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On August 27, Wugen, a clinical biotechnology company dedicated to pioneering the next generation of allogeneic off-the-shelf CAR-T cell therapies, announced the completion of a $115 million equity financing round.Led by Fidelity Management & Research Company,RiverVest Venture Partners, Lightchain Capital, Abingworth, ICG, LYZZ Capital, Tybourne Capital Management, Aisling Capital Management, and other leading life science investors participated in the follow-on investment.Wugen completed a $172 million Series B financing in 2021, and its technology was licensed from Washington University in St. Louis.
The proceeds from this financing will be used to advance the pivotal T-RRex clinical trial of WU-CART-007 in treating relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).Regulatory alignment with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as preparation for commercial production. The company anticipates submitting a Biologics License Application (BLA) in 2027.
WU-CART-007, also known as soficabtagene geleucel, is a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy with the potential to become 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 response rate (CRc) 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, significantly surpassed outcomes achieved with current standard therapies.WU-CART-007 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA), as well as Priority Medicines (PRIME) program eligibility by the European Union, for the treatment of relapsed or refractory T-ALL/T-LBL.Kumar Srinivasan, Ph.D., President and Chief Executive Officer of Wugen, Inc."This financing is a defining moment for Wugen as we advance WU-CART-007 through our ongoing pivotal studies and chart a clear path toward a 2027 BLA submission. Relapsed and refractory T-ALL/T-LBL are aggressive malignancies that are resistant to current treatment options. We are committed to delivering an accessible, off-the-shelf therapy that can significantly improve the care trajectory for patients. We are grateful for the support from a world-class syndicate of investors who share our vision of transforming the treatment landscape for T-cell malignancies."Cherry Thomas, M.D., Chief Medical Officer of Wugen, stated"WU-CART-007 has shown strong performance in a heavily pretreated patient population, combined with controllable safety and scalable manufacturing, making it a potential first-class therapy. Our pivotal T-RRex trial aims to evaluate WU-CART-007 in a single study involving both pediatric and adult patients, with the goal of providing a potential treatment option where current salvage therapies have failed."Reference: Company Announcement
