Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG348, a Novel USP1 Inhibitor for the Treatment of BRCA1/2-mutant and Other HRD+ Cancers
- Category: Small Molecules
- Published on Wednesday, 06 September 2023 17:14
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BOSTON, MA, USA I September 06, 2023 I Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today 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. We plan to initiate the TNG348 clinical trial in the first half of 2024,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “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. 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.
About Tango Therapeutics
Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. For more information, please visit www.tangotx.com.
SOURCE: Tango Therapeutics