Cortex District Member Wugen Receives FDA Breakthrough Designation for T-Cell Therapy

Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational CAR-T cell therapy, Sofi-cel.

Sofi-cel is an investigational, potential first-in-class, allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial (T-RRex) for patients with relapsed or refractory (R/R) T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma (T-ALL/LBL). Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. Sofi-cel previously received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. FDA and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of R/R T-ALL/T-LBL.