Restoring confidence post-Invossa incident was my priority

Kim Sun Jin, CEO of Kolon Life Science

Newly appointed in March 2023, Kim successfully resumed Invossa U.S. trials and focused on instilling confidence within the company

In his 2nd year, restructuring toward ‘reinforcing R&D’… “Strengthening mid-to-long-term growth in new drug development”

“Even in the face of failure, do not worry.

 

As the CEO of the company, I will take full responsibility for everything.

 

We will engage in frequent communication.

 

Once we reach a consensus after thorough discussions, I will bear responsibility for the outcome, regardless of the outcome.” In his inaugural speech in March of the previous year, the newly appointed CEO, Kim Sun Jin, of Kolon Life Science sent the message to the executive and staff members.

 

Kim dedicated a year of relentless efforts toward enhancing the corporate mood after assuming the leadership position at Kolon Life Science.

 

Kim Sun Jin, CEO of Kolon Life Science

CEO Kim became affiliated with Kolon Life Sciences after joining Kolon TissueGene as an independent director in March 2020.

 

At the time, both Kolon TissueGene and Kolon Life Sciences were heavily affected by the Invossa incident.

 

About ten months before his joining, the U.S.

 

Food and Drug Administration (FDA) issued a clinical hold on Invossa in May 2019.

 

The clinical hold was lifted in April 2020, however, the clinical trials in the United States were unable to resume immediately.

 

Patient enrollment was significantly hindered by the Covid-19 pandemic.

 

Further complicating matters, the clinical reagents sent to the Contract Manufacturing Organization (CMO) were inadvertently contaminated with foreign substances.

 

Faced with one challenge with another, CEO Kim, serving as a Chief Medical Officer (CMO) of Kolon TissueGene, committed himself to resolving the problem.

 

Subsequently, the Phase 3 trials for the drug resumed a drug administration in Dec.

 

2021.

 

Kim is recognized for his pivotal role in successful resumption of Phase 3 U.S.

 

trials for Invossa (current project name: TG-C).

 

Although the U.S.

 

trials resumed, the overall corporate mood remained depressed.

 

Recognizing this, Kim stressed the saying ‘Even in the face of failure, do not worry.’ in his inauguration speech.

 

"After the Invossa incident in 2019, Kolon Life Science experienced a somewhat depressed corporate mood overall," Kim recalled.

 

“When someone experiences failure once, the fear of failing again intensifies,” Kim added, “The setback deeply affected everyone.

 

So, I consistently reassured them that what happened was not an individual's fault.

 

I tried to help the members of the company heal from those wounds and rebuild their confidence.” In the 2nd year of joining, CEO restructures the company…”Reinforcing R&D and bringing synergy among the four companies” While focusing on reorganizing the company roles, Kim focused on instilling confidence.

 

Kim placed particular emphasis on restructuring the research division.

 

As part of this effort, research headquarters was established within Kolon Life Science on January 1st of this year, making it the first major organizational change since he assumed the CEO role.

 

Previously, the company's research capabilities were split between bio- and chemical research, and now, these have been merged into one.

 

Additionally, synthetic drug development has been strengthened.

 

The analysis is that after restructuring, the focus is more on new drug development without differentiating between chemical and bio research.

 

Kim evaluated that Kolon Life Science and associated companies have a perfect rotational structure.

 

With Kolon Life Science in the center, Kolon TissueGene is responsible for new drug R&D and clinical development, Kolon Biotech manages production, and Kolon Pharma manages domestic distribution and sales of these products.

 

It is intended to encompass the entire process from discovering new drug candidates to production, distribution, and sales.

 

However, Kim expressed some reservations about the level of organic integration among these companies.

 

Kim believes that there is still room for improvement in utilizing the potential and capabilities of each company up to 100%.

 

"After joining the company, I realized that, with the exception of Kolon Pharma, which is already normalized, other companies fell short," Kim remarked and added, "I focused on eliminating redundant functions across the four companies and internalizing as many R&D technologies as possible." Kim also announced that each company will specialize in R&D based on specific diseases and substances.

 

The goal is to restructure and enhance the efficiency of R&D by allowing each company to maximize its unique expertise.

 

"Just as a conductor leads an orchestra to bring out the unique talents of each musician, we will strive to create synergy among the four companies, allowing them to maximize their respective expertise in research and development, clinical development, production, and distribution," Kim remarked.

 

“Invossa U.S.

 

trials are nearing completion…In development with more stringent conditions” With the new organization, Kim’s goal is to successfully complete the clinical trials for Invossa (TG-C) in the short term and approach the commercialization of other candidate substances in the long term.

 

For Invossa clinical trials, U.S.

 

Phase 3 trials are nearing completion.

 

The patient registration is closing.

 

Industry experts predict that the trials will be near completion by early this year.

 

Following the trial's completion and a subsequent two-year follow-up observation period, the company will be able to submit a Biologics License Application (BLA).

 

“Invossa and TG-C are essentially the same substance,” Kim explained.

 

“While there are minor differences in the volume and manufacturing of cells used in Korea and the United States, there aren’t any differences in the aspect of the safety and the efficacy.” “In cell and gene therapies, differences due to gender, age, or race are typically negligible.

 

Therefore, the results from clinical trials conducted in Korea might be replicable in U.S.

 

trials” Kim said.

 

“I cautiously speculate that we can potentially achieve approval without significant difficulty.” However, having faced setbacks previously, Kim intends to stay vigilant until the very end.

 

Therefore, the U.S.

 

clinical trials will implement more stringent conditions.

 

“For treatments targeting pain, external factors can influence the clinical outcome greatly.

 

I wouldn’t jump to conclusion.

 

We must stay focused until the completion,” Kim added.

 

“While the overall clinical design is similar to that in Korean clinical trials, the U.S.

 

trials are being conducted under more stringent conditions.

 

To that extent, we are confident about these clinical trials,” Kim stressed.

 

Kim elaborated that the development of other candidate products, in addition to Invossa, is actively progressing.

 

Kim added that 'KLS-2031,' a potential therapeutic for radiculoneuropathy, is currently subjected to sub-group analysis with results from the concluded Phase 1/2a clinical trials in the United States.

 

At the same time, non-clinical trials designed to expand indications are nearing completion.

 

For 'KLS-3021,' a chemotherapy candidate currently in development, its indication was determined after additional non-clinical testing.

 

The toxicity and distribution testing is in process prior to clinical trial entry.

 

Kim, as an expert in clinical translation, emphasized the importance of innovative clinical trial designs.

 

“A notable issue in the Korean pharmaceutical and biotech industry is the tendency to replicate clinical designs from overseas.

 

I strongly oppose this approach.

 

Instead, development of innovative designs optimized for candidate substances is needed,” Kim stated.