Press release

First patient dosed in the MIV-818 combination study

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the first patient with hepatocellular carcinoma (HCC) has been dosed with MIV-818 in a phase 1b/2a combination study with the company's candidate drug MIV-818. In the study, MIV-818 will be given in combination with two other medicines, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. Lenvima® and Keytruda®, respectively, are currently approved as monotherapy treatments of HCC*.

The purpose of the study is to evaluate safety, tolerability and also to get an indication of the efficacy of MIV-818, which is a completely new mechanism in the treatment of HCC, in combination with two already existing drugs. It is an open-label study starting with a dose escalation part (phase 1b) for each combination to establish the recommended phase 2 dose (RP2D). Once RP2D has been established for each combination, further cohorts of up to in total 30 patients with HCC will be enrolled in the expansion part of the study (phase 2a), for an initial evaluation of safety and efficacy for the combinations of MIV-818 with Lenvima® or Keytruda®.

The study is initiated at clinics in the UK and will also be conducted in Spain and South Korea. It will include patients with HCC for whom current first-line treatment has shown to be ineffective or intolerable.     

- ” It is very gratifying that we are now moving forward to evaluate MIV-818 in combination with two other treatments with different mechanisms of action” said Magnus Christensen, interim CEO of Medivir.

* Keytruda is approved for the treatment of HCC only in the United States.

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. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC was recently initiated.

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.