Policy & Regulation
Tango Therapeutics granted FDA clearance of IND for TNG462
25 January 2023 -

Tango Therapeutics Inc (NASDAQ:TNGX), a clinical-stage biotechnology company, announced on Wednesday that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for TNG462, a next-generation methylthioadenosine-cooperative (MTA) inhibitor of protein arginine methyl transferase 5 (PRMT5) for the treatment of cancers with methylthioadenosine phosphorylase (MTAP) deletion.

The company expects to initiate a Phase 1/2 clinical trial of TNG462 in mid-2023. This trial will involve patients with an MTAP deletion and will evaluate cancers including non-small cell lung cancer, mesothelioma and cholangiocarcinoma.

Tango Therapeutics also reported that the FDA has granted Orphan Drug Designation (ODD) to TNG908 for the treatment of malignant glioma.

TNG908, an MTA-cooperative PRMT5 inhibitor designed to selectively kill cancer cells with MTAP deletions, is currently being evaluated in a Phase 1/2 clinical trial.

TNG462 has the same mechanism of action as TNG908 with enhanced potency and selectivity in MTAP-deleted xenograft models, Tango Therapeutics explained. In preclinical studies, TNG462 is 45X selective for MTAP-deletions (3-fold greater than TNG908) and 20 times more potent than TNG908, which may provide a wider therapeutic index and stronger target inhibition than TNG908.