Wugen’s Allogeneic CAR-T Therapy Sofi-cel Receives FDA Breakthrough Therapy Designation for Relapsed or Refractory T-Cell ALL/LBL

St. Louis, MO — Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf CAR-T cell therapies for hematologic malignancies, announced on January 21 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to WU-CART-007 (soficabtagene geleucel, “Sofi-cel”) for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma (T-ALL/LBL).

Sofi-cel is a potential first-in-class, allogeneic, anti-CD7 CAR-T therapy currently being evaluated in a global pivotal Phase 2 single-arm study (T-RRex) enrolling both pediatric and adult patients with R/R T-ALL/LBL. In parallel, Wugen plans to initiate an exploratory cohort evaluating Sofi-cel in patients with minimal residual disease (MRD).

The Breakthrough Therapy Designation was granted based on FDA review of clinical data from a global Phase 1/2 trial demonstrating promising activity in this high-risk patient population. The designation is intended to expedite development and regulatory review of therapies that may provide substantial improvement over available treatments for serious or life-threatening diseases.

Sofi-cel has previously received multiple regulatory designations, including Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, as well as PRIME designation from the European Medicines Agency for R/R T-ALL/T-LBL.

Sofi-cel is engineered using CRISPR/Cas9 gene editing to delete CD7 and TRAC, preventing CAR-T cell fratricide and reducing the risk of graft-versus-host disease (GvHD). The therapy is manufactured from healthy donor-derived T cells, enabling an off-the-shelf approach and avoiding the risk of malignant cell contamination associated with autologous CAR-T products.

The pivotal T-RRex trial (NCT06514794) is ongoing, evaluating the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL.