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|Landmark First-In-Human Clinical Study Launch Using a Genetically Engineered Natural Killer Cell for the Treatment of Cancer|
The company plans to promptly initiate this trial, which is believed to be the first ever clinical evaluation of a genetically engineered, allogenic, off-the-shelf, natural killer cell for the treatment of patients with cancer.
"We are thrilled to have received notification from the
haNK Cell Therapy Platform
NantKwest's haNK cell therapy platform, developed to be an allogeneic, off-the-shelf therapy, is focused on optimizing the key role that natural killer cells play in mediating innate immunity, enhancing adaptive immune responses, and, specifically in the case of haNK, improving anti-tumor responses via antibody-dependent cell-mediated cytotoxicity (ADCC).
To achieve this objective, haNK cells have been engineered to express IL-2 and the high-affinity variant of the CD16 receptor (V158 FcγRIIIa). In preclinical studies, the addition of haNK to a variety of therapeutic antibodies has led to increased tumor cell killing when compared to the antibody alone. Thus, this first-in-human clinical study is designed to provide the necessary safety data to rapidly transition to haNK-antibody combination trials.
Dr. Soon-Shiong added, "As only about 10% of patients are born with the high affinity CD16 receptor, we believe the potential for haNK cell therapy to improve patient outcomes for the other 90% of the patient population and become part of the standard-of-care for cancer patients is very compelling."
The primary objective of the study is to determine the safety of haNK cell monotherapy administered intravenously once per week in up to 16 patients with metastatic or locally advanced solid tumors. Other objectives include determination of objective response rate, progression-free survival, overall survival, and any correlations between tumor molecular profiles (based on genomics, transcriptomics, and quantitative proteomics) and patient outcomes.
For additional information, including exclusion and inclusion criteria, contact information and other details, please visit www.clinicaltrials.gov, QUILT trial #3.028.
NantKwest's unique NK cell-based platform, with the capacity to grow active killer cells as a biological cancer therapy, has been designed to induce cell death against cancer or infected cells by three different modes of action: (1) Direct killing using activated NK cells (aNK) that release toxic granules directly into the cell through cell to cell contact, (2) Antibody-mediated killing using haNKs, which are NK cells engineered to incorporate a high affinity receptor that binds to an administered antibody, enhancing the cancer cell killing effect of that antibody, and (3) Targeted activated killing using taNKs, which are NK cells engineered to incorporate chimeric antigen receptors (CARs) to target tumor-specific antigens found on the surface of cancer cells.
Our aNK, haNK and taNK platform addresses certain limitations of T cell
therapies including the reduction of risk of serious "cytokine storms"
reported after T cell therapy. As an "off-the-shelf" therapy,
By leveraging an integrated and extensive genomics and transcriptomics
discovery and development engine, together with a pipeline of multiple,
clinical-stage, immuno-oncology programs that include a Phase 2 trial
for a rare form of melanoma and the planned initiation of a clinical
trial of NK cells targeted to breast cancer, we believe