Wugen to Present New Clinical Data for WU-CART-007 and Preclinical Data for WU-NK-101, Two Investigational Allogeneic Cell Therapies for Challenging Hematologic Cancers, at American Society of Hematology Annual Meeting & Exposition

  • 2023.11.02
  • source:Wugen

-- Oral Presentation Highlights Latest Clinical Findings from First Global, In-Human Phase 1/2 Dose-Escalation Study of Anti-CD7 Off-the-Shelf Allogeneic CAR-T Cell Therapy, WU-CART-007, in Hard-to-Treat T-ALL/LBL Patients  

-- Results from Three Pre-Clinical Studies of Allogeneic Memory Natural Killer (NK) Cell Therapy, WU-NK-101, in Acute Myeloid Leukemia (AML) in Oral and Poster Sessions 

ST. LOUIS, MO and SAN DIEGO, CA, Nov. 2, 2023 – Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for the treatment of hematological and solid tumor malignancies, will be presenting four abstracts, now available online, at the American Society of Hematology (ASH) Annual Meeting and Exposition Dec. 9-12.  

In an oral presentation, Armin Ghobadi, M.D., from Washington University in St. Louis, will share data from study WU-CART-007 1001, “A Phase 1/2 dose-escalation and dose-expansion study of the safety and efficacy of anti-CD7 allogeneic CAR-T cells (WU-CART-007) in patients with relapsed or refractory T-cell Acute Lymphoblastic Leukemia (T ALL)/Lymphoblastic Lymphoma (LBL).” 

In a second oral presentation, Sergio Rutella, M.D., Ph.D., from Nottingham University in the U.K. will present pre-clinical findings for WU-NK-101, a cytokine-reprogrammed, expanded, cryopreserved, off-the-shelf, un-engineered memory-like NK cell product derived from peripheral blood mononuclear cells (PBMCs).   

The Wugen oral and poster presentation schedule at ASH is below. The meeting will take place at the Marriott Marquis in San Diego and virtually. Access the full schedule here

Oral Presentations  

Title: Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL) 

Presenter: Armin Ghobadi, M.D., Washington University, St. Louis, MO 

Presentation time/location: Monday, Dec. 11, 10:45 a.m. PT; Room 6CF 

Session: #704, Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas, 10:30 a.m.- 12 p.m. PT 

Title: WU-NK-101 (W-NK), a Memory-like (ML) NK Cell, Intrinsically Overcomes Factors Restricting Adoptive Cell Therapy (ACT) in Acute Myeloid Leukemia (AML) 

Presenter: Sergio Rutella, M.D., Ph.D., Nottingham Trent University, Nottingham, UK 

Presentation time/location: Sunday, Dec. 10; 10:15 a.m. PT; Room 6A  

Session: #703, Cellular Immunotherapies: Basic and Translational: Novel Approaches for Next Generation Cellular Immunotherapies, 9:30-11 a.m. PT 


Poster Presentations 

Title: Adoptively Infused Memory-like Natural Killer Cells Impact Adaptive Immune Responses in Patients with Acute Myeloid Leukemia 

Presenter: Sergio Rutella, M.D., Ph.D., Nottingham Trent University, Nottingham, UK 

Presentation time/location: Monday, Dec. 11; 6-8 p.m. PT; Halls G-H 

Title: WU-NK-101 (W-NK), a Memory-like (ML) NK cell, Naturally Overcomes Tumor Microenvironment (TME) Metabolic Challenges, Retaining Anti-tumor Potency 

Presenter: Nupur Bhatnagar, Ph.D., Metafora Biosystems, Paris, France 

Presentation time/location: Monday, Dec. 11; 6-8 p.m. PT; Halls G-H 

About WU-CART-007 

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered 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. WU-CART-007 is currently being evaluated in a global Phase 1/2 clinical trial for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL). Additional information is available on clinicaltrials.gov, identifier NCT# 04984356. WU-CART-007 has received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration for the treatment of R/R T-ALL/LBL. 

About WU-NK-101 

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness, making it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Wugen is planning to initiate solid tumor studies of WU-NK-101 in combination with cetuximab. Studies of WU-NK-101 to date have shown promising robust in vivo activity in various tumor indications, retention of anti-cancer activity in TME, resistance to immune suppression, and enhanced activity with checkpoint inhibitors. WU-NK-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.  


About the MonetaTM Platform 

Wugen’s proprietary MonetaTM manufacturing platform is a robust, efficient, scalable process to generate off-the-shelf memory natural killer (NK) cell therapies with enhanced anti-tumor functionality. The MonetaTM platform uses cytokine fusion complexes for streamlined and consistent manufacturing, is free of feeder cells for enhanced safety, and integrates cryopreservation to allow convenient dosing options for cancer patients.  

About Wugen  

Wugen, Inc. is a clinical-stage biotechnology company developing the next generation of off-the-shelf memory natural killer (NK) and CAR-T cell therapies for cancer. Wugen is leveraging its proprietary MonetaTM platform and deep genomic engineering expertise to pioneer a new class of memory NK cell therapies to treat hematological and solid tumor malignancies. For more information, please visit www.wugen.com.