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FDA Clears Tango Therapeutics' IND for PRMT5 inhibitor TNG908

NEW YORK – Tango Therapeutics said on Monday that the US Food and Drug Administration cleared its investigational new drug application for its PRMT5 inhibitor TNG908, allowing the company to proceed with a Phase I/II trial.

Tango, based in Cambridge, Massachusetts, expects to begin the trial of TNG908 in the first half of this year. The study will evaluate TNG908 in patients with MTAP-deleted tumors, specifically malignant peripheral nerve sheath tumor, non-small cell lung cancer, mesothelioma, and cholangiocarcinoma. Tango expects to report preliminary safety and efficacy data from this study in the first half of 2023.

In 2022, Tango will also pick drug candidates for clinical development within two programs: one that inhibits an undisclosed synthetic lethal target and another against USP1. The undisclosed synthetic lethal program will involve a drug that reverses the immune evasion of cancer cells with STK11 loss-of-function mutations and has synergistic activity with PD-1 inhibitors. The company is also eyeing BRCA1-mutant breast, ovarian, and prostate cancer as potential indications for its USP1 inhibitor as a single agent and in combination with PARP inhibitors.

Tango hopes to file INDs for the agents advanced within these programs in 2023.

"Last year we achieved a critical milestone, becoming a publicly traded company with a sufficient cash balance that we believe will fund operations into the second half of 2024," Tango CEO Barbara Weber said in a statement. "We are excited to start 2022 with important corporate updates, including recent achievements and anticipated milestones in our research and development programs."

In April, Tango announced it would go public through a merger with special purpose acquisition company BCTG Acquisition. Tango began trading on the Nasdaq under the symbol "TNGX" on Aug. 11, with a total cash position of around $515 million after transactions costs, including approximately $342 million from BCTG's trust account and a private investment from a public equity financing round.