SEASUN BIOMATERIALS, Aiming at Korea’s Strongest Epigenetic Diagnostic Company
 

.2022.04.26
 

"Epi-sPNA original technology stepping stone … anticancer drug resistance determination, early diagnosis of pancreatic cancer, etc., grafted to DTC screening"

Among domestic genetic diagnosis companies, Seasun Biomaterials (CEO, Park Hee-kyung) is making every effort to research epigenetic diagnosis as a strategic development field that can show differentiated competitive advantage.

In December of last year, the company obtained domestic approval for 'Epi-TOP mMGMT Detection Kit', a MGMT gene methylation diagnostic product for predicting the prognosis of temozolomide anticancer drug used to treat glioblastoma, a malignant brain tumor. It fired the first signal for advancement into epigenetics. In patients with MGMT methylation due to an epigenetic mutation, the anticancer effect of temozolomide is high.

Epigenetic mutation is a series of non-congenital mutations that do not change the unique sequence of genes, but cause various diseases such as cancer, immune diseases, and metabolic diseases due to abnormal changes in gene expression and function due to environmental factors such as aging, obesity, smoking, environmental pollution, and eating, referred to as genetic influence. A typical example is DNA methylation, in which a methyl (CH₃) group is attached to a specific base of a gene sequence. When methylation occurs, the function of the corresponding gene is usually disturbed, but sometimes it is activated and can cause disease or suppress it.

Epigenetic mutations are being developed in the healthcare industry for early diagnosis of disease, lifelong health management monitoring, and determination of anticancer drug suitability (treatment prognosis prediction).

In line with this, Seasun Bio is also preparing for the era of epigenetic medicine. First, in the field of early diagnosis of diseases, the focus is on diagnosing genetic diseases, predicting the risk of onset, and early diagnosis of cancer.

CEO Park Hee-kyung said, "Since cancer has a complex cause and is greatly affected by external environmental factors such as living environment and eating habits, a lot of research on diagnostic methods and technologies based on the epigenetic genome is being conducted recently." "We are developing a diagnostic panel based on DNA methylation biomarkers that can diagnose cancer at an early stage."

Since 2019, Seasun Bio has been selecting promising biomarkers and conducting research clinical trials to improve diagnostic accuracy. Clinical trials for validation with medical institutions are scheduled to begin within the next 1-2 years, and the goal is to commercialize it by 2028 at the latest.

In the case of pancreatic cancer, it was recently selected as a local star company R&D support project hosted by the Ministry of SMEs and Startups and plans to verify the clinical effectiveness of the diagnostic product through a clinical research contract with Kangbuk Samsung Hospital by securing additional epigenetic biomarkers.

Lung cancer is already undergoing clinical research with the Lung Cancer Center of Konkuk University Hospital, and plans to promote the Ministry of Food and Drug Safety's approval of an epigenetic-based lung cancer early diagnosis product in the future and develop an analysis service business.

In the case of colorectal cancer, if a genotype (MSI-H) with high microsatellite instability (MSI) is shown, it is determined whether hereditary or non-heritable through MLH1 methylation test. If hereditary is confirmed, early screening is recommended for the patient's family. Seasun Bio already has approved MSI diagnostic genotype diagnostic products and is developing MLH1 methylation diagnostic products for early diagnosis.

In June 2018, Seasun Bio launched 'Gene's eye', a personal genome analysis service, to treat geriatric diseases such as dementia, macular degeneration, and senile deafness and 11 cancer types (lung cancer, pancreatic cancer, colorectal cancer, ovarian cancer, breast cancer, Stomach cancer, liver cancer, prostate cancer, thyroid cancer, testicular cancer, kidney cancer), diabetes (type 1 and type 2), cardiovascular disease (heart disease, high blood pressure, venous thrombosis, cardiovascular health)-related specific genes can be analyzed to predict personalized disease risk. In the future, by adding DNA methylation, it is expected that it will be possible to predict and prevent more various diseases, improve eating habits, and manage health conditions.

Park Hee-kyung, CEO of Seasun Bio, said, "Seasun Bio has a self-developed material called 'Epi-sPNA' functional PNA oligomer that selectively binds to methylated DNA instead of bisulfate, which is the existing DNA replacement material, and it has improved its competitiveness by increasing the reproducibility and speed of judgment.”

CEO Park said, "The epigenome is a competitive diagnostic field, that provides clues to disease progression that innate genes cannot explain, there are clear and stable biomarkers such as DNA methylation, it provides clues to the conception and progression of all diseases after birth, is more cost-effective than conventional chemical immunoassays, and is easy to quantitatively analyze, it is possible to diagnose earlier than with RNA or protein.”

CEO Park said, "The epigenome is competitive diagnostic field in that provides clues to disease progression that innate genes cannot explain, there are clear and stable biomarkers such as DNA methylation, and it is possible to diagnose earlier than with RNA or protein , provides clues to the conception and progression of all diseases after birth, is more cost-effective than conventional chemical immunoassays, and is easy to quantitatively analyze.”

She added, "For example, if pancreatic cancer can be diagnosed at an early stage by epigenetic diagnostics, treatment costs can be reduced, and prevention or improvement methods can be suggested through epigenomic analysis prediction."

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