Wugen has raised $115 million, tapping a Fidelity-led syndicate to fund its pursuit of FDA approval for the first off-the-shelf CAR-T for T-cell malignancies. A pivotal trial is underway, putting the company on track to seek approval in 2027.
The funding will support T-RRex, an ongoing pivotal trial of WU-CART-007 in relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL). Wugen makes the therapy by engineering donor T cells to target CD7, an antigen expressed in most newly diagnosed T-ALL and T-LBL patients. The biotech reported a 91% response rate in a phase 1/2 trial.
While CAR-T cells have enjoyed successes in B-cell malignancies, efforts to apply the modality to T-cell cancers have run into complications. Making CAR-T cell therapies from a patient’s T cells creates the risk that the drug product will be contaminated with malignant cells. To further complicate matters, CAR-T cells engineered to recognize T-cell antigens can turn on themselves, a problem known as “fratricide.”
WU-CART-007 is designed to overcome the barriers to the treatment of T-cell cancers. Using donor cells eliminates the risk of contamination with malignant cells. To prevent fratricide, Wugen used CRISPR-Cas9 to delete CD7, meaning the CAR-T cells lack the receptor that they target.
St. Louis-based Wugen was focused on the natural killer cell program WU-NK-101 when it raised $172 million in 2021. The biotech started a first-in-human leukemia trial of the candidate in 2023, leading to phase 1 data that researchers said suggested WU-NK-101 could be a best-in-class NK cell therapy.
Yet, WU-CART-007 rose quickly to replace the NK cell therapy as Wugen’s lead asset. The biotech posted phase 1/2 data late in 2023 and reported phase 2 data around the middle of 2024. Before the year drew to a close, Wugen committed to running a pivotal trial. The company said it had dosed the first patients in the pivotal trial in March.
The biotech completed the shift in focus by scrubbing WU-NK-101 from its pipeline. In June, Wugen was still listing WU-NK-101 and another NK cell therapy alongside WU-CART-007 in its pipeline. Today, the NK cell therapies are gone, replaced by an expanded set of indications for WU-CART-007.
Wugen has identified T-cell non-Hodgkin lymphoma, acute myeloid leukemia and autoimmune disorders as other opportunities for WU-CART-007 but is yet to enter the clinic in those settings. The top priority is to deliver data on the cell therapy in T-ALL and T-LBL to support filings for approval in 2027.