Optimal therapeutic solutions for diseases requiring immune regulation and tissue regeneration

IntenCell® is expected to have an excellent therapeutic effect in steroid-refractory graft-versus-host disease (SR-GvHD), a representative immune disease, because of its excellent immunomodulation, anti-inflammation, cell and tissue regeneration, and antibacterial properties. In addition, IntenCell® is anticipated to have excellent therapeutic effects in liver cirrhosis, including liver fibrosis; respiratory diseases, including asthma and pulmonary fibrosis; autoimmune diseases, including inflammatory bowel disease; periodontitis; and temporomandibular arthritis.

key Pipelines, development status in Korea

Allogeneic hematopoietic stem cell transplantation (HSCT) is a potential therapy for intractable hematological diseases in which donor HSCs are intravenously administered to recipients.

Transplanted HSCs migrate to the recipient's bone marrow where they differentiate into platelets, red blood cells, and white blood cells.

GvHD is a systemic disorder that occurs when the graft's immune cells recognize the host cells as foreign and attack them. aGvHD occurs in approximately 50% of allogeneic HSCT recipients.

Although 50% of patients with aGvHD can be treated with steroids, the remaining patients who do not respond to immunosuppressants, including steroids, may eventually succumb to this disease.

In a non-clinical study, compared with naïve mesenchymal stem cell (MSC) treatment, IntenCell® treatment significantly increased the survival rate of aGvHD mice and increased the survival rate more than two-fold.

Currently, SR-aGvHD treatment using IntenCell® is undergoing a phase 1 clinical trial and will soon be commercialized.

SR-aGvHD

Steroid-Refractory acute Graft Versus Host Disease

Nonalcoholic Steatohepatitis (NASH)-related Cirrhosis

Chronic inflammation of the liver, caused by viral infection, excessive alcohol consumption, fat accumulation, or abnormal immune challenge, results in excessive deposition of extracellular matrix. This causes structural changes to the liver and a decrease in the number of hepatocytes, which concurrently leads to loss of liver function or liver cancer.

Liver cirrhosis is a late-stage liver disease in which healthy liver tissue is replaced with scar tissue, resulting in permanent damage to the liver. Viral infection or alcoholic hepatitis are clear causes of liver cirrhosis have a clear causes of liver cirrhosis, and so many treatments have been developed to date. In contrast, NASH-related cirrhosis, which is caused by various chronic diseases, has a complicated mechanism, and so there is currently no approved treatment other than liver transplantation.

Owing to changes in eating habits, the number of patients with liver cirrhosis caused by NASH is increasing rapidly worldwide.

To treat liver fibrosis, it is necessary to control inflammation of the liver tissue and regenerate the tissue in which fibrosis has occurred. IntenCell® is expected to act effectively in the treatment of liver fibrosis by regulating the differentiation of macrophages and dissolving excessively secreted extracellular matrix.

In a preclinical study, IntenCell® decreased fibrotic factors (collagen I and α-SMA) indicating activation of hepatic stellate cells and alleviated irreversible liver fibrosis in a CCl4-induced cirrhotic mouse model.

Pulmonary disease

There are 6 million people with asthma worldwide, and 5% of patients with asthma develop severe asthma as the disease worsens.

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. The patients have a 5-year survival rate of less than 50% and a 10-year survival rate of 15% after diagnosis. IPF affects approximately 3 million people worldwide, and its incidence rate is also increasing.

A curative treatment for IPF has not yet been developed, and available treatments only delay the progression of the disease. The only method to lower the mortality rate is lung transplantation, which is performed in patients aged < 65 years without other underlying diseases.

(Reference: National Institutes of Health)

Intencell® is expected to be the only therapeutic agent for idiopathic pulmonary fibrosis as it has excellent anti-inflammatory effects and is expected to be effective in the regeneration of fibrotic tissues.

In a preclinical study, IntenCell®-derived exosomes (IntenExso®) exhibited anti-inflammatory effects, alveolar epithelial cell regeneration, and fibrolysis.

IntenCell® is expected to be a novel highly effective treatment for pulmonary diseases because of its excellent properties of anti-inflammation and fibrosis-damaged tissue regeneration.