– Genetic tumor microenvironment (TME) signature identified as highly predictive of duration of response to cytokine-induced memory-like (CIML) NK cell therapy –

– WU-NK-101 exhibited enhanced anti-tumor activity, robust bone marrow trafficking, and metabolic flexibility –

– Phase 1 clinical study of WU-NK-101 for off-the-shelf treatment of patients with relapsed / refractory AML to begin in 1H2023 –

ST. LOUIS, MO & SAN DIEGO, CA, USA I December 11, 2022 IWugen, 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 on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, at the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10 – 13, 2022 in New Orleans, Louisiana.

“Conventional NK cells (cNK) have proven dysfunctional in the harsh, acute myeloid leukemia (AML) tumor microenvironment (TME), and attempts to improve anti-tumor performance prior to adoptive transfer have proven limited in their success,” said Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Professor of Cancer Immunotherapy at Nottingham Trent University and presenting author. “These data functionally characterizing the anti-tumor properties of WU-NK-101 are highly encouraging and support the potential for WU-NK-101 as a treatment for relapsed/refractory (r/r) AML. Further, the identification of a TME immune signature highly predictive of response may be an impactful tool to support future clinical studies.”

“These data further validate our approach deploying WU-NK-101 for AML,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen. “In early clinical studies, memory NK cells have already demonstrated impressive efficacy against AML. We look forward to building on those promising signals and advancing WU-NK-101 into the clinic as a novel, off-the-shelf therapy for this indication.”

Today’s presentation highlighted the following:

  • An 8-gene TME immune signature showed excellent predictive ability for response to cytokine-induced memory-like (CIML) NK cells in patients with r/r AML. Responders exhibited TME modulation via innate and immune cell presence as well as metabolic re-programming reflected by enhanced glucose and amino acid consumption.
  • Compared to cNK cells, WU-NK-101 had enhanced anti-tumor activity, trafficked to the bone marrow, and showed metabolic flexibility, potentially mitigating the adverse effects of the highly immuno-suppressive AML TME.
  • WU-NK-101 may represent an effective treatment modality for r/r AML. A Phase 1 study evaluating WU-NK-101 in patients with r/r AML is expected to begin enrollment in the first half of 2023.

The details of Wugen’s presentation at ASH are as follows:

Title: Putative Predictors of Response to WU-NK-101, an Allogeneic, Enhanced Memory (ML)
Natural Killer (NK) Cell Therapy Product, for Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Publication Number: 3294
Session Name: 703. Cellular Immunotherapies: Basic and Translational: Poster II
Session Date and Time: Sunday, December 11, 2022 from 6:00 p.m. – 8:00 p.m. CT
Location: Ernest N. Morial Convention Center, Hall D
Presenting Author: Sergio Rutella, M.D., Ph.D., FRCPath, FRSB, Nottingham Trent University

Additional meeting information can be found at https://www.hematology.org/Meetings/Annual-Meeting.

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™ 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 the MonetaPlatform

Wugen’s proprietary Moneta™ platform is a robust, scalable process to manufacture off-the-shelf memory natural killer (NK) cell therapies with enhanced anti-tumor functionality. The Moneta™ 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 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.