Wugen secures $115M to fast-track first off-the-shelf CAR-T therapy for T-cell cancers

Wugen raised $115M to advance its lead therapy, WU-CART-007, through a pivotal trial targeting FDA approval by 2027.

Why it matters: If approved, WU-CART-007 would be the first off-the-shelf CAR-T therapy for T-cell malignancies, a breakthrough in treating aggressive cancers like relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL), where current CAR-T methods face safety and efficacy hurdles. Unlike many current CAR-T methods, WU-CART-007 targets CD7, common in most T-ALL and T-LBL patients.

Backstory:

• Traditional CAR-T therapies for T-cell cancers risk contamination with cancerous cells or becoming “fratricide”, a self-destructive effect where engineered cells attack themselves.

• Wugen’s solution: Use donor cells and CRISPR to delete the CD7 receptor, making the CAR-T cells resistant to fratricide effects.

• Phase 1/2 trials showed a 91% response rate, prompting Wugen to shift its focus entirely to WU-CART-007.

Big picture: Wugen’s approach could redefine cell therapy for T-cell cancers, a field with high unmet need. Success could pave the way for broader applications, including autoimmune disorders and other hematologic cancers.

What´s next: With Wugen dropping its prior NK cell therapy candidates and betting big on WU-CART-007, the firm will likely target future trials to apply WU-CART-007 for T-cell non-Hodgkin lymphoma, AML, and autoimmune diseases.