Medivir invites to a conference call on new clinical data and further studies with MIV-818

On September 16, 2021 Medivir AB (Nasdaq Stockholm: MVIR) reported that invites to a conference call on the supporting clinical data from the completed dose escalation section of the phase 1b study with MIV-818, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress (Press release, Medivir, SEP 16, 2021, View Source [SID1234587770]). The conference call will be held today, September 16, at 15:00 CET, to update on the study and the plan for the MIV-818 program.

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Medivir’s lead candidate drug MIV-818 has the potential to become a liver-targeted, orally administered drug that can help patients with liver cancer. In April, it was announced that the overall results from the first part of the phase 1b study with MIV-818 were positive with a good safety and tolerability profile. The results from the completed dose escalation part of the phase 1b study will be presented today as an e-poster (number 527P) at ESMO (Free ESMO Whitepaper). The poster is presented by Dr Debashi’s Sarker, King’s College, London.

The overall safety profile was in line with expectations for this type of drug and patient population. A total of nine evaluable patients with various types of advanced cancer in the liver were enrolled. These were patients that had exhausted approved therapies prior to being enrolled. An important sign of efficacy was that four patients with hepatocellular carcinoma (HCC) showed stable disease in the liver over an extended period of time. Furthermore, liver biopsies from patients demonstrated delivery of MIV-818 to the liver, and a selective effect of MIV-818 on cancer cells across different types of cancer.

– "These positive study results provide further support for Medivir’s development of MIV-818 in HCC. We are now looking forward to explore MIV-818 further in combination with two other mechanism of actions," says Fredrik Öberg, Medivir’s Chief Scientific Officer.

Conference call for investors, analysts and the media

Presenters from Medivir: Magnus Christensen, interim CEO, Tom Morris, CMO and Fredrik Öberg, CSO.

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 08.45 CET on September 16, 2021.

About MIV-818

MIV-818 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. MIV-818 has completed a phase 1b monotherapy study, and a combination study in HCC is now planned to be initiated during the second half of 2021.

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.