Tango Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for TNG260 to treat STK11-mutant cancers.

TNG26 is a first-in-class inhibitor of the CoREST complex (co-repressor of repressor element-1 silencing transcription). It is in preclinical development to reverse immune evasion in STK11 mutated cancers.

Tango Therapeutics president and CEO Dr Barbara Weber said: “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.

“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.”

The safety, pharmacokinetics, pharmacodynamics and efficacy of TNG260, in combination with pembrolizumab, will be assessed in the phase 1/2 clinical study.

The study will cover patients with locally advanced or metastatic cancer, or any solid tumour with an STK11 loss-of-function mutation.

The company stated that the combination of TNG260 with an anti-PD-1 antibody enabled sustained complete tumour regressions in syngeneic models with an STK11 mutation and an intact immune system.

The combination also induced immune memory, which prevented re-implantation of the same tumour xenograft.