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Overview
Medivir AB (MVIR) is a pharmaceutical company dedicated to the development of innovative treatments for cancer where there is a high unmet medical need, particularly in oncology and precision medicine. With a core focus on liver cancer, Medivir leverages advanced drug design techniques to create targeted therapy options that aim to deliver substantial clinical benefits while minimizing side effects. The company has built a diversified portfolio that spans human oncology and even extends its innovative approach to veterinary medicine, demonstrating its ability to apply scientific expertise across multiple therapeutic areas.
Clinical Programs and Drug Development
Medivir's lead program, featuring fostroxacitabine bralpamide (commonly known as fostrox), represents a novel and strategic approach in the treatment of primary liver cancer. Fostrox is designed as a liver-targeted, orally administered prodrug, which selectively releases its active chemotherapy agent directly within the liver, thereby maximizing tumor cell kill and minimizing damage to healthy tissue. This smart design is underpinned by rigorous clinical trials, including phase 1b/2a studies in advanced hepatocellular carcinoma (HCC) and preparations for an enhanced phase 2b study. The trials have been meticulously designed with endpoints such as the objective response rate (ORR), duration of response, progression-free survival, and overall survival, ensuring that the therapeutic benefits are clearly demonstrated and measurable.
Research and Partnerships
Central to Medivir's business model is the strategic use of collaborations and partnerships. By engaging with leading Contract Research Organizations (CROs), regulatory experts, and international oncology specialists, Medivir enhances the efficiency and precision of its drug development processes. This collaborative strategy has resulted in successful out-licensing endeavors, such as the arrangement with Vetbiolix, which leverages Medivir's innovation in the non-human application of a selective cathepsin-K inhibitor for the treatment of periodontal disease in dogs. Additionally, the company has garnered key regulatory designations for its compounds, including Orphan Drug and Rare Pediatric Disease Designations for the selective cathepsin K inhibitor MIV-711, underscoring its commitment to addressing critical health issues across age groups.
Operational Excellence and Market Position
Medivir's operational strategy focuses on mitigating clinical and financial risks through rigorous trial designs, close regulatory engagement, and a clear path from early-phase proof-of-concept studies to advanced clinical trials. The company’s methodology of combining innovative drug design with strategic partnerships positions it as an informed and agile player within the competitive pharmaceutical landscape. Despite operating in a complex and challenging market, Medivir has built a reputation for scientific expertise and operational integrity, ensuring that each step from preclinical studies to patient trials is transparently documented and scientifically validated.
Strategic Insights and Industry Impact
Through a finely tuned integration of technology, science, and collaboration, Medivir is setting benchmarks in the field of cancer therapeutics. Its focus on liver-targeted chemotherapy is particularly significant given the high mortality rate associated with primary liver cancer and the limited availability of effective second-line treatments. By employing mechanisms that enhance selective tumor targeting, Medivir not only aims to improve patient outcomes but also contributes to the broader evolution of precision oncology. The company's efforts to leverage out-licensing and co-development arrangements further highlight its commitment to optimizing resource allocation and expediting drug development timelines. This strategic focus reinforces Medivir's role in addressing critical gaps in cancer treatment, while also paving the way for future applications in rare pediatric diseases and veterinary medicine.
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.
FAQ
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