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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), a pharmaceutical company specializing in innovative cancer treatments, has announced its participation in the Pareto Securities Healthcare Conference on September 19, 2024. CEO Jens Lindberg will present an update on the mature and detailed data from the phase 1b/2a study of fostrox-+ Lenvima® in advanced hepatocellular carcinoma (HCC), which was recently showcased at the ESMO conference.
The presentation will be made available on Medivir's website following the event. This announcement highlights Medivir's commitment to sharing important research findings and engaging with the healthcare investment community.
Medivir AB presented positive, mature data from its ongoing phase 1b/2a study of fostroxacitabine bralpamide (fostrox) + Lenvima® in advanced liver cancer at the ESMO Congress. Key findings include:
- Median time to progression (TTP) of 10.9 months
- Objective response rate (ORR) of 24%
- Median duration of response of 7.0 months
- 19% of patients continuing treatment for over a year
- Longest running patient on treatment for over 2 years
The safety profile remains encouraging, with no unexpected adverse events. Fostrox, an orally-administered, liver-targeted inhibitor of DNA replication, shows promise in improving outcomes for second-line liver cancer patients when combined with Lenvima.
Medivir AB (NASDAQ Stockholm: MVIR) is set to present mature clinical data for its fostrox (fostroxacitabine) and Lenvima® (lenvatinib) combination therapy at the ESMO Congress in Barcelona on September 16, 2024. The presentation will focus on results from a phase 1b/2a study treating advanced hepatocellular carcinoma (HCC) that progressed after immunotherapy. Dr. Hong Jae Chon from CHA Bundang Medical Center in Korea will present the abstract.
Following the presentation, Medivir will host a webcast at 13:45 CET, featuring Dr. Chon and Dr. Pia Baumann, Medivir's CMO, to discuss the data and answer questions. Dr. Chon will also provide context by comparing the results to current second-line clinical practices for liver cancer treatment.
Medivir AB (NASDAQ: MVIR) has announced that updated data from its phase 1b/2a study of fostrox (fostroxacitabine) combined with Lenvima® (lenvatinib) for advanced hepatocellular carcinoma (HCC) will be presented at the ESMO Congress in Barcelona, September 13-17, 2024. The presentation, titled 'Fostrox plus lenvatinib in patients with locally advanced unresectable or metastatic HCC progressed on immunotherapy combinations,' will be given by Dr. Hong Jae Chon from CHA Bundang Medical Center in Korea.
The presentation will provide updated clinical data on safety, tolerability, and efficacy endpoints from the ongoing study. This update is particularly significant as patients have been able to remain on treatment long-term, allowing for a detailed analysis of the treatment's evolving safety profile over time.
Medivir AB (NASDAQ: MVIR) announced a change in the number of shares and votes due to issuing 1,700,000 series C shares and reclassifying 114,587 series C shares to ordinary shares. This change is part of an incentive program approved on May 7, 2024. As of June 28, 2024, Medivir has a total of 114,617,968 shares, comprising 112,167,805 ordinary shares and 2,450,163 series C shares, with a combined total of 112,412,821 votes. Each ordinary share entitles one vote and each series C share entitles one-tenth of a vote.
Medivir announced promising results from its Phase 1b/2a trial of fostrox combined with Lenvima® for treating advanced hepatocellular carcinoma (HCC), a challenging condition with effective treatments. The trial showed a 24% overall response rate (ORR) and a median time to progression (TTP) of 10.8 months, significantly better than the current standard treatments. One patient has continued treatment for 22 months. The data supports fostrox’s selective action on tumor cells without harming normal liver function, indicating a favorable safety profile. These findings were presented at the ESMO GI Cancers Congress in Munich.
Medivir is now proceeding with study feasibility and finalizing protocols to open an Investigational New Drug (IND) application in the US by H2 2024. HCC accounts for over 80% of liver cancer cases globally, with approximately 660,000 new cases annually and a five-year survival rate under 20%.
Medivir AB (NASDAQ: MVIR) has announced the selection of a global CRO partner for its upcoming phase 2b study focused on treating second-line hepatocellular carcinoma (HCC) with fostroxacitabine bralpamide (fostrox) and Lenvima. The study aims to compare the efficacy of fostrox + Lenvima versus Lenvima alone. This global, randomized study follows a supportive Type C interaction with the FDA and will be conducted across the US, EU, and Asia. The initiative intends to identify optimal sites and investigators by early 2025, leveraging high interest from HCC experts. The selected CRO, known for its expertise in oncology and HCC studies, will help ensure the study's successful execution.
Medivir (NASDAQ: MVIR), a pharmaceutical company specializing in oncology, announced its participation at Redeye Growth Day on May 30, 2024. CEO Jens Lindberg will present updated data from the ongoing phase 1b/2a clinical trial of fostroxacitabine bralpamide (fostrox) and future development plans at 09:40 CET. The presentation will be live-streamed and available for replay on the event page and Medivir's website.
Medivir focuses on developing innovative treatments for cancers with high unmet medical needs. Their lead candidate, fostrox, is designed to selectively target liver cancer cells, potentially offering significant patient benefits.
Medivir announced that its licensee, Tango Therapeutics, has discontinued the clinical development of TNG348, a USP1 inhibitor aimed at treating BRCA1/2-mutant and HRD+ cancers, due to toxicity observed in phase 1/2 trials. The program was initially licensed from Medivir in 2020. Despite this setback, Medivir emphasized it remains focused on its lead program, fostroxacitabine bralpamide (fostrox), targeting primary liver cancer. The company is accelerating activities to initiate a pivotal phase 2b study for fostrox, which has the potential to secure market approval for treating HCC patients who fail current first-line treatments, a market projected to be worth $2.5 billion annually by 2028.
Medivir AB (MVIR), a pharmaceutical company focused on developing innovative treatments for cancer, has announced that it will host the Q1 Quarterly Results webcast on April 30 at 10 a.m. CET. The webcast has been brought forward due to Nasdaq Stockholm closing earlier. For more information, contact Magnus Christensen, CFO of Medivir AB, at +46 8 5468 3100 or magnus.christensen@medivir.com.
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