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Medivir AB (Nasdaq Stockholm: MVIR) is a pharmaceutical company dedicated to developing innovative treatments for cancer, especially in areas with high unmet medical needs. Medivir's core focus is on creating drugs that address severe medical conditions where existing options are limited or ineffective. Their flagship product is fostroxacitabine bralpamide (fostrox), a smart chemotherapy targeting liver cancer with minimal side effects.

In recent developments, Medivir announced a directed issue of 7,547,170 new ordinary shares to Hallberg Management AB, raising approximately SEK 20 million. This move is aimed at advancing the fostrox development and providing increased financial flexibility. The board expects this strategic partnership to add significant value to the company and its shareholders.

The company's most recent phase 1b/2a study in advanced hepatocellular carcinoma (HCC) showcased promising data at the ASCO GI Symposium. The combination of fostrox and Lenvima was well-tolerated, with continued clinical benefits. This study aligns with Medivir’s strategy to enhance patient outcomes in liver cancer treatment.

Medivir also reported on the clinical pharmacokinetic data of fostrox, highlighting dose linearity and systemic exposure. These findings were shared at the EASL Liver Cancer Summit, underscoring the company’s commitment to scientific rigor and transparency.

Additionally, Medivir's partner Vetbiolix announced positive results from a Proof-of-Concept study in dogs with periodontal disease using VBX-1000 (previously MIV-701). This highlights Medivir’s strategy of leveraging partnerships to expand the clinical utility of its compounds beyond human medicine.

In regulatory achievements, Medivir received Rare Pediatric Disease and Orphan Drug Designations for its cathepsin K inhibitor, MIV-711, aimed at treating Legg-Calvé-Perthes Disease. This designation could significantly accelerate the drug’s development timeline.

The company maintains a robust financial and strategic posture, with a focus on collaborative partnerships to advance its drug candidates. Their lead program, fostrox, is gearing up for a pivotal phase 2b study, with the potential to become the first approved treatment for HCC patients who have progressed on current first-line therapies.

For more information, visit the Medivir website.

