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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.
Medivir AB (NASDAQ Stockholm: MVIR) announced a presentation at the AACR Annual Meeting on April 17, 2023, highlighting a poster titled 'A triple combination of fostrox (MIV-818) with immune checkpoint and kinase inhibition shows increased anti-tumor efficacy in vivo.' Fostrox, an orally administered prodrug for liver-targeted therapy, is undergoing a phase 1/2a clinical study for advanced hepatocellular carcinoma (HCC) in combination with Keytruda® and Lenvima®. Data suggests that this triple combination may enhance anti-tumor effects, showing increased tumor infiltration of CD8+ T cells and PD-L1 expression. Medivir aims to address the significant unmet medical need in HCC treatment, as current therapies often fail to provide satisfactory results for many patients.
Medivir AB (NASDAQ Stockholm: MVIR) has announced the availability of its Annual Report for 2022 on its website. The report highlights significant progress in the clinical development of fostrox, a potential first-line treatment for liver cancer, which commenced Phase 2a trials in early 2023. The recruitment rate for this trial was notably high in the latter half of 2022. Additionally, several out-licensed projects are progressing positively and are anticipated to enter clinical development in 2023. The Annual Report encompasses insights into the company's innovative drug development strategy focused on addressing unmet medical needs in cancer treatment.
Medivir AB (Nasdaq Stockholm: MVIR) announced that it will present data on its leading program, fostroxacitabine bralpamide (fostrox), at the American Association for Cancer Research (AACR) Annual Meeting from April 14-19, 2023, in Orlando, USA. The presentation, led by CSO Fredrik Öberg, will cover the anti-tumor effects of fostrox combined with an anti-PD1 antibody and a kinase inhibitor. The study suggests that this combination may enhance tumor antigen presentation and immune response, addressing the significant unmet medical need in treating hepatocellular carcinoma (HCC), which accounts for high cancer mortality rates.
Medivir AB (Nasdaq Stockholm: MVIR) announced the initiation of treatment for the first patient with hepatocellular carcinoma (HCC) in the phase 2a trial of fostroxacitabine bralpamide (fostrox) in combination with Lenvima®.
This trial is part of an ongoing multicenter study aimed at patients with HCC who have not responded to or cannot tolerate existing therapies. Preliminary results from the phase 1b study indicate that fostrox has a favorable safety profile. The recommended dose for the combination with Lenvima® has been established at 30 mg, and the study aims to recruit up to 30 patients across clinics in Great Britain, Spain, and South Korea.
Medivir AB (Nasdaq Stockholm: MVIR) will participate in the Stockholm Corporate Finance Life Science Day on March 9, 2023. CEO Jens Lindberg is set to present the company's ongoing clinical study with fostroxacitabine bralpamide (fostrox) at 08:30 CET. The presentation will be accessible on Medivir's website post-event. Medivir focuses on developing innovative cancer treatments addressing significant unmet medical needs, particularly targeting liver cancer cells to minimize side effects. The company collaborates with partners, including IGM Biosciences (Nasdaq: IGMS), for further drug development.
Medivir AB (MVIR), a pharmaceutical company focused on innovative cancer treatments, announced that Pia Baumann has joined as Chief Medical Officer. She brings extensive oncology experience, previously holding senior roles at AstraZeneca, Takeda, and Incyte. Baumann's expertise will be pivotal as Medivir advances its drug candidate, fostroxacitabine bralpamide (fostrox), into the expansion phase (phase 2a) in combination with Lenvima®. Medivir aims to address high unmet medical needs in cancer therapy, particularly targeting liver cancer cells with minimal side effects.
Medivir AB (Nasdaq Stockholm: MVIR) has successfully completed the initial dose escalation part (phase 1b) of its study on fostroxacitabine bralpamide (fostrox) for hepatocellular carcinoma (HCC) in combination with Lenvima®. Preliminary results indicate a positive safety and tolerability profile, with no dose-limiting toxicity reported. The recommended dose for the phase 2a study has been set at 30 mg. The trial aims to evaluate the efficacy of fostrox in patients unresponsive to first-line treatments. Further recruitment for the phase 2a part will involve up to 30 patients across 14 clinics in the UK, Spain, and South Korea.
Medivir AB (Nasdaq Stockholm: MVIR) announced its participation in the Redeye Fight Cancer Day on
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