Medivir´s licensee, Tango Therapeutics, has discontinued development of its TNG348 clinical program

Rhea-AI Summary

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.

Positive

• 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.

Negative

• 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.

STOCKHOLM, May 23, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir's licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has announced that the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, is being terminated due to toxicity observed in the initial study cohorts. 

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 ~$2.5bn annually by 2028.

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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https://news.cision.com/medivir/r/medivir-s-licensee--tango-therapeutics--has-discontinued-development-of-its-tng348-clinical-program,c3987012

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https://mb.cision.com/Main/652/3987012/2817873.pdf

Press release (PDF)

View original content:https://www.prnewswire.com/news-releases/medivirs-licensee-tango-therapeutics-has-discontinued-development-of-its-tng348-clinical-program-302154264.html

SOURCE Medivir

FAQ

Why was the TNG348 clinical program discontinued?

The TNG348 clinical program was discontinued due to toxicity observed in the initial phase 1/2 trial study cohorts.

When did Tango Therapeutics announce the discontinuation of TNG348?

Tango Therapeutics announced the discontinuation of TNG348 on May 23, 2024.

What does the discontinuation of TNG348 mean for Medivir?

The discontinuation of TNG348 is a setback for Medivir; however, it does not impact Medivir's focus on its lead program, fostroxacitabine bralpamide.

What is Medivir's next step after the discontinuation of TNG348?

Medivir will continue focusing on advancing its lead program, fostroxacitabine bralpamide, and is planning to initiate a pivotal phase 2b study for the treatment of primary liver cancer.

What is the market potential for Medivir's lead program, fostrox?

Fostrox has the potential to address a market valued at $2.5 billion annually by 2028 for treating HCC patients who have progressed on current first-line treatments.