Medivir’s CEO comments on the latest developments
As Medivir reports its fourth quarter, the company’s focus is on the further improved clinical efficacy of fostrox in combination with Lenvima in liver cancer. After recently having strengthened the cash position by more than 140 million SEK, now the aim is to accelerate the initiation of a pivotal phase IIb study and apply for accelerated approval from the FDA. BioStock reached out to CEO Jens Lindberg for a comment.
The most common form of primary liver cancer, hepatocellular carcinoma (HCC), is a widespread concern, being a significant burden on the patients as well as the healthcare system. Primary liver cancer is the third leading cause of cancer-related deaths. Since most patients are already in an advanced stage of the disease at the time of diagnosis, the treatment must have the desired effect.
Unfortunately, when the first-line standard treatment Tecentriq/Avastin has stopped working, there are no approved alternatives for the second-line treatment.
Low competition in the second line
In other words, the healthcare system is in dire need of new treatment options. Most projects today focus on finding a new best-in-class alternative in the first line. Second-line, on the other hand, increasingly looks like a forgotten population. Swedish Medivir has made the strategic choice to develop its drug candidate fostrox for the second line, where competition is largely absent, as its first indication.
The goal is to become the first regulatory-approved option for patients where current first-line treatment is ineffective or not tolerated. Fostrox is currently being evaluated in a fully recruited phase Ib/IIa study in combination with the cancer drug Lenvima. This combination has so far shown promising clinical efficacy and good tolerability.
Improved clinical benefit
Medivir’s recently released Q4 report focuses on the data presented at the ASCO-GI congress in January, which showed a further increase in the number of patients who have experienced a clinically relevant reduction in their liver tumour and that patients stay on treatment for a long time with interrupted tumour growth. These data also showed that the Overall Response Rate (ORR) increased to 25 per cent, a higher proportion than the 5-10 per cent seen in previous studies within second-line HCC.
Additionally, since these data were presented, the data has improved further, as more than 40 per cent of patients remain on treatment in the study. The median time to progression has increased to 6.3 months, compared to 5.1 months at ASCO GI. The patient who has benefited the longest remains on treatment after 18 months, with a partial response and continued tumour shrinkage.
Moreover, strengthened by two share issues of approximately SEK 140 million in recent months, the development programme has also been accelerated to take fostrox further towards pivotal studies as quickly as possible.
Fostrox has Orphan Drug Designation (ODD) for the treatment of HCC in the US and Europe. Based on this and promising data, in combination with the unmet medical need in HCC, the goal is to obtain accelerated approval by the FDA and thus a shorter time to market.
BioStock reached out to Medivir’s CEO Jens Lindberg for a comment.
Jens, your data continues to improve over time and patients remain on treatment. How was this received at the ASCO-GI Congress?
– With great interest from leading global experts. There are currently no approved treatment options after first-line standard treatment, and very few studies are being conducted to evaluate and develop new drugs for these patients. The fact that fostrox in combination with Lenvima is so well-tolerated in such a difficult-to-treat patient group, and that a majority of patients have lasting disease control with stable or shrinking tumours, is seen as clearly promising. There was also great interest expressed in participating as an investigator in the planned phase IIb study as the combination of fostrox + Lenvima is seen as an attractive treatment option for this patient group.
Your goal is to achieve accelerated approval by regulatory authorities for a shorter time to reach the market. What determines whether you can get one and how have you prepared so far?
– There must be a big unmet medical need for accelerated approval to be realistic, which is the case with second-line HCC where there are no approved alternatives today. The treatment effect also needs to be clear and of a magnitude that is considered clinically relevant. Here, we have had extensive interactions with global experts to even better understand which effect is clinically relevant, and based on that, we have designed the planned phase IIb study. The feedback from the experts was consistent with our early assumptions and confirmed that the effect we see in the ongoing study with fostrox + Lenvima is clinically relevant. Furthermore, they provided valuable input that further strengthened the design of the upcoming study. The next step is for us to take this extensive groundwork to the US regulatory authority that approves drugs, the FDA, to discuss and confirm our plans for the upcoming study. This process has already been initiated and we look forward to a dialogue with the FDA.
How are your discussions with potential partners progressing?
– As mentioned earlier, this work was initiated towards the end of 2023 when the data from the ongoing study was mature enough to show and discuss with potential partners. Right now, we are in the middle of this work with a focus on Asia. Our goal is to establish collaborations and partnerships in 2024 with a focus on both the next phase of development and future commercialisation.
You also have several out-licensed projects. What could these potentially mean in terms of revenue for Medivir?
– These are collaborations with potential upside without additional investments from Medivir. For example, our partner Tango Therapeutics initiated the first clinical study with TNG348, a USP1 inhibitor developed from the preclinical programme they licensed from Medivir, which triggered a milestone payment to Medivir. As TNG348 continues to evolve in BRCAm/HRD+ cancers, the collaboration agreement entitles the company to additional development and sales-related milestone payments as well as royalties on future sales.
– Another example is our partner Infex Therapeutics, which plans to initiate phase I with MET-X, a metallo-beta-lactamase inhibitor developed from the preclinical MBLI programme, licensed from Medivir. Here, the agreement is structured slightly differently. Infex is responsible for the development and Medivir is entitled to a share of the revenues from future commercialisation, out-licensing or other initiatives that generate revenue linked to the MBLI programme.
– In addition to the fostrox programme developing positively, it is gratifying to see two additional preclinical programmes from Medivir being further developed by our partners as they enter the clinical phase.
Also read: Improved clinical data and new shareholder strengthen Medivir (Jan 31, 2024)
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.
