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 —

 Wugen, Inc., a clinical-stage biotechnology company pioneering the next generation of allogeneic, off-the-shelf CAR-T cell therapies,  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.