Wugen Secures $115 Million in New Financing to Advance Off-the-Shelf CAR-T Therapy WU-CART-007

On August 27, Wugen, a universal cell therapy company, announced the completion of a $115 million financing round. This round of financing was participated in by several top-tier investment institutions, and the proceeds will primarily be used to advance the pivotal T-RRex clinical trial of the universal cell therapy WU-CART-007 in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL).

WU-CART-007 (soficabtagene geleucel) is a CD7-targeted, CRISPR gene-edited "off-the-shelf" allogeneic CAR-T cell therapy, with the potential to become the world’s first approved "ready-to-use" CAR-T product for T-cell malignancies. The product utilizes gene-editing technology to knock out its CD7 and T-cell receptor alpha constant (TRAC) genes, effectively preventing self-killing of CAR-T cells and reducing the risk of graft-versus-host disease (GvHD). This therapy is manufactured using T cells derived from healthy donors, avoiding issues such as malignant tumor cell contamination that may occur in autologous CAR-T treatments.

In the completed global Phase I/II clinical trial, WU-CART-007 achieved an overall response rate (ORR) of 91% and a composite complete response rate (CRc) of 73% at the recommended Phase II dose, with a median duration of response exceeding six months and manageable safety. The data, presented at the 2024 American Society of Hematology (ASH) Annual Meeting, demonstrated significantly superior efficacy compared to the current standard of care.

Dr. Kumar Srinivasan, President and CEO of the company, stated that this round of financing comes at a critical stage of the company's development. The company is fully advancing the pivotal clinical study of WU-CART-007 and has set a clear goal to submit its Biologics License Application (BLA) by 2027.

Dr. Cherry Thomas, Chief Medical Officer of the company, stated that WU-CART-007 has demonstrated robust efficacy in patients who have failed multiple lines of treatment, while also offering favorable safety and scalable production advantages, positioning it as a potential first-in-class therapy. Its pivotal T-RRex clinical trial design encompasses both pediatric and adult patients, aiming to provide a potentially curative option for patients who do not respond to current salvage treatments.

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