Last patient with liver cancer included in the monotherapy part of Medivir's phase Ib study with MIV-818

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the last patient with advanced liver cancer has been included in the first part of the phase Ib study with MIV-818. Like the other patients in the study, the patient is dosed in cycles of three weeks starting with MIV-818 as monotherapy for five days. In parallel, the company is preparing part two of the phase Ib study to be able to begin during the second half of 2021.

• It is gratifying that we this far have managed to carry out the study without any major delays despite the ongoing Covid-19 pandemic. We are now preparing for the second part of the study where MIV-818 will be used as combination therapy. Details of the planned combination study will be presented during the second quarter of this year. We believe that MIV-818 has the potential to significantly improve the treatment of patients with liver cancer, said Yilmaz Mahshid, CEO of Medivir.

The first part of the phase Ib study of MIV-818 is a classic dose-escalation study with three cohorts of three patients with advanced liver cancer who have undergone previous treatments. The purpose is to further investigate the safety and tolerability profile and to determine the starting dose for part two of the phase Ib study. Data from the first part of the study is expected to be presented at a future scientific conference.

For further information, please contact:
Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.
Yilmaz.mahshid@medivir.com

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, orally administered drug for patients with HCC and other forms of liver cancer.

About liver cancer
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. 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.

Medivir in brief
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. www.medivir.com.