Medivir’s CEO: “We have attracted interest from the best investigators and hospitals to be part of the phase IIb study”
Medivir’s Q4 report summarises the major progress the company has made during 2024 in the development of drug candidate fostrox in combination with Lenvima for the treatment of advanced liver cancer. Now, the focus shifts to the upcoming phase IIb study, but what does the path forward look like? BioStock reached out to CEO Jens Lindberg for a comment.
Primary liver cancer is the third most common cause of cancer-related deaths globally, with hepatocellular carcinoma (HCC) being the dominant form. For patients with advanced HCC, where first-line treatment has failed, there are currently no approved alternatives.
Medivir is developing the drug candidate fostrox, the first and only “smart” chemotherapy in development for HCC. “Smart” refers to fostrox’s ability to travel directly to the liver, where the active substance is locally released and selectively targets tumour cells. This approach spares normal liver cells and minimises the risk of side effects.
In November, a phase Ib/IIa study was completed in which fostrox was tested in combination with the cancer drug Lenvima after the current standard treatment in the first line no longer provides the desired effect.
Significantly better results than existing alternatives
Medivir’s year-end report, published today, highlights the significant progress made with fostrox throughout the year. Its targeted mechanism and precision allow patients to receive treatment for a longer period, thereby extending clinical benefits.
The study, which concluded in November, showed a median time to disease progression of 10.9 months and a response rate of 24 per cent – significantly better than previous second-line liver cancer treatments. Final study data will be presented at the EASL Liver Cancer Summit in Paris this week, where overall survival data will also be shared.
Positive outlook for continued financing
Looking at the financial aspects of Medivir’s Q4 report, EBITDA amounted to -26.2 MSEK, compared to -20.1 MSEK the previous year. Cash flow from operating activities was -29.4 MSEK, and at the end of the period, cash and short-term investments totaled 62.5 MSEK.
The report also states that available liquidity, together with a 30 MSEK loan commitment from Linc, is expected to cover the company’s financial needs until Q4 2025. The loan will only be utilised if needed, as a secondary financing option. Additionally, Medivir sees good prospects for securing the necessary financing for the continued development of the fostrox program.
Phase IIb study nears start
The next major milestone is the upcoming phase IIb study. The stage is already set with a successful FDA meeting and an approved Investigational New Drug Application (IND), which enables the study to be conducted in the US. Medivir has also partnered with a global CRO and formed a Joint Development Committee with pharmaceutical giant Eisai, which will provide Lenvima for the study.
The study will be double-blind and randomised and include patients with locally advanced or metastatic primary liver cancer. The goal is to demonstrate improved efficacy of fostrox + Lenvima compared to Lenvima alone. Medivir aims to apply for Breakthrough Therapy Designation and initiate the process for Accelerated Approval in the event of a positive study result.
Comments from Medivir’s CEO
BioStock contacted Medivir’s CEO Jens Lindberg for a comment on the progress made and the company’s plans.
Jens, what do the fourth-quarter achievements and study results mean for Medivir?
– Receiving approval for our IND application is an incredibly important step for fostrox’s development. Not only does it enable the U.S. to participate in the planned phase IIb study, but more importantly, it means that the FDA has approved our proposed study design, which serves as a quality seal when applying for approval in other countries.
What response have you received from the medical community following the phase Ib/IIa study?
– An extremely positive response, particularly regarding the fact that patients have experienced clinical benefits far beyond what can be expected from today’s treatment options. This has led to strong interest from clinical experts in participating in the planned phase IIb study.
– Recent scientific conferences have highlighted that the greatest medical need in primary liver cancer is the development of effective second-line treatments for patients who no longer respond to the first-line immunotherapy combination. With the planned phase IIb study, our goal is to address this need and establish fostrox + Lenvima as the first approved treatment for these patients.
How does the FDA’s IND approval impact your clinical strategy?
– It allows us to continue as planned, aiming to make fostrox + Lenvima the first approved treatment for second-line advanced liver cancer. The FDA’s acceptance of our study design enables us to maintain momentum in preparations across other participating countries.
How does the collaboration with Eisai work in practice?
– In addition to Eisai providing Lenvima for the study, which is incredibly valuable to us, we have also established a close development collaboration through a Joint Development Committee (JDC).
– Through this JDC, Eisai contributes invaluable clinical and regulatory expertise to ensure the highest possible quality of the study while minimising the risk of delays.
– With extensive experience in liver cancer, Eisai also provides valuable connections within its network, which has helped us attract the best investigators and hospitals to participate in the study.
What are your expectations regarding the market potential for fostrox + Lenvima?
– The market potential for fostrox + Lenvima in the second line is enormous. Unfortunately, this is partly due to primary liver cancer being one of the fastest-growing cancers globally. The main reason for this is the increasing prevalence of obesity, as a large proportion of overweight individuals develop fatty liver disease, dramatically increasing the risk of liver cancer.
– This, combined with the lack of approved second-line treatments, makes the market potential for the first approved treatment exceptionally large. A conservative estimate suggests an annual potential of $2.5 billion, though it could realistically be as high as $3-4 billion.
This week, you are participating in the EASL conference in Paris, where Dr. Jeff Evans, Professor of Translational Cancer Research at the University of Glasgow, will present your data. How important is this event for increasing the awareness of fostrox?
– It is important both for generating interest in the fostrox program among clinical experts and attracting participation in future studies.
– However, perhaps even more critical is highlighting the progress these results represent for patients with limited treatment options. The key priority for liver cancer patients is the development of new treatment alternatives with novel mechanisms of action.
– With the fostrox + Lenvima combination, we are at the forefront of this development, aiming to bring new hope to patients, families, and physicians. This ambition and opportunity will be powerfully conveyed as we present final data from our recently completed study.
