Medivir reports promising interim data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima

• Central review of the 6 patients in phase 1b dose escalation part was performed
• In these 6 patients, complete response was recorded in 1 patient, partial response in 2 patients, and stable disease in 2 patients read by an independent radiologist using mRECIST
• The interim data from phase 1b further strengthens the previously reported promising safety and efficacy data

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 promising interim safety and efficacy data from its ongoing phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima® in advanced hepatocellular carcinoma (HCC) patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

The interim results confirmed the previously announced favorable safety and tolerability profile. No new or unexpected safety events and the combination continues to be tolerable.

The phase 2a dose expansion part of the study is ongoing and is now fully recruited.  Data from phase 1b/2a is planned to be presented at an upcoming scientific congress.

-          ”We are excited about the interim data from the  phase 1b dose escalation part. HCC patients, for whom current first- or second-line treatment has proven ineffective, is a difficult-to-treat patient group and expectation regarding clinical benefit and tumor shrinkage is low. This is why it is so encouraging to see that overall response is shown in 3 out of 6 patients and even more so that a complete response was recorded in one patient. Considering that the medical need for a new, effective treatment for HCC is large, these are very encouraging data for the future development of fostrox,” says Dr. Pia Baumann, CMO at Medivir.

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: www.medivir.com/investors/presentations

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

E-mail: magnus.christensen@medivir.com

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 08.30 CET on September 4, 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. 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. www.medivir.com.

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

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