Medivir´s licensee, Tango Therapeutics, has discontinued development of its TNG348 clinical program
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 is advancing its lead program, fostroxacitabine bralpamide, targeting primary liver cancer.
- Fostrox has the potential to become the first approved treatment for HCC patients who do not respond to first-line treatments, addressing a market valued at $2.5 billion annually by 2028.
- Medivir is accelerating critical activities to initiate a pivotal phase 2b study with accelerated approval intent for fostrox.
- Tango Therapeutics discontinued the TNG348 clinical program due to toxicity observed in phase 1/2 trials.
- The discontinuation of TNG348 represents a setback for Medivir, which licensed the program to Tango in 2020.
Insights
The discontinuation of the TNG348 clinical program by Tango Therapeutics is a significant development for Medivir. From a financial perspective, this event reflects a potential setback due to the loss of future milestone payments, licensing fees and potential royalties from a successful TNG348 product. Investors should note that the early phase termination of clinical trials due to toxicity often indicates issues in drug safety that could have broader implications for related drug candidates and the company's overall portfolio.
However, it is also essential to consider Medivir's ongoing efforts with their lead program, fostroxacitabine bralpamide (fostrox). The company's focus on accelerating the pivotal phase 2b study with a potential market value projection of
The termination of the TNG348 clinical trial due to observed toxicity is a notable development. USP1 inhibitors, such as TNG348, are designed to target specific cancer cell vulnerabilities, particularly in BRCA1/2-mutant and other HRD+ cancers. The toxicity issues encountered suggest that the drug’s safety profile is not acceptable at this stage of development, which is a critical consideration for any oncology treatment.
It's worth noting that early-phase clinical trials are designed to identify such safety issues. While disappointing, the data gleaned from these trials are invaluable for guiding future research and development. For Medivir, the focus on fostrox, which is moving into a pivotal phase 2b study, highlights an alternative path forward. Fostrox’s potential to become the first approved treatment for HCC patients who have progressed on current first-line standard of care adds a positive outlook, suggesting that Medivir's pipeline still holds promise despite the setback with TNG348.
The decision to discontinue the TNG348 program presents both risks and opportunities for Medivir. In the immediate term, the news may impact investor sentiment negatively due to the high expectations often placed on novel cancer treatments. Clinical trial outcomes are critical drivers of stock performance in the biotech sector.
Despite this setback, Medivir’s commitment to advancing fostrox into a pivotal phase 2b study reflects an agile strategic approach. The potential market for HCC treatments, valued at approximately
TNG348 is a novel USP1 (ubiquitin-specific protease 1) inhibitor, for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers, and has been developed by Tango from the preclinical USP1 program licensed from Medivir in 2020. At present, Medivir has no additional information than what has been announced in Tango's press release: https://ir.tangotx.com/news-releases/news-release-details/tango-therapeutics-announces-discontinuation-tng348-program
The announcement by Tango Therapeutics has no impact on Medivir's focus and development efforts with its lead program fostroxacitabine bralpamide (fostrox) for the treatment of primary liver cancer (HCC). Medivir continues to maximize the momentum of the fostrox development program as it accelerates a number of critical activities to enable initiation of a pivotal phase 2b study with accelerated approval intent. If successful outcome of the planned study, fostrox has the potential to become the first approved treatment for HCC patients who have progressed on current first-line standard of care, a market valued at
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: magnus.christensen@medivir.com
About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.
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SOURCE Medivir
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