Medivir attended the ASCO GI conference recently and presented updated data from the ongoing phase Ib/IIa study with fostrox in advanced hepatocellular carcinoma. The clinical benefit continues to improve as the study progresses and data matures. In the meantime, Medivir has carried out a directed share issue of around SEK 20 million, gaining Hallberg Management as a new strategic shareholder. BioStock spoke with Medivir’s CEO Jens Lindberg to learn more.
Fostroxacitabine bralpamide (fostrox) is a smart, oral chemotherapy that selectively targets cancer in the liver. Swedish biotech Medivir is developing it as a potential treatment for hepatocellular carcinoma (HCC) – the most common form of primary liver cancer. Only 1 in 3 patients respond to the preferred first-line treatment (Tecentriq/Avastin). Medivir is developing fostrox with the aim to become the first regulatory approved alternative in patients where the current first-line treatment is ineffective or intolerable.
The candidate, which has received orphan drug designation (ODD) in both the USA and Europe for this indication, is currently being evaluated in a fully recruited phase Ib/IIa study in combination with the cancer drug Lenvima. All patients in the trial have had a minimum follow-up of at least 18 weeks, and as the study progresses, data continues to improve for the combination.
Positive feedback received at ASCO
The latest results were presented at the ASCO GI Congress in San Francisco on January 19th. According to the presentation, the data suggest that the combination therapy remains tolerable, and, as the data matures, clinical efficacy continues to improve. Overall Response Rate (ORR) has increased to 25 per cent and median time to progression has improved to 5.1 months, with more than 40 per cent of patients still on treatment in the study.
This week, Medivir shared more details about the results as well as the feedback received at ASCO in a conference call. According to Medivir’s CEO Jens Lindberg, who led the webinar together with CSO Fredrik Öberg and CMO Pia Baumann, the takeaway from ASCO is that the company received great support for its development plans through extensive interactions with global experts and potential investigators for the upcoming study. There was also positive feedback on fostrox and its data from experts met for the first time, as well as great interest in participating in the study as an investigator.
SEK 20 million directed issue
The company’s goal is to initiate a pivotal phase IIb study with the goal to gain accelerated approval in 2027. Such approval would reduce the development time significantly. To help reach this goal, Medivir has carried out a directed issue that raised SEK 20 million. The issue was directed at Hallberg Management, a limited liability company, which is wholly-owned by Anders Hallberg. Anders Hallberg has more than 20 years of experience in investing in health care and is one of the founders of the fund company Healthinvest Partners. Until January 2024, Anders Hallberg was fund manager in Healthinvest Alpha Fund.
According to Holdings (2024-01-30), Anders Hallberg is the fourth largest shareholder in Medivir following the directed share issue.
BioStock reached out to Medivir’s CEO to get his perspective on both the ongoing clinical trial with Fostrox, and the directed issue.
Jens, during the conference call, you referred to fostrox as a “smart chemotherapy.” Could you explain that?
– It is a targeted chemotherapy as it selectively targets cancer in the liver. Standard chemotherapy is administered IV which means that it will not only induce cell death in tumor cells but also kill healthy cells and can be quite difficult to tolerate. Fostrox is administered orally and is activated in the liver and selectively targets tumor cells in the liver while sparing healthy liver cells. As a result, it minimises side effects in other parts of the body while killing cancer cells in the liver.
Could you tells us more about the interactions at ASCO and how they will help shape Medivir’s drug development plans moving forward?
– We met with HCC experts from USA, EU and Asia to gain input and feedback on our proposed development program. Their feedback supported our overall plans while helping us further shape some of the important details with regards to study design. Gaining feedback from experts to help shape study design and other aspects of the development program is critical at this stage as we are preparing for regulatory interactions to confirm study design. It is critical for regulatory authorities that clinical experts have been consulted and are in support of planned study design so the interactions at ASCO GI will contribute further to achieving succesful outcome in upcoming regulatory discussions.
Medivir just carried out a rights issue in December. Why did you decide for another capital raise now, and why go with a directed issue?
– As fund manager at Healthinvest, Anders Hallberg has been one of the main shareholders and in the rights issue in December, he increased his share in the company. With Anders leaving Healthinvest as fund manager after the subscription period, he expressed a willingness to invest privately in Medivir now that he is no longer managing the fund, with a strong belief in Medivir and the lead project fostrox. The total capital raise for both rights issue and directed issue is approximately SEK 150 million which was the aim of the rights issue in December.
Anders Hallberg has expressed an interest in being elected to the company’s board of directors. In what way can he be a valuable addition to the board?
– Anders has a long history of investing in health care with an impressive track record and he is a highly respected across stakeholders in the the health care industry. With this background and experience, he complements the current board members and will provide input and expertise with regards to strategic and operational matters. In addition, his expertise and network on the investor side will be highly valuable as the company continues to grow with fostrox program moving forward.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.