On June 3, 2019 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported that the company’s t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial targeting CD19 t-haNK in advanced B-cell lymphoma (Press release, NantKwest, JUN 3, 2019, View Source [SID1234536841]).

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CD19 is a transmembrane protein expressed in B cells and overexpressed in a large percentage of advanced leukemia and lymphoma representing a well validated therapeutic target. The CD19 t-haNK cell therapy is a novel, NK cell based immuno-oncology therapy that includes a CD19-based Chimeric Antigen Receptor (CAR) that has been engineered to create an NK cell that includes the high affinity CD16 (Fc receptor), which enhances an NK cell’s ability to bind and enhance monoclonal antibody activity. Use of a targeted, bi-specific NK cell is intended to enhance the cancer cell killing ability of this novel NK cell therapy.

"Based on extensive and encouraging preclinical results, we have enhanced our ability to modularly combine this proprietary off-the-shelf t-haNK-based therapy with a wide range of monoclonal antibodies using this multi-targeted approach," commented Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. Dr. Soon-Shiong continued, "We are now ready to transition this innovation in NK cell based therapeutics to a Phase I human clinical trials designed to assess the safety, tolerability and efficacy of CD19 t-haNK cell therapy in advanced b-cell lymphoma. Upon completion of the safety phase, NantKwest intends to combine this CD19 t-haNK cell therapy with other synergistic, immunomodulatory agents as part of an integrative, combination therapy approach that we describe as the NANT Cancer Vaccine to further enhance the synergistic effectiveness of this novel therapeutic intervention."

CD19 t-haNK

NantKwest’s CD19-t-haNK cell therapy is designed to provide precise tumor-cell specificity through the use of a CAR construct that utilizes a CD19-specific scFv (single chain antibody fragment) engineered into the company’s proprietary NK cell that includes the CD16 (Fc high affinity receptor).

In pre-clinical studies, cytotoxicity of these GMP-grade, cryopreserved CD19 t-haNK cells were comprehensively evaluated against a panel of cancer cell lines with different levels of CD19 expression in vitro and in vivo, with these studies showing increased activity and selective cytotoxicity towards CD19-expressing tumor cells of various b-cell origins including leukemia.

To better inform routine patient care, these clinical trials will incorporate a state-of-the-art, biomarker analysis using GPS Cancer, which is an integrated, multi-omics, whole genome, transcriptomic platform, both provided by NantHealth, an affiliated company. These comprehensive molecular analysis tools are designed to provide critical information to the clinical study team regarding the unique molecular alterations associated with the patient’s cancer and response rates, potentially enhancing patient management.

Additional information regarding the CD19 t-haNK clinical study can be found at www.nantkwest.com or www.clinicaltrials.gov/.

About NantKwest

NantKwest, a member of the NantWorks ecosystem of companies, is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer and virally induced infectious diseases.