Medivir AB announced that its licensee, Tango Therapeutics, has terminated the phase 1/2 clinical trial of TNG348, a novel USP1 inhibitor, 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.
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