Liver cancer is the second highest cause of cancer-related death worldwide1). MIV-818 is developed for patients with advanced liver cancers for whom existing treatment options provide very little survival benefit.
1) WHO World Cancer Report (2014)
Although existing therapies for advanced hepatocellular carcinoma (HCC) are capable of extending the lives of patients with HCC, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without specific mutations seen in other tumor types. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.
Intrahepatic cholangiocarcinoma, a cancer of the bile duct located inside the liver tissue, accounts for about 15 percent of liver cancers. It has a poor prognosis and no treatment that effectively improves survival. Liver metastases from other tumor sites (principally from colorectal cancer, but also from breast, ovarian and pancreatic cancer) are also a major cause of cancer-related death.
MIV-818, the first oncology drug in development from Medivir’s in-house research, has been specifically designed for liver cancers both in its delivery to the liver and in its way of acting, aimed to make it more effective against liver cancer cells specifically. It has the potential to become the first liver-targeted, orally administered drug to benefit patients with HCC and other forms of liver cancer.
MIV-818 is a liver-targeted nucleotide prodrug of troxacitabine. It has been developed to be an orally administered therapeutic with a high level of anti-tumor activity that is targeted for delivery to the liver. The intention is to maximize delivery of the drug to the tumor or tumors, while minimizing the systemic toxicity. The objective is to improve the anti-tumor effect while simultaneously reducing potential side effects.
In November 2016, MIV-818 was selected as a candidate drug for the treatment of HCC and other forms of liver cancer. In early January 2018, the preclinical GLP safety studies to enable the start of clinical trials were successfully completed, and regulatory submissions will be filed in order to obtain approval to start clinical trials. These are expected to start in the second half of 2018.
Unmet medical need
Limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC.
MIV-818 is a nucleoside pro-drug delivering its active metabolite via oral administration to cancers in the liver while increasing the therapeutic window.
Start of clinical phase I/II study.