Home Interviews Medivir’s CEO: “Fostrox is unique in its kind”

Medivir’s CEO: “Fostrox is unique in its kind”

Medivir’s CEO: “Fostrox is unique in its kind”

25 October, 2024

Medivir’s phase I study, which established clinical proof-of-concept for fostrox as monotherapy in patients with liver cancer, has been published in the Journal of Hepatocellular Carcinoma. The study shows that fostrox is safe and well-tolerated with preliminary anti-tumour activity, confirming that the drug specifically targets cancer cells in the liver while sparing healthy cells. BioStock reached out to CEO Jens Lindberg for a comment.

Medivir is developing fostrox towards the goal of becoming the first approved option after first-line standard treatment for primary liver cancer, hepatocellular carcinoma (HCC) – the most common type of liver cancer and the fastest growing cancer in the US. Despite this, there are no approved treatments after first-line treatment, immunotherapy.

Targeted treatment for liver cancer

Unlike standard chemotherapy, which kills tumour cells and healthy cells inside and outside the liver, fostrox is targeted explicitly at liver cancer cells and is only activated when the drug reaches the liver. This saves healthy liver cells while minimizing side effects in the rest of the body, allowing patients to continue the treatment long-term.

Fostrox is currently in the final stage of an ongoing phase Ib/IIa study in combination with Lenvima, where data was recently presented at the ESMO congress in September. The data indicated a substantially better effect with the combination than would be expected with Lenvima alone. The goal for the upcoming phase IIb study next year is to achieve results that match the promise shown in current data and reach the regulatory shortcuts breakthrough therapy designation and accelerated approval.

Study data published in scientific journal

Medivir has previously conducted a phase Ib monotherapy study with fostrox to establish proof-of-concept, while a phase Ib/IIa combination study in HCC is still ongoing. Results from the ongoing study show promising anti-cancer efficacy with a good safety and tolerability profile.

The completed phase Ia/Ib monotherapy study evaluated the safety and preliminary efficacy of fostrox.

The study confirmed clinical proof-of-concept in the current patient group and that the fostrox liver-directed mechanism selectively induces DNA damage in tumour cells.

Yesterday, Medivir announced that the study had been published in the Journal of Hepatocellular Carcinoma. Read more here.
Commenting, Dr Jeff Evans, Beatson West of Scotland Cancer Centre, one of the study’s clinical investigators, said:

“Primary liver cancer (HCC) has a particularly poor prognosis, and the incidence is projected to increase dramatically, attributed to life style factors such as obesity and fatty liver disease. Despite progress in development of new treatments, there are currently no approved second line treatments in liver cancer post immunotherapy. Fostrox, with its liver-targeted mechanism has, in this first monotherapy study, shown to be safe and tolerable with preliminary anti-tumor activity”, says Dr Jeff Evans, Beatson West of Scotland Cancer Centre, one of the investigators in the study.

Loan facility of SEK 30 million

Medivir plans to initiate a randomised phase IIb study with fostrox + Lenvima in HCC next year, which will require more significant funding. At the end of June, Medivir had just over SEK 126 million in cash and has now also received an additional SEK 30 million loan facility from Linc.
 
The company estimates that existing cash and the loan facility will be sufficient to complete the ongoing phase Ib/IIa combination study and prepare for the upcoming phase IIb study. Various options, including potential agreements and financing to support the development of the phase IIb study, are currently being evaluated.

In a comment to BioStock, CEO Jens Lindberg says:

“The goal of a cancer treatment is to be able to deliver the drug to the tumour and kill tumour cells as targeted as possible while minimizing the impact on healthy cells. We have designed fostrox to achieve this and the study that has now been published confirms that when treating liver cancer with fostrox, we achieve a clear, targeted anti-tumour effect while not affecting healthy cells in the liver. Fostrox is thus unique in its kind as the only liver-directed drug and it has a complementary approach to killing cancer cells compared to all other drugs in 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.

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