US-based biotechnology company Wugen has completed a $115m equity financing round to fund the company's T-RRex trial of CAR-T therapy, WU-CART-007.
The study focuses on the treatment of relapsed/refractory (r/r) T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T LBL).
The investment round was led by Fidelity Management & Research Company and saw contributions from a consortium of life sciences investors. These include RiverVest Venture Partners, LYZZ Capital, Abingworth, Lightchain Capital, Intermediate Capital Group, Aisling Capital Management, and Tybourne Capital Management.
The financing will support regulatory discussions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), as well as the scaling up of manufacturing processes.
Wugen anticipates submitting a biologics licence application (BLA) in 2027.
Also referred to as soficabtagene geleucel, WU-CART-007 is a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy and is set to potentially become the first approved off-the-shelf CAR-T treatment for T-cell malignancies.
Wugen CEO and president Kumar Srinivasan said: “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.”
Recent data from a global Phase I/II trial showcased WU-CART-007 achieving an overall response rate (ORR) of 91% and a composite complete remission rate(CRc) of 73% at the recommended Phase II dose.
The median duration of response surpassed six months, and the safety profile was found to be manageable.
The FDA has granted WU-CART-007 several designations, including fast track, regenerative medicine advanced therapy (RMAT), rare paediatric disease, and orphan drug designation. The European Union has awarded it the priority medicines (PRIME) scheme designation for the treatment of r/r T-ALL/T-LBL.
In 2023, Wugen dosed the first subject in a Phase I trial of the natural killer cell therapy product WU-NK-101 to treat r/r acute myelogenous leukaemia.
