-- WU-NK-101 overcomes limitations encountered with other adoptive cell therapies in solid tumors --

-- WU-NK-101 exhibited robust trafficking, intra-tumor infiltration, and persistence in xenograft tumor models which were further enhanced when combined with monoclonal antibodies (mAbs) --

-- WU-NK-101 maintained robust cytotoxicity in the tumor microenvironment (TME), including against primary CRC samples in the “native” TME --

-- WU-NK-101 demonstrated superior anti-tumor efficacy against colorectal cancer (CRC) tumor cell lines in vivo and in vitro compared to cetuximab (Ctx) monotherapy; efficacy was further augmented when deployed in combination --

-- Data support clinical development of WU-NK-101 for CRC and other solid tumor indications --

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 preclinical data on WU-NK-101, the company’s lead memory natural killer (NK) cell therapy product, in combination with cetuximab (Ctx), at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium taking place January 19-21, 2023, in San Francisco, California.

“Our best-in-class memory NK cell platform is uniquely designed to have broad applications across solid and liquid tumors,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.“WU-NK-101 has a unique CIML phenotype with enhanced metabolic fitness/flexibility and decreased susceptibility to immunosuppression—key properties that in combination with these data, build our conviction in the development trajectory for WU-NK-101 as a novel treatment for solid tumor cancers. We plan to initiate a first-in-human study of WU-NK-101 in combination with cetuximab for CRC in addition to SCCHN later this year.”

Today’s presentation highlighted the following:

• WU-NK-101 potency against colorectal cancer (CRC) cells was further enhanced when combined with Ctx in vitro and in vivo, confirming an antibody-dependent cellular cytotoxicity (ADCC) mechanism of action. WU-NK-101 in combination with Ctx showed improved CRC cell killing compared to WU-NK-101 and Ctx monotherapy.
• WU-NK-101 showed robust homing to the TME, which was further improved when combined with monoclonal antibodies (mAbs). Intra-tumor penetration and persistence was also increased when combined with mAb in in vivo models.
• WU-NK-101 displayed enhanced metabolic fitness/flexibility and maintained cytotoxicity within adverse, immunosuppressive tumor microenvironment (TME)-aligned media as compared to conventional NK (cNK) and T-cells. WU-NK-101 cells maintained cytotoxicity in a 3D TME model with native cellular components from primary CRC samples.
• A Phase 1b clinical trial of WU-NK-101 in combination with Ctx for advanced and/or metastatic CRC and advanced and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) is in development.

The details of Wugen’s presentation at ASCO Gastrointestinal Cancers Symposium are as follows:

Title: WU-NK-101, an Enhanced Memory Natural Killer (NK) Cell Therapy, with Cetuximab (Ctx) for the Treatment of Advanced Colorectal Cancer (CRC).

Abstract Number: 170

Session Name: Poster Session C: Cancers of the Colon, Rectum, and Anus

Session Date and Time: Saturday, January 21, 2023 from 9:30 a.m. – 10:55 a.m. ET

Location: On Demand | Level 1, West Hall

Presenting Author: John Muth, Wugen

Additional meeting information can be found at https://conferences.asco.org/gi/attend.

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.

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