Press release

Medivir announces the design of its upcoming MIV-818 combination study

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced the details of its upcoming phase 1/2a combination study with the company's leading candidate drug, MIV-818, against liver cancer. The unique mechanism of action of MIV-818 makes it attractive to be combined with a multitude of other targeted and non-targeted drugs for the treatment of hepatocellular carcinoma. In the upcoming combination study, MIV-818 will be administered in two combinations, either with lenvatinib, a tyrosine kinase inhibitor or pembrolizumab, an anti-PD-1 check-point inhibitor.

The planned trial will be an open-label, multi-center phase 1/2a study starting with a dose escalation part to establish the recommended phase 2 dose (RP2D). This is followed by the expansion study (phase 2a) with an initial evaluation of the safety and efficacy of the combination of MIV-818 with lenvatinib or pembrolizumab. The study will include patients with hepatocellular carcinoma (HCC) who have progressed on, or are intolerant of, first line standard therapy.  

The study is planned to have two parallel dose-escalation streams. Once the RP2D has been established for the combinations, further cohorts of up to 30 patients with HCC will be enrolled in the phase 2a part of the study. The first patient is expected to be enrolled in the second half of 2021.

For further information, please contact:
Magnus Christensen, Interim CEO, Medivir AB, phone: +46 (0)8 5468 3100.

About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer.

About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. 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.

About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of MIV-818, a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. 
Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list.