Medivir to highlight promising clinical data at EASL
Medivir will present final safety and efficacy data from its phase Ib/IIa liver cancer study of fostrox in combination with Lenvima at the EASL Liver Cancer Summit in Paris, early next year. The data will be shared by Dr. Jeff Evans from the Beatson West of Scotland Cancer Center in Glasgow, UK.
Medivir has developed fostrox, a novel liver-targeted inhibitor of DNA replication designed to selectively deliver its therapeutic effect to tumours while sparing healthy cells. The compound is combined with a prodrug tail that enables oral administration and targeted delivery to the liver, where it is activated.
This mechanism positions fostrox as a first-in-class, orally administered liver-targeted therapy for liver cancer. A prior phase Ib study demonstrated promising anti-cancer efficacy and safety, which paved the way for the recently completed phase Ib/IIa combination study in advanced hepatocellular carcinoma, HCC.
Results from the phase Ib/IIa study
Medivir has consistently highlighted the potential benefits of fostrox, particularly its targeted approach to treating liver cancers. This is supported by robust evidence from its clinical programs.
The phase Ib/IIa clinical study completed in November showed promising outcomes regarding safety and anti-cancer efficacy. Notably, three patients who benefited from the treatment for over 15 months were transitioned to compassionate use after the study closed, ensuring continued access to fostrox. Read more here.
The upcoming clinical study
The company’s efforts to bring fostrox to a wider patient population have gained momentum with the recent IND (Investigational New Drug) approval in the United States. Medivir is now preparing to initiate a randomized phase IIb study to compare the combination of fostrox and Lenvima against Lenvima alone in second-line advanced HCC patients. The trial will be led by Professor Maria Reig, Director of the Barcelona Clinic Liver Cancer group. Read more here.
Presentation at EASL in February
Medivir is now gearing up to present the final safety and efficacy data for fostrox + Lenvima in advanced liver cancer at the European Association for the Study of the Liver (EASL) Liver Cancer Summit in Paris on February 20-22, 2025.
The abstract, titled “Final safety and efficacy results from the phase 1b/2a study of fostrox plus lenvatinib in second/third line patients with advanced hepatocellular carcinoma who progressed on immunotherapy.” will be presented by Dr Jeff Evans, Beatson West of Scotland Cancer Center, Glasgow, UK.
Comment from the CEO
BioStock reached out to Medivir’s CEO Jens Lindberg for a comment.
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.“The acceptance of our data at the EASL Liver Cancer Summit marks a milestone for Medivir and the ongoing development of fostrox. This platform allows us to showcase the potential of our liver-targeted therapy and engage with potential investigators and partners as we prepare for the phase IIb trial. Moreover, the IND approval in the US is crucial as it enables the inclusion of US patients in the study—an essential requirement to qualify for programs like Breakthrough Therapy Designation and Accelerated Approval. All taken together, we are entering a new and exciting phase.”
