Wugen’s NK Cell Therapy Trial Doses First Patient With AML


The company also reported that WU-NK-101 has received orphan drug designation for treating acute myeloid leukemia from the FDA.

The first patient has been dosed in a first-in-human phase 1 clinical trial (NCT05470140) evaluating Wugen’s WU-NK-101, an investigational allogeneic natural killer (NK) cell therapy, for the treatment of acute myeloid leukemia (AML).1

WU-NK-101, which is manufactured with the company’s Moneta platform, consists of NK cells derived from peripheral blood mononuclear cells with a cytokine-induced memory-like phenotype that Wugen expects will give an advantage in factors including antitumor activity, trafficking, proliferation capacity, and metabolic flexibility. In addition to announcing the clinical trial’s initiation, Wugen simultaneously reported that WU-NK-101 has received orphan drug designation in AML from the FDA.

“The start of this clinical trial is a significant step forward in our memory NK cell program, which we believe offers significant advantages over other NK cell therapy approaches and has the potential to benefit patients with a number of tumor types,” Jan Davidson-Moncada, MD, PhD, the chief medical officer of Wugen, said in a statement.1 “Early clinical studies with memory NK cells demonstrated impressive response rates in patients with AML, even those with a high disease burden. We look forward to building on these data while advancing WU-NK-101 as a readily accessible allogeneic cell product. In tandem, we are proud to announce our Orphan Drug Designation for WU-NK-101, which will enhance our efforts to deliver this therapy to AML patients.”

The global, open-label, dose escalation and expansion trial is seeking to recruit approximately 24 patients in total, including up to 18 patients in the dose escalation portion and 6 additional patients in the cohort expansion portion. Participants will receive WU-NK-101 as 3 separate infusions, administered weekly. The study’s primary end points are the incidence of adverse events and the maximum tolerated dose. The study’s secondary end points are overall survival, duration of response, and overall response rate (ORR).

In addition to AML, Wugen is also seeking to evaluate WU-NK-101 in combination with the monoclonal antibody cetuximab for solid tumor indications. The company noted that in preclinical research, WU-NK-101 has demonstrated in vivo activity in multiple different tumor indications, as well as the ability to maintain anticancer activity in the tumor microenvironment. Resistance to immune suppression and improved activity when used in combination with checkpoint inhibitors were also reported.

“Today’s news represents a significant milestone for Wugen, as WU-NK-101 is the first therapeutic candidate from our memory NK cell platform to enter the clinic,” Kumar Srinivasan, PhD, the president and chief executive officer of Wugen, added to the statement.1 “Beginning in AML, where there remains a high unmet need for new therapeutic options, our goal is to deploy our memory NK cell platform to deliver next-generation, best-in-class allogeneic memory NK cell therapies to transform cancer care, including treatment of solid tumors.”

Wugen’s other lead program besides WU-NK-101 is WU-CART-007, an investigational allogeneic CD7-directed chimeric antigen receptor T-cell (CAR-T) therapy, being evaluated in a phase 1/2 clinical trial (NCT04984356) for the treatment of relapsed/refractory (r/r) T-cell acute lymphoblastic leukemia (T-ALL) and r/r T-cell lymphoblastic lymphoma (LBL).2,3 Preliminary results from the trial were recently presented at the European Hematology Association (EHA) 2023 Congress, held June 8-11, both virtually and in Frankfurt, Germany. Among 7 patients in the trial who were treated at dose level 2 (DL2; 3x108 cells) or DL3 (6x108cells) and evaluable for efficacy as of the January 30, 2023, data cut-off date, the ORR was 57% (n = 4). Two of the 4 patients who responded achieved a complete response, 1 patient achieved a partial response, and 1 patient achieved a morphological leukemia-free state. WU-CART-007 was granted fast track and rare pediatric disease designations by the FDA for r/r T-ALL/LBL in July 2022.4

1. Wugen begins first-in-human phase 1 clinical trial of WU-NK-101, its lead allogeneic memory natural killer (NK) cell therapy for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). News release. Wugen, Inc. August 15, 2023. Accessed August 21, 2023. https://wugen.com/wugen-begins-first-in-human-phase-1-clinical-trial-of-wu-nk-101-its-lead-allogeneic-memory-natural-killer-nk-cell-therapy-for-patients-with-relapsed-or-refractory-r-r-acute-myeloid-leukemia-aml-2/
2. Ghobadi A, Aldoss I, Maude S, et al. P356 Phase 1/2 dose-escalation study of anti-CD7 allogenic CAR-T cell in relapsed or refractory (r/r) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL). Presented at: the European Hematology Association (EHA) 2023 Congress, June 8-11, held both virtually and in Frankfurt, Germany. Abstract #P3562.
3. Wugen presents initial data from first-in-human phase 1/2 trial of WU-CART-007 at the European Hematology Association (EHA) 2023 congress. News release. Wugen, Inc. June 9, 2023. Accessed August 21, 2023.https://wugen.com/wugen-presents-initial-data-from-first-in-human-phase-1-2-trial-of-wu-cart-007-at-the-european-hematology-association-eha-2023-congress/
4. Wugen receives U.S. FDA fast track and rare pediatric disease designations for WU-CART-007 for the treatment of R/R T-ALL/LBL. News release. Wugen. July 19,2022. Accessed August 21, 2023. https://finance.yahoo.com/news/wugen-receives-u-fda-fast-120000746.html
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