Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, which in turn is the third leading cause of cancer-related deaths globally. HCC is a very serious condition, as illustrated by the fact that fewer than one in five patients survive five years with current treatments.
Today, patients with HCC are given combination therapy with Tecentriq/Avastin as the first-line standard treatment, but given that so many patients do not respond to treatment, the need for other treatment options is great. However, there are currently no approved alternatives for these patients. It is in this medical vacuum that the Huddinge-based pharmaceutical company Medivir sees that their drug candidate fostrox has the potential to be the first approved treatment.
Achieves 100 times higher concentration in the liver
Medivir's drug candidate Fostrox has orphan drug designation for the treatment of HCC, both in the US and in the EU. Fostrox is the first and only smart chemotherapy under development for HCC. This means that Fostrox has a local, liver-targeted effect that achieves a 100-fold higher concentration of the active drug substance in the liver than is achieved with traditional chemotherapy, with the aim of minimizing the risk of side effects.
The company has achieved this function by coupling the active chemotherapy drug troxacitabine with a prodrug tail that allows fostrox to travel directly to the liver. There, the active substance is released locally and exerts its cell-killing effect selectively on tumor cells, leaving normal liver cells unharmed.
Positive data from phase Ib/IIa study
Medivir is currently conducting a phase Ib/IIa study where fostrox is being tested in combination with the cancer drug Lenvima to offer the world's first approved second-line treatment option for HCC, after current standard first-line treatment has failed. Given the significant medical need, the company believes there is potential for a faster path to approval. At the same time, it sees significant commercial potential in a pharmaceutical market for the treatment of HCC, which by 2028 will be worth approximately USD 2,5 billion annually.
Earlier this fall, all patients in the study had undergone at least two treatment cycles and interim data showed early and sustained improved clinical benefit as well as a good safety and tolerability profile when fostrox is combined with Lenvima.
The company also recently presented interim data from 18 of 21 patients with at least 12 weeks of follow-up, with a 22 percent Overall Response Rate (ORR) and a prolonged median time to progression of approximately five months. This is significantly higher than historical comparisons in second-line HCC. In particular, the data show that the combination treatment improves clinical efficacy while maintaining the tolerability and safety profile, compared to data when Lenvima is given as monotherapy in second-line HCC.
The goal is to obtain accelerated approval from the FDA
Medivir is now working intensively to begin the pivotal Phase IIb study where fostrox is tested in combination with Lenvima, compared to administering Lenvima as monotherapy, with the goal of subsequently applying for accelerated approval in the US.
The company recently held its first so-called Type D meeting with the US Food and Drug Administration. FDA regarding the clinical development plan for fostrox. The response was positive and a final determination of the study design will take place during an upcoming meeting to enable initiation of the study in 2024. The goal is then to apply for and receive accelerated approval in the US in 2027. With this regulatory fast track, the FDA ensures that new drugs with promising safety and efficacy data can reach cancer patients faster. Data from the upcoming phase II study will form the basis for whether or not early regulatory approval can be obtained.
Rights issue of up to approximately SEK 148 million
Between December 7 and 21, Medivir will conduct a rights issue of up to approximately SEK 148 million. The company has received subscription commitments, non-binding letters of intent and guarantee commitments corresponding to approximately 67,65 percent of the rights issue, corresponding to approximately SEK 100 million. Read more here.
The net proceeds of approximately SEK 131,8 million (after deduction of issue costs, which are estimated to amount to approximately SEK 16,2 million) are intended to be used for the following activities:
- Continued follow-up in phase Ib/II of the fostrox study with the goal of generating more and long-term convincing data (approximately 20 percent).
- Accelerate preparations for the pivotal study with Lenvima + fostrox (approximately 15 percent).
- Advance activities to ensure timely launch in various geographies, including the US and Japan, and CMC readiness (approximately 30 percent).
- Advanced partner discussions in Asia (approximately 10 percent).
- General corporate purposes and extension of the company's cash to H1 2025 (approximately 25 percent).
The offer in summary
| Terms & conditions | Each existing ordinary share in Medivir entitles to one (1) subscription right. One (1) subscription right entitles to subscribe for one (1) ordinary share. In addition, investors are offered the opportunity to subscribe for ordinary shares without preferential rights. |
| Subscription period | December 7 – December 21, 2023 |
| Subscription price | 2,65 SEK |
| Issue volume | Up to approximately SEK 148 million |
| Dilution | If the offer is fully subscribed, it will result in a dilution of approximately 49,62 percent of the number of shares in the company. |
Read an interview with the company's CEO Jens Lindberg here: ”Medivir's CEO comments on the ongoing rights issue” (December 7, 2023)
This article has been prepared for marketing purposes and does not constitute a prospectus within the meaning of Regulation (EU) 2017/1129 (the Prospectus Regulation). The full terms and conditions of the rights issue have been set out in a prospectus prepared by Medivir, which was approved by the Swedish Financial Supervisory Authority on 6 December 2023 and published on the same day by the company on (https://www.medivir.se/investerare/foeretraedesemission-2023). The approval of the Swedish Financial Supervisory Authority should not be considered as any kind of endorsement of Medivir or endorsement of the quality of the securities referred to in the prospectus. The prospectus contains a description of the risks and benefits associated with an investment in Medivir and potential investors are advised to read the prospectus in its entirety before making an investment decision.