Press release

Medivir presents data on additive activity of fostrox in combination with Lenvima or sorafenib in non-clinical tumor models at ILCA

Stockholm — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancers with high unmet medical needs, today announces that data on the company's leading program fostroxacitabine bralpamide (fostrox) and its potential effect on hepatocellular carcinoma (HCC), will be presented at the International Liver Cancer Association (ILCA) Annual Meeting, September 7-9 in Amsterdam.

An abstract, titled "Combinations of fostrox (MIV-818), a novel nucleotide prodrug, with lenvatinib or sorafenib, shows increased efficacy in non-clinical hepatocellular carcinoma (HCC) models in vivo" where the study results show the potential of obtaining improved antitumor effect when fostrox is combined with a kinase inhibitor, is presented by Fredrik Öberg, Chief Scientific Officer at Medivir.

-    "Kinase inhibitors, such as Lenvima® (lenvatinib) and sorafenib, exert inhibition of the formation and growth of vessels, an anti-angiogenesis effect, which induces oxygen deficiency in the cells/tumor environment, so-called hypoxia. This mechanism increases the prospect of greater efficacy of fostrox as hypoxia increases conversion to fostrox active metabolite, resulting in a higher cytotoxic activity. In line with this, our preclinical results show that fostrox has the potential to enhance anti-tumor activity together with kinase inhibitors such as Lenvima or sorafenib", says Fredrik Öberg.

-    "Although existing combination therapies for HCC can prolong patients' lives, far from all patients respond to treatment. Fostrox, with its unique, liver-targeted approach, opens up for completely new combinations to effectively treat HCC. The enhanced anti-tumor activity with kinase inhibitors in non-clinical tumor models supports the encouraging clinical results we see in the ongoing phase 1b/2a study with fostrox + Lenvima", says Pia Baumann, Chief Medical Officer at Medivir. 

The abstract and poster will be available on Medivir's website after the presentation.

As a reminder, Medivir will be hosting an Expert Perspectives Webcast on the Evolving Treatment Landscape and the Unique Treatment Challenges in HCC later this week on Friday September 8th at 13:00 CET/07:00 EST. Dr Pia Baumann, CMO at Medivir, will also participate in the webcast and provide additional comments regarding the development of fostrox and data.

The webcast will be streamed via a link on the website: 
The presentation will be available on Medivir´s website after the webcast. 

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100

About fostrox
Fostrox 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. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently 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 pro-drug designed to selectively treat liver cancer 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. 

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