On December 12, 2021 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that new preclinical data supporting the safety and efficacy profile of WU-CART-007 for T-cell malignancies (Press release, Wugen, DEC 12, 2021, View Source [SID1234596862]). Further, today’s data highlighted Wugen’s clinical readiness and robust manufacturing process for WU-CART-007. The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for WU-CART-007 and Wugen is preparing for enrollment of a Phase 1/2 clinical trial for relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL) (NCT#04984356).

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WU-CART-007 is an off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy designed to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting.

"Adult and pediatric patients with T-cell malignancies experience high rates of relapse and mortality," said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. "We believe WU-CART-007 is the first off-the-shelf allogeneic CAR-T cell therapy targeting this category of hematological cancers to receive an IND clearance from the FDA, and our program has tremendous potential to address this critical unmet need for patients. Today’s preclinical data validate our approach and support the clinical advancement of WU-CART-007. We look forward to enrolling patients in our Phase 1/2 clinical trial to evaluate WU-CART-007 in R/R T-ALL and LBL."

Key findings reported in the poster include:

Wugen has developed a robust manufacturing process to enable clinical development of WU-CART-007, using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination, and CRISPR/Cas9 gene editing to prevent fratricide and mitigate the risk of GvHD.
WU-CART-007 models primarily a T-cell central memory phenotype with enhanced functionality.
WU-CART-007 exhibits strong CD7-specific anti-tumor activity in vitro and in vivo, with a favorable off-target profile.
Robust pre-clinical data support clinical development of WU-CART-007 in CD7+ hematological malignancies. A Phase 1/2 clinical trial evaluating WU-CART-007 in patients with R/R T-ALL/LBL will open for enrollment in December 2021.