Research & Development
Tango Therapeutics gains FDA Clearance for TNG348 phase 1/2 clinical study
11 September 2023 -

Pharmaceutical company Medivir AB (STO: MVIR) announced on Monday that its partner, Tango Therapeutics (NASDAQ:TNGX), a biotechnology company discovering and developing novel medicines targeting cancer, has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug application for TNG348, a novel USP1 (ubiquitin-specific protease 1) inhibitor designed to treat BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers. These HRD+ cancers, which include BRCA1/2 mutations, are prevalent in ovarian (up to 50%), breast (25%), prostate (10%), and pancreatic (5%) cancers.

Tango Therapeutics plans to initiate a phase 1/2 study for TNG348 in the first half of 2024, evaluating both single-agent and combination therapy with a PARP-inhibitor. Promising preclinical data has demonstrated a synergistic effect with PARP inhibitors in PARP-naïve models, and TNG348 has shown activity in models resistant to PARP inhibitors. These findings indicate the potential benefit of TNG348 for patients, either as a standalone treatment or in combination with PARP inhibitors.

TNG348, a USP-1 inhibitor, originated from Medivir's preclinical USP-1 program, which was licensed to Tango Therapeutics in 2020. Under the licensing agreement, Medivir stands to receive multiple development and commercial milestone payments, as well as royalties on future sales.