Tango Therapeutics receives clearance from FDA for TNG348

Tango Therapeutics announced that the FDA has cleared the Company’s Investigational New Drug, or IND, application for TNG348, a novel inhibitor of USP1, or ubiquitin-specific protease 1, for the treatment of BRCA1/2 mutant and other HRD+ 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. We plan to initiate the TNG348 clinical trial in the first half of 2024,” said Barbara Weber, President and CEO of Tango Therapeutics. 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. HRD+ cancers, including BRCA1/2 mutations, represent up to 50% of ovarian cancers, 25% of breast cancers, 10% of prostate cancers and 5% of pancreatic cancers.