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Tango Therapeutics to Start Phase I/II Trial of TNG260 in STK11-Mutant Cancers

NEW YORK – Tango Therapeutics said on Monday that it will begin a Phase I/II clinical trial evaluating its investigational TNG260 with Merck's Keytruda (pembrolizumab) as a treatment for cancers harboring STK11 loss-of-function mutations.

The US Food and Drug Administration cleared Tango's investigational new drug application, allowing the Boston-based firm to study TNG260, an agent that inhibits the corepressor of repressor element-1 silencing transcription, or CoREST, complex.

In the Phase I/II trial, Tango will evaluate the treatment combination's safety, pharmacokinetics, pharmacodynamics, and efficacy in patients with locally advanced or metastatic STK11-mutant cancers, including non-small cell lung cancer.

According to Tango, the CoREST complex plays a role in regulating immunomodulatory protein expression in STK11-mutant cancers. In preclinical models, combining TNG260 with Keytruda led to tumor regression and induced immune memory.

"STK11 mutations drive resistance to standard-of-care immunotherapy and are a major challenge in treating many cancers, including non-small cell lung cancer," Tango President and CEO Barbara Weber said in a statement. "We expect that TNG260 will be among the first oncology molecules to leverage the benefits of genetically based patient selection."

Weber added that the firm plans to begin the Phase I/II clinical trial in the second half of 2023.

In January, the FDA also cleared Tango's IND for the investigational agent TNG462, allowing the firm to study it in cancers with MTAP-deletions.