
Its lead candidate, WU-CART-007 (soficabtagene geleucel), is an off-the-shelf, CD7-targeted CAR-T therapy engineered with CRISPR/Cas9 to eliminate CD7 and TRAC, preventing fratricide and minimizing the risk of graft-versus-host disease.Data from a global Phase I/II study showed strong efficacy, with a 91% overall response rate, 73% complete remissions, and a median response duration exceeding six months. Safety was considered manageable, positioning the therapy competitively against current standards of care.
In August 2025, Wugen secured $115 million in equity financing led by Fidelity Management & Research Company, joined by RiverVest, Lightchain, Abingworth, ICG, LYZZ Capital, Tybourne, and Aisling. Proceeds will fund the pivotal T-RRex trial in relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. A BLA submission is targeted for 2027.
WU-CART-007 has received multiple expedited designations, including RMAT, Fast Track, Orphan Drug, Rare Pediatric Disease (U.S.), and PRIME (EU).
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze