Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that an abstract for the combination of fostroxacitabine bralpamide (fostrox) + Lenvima® in hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal (GI) Cancers Congress in June 26-29, 2024 in Munich.

The abstract, titled “Liver pharmacodynamics in an open-label phase Ib/IIa study of fostroxacitabine bralpamide (fostrox, MIV-818) in combination with lenvatinib in 2L/3L hepatocellular carcinoma” will be presented at the conference by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea. Dr Chon is one of the investigators in the ongoing phase Ib/IIa study.

The presentation will include pharmacodynamic data from patients in the ongoing phase Ib/IIa clinical study with fostrox + Lenvima combination, evaluating the impact on normal liver function and DNA damage in tumor cells vs healthy cells. The presentation will also include an update on efficacy endpoints as the study has continued to mature and patients have been able to stay on treatment.

The poster will be available on Medivir’s website after the presentation.

For additional information, please contact;

Magnus Christensen, CFO, Medivir AB

Telephone: +46 8 5468 3100.

E-mail: magnus.christensen@medivir.com

About fostrox

Fostrox is a type of smart chemotherapy that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. The prodrug design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing.

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 approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). 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 fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy 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. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list. www.medivir.com.

1)       Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118.