The FDA has cleared Tango Therapeutics Inc's (NASDAQ:TNGX) Investigational New Drug (IND) application for its lead program, TNG908.
- TNG908 is a synthetic lethal small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) designed to kill cancer cells with a methylthioadenosine phosphorylase (MTAP) deletion.
- MTAP deletions occur in 10% - 15% of all human cancers.
- Tango expects to initiate a Phase 1/2 trial in 1H of 2022, with preliminary safety and efficacy data expected in 1H of 2023.
- Enrollment will be limited to patients with confirmed MTAP-deleted tumors.
- Related: Three Analysts Initiate Coverage On This Newly Listed Precision Oncology Firm.
- The Company is also working on Target 3, an undisclosed synthetic lethal target.
- In animal studies, Target 3 inhibition, combined with an anti-PD1 antibody, resulted in complete regressions and the induction of immune memory against re-implantation of tumors.
- Tango expects to advance a development candidate in the first half of 2022 and file an IND in 2023.
- The Company anticipates advancing a development candidate for their ubiquitin-specific protease 1 (USP1) program in 2H of 2022.
- Price Action: TNGX shares are down 5.96% at $7.81 during the market session on the last check Monday.