Our Phase 1/2 first-in-human trial to evaluate TNG908 in patients with MTAP-deleted tumors is being conducted in two parts. The dose escalation phase will evaluate safety, efficacy, pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic cancer of any histology (with the exception of central nervous system tumors) with an MTAP deletion. After determining the optimally-effective dose for TNG908, we will further evaluate safety and efficacy in multiple tumor types in specific cohorts, including malignant peripheral nerve sheath tumor (MPNST – a rare sarcoma), non-small cell lung cancer, mesothelioma, cholangiocarcinoma, and glioblastoma. In parallel, we will enroll a histology-agnostic arm to evaluate all other tumor types with MTAP deletion. Given that MTAP deletion occurs in approximately 10-15% of human cancers, we may open other histology-specific arms based on activity observed in the trial.
The FDA cleared the Investigational New Drug (IND) application for TNG908 in January 2022, and granted Fast Track Designation to TNG908. Additionally, the FDA granted Orphan Drug Designation for the treatment of MPNST with TNG908. Patients are being actively enrolled in the Phase 1/2 clinical trial. We expect to have initial safety and efficacy available in the first half of 2023.