Pancreatic cancer is cancer that occurs in the pancreas, which secretes digestive enzymes. The pancreas is deeply surrounded by other organs in the abdomen, and there are almost no symptoms even if one develops cancer, making early detection and diagnosis difficult. Due to this, pancreatic cancer ranks third in cancer mortality rates worldwide, and its five-year relative survival rate is 15.8%, the lowest among all types of cancer.
Only 1 in 5 patients with pancreatic cancer is eligible for surgery, and even after surgery, 70-80% relapse within 2 years. Various anticancer drugs, including FOLFIRINOX and gemcitabine, have emerged, but due to tissue fibrosis that hardens around the cancer cells, it is difficult for these drugs to reach inside the cancer cells.
The domestic bio corporation IMGT has developed technology to overcome these limitations. It is an ultrasonic medical device called 'IMD10' that helps drugs pass through blood vessels and cancer cell walls to be delivered to cancer cells.
On the 9th, in the building of the Healthcare Innovation Park at Bundang Seoul National University Hospital, IMGT CEO Son Geon-ho said, "Focal ultrasound uses stronger energy than that used in diagnostic ultrasound to irradiate the body, treating tumors or affected areas with thermal stimulation," adding, "It allows for precise and deep penetration, minimizing damage to normal cells."
◇Opening pathways for anticancer drugs with focused ultrasound
IMGT, a bio corporation founded by Professor Lee Hak-jong of Seoul National University in 2010, was listed on the KONEX in July 2023. CEO Son Geon-ho, who received a Ph.D. in electronic engineering from Kyungpook National University and researched ultrasonic devices at medical device companies such as Medison Research Institute and Siemens Korea for nearly 20 years, joined the company in 2020, serving as co-CEO with Lee Hak-jong.
CEO Son noted, "Diagnostic ultrasound devices are dominated by global companies like Philips from the U.S. and Siemens from Germany, so I felt the need to expand to treatment," and added, "At that time, Professor Lee Hak-jong, whom I knew from a related society, was developing a drug delivery system using ultrasound, which piqued my interest."
The key technology of IMD10 is focused ultrasound. When administering an anticancer drug intravenously and using IMD10 in conjunction, the focused ultrasound creates tiny holes in the tissue surrounding the cancer cells. This opens a pathway for the drug to enter the cells. Additionally, the ultrasound induces tiny vibrations in the tissue that temporarily loosen the cell membrane, allowing drugs to penetrate more easily.
The company conducted an exploratory clinical trial combining the standard anticancer drug FOLFIRINOX with IMD10 on 30 domestic pancreatic cancer patients in 2022. Interim analysis showed that the hazard ratio (HR) compared to the sole therapy of FOLFIRINOX was 0.41, indicating an increase in the median overall survival time (mOS) by 5.1 months based on the date of the interim results announcement. The HR is an indicator used to measure survival rates in anticancer treatment; a lower value indicates a reduced risk of death. The HR for global anticancer drugs is known to be around 0.7.
IMD10 is being noted as a new therapeutic approach that can complement the weaknesses of existing anticancer treatments. To date, there has been no medical device that assists in delivering anticancer drugs using ultrasound that has been commercialized. The U.S. Food and Drug Administration (FDA) designated IMD10 as a breakthrough medical device in February. The Korea Ministry of Food and Drug Safety also selected it as one of its top 10 representative projects for 2025.
CEO Son remarked, "IMD10 is a new technology that does not exist in the market; we started development in 2020 and faced many challenges," adding, "Thanks to the detailed support from the Ministry of Health and Welfare, which provided consultation on clinical trials and approvals, we have reached the confirmatory clinical trial stage."
◇Beginning confirmatory clinical trials in the second half of the year, concurrently in Korea and the U.S.
IMGT is currently preparing for confirmatory clinical trials, the final step for simultaneous approval in Korea and the United States. The clinical trial plan (IDE) paperwork will be completed and submitted to the Ministry of Food and Drug Safety and the FDA in the second half of the year.
CEO Son stated, "This confirmatory clinical trial is planned to proceed for about three years with 300 pancreatic cancer patients in stages 2 and 3 in Korea and the U.S. We will conduct it at two locations in the U.S., including Dana-Farber Cancer Institute, which is affiliated with Harvard Medical School, and at Seoul National University Hospital and Bundang Seoul National University Hospital in Korea."
The company expects that if the confirmatory clinical trial of IMD10 is successful, it will not only lead to commercialization in the Korean and U.S. markets but also accelerate global expansion through research and development, technology exports, and product line expansion.
CEO Son mentioned that the reason the company set pancreatic cancer as the first target of IMD10 is that it is the most deadly and challenging form of cancer. He believes that achieving results in pancreatic cancer can easily extend the treatment target to other cancers.
The company views sarcomas, which occur throughout the body without regard to location, and cholangiocarcinoma, located near the pancreas, as the next treatment targets. Additionally, it is also conducting exploratory clinical trials for chronic pain treatment and developing ultrasonic devices for treating neurological disorders.