Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG462; Provides Additional Business Updates

TNG908 granted Orphan Drug Designation in U.S. for the treatment of malignant glioma

Excerpt from the Press Release:

BOSTON, Jan. 25, 2023 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for TNG462, a next-generation MTA-cooperative PRMT5 inhibitor for the treatment of patients with MTAP-deleted cancers. The Company also announced that TNG908 was granted Orphan Drug Designation (ODD) for the treatment of malignant glioma and provided additional business highlights.

“The IND clearance for TNG462 is a critical step toward addressing the significant unmet need of patients with MTAP-deleted solid tumors,” said Barbara Weber, M.D., President and Chief Executive Officer of Tango Therapeutics. “By advancing both TNG908 and TNG462 into the clinic, we not only increase our strategic optionality to develop and potentially commercialize a PRMT5 inhibitor, but also maximize the opportunity to help patients with MTAP-deleted cancers given the breadth of potential indications. We look forward to results from these trials to optimize our development plans for these programs.”

Recent Business Highlights

Pipeline Update

TNG462 IND cleared; first-in-human clinical trial initiation expected in mid-2023.

• The U.S. FDA has cleared the 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.

Click the button below to read the entire Press Release:

Continue Reading The Press Release