Wugen Presents Latest Data from First-In-Human Phase 1/2 Trial of WU-CART-007 in Patients with Difficult-to-Treat Blood Cancers at American Society of Hematology Annual Meeting -- Positive trends continue as more patients receive treatment with WU-CART-007 in this study exploring the drug’s potential in improving standard of care -- WU-CART-007 continues to demonstrate favorable tolerability profiles in additional patients with R/R T-ALL/LBL -- Initial evidence of anti-leukemic activity and notable clinical improvement reinforced by composite complete remission rate of 60% at dose levels (DL) 2 and 3
Patients with relapsing or refractory (R/R) T-ALL face grim prognoses, with around 30% of patients failing to respond to first-line standard of care treatments, and for those who do respond, approximately 50% relapse. “For a disease that disproportionately affects younger individuals, the need to find better treatments feels especially urgent,” said Armin Ghobadi, M.D, associate professor of medicine and clinical director of Center for Gene and Cellular Immunotherapy (CGCI) in the Division of Medical Oncology at the Washington University School of Medicine in St. Louis. “It’s encouraging to see positive momentum -- with favorable tolerability and efficacy data continuing to be reported as the study has expanded to include more patients with such difficult-to-treat blood cancers.” “As we at Wugen work diligently to reshape the treatment landscape for patients suffering from diseases with limited treatment options, we believe early results from this study speak to the larger potential of innovative allogeneic cell therapies to enhance the quality of life for patients with more effective and accessible treatments,” said Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. “We look forward to reporting topline Phase 2 results in the coming year, which will mark a pivotal milestone in our commitment to redefining the standard of care for these cancers.” Initial data presented at the European Hematology Association Congress in June 2023 showed that treatment with WU-CART-007 resulted in overall favorable efficacy and tolerability profiles compared to the baseline standard of care. In the latest update, an additional 13 patients were treated with WU-CART-007, which showed clinically acceptable safety profiles and preliminary evidence of anti-leukemic activity, demonstrating a notable clinical improvement. WU-CART-007 remains on track to complete enrollment by the end of this year. Positive and consistent data from the WU-CART-007 Phase 1/2 trial collectively underscore its potential to address unmet medical needs for difficult-to-treat blood cancers as it advances to the next crucial phase of development. These early results suggest that WU-CART-007 may offer a novel and effective therapeutic avenue, providing hope for improved outcomes in a patient population where viable alternatives are scarce. As of Nov. 28, 2023, 25 patients have been dosed with WU-CART-007. Disease burden at baseline consisted of extramedullary only disease (EMD) in 28% (7/25) of patients, and a median bone marrow (BM) blast count of 63.2% (range 5%-95%) in patients with BM disease. Overall, WU-CART-007 demonstrated a manageable safety profile: Most reports of cytokine release syndrome (CRS) were low-grade (84%; 21/25), with the exception of five Grade ≥ 3 report, which were manageable with supportive care. WU-CART-007 showed dose-dependent anti-tumor activity with no responses seen at DL1. In evaluable patients at DL≥ 2 (18/22), the Composite Complete Remission Rate (CRc) in patients was 67%. At the recommended Phase 2 dose (RP2D), the CRc rate was 73%. No patients developed novel anti-HLA antibodies against the donor, and of the 18 patients who were tested, no anti-drug antibodies against the CAR-construct were detected.
Phenotypic analysis revealed in vivo WU-CART-007 cells expressed activation markers (KI67, CD38, HLA-DR) and were largely an effector memory CD45RA+ (EMRA) CM phenotype (CD45RA+, CD197+). ASH meeting information can be found here: https://www.hematology.org/meetings/annual-meeting.
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™ 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.