Tango Therapeutics’ IND application for TNG260 receives FDA clearance

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.