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Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG260, a First-in-Class CoREST Inhibitor for the Treatment of STK11-Mutant Cancers
BOSTON, April 03, 2023 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and
About this update from Tango Therapeutics, Inc.
[{"type":"text","content":"BOSTON, April 03, 2023 (GLOBE NEWSWIRE) -- 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 TNG260, a first-in-class inhibitor of the CoREST complex (Co-repressor of Repressor Element-1 Silencing Transcription), for the treatment of STK11-mutant cancers. “FDA clearance of our IND application to initiate the TNG260 phase 1/2 trial is an important milestone in the development of this novel treatment for STK11-mutant cancers. STK11 mutations drive resistance to standard of care immunotherapy and are a major challenge in treating many cancers, including non-small cell lung cancer,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “We expect that TNG260 will be among the first oncology molecules to leverage the benefits of genetically-based patient selection (STK11-mutation) with checkpoint inhibitor therapy. We look forward to initiating the Phase 1/2 clinical trial of TNG260 in the second half of 2023.” STK11 loss-of-function mutations are present in approximately 15% of non-small cell lung cancer (NSCLC), 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers. The Phase 1/2 clinical trial will evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260 in combination with pembrolizumab in patients with locally advanced or metastatic cancer of any solid tumor with an STK11 loss-of-function mutation. The CoREST complex has been shown to play a major role in regulating the expression of immunomodulatory proteins in STK11-mutant cancers. In syngeneic models with an STK11 mutation and an intact immune system, the combination of TNG260 with an anti-PD-1 antibody resulted in sustained complete tumor regressions and the induction of immune memory that prevented re-implantation of the same tumor xenograft. 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 t...