Tango Therapeutics a Collaborator of Medivir Has Obtained FDA Clearance to Commence the Phase 1/2 Clinical Study for TNG348
Monday, September 11, 2023
Medivir AB (NASDAQ Stockholm: MVIR), a pharmaceutical company with a focus on innovative cancer treatments addressing significant unmet medical needs, has made an announcement today. The news pertains to Medivir's partner, Tango Therapeutics, which has obtained FDA clearance for its Investigational New Drug (IND) application for TNG348.
TNG348 represents a novel inhibitor targeting USP1 (ubiquitin-specific protease 1) designed for the treatment of cancers characterized by BRCA1/2 mutations and other forms of homologous recombination deficiency (HRD+). HRD+ cancers, which include those with BRCA1/2 mutations, are prevalent in various cancer types, such as ovarian (50%), breast (25%), prostate (10%), and pancreatic (5%) cancers.
Tango Therapeutics is planning to initiate a Phase 1/2 study involving TNG348 in the first half of 2024, assessing its efficacy both as a standalone treatment and in combination with a PARP inhibitor. Notably, preclinical data has indicated a synergistic effect with PARP inhibitors in PARP-naïve models, and TNG348 has demonstrated activity in models resistant to PARP inhibitors. These findings suggest that TNG348 could potentially benefit patients as a monotherapy or in combination with PARP inhibitors.
TNG348 originally stems from Medivir's preclinical USP-1 program, which Tango Therapeutics licensed in 2020. As part of the licensing agreement, Medivir is entitled to receive multiple development and commercial milestone payments, as well as royalties on future sales.
Jens Lindberg, CEO of Medivir, expressed his enthusiasm, stating, "It is very encouraging to see another preclinical molecule developed by Medivir being evaluated in patients. The promising preclinical data generated by Tango Therapeutics has piqued our interest, and we eagerly await the progress of TNG348 in its clinical development.
