Tango Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for TNG348, a novel inhibitor of USP1 (ubiquitin-specific protease 1), for the treatment of BRCA1/2 mutant and other HRD+ (homologous recombination deficient) cancers. FDA clearance to start the TNG348 phase 1/2 clinical study is an important step in the development of a novel treatment with the potential to treat a substantial number of ovarian, prostate and breast cancers. Preclinical data demonstrate that USP1 inhibition blocks DNA repair with a mechanism distinct from PARP inhibitors and that TNG348 is active in xenografts with both primary and acquired resistance to PARP inhibitors.

Preclinical data further show that USP1 is synergistic with PARP inhibitors in xenograft models naïve to PARPi therapy. These data suggest that TNG348 may benefit patients who have progressed on a PARP inhibitor or be used in combination for patients currently being treated with single agent PARPi therapy." The phase 1/2 clinical trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant and other HRD+ cancers.