Hepatocellular carcinoma (HCC) is a primary malignancy of the liver and occurs predominantly in patients with underlying chronic liver disease and cirrhosis. The cell(s) of origin are believed to be the hepatic stem cells, although this remains the subject of investigation. HCC, while an orphan indication in the US and EU, is now the third leading cause of cancer deaths worldwide, with over 500,000 people affected. The incidence of HCC is highest in Asia and Africa, where the endemic high prevalence of hepatitis B and hepatitis C strongly predisposes to the development of chronic liver disease and subsequent development of HCC.
The threat of HCC is expected to continue to grow in the coming years. The peak incidence of HCC associated with hepatitis C virus (HCV) infection has not yet occurred. There is also a growing problem with cirrhosis, which develops in the setting of nonalcoholic fatty liver disease (NAFLD), or nonalcoholic steatohepatitis (NASH). NASH typically develops in the setting of obesity, type 2 diabetes, dyslipidemia, and hypertension, and it will undoubtedly remain a significant problem, given the obesity epidemic occurring in the United States.
Thus, developing effective and efficient care for patients with end-stage liver disease and HCC must become a significant focus. Treatment options for HCC are still limited. Patients typically have surgical resections of the liver which is one primary treatment option. While transplantation remains one of the best options for patients with HCC, the limited supply of good quality donor organs makes this option unavailable to most patients diagnosed with the disease. Other alternative therapies have limited effectiveness, including radiofrequency ablation (RFA) and systemic therapies such as sorafenib, which have limited benefit on overall survival and significant side effects.
There is a significant unmet medical need to find new therapies that may not only prolong survival of patients with HCC without significantly impacting the quality of life, but also therapies that have the potential to cure the disease. The REIC immune-oncology technology has been demonstrated to have a real potential to be a break through therapy in HCC based on preclinical models. MTG is focused on moving our MTG-201 and MTG-202 products into the clinic to evaluate the potential for this novel therapy to treat patients with HCC and potentially in combination with other immune-therapies.