DanDi Bioscience

http://www.hitnews.co.kr/news/articleView.html?idxno=44659

This post has been translated from the original article dated 04/06/2023.

"HLB Science Accelerates Clinical Trials for Sepsis..."Dream of collaborating with Big Pharma"

"We plan to focus on phase 1 clinical trials of sepsis treatment in France this year. We aim to be listed before KOSDAQ in 2024. We will start developing a first-in-class innovative drug in the field of sepsis, which is impregnable."

HLB Science Advisor Park Young-min (former CEO, professor of Konkuk University Medical School) established Dandi Bioscience in 2016 and is challenging the development of DFPep (Dual Functional Peptide) based sepsis and Alzheimer's dementia treatments.

Dandi Bioscience was listed on the KONEX market in 2020 and changed its name to HLB Science last year. HLB Science is developing sepsis treatments, Alzheimer's dementia treatments, and diagnostic kits. The company's new drug development can greatly benefit from the HLB Bio-ecosystem, in which bio companies in the group cooperate with each other in the overall development of new drugs, led by HLB.

The company's most advanced pipeline is DD-S052P, an antibiotic that targets sepsis and super bacteria. In particular, the company plans to focus on phase 1 clinical trials for sepsis treatments this year. In January, HLB Science hired Dr. Soo-jung Kim, who has extensive experience performing non-clinical and clinical development tasks for new anticancer drugs and antibiotics, as its new research director.

The company is also participating in the establishment of global partnership strategies led by the Emperor of HLB Group, CMO (Marketing General), and CSO Choi Soo-hwan (Bio Strategy General). Currently, HLB Science is stepping up research and development of new drugs with CEO Yoon Jong-sun at the center.

Advisor Park Young-min resigned as CEO on the 28th of last month, and as an advisor, he will be able to focus on research such as sepsis.

France's first phase of sepsis treatment..."Ensure meaningful data"

Sepsis is a fatal disease that causes problems in the entire organ due to the body's reaction to defeat microorganisms that have invaded the body. Bacteria account for 90% of sepsis, and 70% of them are gram-negative bacteria with endotoxin (LPS). It is a very serious disease, with 48.9 million people developing sepsis a year and 11 million of them dying (The Lancet, 2020), but it is a disease with high unmet medical needs because there is no special treatment at present.

DD-S052P is a new concept antibiotic with dual function and can maintain the ability to remove pathogens through antibacterial activity and acquired immune response. "We have been focusing on developing sepsis treatments since 2009," adviser Park said. "DD-S052P has dual activity because it has the advantage of existing antibiotics and can neutralize endotoxins in substances that cause sepsis."

DD-S052P is a new drug candidate that can prevent △antibiotic resistance suppression △ cytokine storm suppression △ organ failure. HLB Science is currently conducting a phase 1 clinical trial for sepsis treatment in France.

"The clinical results of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are mutually compatible. Due to the COVID-19 pandemic, clinical trials in the United States were not possible," adviser Park said. "The alternative was French clinical trials. CRO (clinical trial trustee) that has a contract with the company has a clinical site in France."

HLB Science announced in July last year that it had received approval from the National Medicines and Health Products Safety Administration (ANSM) for phase 1 clinical trials (IND) for sepsis and gram-negative superbacterial infections.

"We want to secure meaningful data in the middle of phase 1 clinical trials. We hope to receive global attention from big pharma when we complete the protocol preparation for phase 2 clinical trials," Park said. "HLB Science is a small biotech but we want to collaborate with big pharma that has clinical development capabilities."

HLB Science is also strengthening its pipeline R&D (R&D) through collaboration with biotech companies in Korea. The company signed an MOU with Theranochem in November last year to discover anti-cancer pipelines and is jointly developing a triple negative breast cancer treatment targeting the mitochondria with Theranochem.

"Through this agreement, the company is pursuing an efficient division of labor. We have experience in submitting clinical INDs, and Terranochem is a company with solid basic science capabilities," he said. "We are creating a culture of discussion with members through open discussion."

※ I would like to inform you that I was transferred from CEO Park Young-min at the time of the interview for Hit News to the advisor at the time of publication.