Medivir’s recently published Annual Report for 2023 focuses primarily on the drug candidate fostrox. Clinical data shows improved efficacy in patients with advanced primary liver cancer when the drug is combined with Lenvima. The company continues to accelerate clinical development with the aim of establishing fostrox as the first approved treatment for second-line liver cancer. BioStock reached out to the company’s CEO Jens Lindberg for a comment on the past year, and to learn of his expectations for the rest of 2024.

Patients diagnosed with hepatocellular carcinoma (HCC), the primary form of liver cancer, typically present at an advanced stage of the disease. On the positive side, today’s first-line treatment, Tecentriq/Avastin, has improved the outlook for many patients. On the negative side, many patients stop responding to treatment after some time. For these, there are currently no approved treatments available, i.e. – no alternative in the second line. This is concerning as HCC ranks as the third leading cause of cancer-related fatalities worldwide.

Despite this, many pharmaceutical companies continue to focus on the development of more first-line options. One exception is Huddinge-based Medivir, which has seen the potential for its drug candidate fostrox in the second line, where competition is virtually non-existent.

The goal is to establish fostrox – which has orphan drug designation for the treatment of HCC in the US and Europe – as the first approved option for patients where current first-line treatment is ineffective or not tolerated.

Progress during 2023

The safety and tolerability of fostrox is currently being evaluated in a fully-enrolled phase Ib/IIa study in combination with the cancer drug Lenvima. In March last year, the first patient was dosed in the expansion phase. Thanks to the great interest among investigators and patients to participate in the study, patients were recruited quickly. The last patient was included after the summer.

The initial clinical results indicated a favourable tolerability profile with promising tumour management. Subsequent assessments have revealed, among other findings, a complete tumour response and two partial tumour responses in the first six patients.

During the autumn, the company presented more mature data from the 18 patients in phase Ib/IIa who had undergone at least 12 weeks of follow-up. The results continued to show clear patient benefit with the fostrox + Lenvima combination. The year ended with a positive Type D meeting with the US Food and Drug Administration (FDA) regarding the development plan for fostrox before the first data were presented at the ASCO-GI conference in San Francisco. The data showed further clear signs of clinical benefit and improvement, the longer patients remain on treatment.

Based on these promising data, in combination with the unmet medical need in HCC, the ambition is to conduct a phase IIb study to apply for accelerated approval by the FDA and thus a shorter time to market approval.

The CEO comments

In addition to all the clinical progress achieved in 2023, Medivir also carried out a rights issue in late autumn that provided the company with approximately SEK 129 million, followed by a directed share issue of approximately SEK 20 million when we entered 2024.

BioStock reached out to the company’s CEO Jens Lindberg for a retrospective and an update on the current situation.

Jens, what stands out as the most important factors for the continued development of fostrox?

– A couple of things. On the one hand, there is great interest among investigators and patients to participate in our ongoing study. It is clear that fostrox’s unique, liver-directed mechanism of action is seen as an attractive treatment for advanced liver cancer, which creates the conditions for rapid recruitment in our upcoming phase IIb study. The second is of course the promising data we have been able to show with the combination, and above all that, we see a clearly higher proportion of patients who respond to the treatment and that they benefit from the treatment for longer than can be expected from the treatment options available today.

What conclusions do you draw from the fact that patients continue to benefit the longer they are under treatment?

– The fostrox + Lenvima combination is very well tolerated which is particularly important for patients to be able to remain on and benefit from the treatment for as long as possible. Moreover, it also gives a clear hope for patients, that even if this is advanced liver cancer in the second line of treatment, there is potential for patients to have long-term benefits from the treatment.

You have been successful in raising capital despite challenging economic conditions, particularly within the high-risk life science sector. What do you attribute this success to?

– On the one hand, of course, the data we have shown with Fostrox in liver cancer looks so promising, but I also believe that our positioning of fostrox in second-line treatment, where there are currently no approved treatment options, has also had a positive impact. Of course, I hope that those who have chosen to invest in Medivir also do so because they have confidence in Medivir’s management and employees.

What milestones lie ahead in the coming period?

– Firstly, to confirm the study design of the planned phase IIb study with the regulatory authority in the US and our investigators, while we will also choose a CRO partner to conduct the study.

– Another important aspect is the establishment of partnerships with a focus on Asia for the development and commercialisation of fostrox, where we started the work of finding the right partner(s) at the end of 2023.

– Finally, we are very much looking forward to presenting additional data from the ongoing study at a couple of scientific congresses in 2024, given that such a large proportion of patients continue to be on treatment longer than expected and benefit from the combination.

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