Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting
Wugen to Present Correlative Data and Long-Term Follow-Up Updates for Off-the-Shelf, Allogeneic CD7-Targeted CAR-T Cell therapy at the 2025 ASH Annual Meeting
— Results from the Phase 1/2 Trial are a Foundation for the Ongoing Pivotal Study of Soficabtagene Geleucel for R/R T-Cell ALL/ LBL in Pediatric and Adult Patients
ST. LOUIS, Mo., Dec. 05, 2025 (GLOBE NEWSWIRE) — Wugen, Inc., a clinical-stage U.S. biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological malignancies, today announced an upcoming scientific presentation of the company’s Phase 1/2 study of WU-CART-007 (Soficabtagene Geleucel “Sofi-cel”). Researchers will present Phase 1/2 correlative data and long-term follow-up update for its investigational cell therapy this week at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 6-9 in Orlando.
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).
In the Phase 1/2 Study, Sofi-cel exhibited over one-hundred-fold expansion following infusion and persisted in circulation for up to three months. The serum cytokine profile was consistent with the mechanism of action. In the Long-Term Follow-Up study, there were no reported late adverse-events of special interest or drug-related serious adverse effects. Three patients who received a successful allogeneic stem cell transplant in the Phase 1/2 study remain alive approximately two years after Sofi-cel infusion, highlighting the promise of this investigational therapy in a challenging patient population.
“The robust cellular pharmacokinetics and long-term survival observed in heavily pretreated patients with R/R T-ALL/LBL in the Phase 1/2 study give confidence in the therapeutic potential of Soficabtagene Geleucel,” said Wugen Chief Medical Officer, Cherry Thomas, M.D. “The T-RRex investigators bring extensive experience in this challenging disease and are committed to delivering meaningful clinical benefit for patients with limited treatment options.”
The pivotal Phase 2 T-RRex study (NCT06514794) is a single-arm trial evaluating the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL. The study is currently enrolling patients aged ≥ 1 year with R/R T-ALL/LBL and will include an exploratory cohort assessing patients with minimal residual disease (MRD)-positive status.
Wugen Presentation at ASH
Presenter: Alexander S. Hamil, Ph.D., Wugen Inc., St. Louis
Presentation type: Poster
Time/location: Sunday, Dec. 7, 6:00-8:00 p.m. ET; OCCC – West Halls B3-B4
Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Poster II
About Soficabtagene Geleucel (Sofi-cel)
Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat T-cell cancers. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T cell receptor alpha constant (TRAC) genes, thereby preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host disease (GvHD). Sofi-cel is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-ALL/T-LBL. More information on the Phase 1/2 trial is available on clinicaltrials.gov, identifier NCT04984356 and on the pivotal trial on clinicaltrials.gov, identifier NCT06514794.
Sofi-cel has received Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration and Priority Medicines (PRIME) Scheme designation in the European Union for the treatment of relapsed or refractory T-ALL/T-LBL. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients in need.
About Wugen
Wugen, Inc., headquartered in St. Louis, Missouri, is a clinical-stage biotechnology company focused on developing next-generation, allogeneic CAR-T cell therapies for cancer. Wugen’s proprietary gene-editing platform is designed to overcome key limitations of first-generation cell therapies, enabling scalable, off-the-shelf treatments with biologics-like cost of goods margins. The lead program, Soficabtagene Geleucel, targets CD7 and has demonstrated best-in-class efficacy in T-ALL/T-LBL, with the potential to be the first approved allogeneic CAR-T therapy for T-cell malignancies.
Investor Contact:
Mark Lewis
Wugen
Mlewis@wugen.com
314-501-1968