Press release

Medivir has determined the recommended phase 2 dose for fostrox in combination with Lenvima in HCC

Stockholm, Sweden — 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 the initial dose escalation part (phase 1b) of the company's 1b/2a study with the candidate drug fostroxacitabine bralpamide (fostrox) in hepatocellular carcinoma (HCC), in combination with Lenvima®, was successfully completed. 

The preliminary results from the dose cohorts are positive with a good safety and tolerability profile and no dose-limiting toxicity has been observed. The recommended dose (RP2D) for the first combination arm of the phase 2a part of the study has been determined to 30 mg for fostrox.

-        ” It is very satisfactory that we have now completed the first part of the study with good preliminary results and have been able to determine the starting dose for the first combination arm in the phase 2a part of the study. With the great interest we have seen in the study, it is also gratifying for the patients that we can now start the first combination arm in the phase 2a part,” says Jens Lindberg, CEO at Medivir AB. ”Although Lenvima is now widely used as a second-line treatment for advanced HCC, there is still a need to improve the number of patients who respond to the treatment. By using fostrox in addition to Lenvima®, our hope is that more of these patients will obtain a clinical response to their treatment.”  

In the open-label multi-center study, fostrox is given in combination with two other medicines, either with Lenvima®, a tyrosine kinase inhibitor, or with Keytruda®, an anti-PD-1 checkpoint inhibitor. The study includes patients with HCC for whom current first-line treatment has shown to be ineffective or intolerable. The purpose of the study is to evaluate safety and tolerability, as well as to get an indication of the efficacy of fostrox in combination with two already existing drugs. The phase 1b dose escalation part with Keytruda is still ongoing. Currently six patients are on active treatment in the study.

In the phase 2a part of the study, a total of up to 30 further patients with HCC will be recruited for an initial evaluation of safety and efficacy. The study is being conducted at 14 clinics in the UK, Spain and South Korea.

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

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. 
The information was submitted for publication, through the agency of the contact person set out above, at 10.10 CET on February 20, 2023

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 and other forms of liver cancer. 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 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 fostroxacitabine bralpamide (fostrox), 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.