Q2 marked continued progress for Medivir in advanced liver cancer
At the ESMO GI congress in June, Medivir presented greatly improved results for patients with advanced liver cancer in the ongoing phase Ib/IIa study with fostrox in combination with Lenvima. The company is increasingly optimistic about the possibility of launching the first approved drug treatment after first-line treatment of the disease. This is evident from Medivir’s interim report.
– We are now looking forward to presenting detailed and mature clinical data from the study with fostrox at the ESMO Cancer Congress in Barcelona in September, says CEO Jens Lindberg.
Medivir is developing fostrox for the treatment of primary liver cancer, hepatocellular carcinoma (HCC) – the most common type of liver cancer and the fastest growing cancer in the United States. The goal is for the combination of fostrox and Lenvima to be the first approved option after first-line standard treatment for these patients. The next major milestone for the company will be a phase IIb study, which could start as early as the beginning of next year.
Different from today’s standard treatment
Fostrox is an orally administered, targeted chemotherapy that selectively targets liver cancer cells, while sparing healthy liver cells. This differs from standard chemotherapy, which is given intravenously and kills both tumour cells and healthy cells inside and outside the liver. Thereby minimizing unwanted side effects in other parts of the body.
Positive data presented at ESMI GI
In the recent published interim report for H1, Medivir summarizes an eventful first half of the year. Among other things, the company presented greatly improved clinical data from the phase Ib/IIa study at ESMO GI in Munich. The combination therapy provides a markedly better effect than has previously been shown in second-line liver cancer treatment, including with Lenvima as monotherapy or other treatment options.
More specifically, the treatment is well tolerated over a longer period of treatment, while the clinical effect continues to improve – now with a 24 per cent better effect, which can be compared to 5–10 percent shown in previously published studies in second-line HCC. The most recent measurement in June showed an estimated median time to progression of 10.8 months, which is substantially longer than what other studies in second-line HCC have shown.
»It is tremendously encouraging that the patient in the study who has benefited the longest is still responding to treatment after two years« — CEO Jens Lindberg in the interim report
New data to be presented in September
Strengthened by these positive data, the company continues its preparations for the planned phase IIb study. Part of this work was the so-called Type C meeting held with the FDA in April. Read an interview with Jens Lindberg here where he discusses this topic.
For the phase IIb study, where the combination therapy will be evaluated compared to Lenvima alone, Medivir has selected a global CRO partner with specialist expertise in oncology studies and HCC studies in particular. Feasibility, operational and regulatory study preparations are now awaited, as well as the completion of the study protocol to open an IND in the US, i.e. an application to initiate clinical trials, which is expected this autumn.
The next opportunity to find out more about how the study is progressing is at the ESMO congress in Barcelona on 13–17 September. There, Medivir will present detailed and mature data highlighting the clinical value of the combination in second-line liver cancer.
Other advancements in Medivir’s pipeline
Meanwhile, the company is making progress in preparations for a phase II/III study with the drug candidate MIV-701, later renamed VBX-1000, which is being developed for periodontitis in dogs.
In 2019, Medivir entered into a license agreement for MIV-701 with the French veterinary company Vetbiolix for further development and commercialisation. If the drug reaches the market, the value-creating potential for Medivir lies in future royalty payments on net sales and/or share of partnering payments that Vetbiolix receives in the event of future partnering agreements with VBX-1000. Read more here.
Furthermore, Medivir’s MIV-711 project has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for the treatment of Legg-Calvé-Perthes Disease. The goal is to identify a license partner to drive clinical development forward. Read more here.
Financial position
Following a rights issue carried out in December 2023, Medivir received SEK 129 million before issue costs. For increased financial flexibility, this was followed up with a directed share issue in January 2024 that added an additional SEK 20 million to the coffers, which indicates that the company has strong backing from its largest shareholders.
In this case, the share issue was directed to its fourth largest shareholder, Hallberg Management, a company wholly owned by Anders Hallberg. Hallberg is one of the founders of the fund management company Healthinvest Partners, and who, until January 2024, was a fund manager at Healthinvest Alpha Fund.
The interim report for H1 shows that the company’s cash amounted to SEK 126.7 million at the end of the period, and that cash flow from operating activities amounted to SEK -26.3 million in Q2.
Comments from the CEO
BioStock reached out to Medivir’s CEO Jens Lindberg for a comment on the latest progress and to learn about his expectations for the presentation at the ESMO Cancer Congress in Barcelona in mid-September.
– Fostrox is a unique drug candidate for liver cancer with its tumour-selective effect locally in the liver. The data we presented in June at ESMO GI clearly confirmed that fostrox causes DNA damage and thereby kills cancer cells locally in the liver, with minimal impact on healthy cells.
– The tumour-selective effect in the liver is a strong contributing factor to the fact that fostrox in combination with Lenvima shows a substantially better effect in second-line liver cancer than previously shown in other published studies. These data strengthen our conviction of the potential of fostrox as a valuable treatment option for liver cancer.
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.
