# Wugen

> Wugen is a clinical-stage biotechnology company in St. Louis engineering off-the-shelf, allogeneic cell therapies for cancer. Spun out of Washington University in St. Louis in 2018, it builds CRISPR-edited CAR-T cells and cytokine-induced memory NK cells designed to be manufactured once from healthy donors and delivered to many patients. Its lead program, WU-CART-007 (soficabtagene geleucel), is a CD7-targeted allogeneic CAR-T in a pivotal trial for relapsed/refractory T-cell leukemia and lymphoma, carrying FDA Breakthrough Therapy, RMAT, Fast Track, Orphan Drug and Rare Pediatric Disease designations.

- **Founded:** 2018
- **Headquarters:** St. Louis, Missouri, United States
- **Founders:** Matthew Cooper (Co-Founder & Chief Scientific Officer), John F. DiPersio (Scientific Founder (Washington University))
- **Team size:** Approximately 50-100 employees (estimate; not officially disclosed)
- **Products:** WU-CART-007 (soficabtagene geleucel), WU-NK-101, Allogeneic CAR-T platform, MemoryNK platform
- **Notable:** FDA Breakthrough Therapy Designation for WU-CART-007 in R/R T-ALL/T-LBL (January 2026), Stacked regulatory designations for WU-CART-007: RMAT, Fast Track, Orphan Drug, Rare Pediatric Disease and EU PRIME, Selected for the FDA CMC Development and Readiness Pilot (CDRP) Program

## Products & services

- **WU-CART-007 (soficabtagene geleucel)** — Lead program: a CD7-targeted, CRISPR-edited allogeneic CAR-T cell therapy for relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL). In a pivotal Phase 2 trial (T-RRex). CRISPR edits delete CD7 on the therapeutic cells to prevent fratricide and disrupt the TCR to reduce graft-versus-host disease.
- **WU-NK-101** — An off-the-shelf cytokine-induced memory-like (CIML) NK cell therapy in first-in-human Phase 1 for relapsed/refractory acute myeloid leukemia (AML), with solid-tumor potential. Holds FDA Orphan Drug Designation.
- **Allogeneic CAR-T platform** — A donor-derived, gene-edited CAR-T manufacturing platform: cells from young healthy donors are engineered once and used to treat many patients, enabling product homogeneity, faster availability and stockpiled inventory.
- **MemoryNK platform** — A platform producing hyper-functional, long-lasting cytokine-induced memory-like NK cells with enhanced anti-tumor activity, proliferation and metabolic fitness, licensed from Washington University.

## Achievements

- FDA Breakthrough Therapy Designation for WU-CART-007 in R/R T-ALL/T-LBL (January 2026)
- Stacked regulatory designations for WU-CART-007: RMAT, Fast Track, Orphan Drug, Rare Pediatric Disease and EU PRIME
- Selected for the FDA CMC Development and Readiness Pilot (CDRP) Program
- Reported 91% overall response rate and 73% composite complete remission for WU-CART-007 at the recommended Phase 2 dose
- Raised approximately $323M total across Series A, B and C
- First patients dosed in the pivotal global T-RRex trial (March 2025)
- FDA Orphan Drug Designation for WU-NK-101 in AML

## Latest updates

- **2026-01** — FDA grants WU-CART-007 Breakthrough Therapy Designation for relapsed/refractory T-ALL/T-LBL.
- **2025-12** — Presented Phase 1/2 correlative data for WU-CART-007 at ASH 2025.
- **2025-08** — Closed a $115M Series C led by Fidelity to fund the pivotal WU-CART-007 study and a planned 2027 BLA filing.
- **2025-03** — Dosed first patients in the pivotal global Phase 2 T-RRex trial of WU-CART-007.
- **2024-12** — Reported 91% ORR / 73% composite complete remission for WU-CART-007 and preclinical WU-NK-101 data at ASH 2024.
- **2024-06** — Presented Phase 2 data at EHA showing WU-CART-007 surpassing standard of care in T-ALL/LBL.

## Links

- Website: https://wugen.com
- LinkedIn: https://www.linkedin.com/company/wugen
- Twitter/X: https://twitter.com/wugen3

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Profile page: https://yespress.io/wugen
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Last updated: 2026-06-10