Medivir’s CEO: “There is an obvious need for fostrox”
Medivir has gone through an eventful period, marked by the presentation of clinical results at ESMO and a new collaboration agreement with pharmaceutical giant Eisai. The next target is a randomized phase IIb study to enable breakthrough therapy designation and accelerated approval process. CEO Jens Lindberg notes that these recent developments have strengthened fostrox’s potential to become the first approved treatment for second-line liver cancer.
Medivir has designed fostrox to target only tumour cells locally in the liver, without harming healthy cells. The drug candidate is in the final stage of an ongoing phase Ib/IIa study in combination with Eisai’s lenvatinib mesylate (Lenvima).
Promising data presented at ESMO
At the ESMO conference in September, Medivir presented data indicating that the combination is well tolerated and demonstrates promising anti-tumour activity. The results suggest that efficacy is superior to what can be expected with Lenvima alone, with patients tolerating the combination well, enabling them to stay on treatment longer and experience extended benefits.
Watch an interview here with Dr. Pia Baumann, Medivir’s Chief Medical Officer, discussing the promising data from ESMO in Barcelona.
“The median time to progression (TTP) of 10.9 months1 (4.1 – 18.1) is significantly longer than previously seen in second-line liver cancer and the combination shows an Objective Response Rate (ORR) of 24% with a median duration of response of 7.0 months. This should be viewed in relation to the dismal prognosis second-line liver cancer patients generally have, with a treatment response of 5 – 10%, and an expected median TTP of only 3 – 4 months” – Jens Lindberg, CEO
Publication and collaboration
Following the promising clinical Ib/IIa study data, Medivir entered a new collaboration and supply agreement with Eisai. The companies will conduct a randomized phase IIb study comparing fostrox plus lenvatinib to lenvatinib monotherapy as a second-line treatment for HCC. Eisai will supply lenvatinib for the study, while Medivir retains full rights to fostrox. Read more here.
“The commitment from Eisai is a strong validation of the promising data with fostrox + Lenvima presented at ESMO. If Eisai didn’t believe that the combination is likely to show better efficacy than Lenvima alone, they would never commit any resources or time to take it forward. For ethical reasons, a company only will never expose patients to the risk of additional side effects with a new combination unless there is strong belief it adds clinical benefit. We look forward to working with Eisai with the aim of making fostrox + Lenvima the first approved drug therapy in second-line liver cancer – a market worth ~$2.5 billion annually” – Jens Lindberg
During a telephone conference yesterday, CEO Jens Lindberg said that the agreement with Eisai is very advantageous. Eisai is covering the costs of the drug substance—lenvatinib—for the upcoming phase II study. The quantities required would otherwise have cost Medvir at least USD 15 million to purchase and, in addition to promising clinical data, this contributes positively in partnering discussions as it removes the uncertainty of drug supply.
Moreover, in October, Medivir published phase I study results, which demonstrated proof-of-concept for fostrox as monotherapy, in the Journal of Hepatocellular Carcinoma. Read more here: Medivir’s CEO: “Fostrox is unique in its kind”.
Financing through partnerships is prioritized
The recently published Q3 report stated that cash flow from operating activities amounted to -33.4 million SEK in the third quarter, with cash and cash equivalents totaling 92.6 million SEK by the end of the period. CEO Jens Lindberg concludes that current funds are sufficient to complete the ongoing phase IIa combination arm. The SEK 30 million loan facility from Linc, secured in October, will serve as a backup, only be utilized if necessary, with Medivir prioritizing other financing avenues such as equity issues or new partnering agreements.
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