WU-NK-101

P1, N=30, Not yet recruiting, Wugen, Inc. | Phase classification: P1b --> P1 | Initiation date: Nov 2023 --> Jun 2024

Patients were lymphodepleted with fludarabine and cyclophosphamide...Multi-modal analyses of WU-NK-101 highlight unique transcriptional and functional states, which could underpin in vivo potency and persistence. WU-NK-101 are currently being evaluated in a phase 1 study of R/R AML (#NCT05470140).

Overall, W-NK inherently survives and maintains function in the TME, a limiting factor for immune cell-based ACT. These data herald the promise of NK cell therapy; a Phase 1 clinical study of W-NK in acute myeloid leukemia is currently open and enrolling patients (NCT# 05470140).

P1, N=24, Recruiting, Wugen, Inc. | Not yet recruiting --> Recruiting

P1b, N=30, Not yet recruiting, Wugen, Inc. | Initiation date: May 2023 --> Nov 2023

Patients will receive a lymphodepleting chemotherapy regimen (cyclophosphamide 50 mg/kg and fludarabine 125mg/kg) starting on days -6 to -2 prior to receiving WU-NK-101... Response assessment will take place on Day 28 (+/-3 days), by bone marrow aspirate and core biopsy, and response will be defined per 2022 European LeukemiaNet criteria. Response rate, duration of response, and mortality rate at 1 and 3 months will be evaluated. Clinical trial, Cellular therapy, NK cell, Acute myeloid leukemia

ML-NK cell infusion was associated with TME modulation and engagement of the endogenous adaptive immune response. The high T-cell infiltration to the tumor site post-treatment points to the recruitment of the adaptive immune system and signals the potential for durable effectiveness. A phase 1 study of WU-NK-101 in R/R AML is in development (#NCT05470140).

P1, N=24, Not yet recruiting, Wugen, Inc. | Initiation date: Mar 2023 --> Jul 2023

In summary, WU-NK-101 has the potential to reverse primary and acquired mechanisms of ICB resistance. A Phase 1b clinical trial of WU-NK-101 as salvage therapy post-ICB is in development.

P1b, N=30, Not yet recruiting, Wugen, Inc.

P1, N=24, Not yet recruiting, Wugen, Inc. | Initiation date: Dec 2022 --> Mar 2023

Successive cohorts of 3 to 6 patients will be enrolled using a standard 3 + 3 design.Once the maximum tolerated/administered dose is defined, 6 additional patients will be enrolled in the Cohort Expansion Phase to further characterize the safety, tolerability, as well as determine the recommended Phase 2 dose of WU-NK-101.Patients will receive a lymphodepleting chemotherapy regimen (cyclophosphamide 50mg/kg and fludarabine 125mg/kg) starting on days -6 to -2 prior to receiving WU-NK-101...Key exclusions are circulating blast count >30,000/µL by morphology or flow cytometry (cytoreductive therapies such as leukapheresis or hydroxyurea are allowed); uncontrolled or untreated bacterial or viral infections; uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG suggestive of acute ischemia or active conduction system abnormalities; and severe renal impairment.Response assessment will take place on Day 28 (+/-3 days), by bone marrow aspirate and core biopsy, and response will be defined per 2022 European LeukemiaNet criteria. Response rate, duration of response, and mortality rate at 1 and 3 months will be evaluated.

Cytokine-induced memory-like (CIML) NK cells are more potent for anti-tumor responses than conventional NK (cNK) cells, are well tolerated, and active in patients with R/R AML (NCT#01898793) with complete response (CR)/CR with partial/incomplete hematologic recovery rate of 47% and a median DOR of 9.4 months after a single infusion (Berrien-Elliott, et al...Compared to cNK cells, WU-NK-101 had enhanced trafficking to the BM, anti-tumor activity, and a metabolic profile consistent with aerobic glycolysis, potentially contributing to mitigating TME adversity. Due to their resilience to an immunosuppressive TME, WU-NK-101 cells may represent an effective treatment modality for R/R AML; a phase 1 study of WU-NK-101 in R/R AML is in development (NCT #05470140).

P1, N=24, Not yet recruiting, Wugen, Inc.