Wugen, a clinical-stage biotechnology company based in St. Louis, has announced the closing of a $115 million equity financing round. The investment, led by Fidelity Management & Research Company and joined by a consortium of life sciences investors including RiverVest Venture Partners, Lightchain Capital, Abingworth, ICG, LYZZ Capital, Tybourne Capital Management, and Aisling Capital Management, marks a pivotal moment in Wugen’s journey to bring its innovative CAR-T cell therapy to patients battling aggressive T-cell malignancies.
The funding will be used to advance Wugen’s lead candidate, WU-CART-007—also known by its scientific name, soficabtagene geleucel—through its ongoing pivotal clinical trial, known as T-RRex. This trial is focused on patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). These two rare and difficult-to-treat blood cancers often resist conventional therapies. For these patients, treatment options are limited, and outcomes can be devastating. Wugen’s therapy offers a new path forward.
WU-CART-007 is a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy. Unlike traditional CAR-T treatments, which are custom-made from a patient’s own cells, Wugen’s approach uses healthy donor cells that are genetically engineered to eliminate the risk of contamination and self-targeting—a phenomenon known as fratricide. This “off-the-shelf” model not only simplifies manufacturing and delivery but also makes the therapy more accessible to patients who may not be eligible for autologous CAR-T due to disease burden or logistical constraints.
Compelling clinical data back the promise of WU-CART-007. In a recently completed global Phase 1/2 study, the therapy achieved an overall response rate of 91% and a composite complete remission rate of 73% at the recommended Phase 2 dose. The median duration of response exceeded six months, and the safety profile was considered manageable. These results, presented at the 2024 American Society of Hematology Annual Meeting, significantly outperformed existing standards of care and generated considerable excitement among clinicians and researchers.
With the new funding in place, Wugen is now focused on accelerating the T-RRex trial, engaging with regulatory authorities including the U.S. Food and Drug Administration and the European Medicines Agency, and laying the groundwork for commercial-scale manufacturing. The company anticipates submitting a Biologics License Application in 2027, a milestone that could make WU-CART-007 the first approved off-the-shelf CAR-T therapy for T-cell malignancies.
KEY QUOTES:
“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. 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.”
Kumar Srinivasan, Ph.D., MBA, president and chief executive officer of Wugen
“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. 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.”
Cherry Thomas, M.D., chief medical officer of Wugen
“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. 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.”
Niall O’Donnell, Ph.D., Managing Director at RiverVest
