Blood vessels are composed of two layers: the inner endothelial cells that create the path for blood flow and the smooth muscle cells that surround and maintain the shape of the blood vessel. In our bodies, there are stem cells that can grow into endothelial cells and smooth muscle cells, which are a type of primitive cell. Theoretically, it is said that damaged blood vessels can be rebuilt using stem cells.
Mesenchymal stem cells (MSCs) found in bone marrow, fat, and umbilical cord blood can grow into smooth muscle cells and have been developed as vascular therapeutics, but they primarily regenerated small capillaries. Bone marrow and umbilical cord blood contain endothelial progenitor cells (EPCs), which are stem cells that can grow into endothelial cells. However, due to the lack of technology to cultivate them in large quantities, regeneration of larger arteries has not been possible. Ultimately, the technology to simultaneously create endothelial cells and smooth muscle cells was a significant challenge in vascular regeneration.
A domestic biotech corporation has found the key to solve this challenge for the first time. Professor Lim Sung-bin of the Clinical Pharmacology Department at Kyunghee University founded Elpis Cell Therapeutics in 2019. Meeting with CEO Lim at the Seoul Bio Hub in Hongneung on the 28th of last month, he said, "We have successfully isolated vascular progenitor cells (VPCs) that can simultaneously produce endothelial cells and smooth muscle cells from adult stem cells and proliferate them in large quantities. Thanks to this, the development of cell therapies to regenerate interrupted arteries has become possible."
The vascular progenitor cells discovered by Elpis are similar to mesenchymal stem cells, but they can grow into endothelial cells and smooth muscle cells. CEO Lim stated that by simply changing the culture medium without genetic modification, vascular progenitor cells can be mass-produced from stem cells obtained from bone marrow and adipose tissue.
The company name Elpis (Elphis) means 'hope' in Greek. It embodies the intention to create therapies that provide hope to patients with rare and intractable diseases. CEO Lim is developing vascular disease treatments based on vascular progenitor cell technology. A representative candidate is the treatment for severe limb ischemia, 'EL-100.'
Severe limb ischemia is a disease in which major vessels in the legs are blocked due to diabetes, hyperlipidemia, or hypertension, causing tissue death. In severe cases, amputations may be necessary, and the blood can become infected with pathogens, leading to life-threatening sepsis. The two-year mortality rate reaches 30-40%, but currently, there are no approved treatments by the U.S. Food and Drug Administration (FDA). Although microvascular stents are implanted into the vessels to expand them, or drugs are used to block blood clots, there is a high risk of side effects such as vascular damage or clot recurrence.
After finding a mass cultivation method for vascular progenitor cells, Elpis uncovered that administering vascular progenitor cells along with mesenchymal stem cells can regenerate a perfect vascular structure with both endothelial and muscle cells. The research results were published last year in the international journal 'Stem Cell Research & Therapy.'
Elpis confirmed the effectiveness of EL-100 in animal experiments. When stem cell therapies were administered to the legs of mice with interrupted blood flow, new blood vessels formed in the deteriorating tissue, and blood flow improved. New arteries were created. In contrast, the control group that did not receive the treatment saw tissue death, leaving no choice but to amputate the leg.
CEO Lim noted, "The animal experiment of EL-100 is the only case that has proven arterial formation using stem cell therapy," adding, "We will do our utmost to demonstrate vascular regeneration effects in humans through clinical trials in the future."
Elpis is currently awaiting approval for its Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety. After recently completing the final supplemental phase, it expects approval within the year. Phase 1 is expected to be conducted at Seoul National University Hospital with 10 patients.
The company is also developing EL-100 as a treatment for diabetic foot ulcers in addition to severe limb ischemia. About 15-25% of diabetic patients develop foot ulcers due to complications that impede blood flow, causing skin tissue damage. Even minor wounds can worsen to the point of requiring amputations, which can be life-threatening. EL-100 can improve blood flow to resolve these issues.
CEO Lim stated that if safety is proven in the Phase 1 trial for the severe limb ischemia treatment, Phase 2 can be initiated to assess efficacy directly for diabetic foot ulcers. The company is also working on other treatments, including the stroke treatment 'EL-101,' the vascular disease treatment using adipocytes 'EL-110,' and the treatment for developmental disorders 'EL-400.'
CEO Lim graduated from Kyunghee University School of Medicine and received his master's and doctoral degrees. He served as a professor in the Clinical Pharmacology Department at Kyunghee University Hospital and the head of the Clinical Trial Center. He has conducted over 200 clinical trials, and afterwards established the Valuation Research Institute, where he has been responsible for assessing the technical capabilities of over 100 biotech corporations as a technology-specialized listing evaluation committee member.
Elpis's rapid growth has been largely attributed to the technical expertise of its Chief Scientific Officer (CSO), Professor Son Young-sook, from the Department of Genetic Biotechnology at Kyunghee University. Professor Son is an authority in the field of stem cells and is also the founder of Bio Solution, a company specializing in stem cell therapies.
While researching stem cell therapies, CEO Lim decided to start the company and proposed that Professor Son join. Both the research on vascular progenitor cells and EL-100 originated from Professor Son's studies. Additionally, Vice President Hong Sun-min, an expert in natural killer (NK) cell therapies and a former general manager at CHA Hospital, joined to create a 'super team.'
CEO Lim commented, "Clinical pharmacology was primarily a discipline for evaluating already developed substances," adding, "I have had a thirst to develop new drugs directly, and it has become possible to become a key player in new drug development by creating a strong team with Professor Son and Vice President Hong."
References
Stem Cell Research & Therapy (2024), DOI: https://doi.org/10.1186/s13287-024-03994-9