Rhea-AI Summary
Medivir AB (MVIR) has announced changes in the number of shares and votes due to rights and directed issues, resulting in a total increase of 56,211,817 ordinary shares. The company now has a total of 112,917,968 shares, with 112,053,218 ordinary shares and 864,750 class C-shares. Each ordinary share entitles to one vote, while each class C-share entitles to one tenth of a vote.
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Medivir AB (MVIR) announces participation at the Redeye Fight Cancer Day, presenting updated data from the ongoing phase 1b/2a clinical study with fostroxacitabine bralpamide (fostrox) focused on liver cancer treatment. The company emphasizes its commitment to addressing high unmet medical needs in cancer therapy, leveraging collaborations and partnerships to drive drug development.
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Medivir AB (MVIR) presents updated data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC) at the ASCO GI Symposium. The data shows that fostrox + Lenvima remains tolerable with no unexpected safety events and continues to improve clinical benefit. The company plans to discuss final study design of the planned phase 2b study with accelerated approval intent.
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Medivir AB (MVIR) has announced a directed issue of 7,547,170 new ordinary shares, resulting in approximately SEK 20 million before issue costs. The right to subscribe for shares in the Directed Issue belongs to Hallberg Management AB, controlled by Anders Hallberg. The subscription price is SEK 2.65 per share. The Directed Issue aims to provide additional capital for the development of the Company's drug candidate fostrox and to strengthen the Company's shareholder base. The board of directors considers it a positive move for the Company and its shareholders, following the completion of the Rights Issue in December 2023.
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Medivir AB (Nasdaq Stockholm: MVIR) announced improved clinical benefit with fostrox + Lenvima in treating advanced hepatocellular carcinoma (HCC). The overall response rate (ORR) increased to 25%, with a median time to progression of 5.1 months and >40% of patients still on treatment. The combination showed a good safety profile, with the longest running patient still on treatment after ~17 months with a sustained partial response. The phase 1b/2a study data will be presented at the ASCO GI Symposium, supporting the initiation of a registrational phase 2b study in second-line HCC in 2024.
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Medivir AB (Nasdaq Stockholm: MVIR) announced the presentation of clinical pharmacokinetic data for fostroxacitabine bralpamide (fostrox) at the EASL Liver Cancer Summit. The data will support regulatory interactions and further development of fostrox in patients with hepatocellular carcinoma (HCC).
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Medivir AB (MVIR) Announces First Patient Dosed with TNG348, a Novel USP1 Inhibitor by Licensee Tango Therapeutics (TNGX) for the Treatment of HRD+ Cancers
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Medivir AB (Nasdaq Stockholm: MVIR) announces improved durable clinical benefit in maturing data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC), measured by local review. Consistent anti-tumor activity, >75% of patients experiencing tumor shrinkage in target lesions, with 80% sustained disease control at 12 weeks. Longest running patient still on treatment after 16 months with sustained partial response. The company plans to initiate a registrational phase 2b study in second-line HCC in 2024. Additional data from the ongoing phase 1b/2a study will be presented at the ASCO Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco, USA.
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Medivir AB (MVIR) has signed an agreement with Lonza for the manufacture of a new GMP campaign of fostrox drug substance for the planned phase 2b to enable study drug availability by the end of 2024. This collaboration aims to ensure maximum momentum in the fostrox development program, with plans for accelerated approval after the planned phase 2b study. Based on promising clinical data for fostrox + Lenvima, the company is moving forward with an intent to initiate phase 2b study with accelerated approval. This development has the potential to become the first approved treatment option for patients that have progressed on the current first line standard of care, addressing high unmet medical need.
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Medivir AB (MVIR) and its partner IGM Biosciences have announced a strategic pipeline prioritization and reduction of workforce to extend cash runway. IGM's DR-5 agonist, aplitabart and birinapant, licensed from Medivir, is impacted. However, Medivir's lead program, fostrox, for the treatment of primary liver cancer, remains unaffected and shows promising results in ongoing clinical studies.
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FAQ

What is Medivir's primary focus?

Medivir focuses on developing innovative treatments for cancer, particularly in areas with high unmet medical needs.

What is fostrox?

Fostroxacitabine bralpamide (fostrox) is a smart chemotherapy designed to selectively treat liver cancer cells with minimal side effects.

What recent financial actions has Medivir taken?

Medivir recently completed a directed issue of 7,547,170 new shares, raising approximately SEK 20 million to advance its drug development programs.

What are Medivir's recent clinical study results?

Recent studies show that the combination of fostrox and Lenvima is well-tolerated and offers continued clinical benefits for advanced hepatocellular carcinoma (HCC).

Who are Medivir's strategic partners?

Medivir collaborates with various partners, including Hallberg Management AB, Vetbiolix, and Tango Therapeutics, to advance its drug development programs.

What regulatory achievements has Medivir recently obtained?

Medivir received Rare Pediatric Disease and Orphan Drug Designations for MIV-711, aimed at treating Legg-Calvé-Perthes Disease.

What is the significance of the directed issue to Hallberg Management AB?

The directed issue provides Medivir with additional capital and strategic partnership, allowing for accelerated development of fostrox and enhanced financial flexibility.

What is the status of Medivir's phase 2b study for fostrox?

Medivir is preparing for a global phase 2b study for fostrox, including a dose run-in period and focusing on Objective Response Rate (ORR) as the primary endpoint.

What other therapeutic areas is Medivir involved in?

Beyond cancer, Medivir collaborates on treatments for veterinary diseases, such as periodontal disease in dogs, through partnerships like the one with Vetbiolix.

Where can I get more information about Medivir's developments?

For more detailed information, visit Medivir's official website at www.medivir.com.

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