Wugen Secures $115 Million to Advance Pivotal Study of First-in-Class Allogeneic CAR-T Therapy, WU-CART-007

— Financing led by Fidelity Management & Research Company with participation from RiverVest Venture Partners, Lightchain Capital, LYZZ Capital, Abingworth, Intermediate Capital Group (ICG), Tybourne Capital Management, Aisling Capital Management, and other top-tier life sciences investors —

— Proceeds will fund the ongoing pivotal T-RRex trial in relapsed/refractory T-ALL/T-LBL —

— WU-CART-007 achieved 91% overall response rate in global Phase 1/2 trial, substantially outperforming current standard of care —

— BLA filing targeted for 2027; therapy holds potential to be first approved “off-the-shelf” CAR-T for T-cell malignancies —

ST. LOUIS, Mo., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Wugen, Inc., a clinical-stage biotechnology company pioneering the next generation of allogeneic, off-the-shelf CAR-T cell therapies, today announced the closing of $115 million equity financing led by Fidelity Management & Research Company, with participation from RiverVest Venture Partners, Lightchain Capital, Abingworth, ICG, LYZZ Capital, Tybourne Capital Management, Aisling Capital Management, and other leading life sciences investors. The proceeds will advance the ongoing pivotal T-RRex study of WU-CART-007 in relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

WU-CART-007, also known as soficabtagene geleucel, is a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy with potential to be the first approved “off-the-shelf” CAR-T for T-cell malignancies. In a completed global Phase 1/2 study, WU-CART-007 achieved an overall response rate (ORR) of 91% and a composite complete remission (CRc) rate of 73% at the recommended Phase 2 dose. The median duration of response exceeded six months with manageable safety. These data, presented at the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition, substantially surpass the outcomes achieved with current standard-of-care therapies.

“This financing comes at a decisive time for Wugen as we advance WU-CART-007 through our ongoing pivotal study with a clear path to a BLA filing in 2027,” said Kumar Srinivasan, Ph.D., MBA, president, and chief executive officer of Wugen. “Relapsed and refractory T-ALL/T-LBL are aggressive malignancies resistant to current treatment options. We are committed to delivering an accessible, off-the-shelf therapy that can significantly improve the trajectory of patients' care. We are grateful for the support of a world-class syndicate of investors who share our vision of transforming the treatment landscape for T-cell malignancies.”

“WU-CART-007’s robust response in a heavily pretreated patient population—coupled with manageable safety and scalable manufacturing—positions it as a potential first-in-class therapy,” said Cherry Thomas, M.D., chief medical officer of Wugen. “Our pivotal T-RRex trial is designed to evaluate WU-CART-007 in a single study for both pediatric and adult patients, with the goal of offering a potentially curative option where current salvage therapies fail.”

“RiverVest has been impressed by the Wugen team’s efforts advancing WU-CART-007 into this pivotal study, and we are pleased that several of the world’s leading cancer centers are participating,” said Niall O’Donnell, Ph.D., Managing Director at RiverVest. “We are optimistic about Wugen's potential to transform care for patients who currently face poor outcomes and limited treatment options, and we look forward to supporting WU-CART-007’s continued progress.”

Use of Proceeds and Next Steps
Proceeds from this financing will fund the advancement of the pivotal T-RRex trial in patients with relapsed/refractory or minimal residual disease-positive T-ALL/T-LBL, regulatory engagement with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and preparations for commercial-scale manufacturing. The company anticipates a Biologics License Application (BLA) submission in 2027.

About WU-CART-007
WU-CART-007 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). WU-CART-007 is manufactured using healthy donor-derived T cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. WU-CART-007 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.

WU-CART-007 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, WU-CART-007, 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, Ph.D.
Wugen
Mlewis@wugen.com
314-501-1968

Media Contact:
Cory Tromblee
Scient PR
cory@scientpr.com

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