Pharma Focus America

Tango Therapeutics Commences First Patient Dosing in Phase 1/2 Trial for TNG260 in STK11-Mutant Cancer Patients

Tuesday, July 25, 2023

Tango Therapeutics, a clinical-stage biotechnology company focused on discovering and delivering precision cancer medicines, has announced an important milestone. They have commenced the phase 1/2 trial for their drug candidate, TNG260, in combination with pembrolizumab, to treat patients with STK11-mutant cancers.

The trial is significant as it will be the first to utilize genetic patient selection along with checkpoint inhibitor therapy to address the cancer-specific immune evasion caused by STK11 loss-of-function mutations. STK11-mutant cancers often exhibit resistance to immunotherapy, and TNG260 has been specifically designed to tackle this issue.

During the phase 1/2 trial, the safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of TNG260 will be assessed. The study will include a one-cycle single-agent run-in phase to evaluate the safety and PK of TNG260 before combining it with pembrolizumab. The trial will involve patients with locally advanced or metastatic solid tumors carrying STK11 loss-of-function mutations. These mutations are observed in various cancer types, including non-small cell lung cancer, cervical cancer, carcinoma of unknown primary, breast cancer, and pancreatic cancer.

Preclinical studies have shown that TNG260, a first-in-class inhibitor of the CoREST complex, can reverse the immune evasion effect caused by STK11 loss-of-function mutations. This restoration of sensitivity to anti-PD-1 antibodies has led to complete remissions in a majority of animal models. Furthermore, TNG260 has demonstrated the ability to establish immune memory, preventing tumor re-implantation and regrowth.

TNG260 received Fast Track designation from the U.S. Food and Drug Administration in April 2023 for its potential in combination with an anti-PD-1 antibody to treat patients with previously treated advanced non-small cell lung cancer with STK11-mutations. This designation is intended to expedite the development and review process of the treatment for this specific indication.



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