a year to commercialize results," adding, "Through a KOSDAQ transfer listing, we will leap forward as a developer of innovative new drugs in the global market."

There was also a prior change in the largest shareholder. Hyeong In-woo, head of Smart & Growth and known as an early investor in the bio company Alteogen, became the largest shareholder of Ensol Biosciences in Jun. Aforementioned, Hyeong said the additional acquisition of Ensol Biosciences equity was for simple investment purposes and that there were no plans to participate in management.

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