Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress

-- WU-CART-007 was well-tolerated in patients with R/R T-ALL/LBL, with low incidence of high-grade CRS and immune-related adverse events --

-- WU-CART-007 demonstrated preliminary evidence of anti-leukemic activity; achieved 57% overall response rate (ORR) at Dose Levels (DL) 2 and 3 --

-- Additional oral presentation for WU-NK-101 highlighted clinical data showcasing the ability of memory natural killer cells to engage the adaptive immune system --

ST. LOUIS & SAN DIEGO--(BUSINESS WIRE)--Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today presented data for its two lead programs, WU-CART-007 and WU-NK-101, in separate presentations at the European Hematology Association (EHA) 2023 Congress, taking place from June 8 – 11, 2023 in Frankfurt, Germany.

“We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen. “T-ALL/LBL are very challenging hematologic cancers. Many children and adults relapse after first line therapy and are left with very limited treatment options thereafter, often leading to high mortality. We are hopeful today’s data can be an early step to advance our goal of harnessing the power of innovative CAR-T cell therapies to address this stark unmet need.”

In a presentation titled “Phase 1/2 Dose-Escalation/Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell in Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma (T-ALL/LBL),” Wugen highlighted:

• As of the January 30, 2023, data cut-off, 12 patients had been enrolled in the dose escalation phase of the study (Dose Levels (DL) 1-3), all of whom received WU-CART-007. Prior to enrollment, all patients had been heavily pretreated, with a median of 5 prior lines of therapy. Disease assessment at baseline (BL) showed extensive disease with high disease burden, median bone marrow (BM) blast count of 61.5% (range 43-85%), and extramedullary disease (EMD) in 67% (8/12) of patients. Nine patients had R/R T-ALL and three patients had R/R T-LBL.
• Overall, WU-CART-007 was well-tolerated across all dose levels.
  • No cases of Graft versus Host Disease (GvHD), prolonged T-cell aplasia, or pancytopenia in the absence of disease were reported. One unrelated dose-limited toxicity (DLT) of encephalopathy, secondary to an intracranial bleed associated with a Rhizomucor infection, was reported.
  • All reports of cytokine release syndrome (CRS) were low-grade, Grade 1 or 2, (86%, 7/8) except for one Grade 3 report which resolved within 72 hours after treatment with tocilizumab, dexamethasone, and low dose vasopressors.
  • One instance of Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), which resolved spontaneously, was reported in a patient at DL3.
• The Objective Response Rate (ORR) in efficacy evaluable patients was 57% overall (4/7), including 2 Complete Responses (CR), 1 morphological leukemia-free state (MLFS), and 1 Partial Response (PR). At the time of the data cut, with a median follow-up of 107 days, the duration of response extending to 86 days had been reported.

In a presentation titled “Adoptively Infused Memory-Like (ML) Natural Killer (NK) Cells Elicit Adaptive Immune Responses in Patients with Acute Myeloid Leukemia (AML),” Wugen highlighted:

• The infusion of ML-NK cells was associated with modulation of the AML tumor microenvironment and engagement of the endogenous adaptive immune response.
• Post-infusion of ML-NK cells, high T-cell infiltration to the tumor site signaled the recruitment of the adaptive immune system and the potential for durable effectiveness in patients with R/R AML.

Additional meeting information can be found at https://ehaweb.org/congress/eha2023-hybrid-congress/eha2023/.

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 that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary Moneta^TM 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) and solid tumors.

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 Moneta^TM 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.