U.S. FDA Grants to Wugen’s WU-CART-007 Breakthrough Therapy Designation for Treatment of Relapsed or Refractory T Cell Acute Lymphoblastic Leukemia / T Cell Lymphoblastic Lymphoma

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ST. LOUIS--(BUSINESS WIRE)--Jan 21, 2026--

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.

Regulators granted Wugen this designation following their review of data that included results from the global Phase 1/2 clinical trial evaluating Sofi-cel in patients with R/R T-ALL/LBL.

The pivotal Phase 2 T-RRex study is a single-arm trial designed to evaluate the safety and efficacy of Sofi-cel in patients with R/R T-ALL/LBL.

“The FDA’s Breakthrough Therapy designation underscores the promising clinical data we have generated and the potential for Sofi-cel to make a meaningful difference for patients with Relapsed or Refractory T-ALL/LBL. This recognition enables close collaboration with the FDA to accelerate development and, ultimately, help bring this innovative therapy to patients as quickly as possible,” said Cherry Thomas, M.D., Wugen Chief Medical Officer.

“Our goal is to bring this investigational off-the-shelf allogeneic CAR-T treatment to patients as soon as possible,” said Kumar Srinivasan, Ph.D., M.B.A., Wugen President and Chief Executive Officer. “Receiving Breakthrough Therapy Designation from the FDA is a significant milestone for our company and a testament to the potential of our therapy to address a critical unmet medical need.”

About Breakthrough Therapy Designation

Breakthrough Therapy Designation is intended to expedite the review of drugs for serious or life-threatening conditions. The criteria for designation require preliminary clinical evidence that demonstrates the drug may substantially improve on at least one clinically significant endpoint over available therapy.

A Breakthrough Therapy Designation conveys intensive FDA guidance on an efficient drug development, an organizational commitment involving senior FDA leadership, FDA collaboration to optimize clinical trial design, where scientifically appropriate, including minimizing patient exposure to potentially less effective therapies, and eligibility for rolling review of a marketing application, and eligibility for rolling review and priority review.

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 pivotal trial is available at 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. FDA 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., founded and 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. Soficabtagene Geleucel, manufactured in the United States, targets CD7 and has the potential to be the first approved allogeneic CAR-T therapy for T-cell malignancies.

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CONTACT: Investor Contact:

Mark Lewis

Wugen

[email protected]

314-501-1968

KEYWORD: MISSOURI UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA PHARMACEUTICAL HEALTH

SOURCE: Wugen, Inc

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PUB: 01/21/2026 08:00 AM/DISC: 01/21/2026 08:00 AM

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