Press release

Positive data from the remetinostat phase II study in basal cell carcinoma published in Clinical Cancer Research

Stockholm — Medivir AB (Nasdaq Stockholm: MVIR) announced today that positive data from the investigator-initiated study evaluating the effects of remetinostat in basal cell carcinoma (BCC) patients has been published in Clinical Cancer Research (online first doi: 10.1158/1078-0432.CCR-21-0560). This clinical study was conducted at the Stanford University School of Medicine in California, USA under the leadership of the principal investigator, Dr Kavita Sarin.

Results of the open-label clinical trial of the topical HDAC inhibitor, remetinostat, as neoadjuvant treatment for BCC were reported. Thirty-three per-protocol tumors from 25 participants were included in the analysis. The overall response rate (ORR), defined as the proportion of tumors achieving more than 30% decrease in the longest diameter from baseline to week 8, was 69.7% [90% confidence interval (CI), 54%–82.5%]. On pathologic examination, 54.8% of tumors demonstrated complete resolution. No systemic adverse events were reported.

The results were also commented on in a press release by the American Association for Cancer Research (AACR):

-    “These very positive results further support the potential of remetinostat to be used in additional skin-associated cancers beyond cutaneous T-cell lymphoma (CTCL)”, said Magnus Christensen, interim CEO of Medivir.

For further information, please contact:
Magnus Christensen, Interim CEO, Medivir AB
Phone: +46 (0)8 5468 3100

About remetinostat
Remetinostat is a topical histone deacetylase (HDAC) inhibitor. A clinical phase II study in mycosis-fungoides cutaneous T-cell lymphoma (MF-CTCL) has been completed demonstrating that remetinostat reduced severity of CTCL skin lesions with an objective response rate (ORR) of 40%. The study also showed a clinically significant reduction in the severity of pruritus (itching) in 80% of the patients. In addition, two investigator-initiated phase II studies have been conducted at Stanford University in the USA, demonstrating efficacy in both Basal Cell Carcinoma (BCC) and cutaneous Squamous Cell Carcinoma (SCC). Results from the BCC study was recently published, and publication of final data from the SCC study is now being prepared.

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 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.